PLCO
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Screening for Prostate Cancer in Older Patients (PLCO Screening Trial)

Registry of Trials clinicaltrials.gov
Year 1993
Liens Registry of Trials
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This clinical trial studies whether screening methods used to diagnose cancer of the prostate, lung, colon, rectum, or ovaries can reduce deaths from these cancers. Screening tests may help doctors find cancer cells early and plan better treatment for prostate cancer.

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A randomised study of chest x-ray screening for lung cancer as part of the Prostate, Lung, Colorectal, and Ovarian (PLCO) Trial

Auteurs Kramer BS , Gohagan J , Prorok PC
Journal Lung Cancer
Year 1994
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Satisfaction des patients à dépistage par sigmoïdoscopie flexible.

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Journal Archives of internal medicine
Year 2000
Liens Pubmed DOI
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CONTEXTE: Le dépistage sigmoïdoscopie flexible est une procédure cancer du sous-utilisés de la prévention. Les médecins citent souvent l'inconfort du patient comme une raison pour ne pas demander la sigmoïdoscopie, mais les expériences des patients et les attitudes envers la sigmoïdoscopie n'ont pas été bien étudié. OBJECTIF: Pour mesurer la satisfaction du patient et les déterminants de la satisfaction avec la sigmoïdoscopie de dépistage. Méthodes: Un instrument pour évaluer la satisfaction avec la sigmoïdoscopie de dépistage a été développé. Les réponses ont été évaluées avec une analyse factorielle, testé pour la reproductibilité et la cohérence interne, et validée par rapport à une norme externe. Résultats: Un total de 1221 patients (666 hommes et 555 femmes, âge moyen 61,8 ans) ont été interrogés après la sigmoïdoscopie. Examens ont été effectués par une infirmière praticienne (n = 668), interniste (n = 344), ou un spécialiste gastro-intestinal (n = 184). Plus de 93% des participants étaient d'accord ou d'accord, ils seraient disposés à subir un autre examen, et de 74,9% recommande fortement la procédure à leurs amis. En ce qui concerne la douleur et l'inconfort, 76,2% fortement d'accord ou d'accord que l'examen n'a pas causé beaucoup de douleur, 78,1% ont déclaré qu'il n'avait pas causer beaucoup d'inconfort, et 68,5% pensaient qu'il était plus à l'aise que prévu. Quinze pour cent à 25% des patients ont indiqué qu'ils avaient beaucoup de douleur, une gêne, ou plus d'inconfort que prévu. Les femmes étaient plus susceptibles d'avoir des douleurs importantes ou de l'inconfort que les hommes (odds ratio ajusté: 2,9; intervalle de confiance à 95%, 01.09 à 04.03; P <.001). CONCLUSIONS: Environ 70% des personnes qui subissent une sigmoïdoscopie de dépistage sont satisfaits et de trouver la procédure plus à l'aise que prévu, alors que seulement 15% à 25% à trouver la procédure désagréable. Les médecins ne devraient pas projeter l'inconfort sur les patients comme une raison pour ne pas demander une sigmoïdoscopie de dépistage.

Primary study

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Conception de la prostate, du poumon, colorectal et des ovaires (PLCO) Essai de dépistage du cancer.

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Journal Controlled clinical trials
Year 2000
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Les objectifs de l'essai de la prostate, du poumon, colorectal et des ovaires de dépistage du cancer sont à déterminer dans les âges 55-74 dépistés à l'entrée si le dépistage avec la sigmoïdoscopie flexible (60 cm sigmoïdoscope) peut réduire la mortalité due au cancer colorectal, si le dépistage de la poitrine aux rayons X peut réduire la mortalité par cancer du poumon, si les hommes de dépistage avec un toucher rectal (TR) et du sérum de la prostate-specific antigen (PSA) peut réduire la mortalité par cancer de la prostate, et si le dépistage des femmes avec CA125 et l'échographie transvaginale (TVU) peut réduire la mortalité de l'ovaire le cancer. Les objectifs secondaires sont d'évaluer les variables de contrôle autres que la mortalité pour chacune des interventions, y compris la sensibilité, la spécificité et la valeur prédictive positive; pour évaluer l'incidence, le stade, et la survie des cas de cancer, et d'enquêter sur biologique et / ou des caractérisations pronostiques de tissu tumoral et produits biochimiques comme points intermédiaires. Le design est une étude multicentrique, à deux bras, essai randomisé avec 37.000 femmes et 37.000 hommes dans chacun des deux bras. Dans le groupe d'intervention, les tests de PSA et CA125 sont effectuées à l'entrée, puis annuellement pendant 5 ans. Les DRE, TVU, et à la poitrine examens radiologiques sont effectués à l'entrée et puis chaque année pendant 3 ans. Sigmoïdoscopie est effectué à l'entrée, puis au point de 5 ans. Les participants du groupe témoin suivre leurs pratiques habituelles de soins médicaux. Les participants seront suivis pendant au moins 13 ans à compter de la randomisation afin de connaître tous les cancers de la prostate, du poumon, côlon et du rectum, et de l'ovaire, ainsi que les décès de toutes causes. Une phase pilote a été entrepris pour évaluer la randomisation, le dépistage, et les procédures de collecte de données de l'essai et pour estimer les paramètres de conception tels que le respect et les niveaux de contamination. Ce document décrit l'éligibilité, le consentement, et autres caractéristiques de conception des procédures d'essai, la randomisation et le dépistage, et un aperçu des procédures de suivi. Exemple de calcul de la taille sont signalés, et un plan d'analyse des données est présentée.

Primary study

Unclassified

Large-scale randomized prostate cancer screening trials: program performances in the European Randomized Screening for Prostate Cancer trial and the Prostate, Lung, Colorectal and Ovary cancer trial.

Journal International journal of cancer
Year 2002
Liens Pubmed DOI

Cet article est inclus dans 1 Systematic review Systematic reviews (1 reference)

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Two large-scale randomized screening trials, the Prostate, Lung, Colorectal and Ovary (PLCO) cancer trial in the USA and the European Randomized Screening for Prostate Cancer (ERSPC) trial in Europe are currently under way, aimed at assessing whether screening reduces prostate cancer mortality. Up to the end of 1998, 102,691 men have been randomized to the intervention arm and 115,322 to the control arm (which represents 83% of the target sample size) from 7 European countries and 10 screening centers in the USA. The principal screening method at all centers is determination of serum prostate-specific antigen (PSA). The PLCO trial and some European centers use also digital rectal examination (DRE) as an ancillary screening test. In the core age group (55-69 years), 3,362 of 32,486 men screened (10%) had a serum PSA concentration of 4 ng/ml or greater, which is 1 cut-off for biopsy (performed in 84%). An additional 6% was referred for further assessment based on other criteria, with much less efficiency. Differences in PSA by country are largely attributable to the age structure of the study population. The mean age-specific PSA levels are lower in the PLCO trial (1.64 ng/ml [in the age group 55-59 years], 1.80 [60-64 years] and 2.18 [65-69 years) than in the ERSPC trial (1.28-1.71 [55-59], 1.75-2.87 [60-64] and 2.48-3.06 [65-69 years]). Detection rates at the first screen in the ERSPC trial range from 11 to 42/1,000 men screened and reflect underlying differences in incidence rates and screening procedures. In centers with consent to randomization design, adherence in the screening arm is 91%, but less than half of the men in the target population are enrolled in the trial. In population-based centers in which men were randomized prior to consent, all eligible subjects are enrolled, but only about two-thirds of the men in the intervention arm undergo screening. Considerable progress has been made in both trials. Enrollment will be completed in 2001. A substantial number of early prostate cancers have been detected. The differences between countries seem to reflect both underlying prostate cancer incidence and screening policy. The trials have the power to show definitive results in 2005-2008.

Primary study

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Résultats de la sigmoïdoscopie répétition 3 ans après un examen négatif.

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Journal JAMA : the journal of the American Medical Association
Year 2003
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CONTEXTE: La fréquence nécessaire du dépistage du cancer colorectal endoscopique après un examen négatif est incertaine. OBJECTIF: Examiner le rendement des adénomes et des cancers du côlon distal trouvé par répétition sigmoïdoscopie flexible (FSG) 3 ans après un examen négatif. Schéma, environnement et participants: Les participants ont été tirés de la prostate, du poumon, colorectal, dépistage et à un procès Cancer de l'ovaire (PLCO), une étude randomisée, contrôlée étude communautaire de dépistage du cancer. La moyenne (écart-type) était de 65,7 ans (4,0) ans au début de l'étude (1993-1995) et 61,6% étaient des hommes. Les individus ont subi FSG dépistage au départ et à 3 ans dans le cadre du protocole et ont été renvoyés à leur médecin traitant pour une évaluation approfondie de l'écran des anomalies détectées. Les résultats des évaluations diagnostiques suivantes ont été suivis de façon standardisée. De 11 583 admissibles au dépistage répétition FSG 3 ans après un premier examen négatif, 9.317 (80,4%) ont retourné. Principaux critères de jugement: la détection des polypes ou de masse dans le côlon distal à répétition FSG 3 ans; l'incidence d'adénome ou de cancer du côlon distal à 3 ans d'examen, la détermination de la raison pour la détection (profondeur accrue de l'insertion ou de la préparation à l'amélioration de l'exercice 3 examen ou de détection dans une zone déjà examinés). RÉSULTATS: Un total de 1292 participants qui retournent (13,9%) ont eu un polype ou de masse détectés par FSG 3 ans après l'examen initial. Dans le côlon distal, 3,1% (292/9317) ont été trouvés à avoir un adénome ou de cancer. L'incidence de l'adénome avancé (n = 72) ou un cancer (n = 6) dans le côlon distal a été de 78 (0,8%) de 9317. Parmi les personnes à un stade avancé adénomes distaux détectés à l'examen de 3 ans, 80,6% (58/72) avaient des lésions trouvées dans une partie du côlon qui a été suffisamment examinée lors de la sigmoïdoscopie initiale. CONCLUSIONS: Répétition FSG 3 ans après un examen négatif permet de détecter des adénomes avancés et le cancer du côlon distal. Bien que le pourcentage global des anomalies détectées est modeste, ces données soulèvent des inquiétudes quant à l'impact d'un intervalle de dépistage prolongée après un examen négatif.

Primary study

Unclassified

Un essai randomisé sur les méthodes de recrutement pour les anciens hommes afro-américains dans la prostate, du poumon, colorectal et de l&#39;ovaire (PLCO) de dépistage du cancer de première instance.

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Auteurs Ford ME , Havstad SL , Davis SD
Journal Clinical trials (London, England)
Year 2004
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CONTEXTE: Les taux d&#39;incidence pour de nombreux types de cancer sont plus élevés chez les hommes afro-américains que dans la population générale, mais les hommes africains-américains sont moins susceptibles de participer à des essais de dépistage du cancer. Ce document décrit les résultats d&#39;un essai randomisé (le projet AAMEN) visant à recruter des hommes afro-américains âgés de 55-74 ans pour une prostate, du poumon et colorectal essai de dépistage du cancer. MÉTHODES: Les interventions de recrutement répondent aux quatre types d&#39;obstacles à la participation des essais cliniques: les barrières socioculturelles, les obstacles économiques, les barrières individuelles et les obstacles inhérents à la conception des études. Les sujets ont été randomisés pour recevoir un groupe de contrôle ou de l&#39;un des trois bras d&#39;intervention de plus en plus intensive, qui a utilisé différentes combinaisons de courrier, par téléphone et en personne de recrutement confessionnelles. RÉSULTATS: Sur les 39.432 hommes afro-américains résidant dans la population étudiée définie géographiquement (sud-est du Michigan et le nord de l&#39;Ohio), 17.770 hommes (45%) pourrait être contacté, et 12.400 (31% des 39 432) ont été jugés admissibles à participer. Aucune différence statistiquement significative de l&#39;âge, l&#39;éducation ou le niveau de revenu ont été trouvés entre les participants dans les quatre bras de l&#39;étude. Un rendement significativement plus élevé de scolarisation (3,9%) a été observée chez les plus intensives, groupe d&#39;intervention basé sur l&#39;église, par rapport aux rendements effectifs dans les deux autres bras d&#39;intervention (2,5 et 2,8%) ou le groupe témoin (2,9%) (P &lt; 0,01). CONCLUSIONS: L&#39;intervention qui a impliqué le plus haut taux de contact en face-à-face avec les participants à l&#39;étude a produit le rendement le plus élevé de scolarisation, mais plusieurs stratégies que l&#39;on croyait pourrait améliorer le rendement n&#39;a eu aucun effet. Ces résultats, qui sont conformes avec la littérature actuelle sur le recrutement basée sur la population, devrait faciliter le développement des efforts de recrutement à venir impliquant des hommes afro-américains âgés.

Primary study

Unclassified

Baseline radiographie pulmonaire pour la détection du cancer du poumon dans le randomisée de la prostate, du poumon, colorectal et essai de dépistage du cancer de l'ovaire.

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Journal Journal of the National Cancer Institute
Year 2005
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CONTEXTE: la prostate, du poumon, colorectal et ovarien essai de dépistage du cancer (PLCO) a été lancé en 1992 pour examiner les causes spécifiques réduction de la mortalité de dépistage de ces quatre cancers chez les hommes et les femmes. Nous rapportons pulmonaires résultats de détection du cancer de l'examen de dépistage de base. MÉTHODES: Parmi les 154 942 participants inscrits, qui étaient âgés de 55-74 ans sans antécédents de cancers PLCO, 77 465 ont été randomisés pour le groupe d'intervention. Les fumeurs actuels ou anciens et les personnes n'ayant jamais fumé dans cette branche ont reçu une première vue unique radiographie thoracique postéro-antérieure. RÉSULTATS: Dans l'écran initial, 5991 (8,9%, 95% intervalle de confiance [IC] = 8,7% à 9,2%) des radiographies étaient suspectes de cancer du poumon: 8,2% (IC = de 7,9% à 8,5% à 95%) pour les femmes et 9,6% (IC = 9,3% à 10,0% à 95%) pour les hommes. Les taux étaient plus élevés pour les groupes plus âgés et pour les fumeurs. Parmi les 5991 participants avec un dépistage positif, 206 (3,4%, IC = 3,0% à 3,9% à 95%) ont subi l'examen biopsie, 126 (61,2%, IC = 54,5% à 67,8% à 95%) d'entre eux ont été diagnostiqués avec un cancer du poumon dans les 12 mois de l'écran (59 femmes et 67 hommes). La valeur prédictive positive était de 2,1% (IC = 1,7% à 2,5% à 95%), et 1,9 cancers du poumon ont été détectés pour 1000 écrans. Parmi ces cancers, 44% (IC = 35% à 52% à 95%) étaient au stade du cancer du poumon non à petites cellules I. Les taux élevés de cancer du poumon ont été trouvés chez les fumeurs actuels (6,3 pour 1000 écrans) et chez les anciens fumeurs qui avaient fumé au cours des 15 dernières années (4,9 pour 1000 écrans). Le taux de détection du cancer du poumon chez les non-fumeurs était de 0,4 pour 1000 écrans, ce groupe représentait 11% (IC = 5,6% à 16,6% à 95%) des cancers identifiés. CONCLUSIONS: Dans l'écran de base, près de la moitié des cancers étaient I. stade si cette expérience se traduit par une réduction de la mortalité par cancer du poumon est encore à voir.

Primary study

Unclassified

Sigmoïdoscopie flexible dans l'essai PLCO dépistage du cancer: résultats de l'examen de dépistage de base d'un essai randomisé.

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Journal Journal of the National Cancer Institute
Year 2005
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CONTEXTE: La prostate, du poumon, colorectal et de l'ovaire (PLCO) essai de dépistage du cancer est un essai clinique randomisé pour évaluer l'efficacité du dépistage du cancer, y compris l'effet du dépistage sur la mortalité sigmoïdoscopie flexible cancer colorectal. Nous rapportons ici les résultats de l'examen initial de dépistage sigmoïdoscopie flexible. Méthodes: L'analyse comprenait 77.465 hommes et femmes âgés de 55-74 ans qui ont été inscrits dans 10 centres de dépistage. Le procès administré des questionnaires de base des facteurs de risque, offert 60 cm examens sigmoïdoscopie flexible, appelé les patients atteints d'écran polypes colorectaux détectés ou des masses aux médecins personnels, et suivi des sujets ayant des polypes ou des masses pour déterminer les résultats du suivi diagnostique. Cochran-Mantel-Haenszel et la régression logistique ont été utilisés pour tester les différences dans les proportions selon le sexe et l'âge. RÉSULTATS: Un total de 64 658 sujets (83,5%) ont subi une sigmoïdoscopie souple dépistage et au moins un polype ou de masse a été identifiée dans 15150 sujets (23,4%). Parmi ceux-ci, 74,2% ont reçu un suivi plus faibles des procédures endoscopiques. Suivi endoscopie digestive basse est plus fréquente chez les sujets avec plus au moins un (> ou = 0,5 cm) polype ou de masse (86,0% [intervalle de confiance à 95% {IC} = 84,6% à 87,4%] et 81,0% [IC 95% = 79,8% à 82,2%] chez les femmes et les hommes, respectivement) que chez ceux avec un plus petit (<0,5 cm) polype ou de masse (69,1% [IC 95% = 67,5% à 70,6%] et 65,4% [IC 95% = 64,1% à 66,7%] chez les femmes et les hommes, respectivement). Les rendements pour 1000 blindé, selon le groupe d'âge de 5 ans, ont été les suivants: pour le cancer colorectal, 1.1 à 2.5 2.4 à 5.6 chez les femmes et chez les hommes, car avancée adénome, de 18,0 à 30,4 chez les femmes et de 36,1 à 49,1 chez les hommes; et pour le cancer colorectal ou de tout adénome, 50,6 à 79,6 chez les femmes et chez les hommes de 101,9 à 128,6. Environ 77% (130/169) des patients étaient adénocarcinome colorectal de stade I ou II au moment du diagnostic. CONCLUSIONS: acceptation du dépistage sigmoïdoscopie flexible est élevé. Suivi diagnostique varie en fonction de la taille des polypes, mais les taux de détection du cancer ou d'adénome répondu aux attentes.

Primary study

Unclassified

Résultats de mortalité d'un essai de dépistage de la prostate-cancer randomisée.

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Journal The New England journal of medicine
Year 2009
Liens Pubmed DOI PubMed Central
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CONTEXTE: L'effet du dépistage de la prostate-spécifique de l'antigène (APS) et le toucher rectal sur le taux de décès par cancer de la prostate est inconnue. C'est le premier rapport de la prostate, du poumon, colorectal, et de l'ovaire (PLCO) Essai de dépistage du cancer de la prostate sur la mortalité par cancer. Méthodes: De 1993 à 2001, nous avons assignés au hasard 76,693 hommes à 10 centres d'étude aux États-Unis pour recevoir soit un dépistage annuel (38,343 sujets) ou les soins habituels comme le contrôle (38,350 sujets). Les hommes du groupe de dépistage ont été offerts annuelle test de l'APS pendant 6 ans et le toucher rectal pour 4 ans. Les sujets et les fournisseurs de soins de santé a reçu les résultats et a décidé sur le type de suivi-évaluation. Le traitement habituel parfois inclus le dépistage, comme certaines organisations ont recommandé. Les numéros de tous les cancers et les décès et les causes de la mort ont été constatées. RÉSULTATS: Dans le groupe dépistage, les taux de conformité était de 85% pour le test PSA et 86% pour le toucher rectal. Les taux de dépistage dans le groupe contrôle a augmenté de 40% la première année à 52% la sixième année pour le dosage du PSA et à distance de 41 à 46% pour le toucher rectal. Après 7 ans de suivi, l'incidence du cancer de la prostate par 10.000 années-personnes était de 116 (2820 cancers) dans le groupe dépistage et 95 (2322 cancers) dans le groupe contrôle (ratio des taux, 1,22, intervalle de confiance 95% [IC ], 1.16 à 1.29). L'incidence de la mort pour 10.000 années-personnes était de 2,0 (50 décès) dans le groupe dépistage et de 1,7 (44 décès) dans le groupe contrôle (ratio des taux, 1,13, IC 95%, 0,75 à 1,70). Les données à 10 ans étaient 67% complète et conforme à ces conclusions générales. CONCLUSIONS: Après 7 à 10 ans de suivi, le taux de décès par cancer de la prostate était très bas et ne différait pas significativement entre les deux groupes d'étude. (Nombre ClinicalTrials.gov, NCT00002540.)

Primary study

Unclassified

Cumulative incidence of false-positive results in repeated, multimodal cancer screening

Journal Annals of family medicine
Year 2009
Liens Pubmed DOI PubMed Central
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PURPOSE: Multiple cancer screening tests have been advocated for the general population; however, clinicians and patients are not always well-informed of screening burdens. We sought to determine the cumulative risk of a false-positive screening result and the resulting risk of a diagnostic procedure for an individual participating in a multimodal cancer screening program. METHODS: Data were analyzed from the intervention arm of the ongoing Prostate, Lung, Colorectal, and Ovarian (PLCO) Cancer Screening Trial, a randomized controlled trial to determine the effects of prostate, lung, colorectal, and ovarian cancer screening on disease-specific mortality. The 68,436 participants, aged 55 to 74 years, were randomized to screening or usual care. Women received serial serum tests to detect cancer antigen 125 (CA-125), transvaginal sonograms, posteroanterior-view chest radiographs, and flexible sigmoidoscopies. Men received serial chest radiographs, flexible sigmoidoscopies, digital rectal examinations, and serum prostate-specific antigen tests. Fourteen screening examinations for each sex were possible during the 3-year screening period. RESULTS: After 14 tests, the cumulative risk of having at least 1 false-positive screening test is 60.4% (95% CI, 59.8%-61.0%) for men, and 48.8% (95% CI, 48.1%-49.4%) for women. The cumulative risk after 14 tests of undergoing an invasive diagnostic procedure prompted by a false-positive test is 28.5% (CI, 27.8%-29.3%) for men and 22.1% (95% CI, 21.4%-22.7%) for women. CONCLUSIONS: For an individual in a multimodal cancer screening trial, the risk of a false-positive finding is about 50% or greater by the 14th test. Physicians should educate patients about the likelihood of false positives and resulting diagnostic interventions when counseling about cancer screening.

Primary study

Unclassified

Assessing contamination and compliance in the prostate component of the Prostate, Lung, Colorectal, and Ovarian (PLCO) Cancer Screening Trial.

Journal Clinical trials (London, England)
Year 2010
Liens Pubmed DOI https://www.embase.com/search/results?subaction=viewrecord&id=L359343516&from=export
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Background Recently, the Prostate, Lung, Colorectal, and Ovarian (PLCO) Cancer Screening Trial published 7-year complete prostate cancer mortality results, which showed no benefit of screening with prostate specific antigen (PSA) and digital rectal examination (DRE). An issue of concern was the substantial level of contamination, or use of PSA and DRE in control arm men. Purpose To provide a detailed description of contamination in PLCO. Methods Surveys inquiring about the most recent PSA and DRE use were given to a sample of control arm men throughout the screening phase of PLCO (years 0-5). A probability model was utilized to translate survey results into actual frequency counts of tests. To assess the impact of contamination, Surveillance, Epidemiology, and End Results (SEER) incidence rates from the pre-screening era (1985-1987) as well as contemporaneous rates, were applied to PLCO person-years of observation. Results Of 38,350 control arm men, 2427 were surveyed. Pre-trial screening and college education were statistically significantly associated with increased contamination rates. The estimated mean number of screening PSAs (DREs) in the control arm was 2.7 (1.1); this compares to 5.0 (3.5) in the screened arm. 1984 and 2538 prostate cancers were observed in the control and screened arms, respectively, during the screening phase. In the absence of screening, 960 and 949 would have been expected; with contemporaneous incidence rates, 1630 and 1611 were expected. Limitations Due to the limitations of the surveys, in terms of both reach and scope, the exact level of PSA and DRE use in control arm men cannot be known. Conclusions Use of prostate screening by control arm men was substantial, but also substantially less than in screened arm men. Detailed quantitative analyses of screening use across arms are critical for understanding current and future findings from the prostate component of PLCO. © The Author(s), 2010.

Primary study

Unclassified

Lung cancer screening in the randomized prostate, lung, colorectal, and ovarian (PLCO) cancer screening trial

Journal Journal of the National Cancer Institute
Year 2010
Liens Pubmed DOI PubMed Central
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Background: The 5-year overall survival rate of lung cancer patients is approximately 15%. Most patients are diagnosed with advanced-stage disease and have shorter survival rates than patients with early-stage disease. Although screening for lung cancer has the potential to increase early diagnosis, it has not been shown to reduce lung cancer mortality rates. In 1993, the Prostate, Lung, Colorectal, and Ovarian (PLCO) Cancer Screening Trial was initiated specifically to determine whether screening would reduce mortality rates from PLCO cancers.MethodsA total of 77464 participants, aged 55-74 years, were randomly assigned to the intervention arm of the PLCO Cancer Screening Trial between November 8, 1993, and July 2, 2001. Participants received a baseline chest radiograph (CXR), followed by three annual single-view CXRs at the 10 US screening centers. Cancers were classified as screen detected and nonscreen detected (interval or never screened) and according to tumor histology. The positivity rates of screen-detected cancers and positive predictive values (PPVs) were calculated. Because 51.6% of the participants were current or former smokers, logistic regression analysis was performed to control for smoking status. All statistical tests were two-sided. Results: Compliance with screening decreased from 86.6% at baseline to 78.9% at the last screening. Overall positivity rates were 8.9% at baseline and 6.6%-7.1% at subsequent screenings; positivity rates increased modestly with smoking risk categories (P trend <.001). The PPVs for all participants were 2.0% at baseline and 1.1%, 1.5%, and 2.4% at years 1, 2, and 3, respectively; PPVs in current smokers were 5.9% at baseline and 3.3%, 4.2%, and 5.6% at years 1, 2, and 3, respectively. A total of 564 lung cancers were diagnosed, of which 306 (54%) were screen-detected cancers and 87% were non-small cell lung cancers. Among non-small cell lung cancers, 59.6% of screen-detected cancers and 33.3% of interval cancers were early (I-II) stage. Conclusions: The PLCO Cancer Screening Trial demonstrated the ability to recruit, retain, and screen a large population over multiple years at multiple centers. A higher proportion of screen-detected lung cancers were early stage, but a conclusion on the effectiveness of CXR screening must await final PLCO results, which are anticipated at the end of 2015. © The Author 2010. Published by Oxford University Press. All rights reserved.

Primary study

Unclassified

Le dépistage par radiographie du thorax et de la mortalité par cancer du poumon: la prostate, du poumon, colorectal et ovarien (PLCO) essai randomisé.

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Journal JAMA : the journal of the American Medical Association
Year 2011
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CONTEXTE: L'effet sur la mortalité du dépistage du cancer du poumon avec les radiographies thoraciques moderne est inconnue. Objectif: évaluer l'effet sur la mortalité du dépistage du cancer du poumon avec les radiographies de la prostate, du poumon, colorectal et ovarien (PLCO) de première instance de dépistage du cancer. Schéma, environnement et participants Essai randomisé impliquant 154 901 participants âgés de 55 à 74 ans et 77 445 d'entre eux ont été affectés à des projections annuelles et 77 456 aux soins habituels à 1 des 10 centres de dépistage à travers les États-Unis entre Novembre 1993 et ​​Juillet de 2001. Les données provenant d'un sous-ensemble de participants admissibles pour la première National Lung Screening (NLST), qui a comparé la radiographie thoracique avec le dépistage par tomodensitométrie hélicoïdale (CT), ont été analysés. INTERVENTION: Les participants du groupe d'intervention ont été proposés vue postéro radiographie thoracique annuel pendant 4 ans. Diagnostic suivi des résultats positifs de dépistage a été déterminée par les participants et leurs professionnels de la santé. Les participants au groupe de soins habituels ne sont pas épargnés interventions et ont reçu des soins médicaux d'habitude. Tous les cancers diagnostiqués, des décès et des causes de décès ont été constatés par les plus tôt de 13 ans de suivi ou jusqu'au 31 Décembre 2009. Principaux critères de jugement: La mortalité par cancer du poumon. Les critères secondaires incluaient l'incidence du cancer du poumon, les complications liées aux procédures de diagnostic et la mortalité toutes causes confondues. Résultats: l'observance du dépistage était de 86,6% au départ et 79% à 84% à 1 à 3 ans, le taux d'utilisation de dépistage dans le groupe de soins habituels était de 11%. Les taux d'incidence du cancer du poumon cumulés dans les 13 ans de suivi étaient de 20,1 pour 10.000 personnes-années dans le groupe d'intervention et de 19,2 pour 10.000 personnes-années dans le groupe de soins habituels (rapport de taux [RR], 1,05, IC 95%, 0,98 1,12). Un total de 1 213 décès par cancer du poumon a été observée dans le groupe d'intervention par rapport à 1230 dans le groupe de soins habituels à travers 13 ans (mortalité RR, 0,99, IC 95%, 0,87 à 1,22). Stade et l'histologie était similaire entre les 2 groupes. Le risque relatif de mortalité pour le sous-ensemble de participants admissibles pour le NLST, sur la même période de 6 ans de suivi, était de 0,94 (IC 95%, 0,81 à 1,10). CONCLUSION: Le dépistage annuel avec radiographie thoracique n'a pas réduit la mortalité par cancer du poumon par rapport aux soins habituels. Essai d'enregistrement: clinicaltrials.gov Identifier: NCT00002540.

Primary study

Unclassified

Effect of screening on ovarian cancer mortality: the Prostate, Lung, Colorectal and Ovarian (PLCO) Cancer Screening Randomized Controlled Trial.

Journal JAMA
Year 2011
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<b>CONTEXT: </b>Screening for ovarian cancer with cancer antigen 125 (CA-125) and transvaginal ultrasound has an unknown effect on mortality.<b>OBJECTIVE: </b>To evaluate the effect of screening for ovarian cancer on mortality in the Prostate, Lung, Colorectal and Ovarian (PLCO) Cancer Screening Trial.<b>Design, Setting, and Participants: </b>Randomized controlled trial of 78,216 women aged 55 to 74 years assigned to undergo either annual screening (n = 39,105) or usual care (n = 39,111) at 10 screening centers across the United States between November 1993 and July 2001. Intervention The intervention group was offered annual screening with CA-125 for 6 years and transvaginal ultrasound for 4 years. Participants and their health care practitioners received the screening test results and managed evaluation of abnormal results. The usual care group was not offered annual screening with CA-125 for 6 years or transvaginal ultrasound but received their usual medical care. Participants were followed up for a maximum of 13 years (median [range], 12.4 years [10.9-13.0 years]) for cancer diagnoses and death until February 28, 2010.<b>MAIN OUTCOME MEASURES: </b>Mortality from ovarian cancer, including primary peritoneal and fallopian tube cancers. Secondary outcomes included ovarian cancer incidence and complications associated with screening examinations and diagnostic procedures.<b>RESULTS: </b>Ovarian cancer was diagnosed in 212 women (5.7 per 10,000 person-years) in the intervention group and 176 (4.7 per 10,000 person-years) in the usual care group (rate ratio [RR], 1.21; 95% confidence interval [CI], 0.99-1.48). There were 118 deaths caused by ovarian cancer (3.1 per 10,000 person-years) in the intervention group and 100 deaths (2.6 per 10,000 person-years) in the usual care group (mortality RR, 1.18; 95% CI, 0.82-1.71). Of 3285 women with false-positive results, 1080 underwent surgical follow-up; of whom, 163 women experienced at least 1 serious complication (15%). There were 2924 deaths due to other causes (excluding ovarian, colorectal, and lung cancer) (76.6 per 10,000 person-years) in the intervention group and 2914 deaths (76.2 per 10,000 person-years) in the usual care group (RR, 1.01; 95% CI, 0.96-1.06).<b>CONCLUSIONS: </b>Among women in the general US population, simultaneous screening with CA-125 and transvaginal ultrasound compared with usual care did not reduce ovarian cancer mortality. Diagnostic evaluation following a false-positive screening test result was associated with complications. Trial Registration clinicaltrials.gov Identifier: NCT00002540.

Primary study

Unclassified

Comorbidity and mortality results from a randomized prostate cancer screening trial.

Journal Journal of clinical oncology : official journal of the American Society of Clinical Oncology
Year 2011
Liens Pubmed DOI PubMed Central
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<b>PURPOSE: </b>Estimates of prostate cancer-specific mortality (PCSM) were similar for men randomly assigned to intervention compared with usual care on the Prostate, Lung, Colorectal and Ovarian PC screening study. However, results analyzed by comorbidity strata remain unknown.<b>Patients and METHODS: </b>Between 1993 and 2001, of 76,693 men who were randomly assigned to usual care or intervention at 10 US centers, 73,378 (96%) completed a questionnaire that inquired about comorbidity and prostate-specific antigen (PSA) testing before random assignment. Fine and Gray's multivariable analysis was performed to assess whether the randomized screening arm was associated with the risk of PCSM in men with no or minimal versus at least one significant comorbidity, adjusting for age and prerandomization PSA testing.<b>RESULTS: </b>After 10 years of follow-up, 9,565 deaths occurred, 164 from PC. A significant decrease in the risk of PCSM (22 v 38 deaths; adjusted hazard ratio [AHR], 0.56; 95% CI, 0.33 to 0.95; P = .03) was observed in men with no or minimal comorbidity randomly assigned to intervention versus usual care, and the additional number needed to treat to prevent one PC death at 10 years was five. Among men with at least one significant comorbidity, those randomly assigned to intervention versus usual care did not have a decreased risk of PCSM (62 v 42 deaths; AHR, 1.43; 95% CI, 0.96 to 2.11; P = .08).<b>CONCLUSION: </b>Selective use of PSA screening for men in good health appears to reduce the risk of PCSM with minimal overtreatment.

Primary study

Unclassified

Aspirin but not ibuprofen use is associated with reduced risk of prostate cancer: a PLCO study.

Journal British journal of cancer
Year 2012
Liens Pubmed DOI PubMed Central
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BACKGROUND: Although most epidemiological studies suggest that non-steroidal anti-inflammatory drug use is inversely associated with prostate cancer risk, the magnitude and specificity of this association remain unclear. METHODS: We examined self-reported aspirin and ibuprofen use in relation to prostate cancer risk among 29 450 men ages 55-74 who were initially screened for prostate cancer from 1993 to 2001 in the Prostate, Lung, Colorectal, and Ovarian Cancer Screening Trial. Men were followed from their first screening exam until 31 December 2009, during which 3575 cases of prostate cancer were identified. RESULTS: After adjusting for potential confounders, the hazard ratios (HRs) of prostate cancer associated with <1 and ≥ 1 pill of aspirin daily were 0.98 (95% confidence interval (CI), 0.90-1.07) and 0.92 (95% CI: 0.85-0.99), respectively, compared with never use (P for trend 0.04). The effect of taking at least one aspirin daily was more pronounced when restricting the analyses to men older than age 65 or men who had a history of cardiovascular-related diseases or arthritis (HR (95% CI); 0.87 (0.78-0.97), 0.89 (0.80-0.99), and 0.88 (0.78-1.00), respectively). The data did not support an association between ibuprofen use and prostate cancer risk. CONCLUSION: Daily aspirin use, but not ibuprofen use, was associated with lower risk of prostate cancer risk.

Primary study

Unclassified

Du cancer colorectal incidence et la mortalité par le dépistage sigmoïdoscopie flexible.

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Journal The New England journal of medicine
Year 2012
Liens Pubmed DOI PubMed Central
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CONTEXTE: Les avantages du dépistage endoscopique du cancer colorectal, le dépistage du cancer sont incertaines. Nous avons évalué l'effet du dépistage par sigmoïdoscopie flexible sur l'incidence du cancer colorectal et la mortalité. Méthodes: De 1993 à 2001, nous avons aléatoirement 154.900 hommes et femmes de 55 à 74 ans l'âge soit pour le dépistage par sigmoïdoscopie flexible, avec une projection répétée à 3 ou 5 ans, ou aux soins habituels. Les cas de cancer colorectal et les décès dus à cette maladie ont été constatés. Résultats: Parmi les 77 445 participants assignés au hasard à un dépistage (groupe d'intervention), 83,5% ont subi une sigmoïdoscopie base flexible et 54,0% ont été dépistés à 3 ou 5 ans. L'incidence du cancer colorectal après un suivi médian de 11,9 ans était de 11,9 cas pour 10.000 personnes-années dans le groupe d'intervention (1012 cas), comparativement à 15,2 cas pour 10.000 personnes-années dans le groupe de soins habituels (1287 cas ), ce qui représente une réduction de 21% (risque relatif: 0,79, intervalle de confiance 95% [IC], 0,72 à 0,85; P <0,001). Des réductions significatives ont été observées dans l'incidence de cancer à la fois distale colorectal (479 cas dans le groupe d'intervention vs 669 cas dans le groupe de soins habituels; risque relatif: 0,71; IC 95%, 0,64 à 0,80, p <0,001) et proximale colorectal cancer (512 cas vs 595 cas; risque relatif, 0,86; IC 95%, 0,76 à 0,97, p = 0,01). Il y avait 2,9 décès par cancer colorectal par 10.000 personnes-années dans le groupe d'intervention (252 décès), contre 3,9 pour 10.000 personnes-années dans le groupe de soins habituels (341 décès), ce qui représente une réduction de 26% (risque relatif , 0,74, IC 95%, 0,63 à 0,87, P <0,001). La mortalité par cancer colorectal distal a été réduite de 50% (87 décès dans le groupe d'intervention vs 175 dans le groupe de soins habituels, risque relatif, 0,50, IC 95%, 0,38 à 0,64, p <0,001), la mortalité par cancer colorectal proximale n'a pas été affectée (143 et 147 décès, respectivement, risque relatif, 0,97, IC 95%, 0,77 à 1,22, p = 0,81). CONCLUSIONS: Le dépistage de la sigmoïdoscopie flexible a été associée à une diminution significative de l'incidence du cancer colorectal (à la fois dans le côlon distal et proximal) et de mortalité (côlon distal uniquement). (Financé par l'Institut national du cancer; PLCO ClinicalTrials.gov nombre, NCT00002540.).

Primary study

Unclassified

Le dépistage du cancer de la prostate dans l'étude randomisée de la prostate, du poumon, colorectal, dépistage et à un procès Cancer de l'ovaire: résultats de mortalité après 13 ans de suivi.

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Journal Journal of the National Cancer Institute
Year 2012
Liens Pubmed DOI PubMed Central
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CONTEXTE: La composante de la prostate de la prostate, du poumon, colorectal et ovarien (PLCO) Essai de dépistage du cancer a été menée afin de déterminer si il ya une réduction de la mortalité par cancer de la prostate en utilisant du sérum de dépistage d'antigène prostatique spécifique (APS) et le toucher rectal (DRE). La mortalité après 7-10 ans de suivi a été rapporté précédemment. Nous rapportons un suivi prolongé jusqu'à 13 ans après le procès. Méthodes: Un total de 76 685 hommes, âgés de 55 à 74 ans, ont été recrutés dans 10 centres de dépistage entre Novembre 1993 et ​​Juillet 2001 et assignés au hasard à l'intervention (dépistage organisé du test PSA annuel de 6 ans et annuelle DRE pour 4 ans; 38 340 hommes) et de contrôle (soins habituels, qui sont parfois inclus dépistage opportuniste; 38 345 hommes) bras. Le dépistage a été achevée en Octobre 2006. Tous les cancers de la prostate incidents et décès de cancer de la prostate à travers 13 ans de suivi ou par le biais Décembre 31, 2009, ont été constatés. Les risques relatifs (RR) ont été estimés comme étant le ratio des taux observés dans les groupes d'intervention et de contrôle, et les intervalles de confiance à 95% (IC) ont été calculés en supposant une distribution de Poisson pour le nombre d'événements. Modèle de régression de Poisson a été utilisée pour étudier les interactions à l'égard de la mortalité par cancer de la prostate entre bras de l'essai et de l'âge, de l'état de comorbidité et préventive test de l'APS. Tous les tests statistiques étaient bilatéraux. RÉSULTATS: Environ 92% des participants à l'étude ont été suivis jusqu'à 10 ans et de 57% à 13 ans. A 13 ans, 4250 participants avaient reçu un diagnostic de cancer de la prostate dans le groupe d'intervention par rapport à 3815 dans le groupe témoin. Taux d'incidence cumulée de cancer de la prostate dans les groupes d'intervention et de contrôle étaient 108,4 et 97,1 pour 10 000 personnes-années, respectivement, résultant en une augmentation relative de 12% dans le groupe intervention (RR = 1,12, IC 95% = 1,07 à 1,17) . Après 13 ans de suivi, les taux de mortalité cumulatifs du cancer de la prostate dans les groupes d'intervention et de contrôle étaient de 3,7 et 3,4 décès pour 10 000 personnes-années, respectivement, soit une différence non statistiquement significative entre les deux bras (RR = 1,09, IC à 95% = 0,87 à 1,36). Aucune interaction statistiquement significative en ce qui concerne la mortalité par cancer de la prostate ont été observées entre les bras de l'essai et de l'âge (P (interaction) = .81), avant le procès test de l'APS (P (interaction) = .52), et la comorbidité (P (interaction) = 0,68 ). CONCLUSIONS: Après 13 ans de suivi, il n'y avait aucune preuve d'un avantage de mortalité pour le dépistage annuel organisé à l'essai PLCO par rapport à un dépistage opportuniste, qui fait partie du traitement habituel, et il n'y avait aucune interaction apparente avec comorbidité de base au vieillissement, ou des tests PSA provisoire.

Primary study

Unclassified

Serum α-tocopherol and γ-tocopherol concentrations and prostate cancer risk in the PLCO Screening Trial: a nested case-control study.

Journal PloS one
Year 2012
Liens Pubmed DOI PubMed Central
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BACKGROUND: Vitamin E compounds exhibit prostate cancer preventive properties experimentally, but serologic investigations of tocopherols, and randomized controlled trials of supplementation in particular, have been inconsistent. Many studies suggest protective effects among smokers and for aggressive prostate cancer, however. METHODS: We conducted a nested case-control study of serum α-tocopherol and γ-tocopherol and prostate cancer risk in the Prostate, Lung, Colorectal and Ovarian Cancer Screening Trial, with 680 prostate cancer cases and 824 frequency-matched controls. Multivariate-adjusted, conditional logistic regression models were used to estimate odds ratios (OR) and 95% confidence intervals (CIs) for tocopherol quintiles. RESULTS: Serum α-tocopherol and γ-tocopherol were inversely correlated (r = -0.24, p<0.0001). Higher serum α-tocopherol was associated with significantly lower prostate cancer risk (OR for the highest vs. lowest quintile = 0.63, 95% CI 0.44-0.92, p-trend 0.05). By contrast, risk was non-significantly elevated among men with higher γ-tocopherol concentrations (OR for the highest vs. lowest quintile = 1.35, 95% CI 0.92-1.97, p-trend 0.41). The inverse association between prostate cancer and α-tocopherol was restricted to current and recently former smokers, but was only slightly stronger for aggressive disease. By contrast, the increased risk for higher γ-tocopherol was more pronounced for less aggressive cancers. CONCLUSIONS: Our findings indicate higher α-tocopherol status is associated with decreased risk of developing prostate cancer, particularly among smokers. Although two recent controlled trials did not substantiate an earlier finding of lower prostate cancer incidence and mortality in response to supplementation with a relatively low dose of α-tocopherol, higher α-tocopherol status may be beneficial with respect to prostate cancer risk among smokers. Determining what stage of prostate cancer development is impacted by vitamin E, the underlying mechanisms, and how smoking modifies the association, is needed for a more complete understanding of the vitamin E-prostate cancer relation.

Primary study

Unclassified

Second cancers following radiotherapy in prostate cancer patients in the prostate, lung, colorectal and ovarian (PLCO) cancer screening trial

Journal The Journal of Urology
Year 2013
Liens DOI https://www.embase.com/search/results?subaction=viewrecord&id=L71031275&from=export
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INTRODUCTION AND OBJECTIVES: An increased risk of second cancers has been observed after radiotherapy (RT) for the treatment of prostate cancer. The increase in bladder and rectal cancers is likely due to the direct effect of radiation. However, the explanation for an increase in cancers at sites far outside the radiation therapy field, particularly lung cancer, is less clear but may be due to confounding. We examined the association between RT and second cancers in PLCO and assessed the impact of adjusting for potential confounders such as smoking. METHODS: During 1993-2001, 76,685 men aged 55-74 years were randomized into the PLCO trial. For this study, men diagnosed with first primary prostate cancer and who had a baseline questionnaire, known treatment data and at least 30 days of follow-up post initial treatment were followed for a second cancer diagnosis (other than prostate cancer). Poisson regression models were used to estimate the risk of any second cancer diagnosis and site-specific cancers following initial prostate cancer treatment. The mean (SD) age at prostate cancer diagnosis was 68.7 (5.8) years; mean follow-up time was 6.0 (range 0.1-12.9) years. RESULTS: Of the 7479 men with prostate cancer, 43% were treated with RT, 37% underwent radical prostatectomy, 8% received primary hormone therapy and 12% received no definitive or other treatment. Men who received RT were slightly older than those who did not, but there were no differences in smoking history, co-morbidities, BMI or education. In total, 570 second cancers were diagnosed. The rate of second cancers was 15.5/1000 person-years in those treated with RT versus 11.4 in men not treated with RT [relative risk (RR =1.25, 95% CI 1.1-1.5). Men treated with RT had significantly increased risk of lung cancer (RR=1.6; 95% CI 1.1-2.4) compared to men not treated with RT, after adjusting for age, race, education, family history of cancer, COPD and smoking. The RRs for any second cancer and for lung cancer were greater 5+ years post-treatment (RR=1.6, 95%CI: 1.2-2.1 and RR=3.1, 95%CI: 1.7-5.7 respectively). The RRs for bladder cancer (RR=1.6, 95% CI: 0.9-2.8) and colorectal cancer (RR=1.5, 95% CI: 0.9-2.4) were non-significantly elevated. CONCLUSIONS: In PLCO, men treated with RT for prostate cancer had an increased risk of developing any second cancer compared to men who did not receive RT. This is the first study to examine these risks and control for potential confounding factors. The increased risk of lung cancer is intriguing and warrants further investigation given the frequency and fatality of this disease.

Primary study

Unclassified

Mortality and complications after prostate biopsy in the Prostate, Lung, Colorectal and Ovarian Cancer Screening (PLCO) trial.

Auteurs Pinsky PF , Parnes HL , Andriole G
Journal BJU international
Year 2014
Liens Pubmed DOI PubMed Central
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OBJECTIVE: To examine mortality and morbidity after prostate biopsy in the intervention arm of the Prostate, Lung, Colorectal and Ovarian Cancer Screening (PLCO) trial. SUBJECTS AND METHODS: Abstractors from the PLCO trial recorded the types and dates of diagnostic follow-up procedures after positive screens and documented the types and dates of resultant complications. Cancers and deaths among the participants were tracked. The mortality rate in the 120-day period after prostate biopsy was compared with a control rate of deaths in the 120-day period after a negative screen in men without biopsy. Multivariate analysis was performed to control for potential confounders, including age, comorbidities and smoking. Rates of any complication, infectious and non-infectious complications were computed among men with a negative biopsy. Multivariate analysis was used to examine the risk factors for complications. RESULTS: Of the 37,345 men enrolled in the PLCO trial (intervention arm), 4861 had at least one biopsy after a positive screen and 28,661 had a negative screen and no biopsy. The 120-day mortality rate after biopsy was 0.95 (per 1000), compared with the control group rate of 1.8; the multivariate relative risk was 0.49 (95% CI: 0.2-1.1). Among 3706 negative biopsies, the rates (per 1000) of any complication, infectious and non-infections complications were 20.2, 7.8 and 13.0, respectively. A history of prostate enlargement or inflammation was significantly associated with higher rates of both infectious (odds ratio [OR] = 3.7) and non-infectious (OR = 2.2) complications. Black race was associated with a higher infectious complications rate (OR = 7.1) and repeat biopsy was associated with lower rates of non-infectious complications (OR = 0.3). CONCLUSION: Mortality rates were not found to be higher after prostate biopsy in the PLCO trial and complications were relatively infrequent, with several risk factors identified.

Primary study

Unclassified

Incidence and mortality of colorectal cancer in individuals with a family history of colorectal cancer.

Journal Gastroenterology
Year 2015
Liens Pubmed DOI PubMed Central
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BACKGROUND & AIMS: Little is known about the change in risk conferred by family history of colorectal cancer (CRC) as a person ages. We evaluated the effect of family history on CRC incidence and mortality after 55 years of age, when the risk of early onset cancer had passed. METHODS: We collected data from participants in the randomized, controlled Prostate, Lung, Colorectal and Ovarian cancer screening trial of flexible sigmoidoscopy versus usual care (55-74 years old, no history of CRC), performed at 10 US centers from 1993 to 2001. A detailed family history of colorectal cancer was obtained at enrollment, and subjects were followed for CRC incidence and mortality for up to 13 years. RESULTS: Among 144,768 participants, 14,961 subjects (10.3%) reported a family of CRC. Of 2090 incident cases, 273 cases (13.1%) had a family history of CRC; among 538 deaths from CRC, 71 (13.2%) had a family history of CRC. Overall, family history of CRC was associated with an increased risk of CRC incidence (hazard ratio [HR], 1.30; 95% confidence interval [CI], 1.10-1.50; P<.0001) and increased mortality (HR, 1.31; 95% CI, 1.02-1.69; P = .03). Subjects with 1 first degree relative (FDR) with CRC (n = 238; HR, 1.23; 95% CI, 1.07-1.42) or ≥2 FDRs with CRC (n = 35; HR, 2.04; 95% CI, 1.44-2.86) were at increased risk for incident CRC. However, among individuals with 1 FDR with CRC, there were no differences in risk based on age at diagnosis in the FDR (for FDR <60 years of age: HR, 1.27; 95% CI, 0.97-1.63; for FDR 60-70 years of age: HR, 1.33; 95% CI, 1.06-1.62; for FDR >70 years of age: HR, 1.14; 95% CI, 0.93-1.45; P trend = .59). CONCLUSIONS: After 55 years of age, subjects with 1 FDR with CRC had only a modest increase in risk for CRC incidence and death; age of onset in the FDR was not significantly associated with risk. Individuals with ≥2 FDRs with CRC had continued increased risk in older age. Guidelines and clinical practice for subjects with a family history of CRC should be modified to align CRC testing to risk. ClinicalTrials.gov number, NCT00002540.

Primary study

Unclassified

Occurrence of Distal Colorectal Neoplasia Among Whites and Blacks Following Negative Flexible Sigmoidoscopy: An Analysis of PLCO Trial.

Journal Journal of general internal medicine
Year 2015
Liens Pubmed DOI PubMed Central
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<b>BACKGROUND: </b>It is unclear whether the higher rate of colorectal cancer (CRC) among non-Hispanic blacks (blacks) is due to lower rates of CRC screening or greater biologic risk.<b>OBJECTIVE: </b>We aimed to evaluate whether blacks are more likely than non-Hispanic whites (whites) to develop distal colon neoplasia (adenoma and/or cancer) after negative flexible sigmoidoscopy (FSG).<b>DESIGN: </b>We analyzed data of participants with negative FSGs at baseline in the Prostate, Lung, Colorectal, and Ovarian (PLCO) cancer screening trial who underwent repeat FSGs 3 or 5 years later. Subjects with polyps or masses were referred to their physicians for diagnostic colonoscopy. We collected and reviewed the records of diagnostic evaluations.<b>Participants: </b>Our analytic cohort consisted of 21,550 whites and 975 blacks.<b>Main Measures: </b>We did a comparison by race (whites vs. blacks) in the findings of polyps or masses at repeat FSG, the follow-up of abnormal test results and the detection of colorectal neoplasia at diagnostic colonoscopy.<b>Key RESULTS: </b>At the follow-up FSG examination, 304 blacks (31.2 %) and 4183 whites (19.4 %) had abnormal FSG, [adjusted relative risk (RR) = 1.00; 95 % confidence interval (CI), 0.90-1.10]. However, blacks were less likely to undergo diagnostic colonoscopy (76.6 % vs. 83.1 %; RR = 0.90; 95 % CI, 0.84-0.96). Among all included patients, blacks had similar risk of any distal adenoma (RR = 0.86; 95 % CI, 0.65-1.14) and distal advanced adenoma (RR = 1.01; 95 % CI, 0.60-1.68). Similar results were obtained when we restricted our analysis to compliant subjects who underwent diagnostic colonoscopy (RR = 1.01; 95 % CI, 0.80-1.29) for any distal adenoma and (RR = 1.18; 95 % CI, 0.73-1.92) for distal advanced adenoma.<b>CONCLUSIONS: </b>We did not find any differences between blacks and whites in the risk of distal colorectal adenoma 3-5 years after negative FSG. However, follow-up evaluations were lower among blacks.

Primary study

Unclassified

Early detection versus primary prevention in the PLCO flexible sigmoidoscopy screening trial: Which has the greatest impact on mortality?

Auteurs Doroudi M , Schoen RE , Pinsky PF
Journal Cancer
Year 2017
Liens Pubmed DOI PubMed Central
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<b>BACKGROUND: </b>Screening for colorectal cancer (CRC) with flexible sigmoidoscopy (FS) has been shown to reduce CRC mortality. The current study examined whether the observed mortality reduction was due primarily to the prevention of incident CRC via removal of adenomatous polyps or to the early detection of cancer and improved survival.<b>METHODS: </b>The Prostate, Lung, Colorectal, and Ovarian (PLCO) cancer screening trial randomized 154,900 men and women aged 55 to 74 years. Individuals underwent FS screening at baseline and at 3 or 5 years versus usual care. CRC-specific survival was analyzed using Kaplan-Meier curves and proportional hazards modeling. The authors estimated the percentage of CRC deaths averted by early detection versus primary prevention using a model that applied intervention arm survival rates to CRC cases in the usual-care arm and vice versa.<b>RESULTS: </b>A total of 1008 cases of CRC in the intervention arm and 1291 cases of CRC in the usual-care arm were observed. Through 13 years of follow-up, there was no significant difference noted between the trial arms with regard to CRC-specific survival for all CRC (68% in the intervention arm vs 65% in the usual-care arm; P =.16) or proximal CRC (68% vs 62%, respectively; P = .11) cases; however, survival in distal CRC cases was found to be higher in the intervention arm compared with the usual-care arm (77% vs 66%; P&lt;.0001). Within each arm, symptom-detected cases had significantly worse survival compared with screen-detected cases. Overall, approximately 29% to 35% of averted CRC deaths were estimated to be due to early detection and 65% to 71% were estimated to be due to primary prevention.<b>CONCLUSIONS: </b>CRC-specific survival was similar across arms in the PLCO trial, suggesting a limited role for early detection in preventing CRC deaths. Modeling suggested that approximately two-thirds of avoided deaths were due to primary prevention. Future CRC screening guidelines should emphasize primary prevention via the identification and removal of precursor lesions. Cancer 2017;123:4815-22. © 2017 American Cancer Society.

Primary study

Unclassified

Extended mortality results for prostate cancer screening in the PLCO trial with median follow-up of 15 years.

Journal Cancer
Year 2017
Liens Pubmed DOI PubMed Central
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<b>BACKGROUND: </b>Two large-scale prostate cancer screening trials using prostate-specific antigen (PSA) have given conflicting results in terms of the efficacy of such screening. One of those trials, the Prostate, Lung, Colorectal, and Ovarian (PLCO) Cancer Screening Trial, previously reported outcomes with 13 years of follow-up. This study presents updated findings from the PLCO trial.<b>METHODS: </b>The PLCO trial randomized subjects from 1993 to 2001 to an intervention or control arm. Intervention-arm men received annual PSA tests for 6 years and digital rectal examinations for 4 years. This study used a linkage with the National Death Index to extend mortality follow-up to a maximum of 19 years after randomization.<b>RESULTS: </b>Men were randomized to the intervention arm (n = 38,340) or the control arm (n = 38,343). The median follow-up time was 14.8 years (25th/75th, 12.7/16.5 years) in the intervention arm and 14.7 years (25th/75th, 12.6/16.4 years) in the control arm. There were 255 deaths from prostate cancer in the intervention arm and 244 deaths from prostate cancer in the control arm; this meant a rate ratio (RR) of 1.04 (95% confidence interval [CI], 0.87-1.24). The RR for all-cause mortality was 0.977 (95% CI, 0.950-1.004). It was estimated that 86% of the men in the control arm and 99% of the men in the intervention arm received any PSA testing during the trial, and the estimated yearly screening-phase PSA testing rates were 46% and 84%, respectively.<b>CONCLUSIONS: </b>Extended follow-up of the PLCO trial over a median of 15 years continues to indicate no reduction in prostate cancer mortality for the intervention arm versus the control arm. Because of the high rate of control-arm PSA testing, this finding can be viewed as showing no benefit of organized screening versus opportunistic screening. Cancer 2017;123:592-599. © 2016 American Cancer Society.

Primary study

Unclassified

Do cancer survivors develop healthier lifestyle behaviors than the cancer-free population in the PLCO study?

Journal Journal of cancer survivorship : research and practice
Year 2017
Liens Pubmed DOI PubMed Central
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BACKGROUND: Current studies report mixed results in health status and health behaviors after a diagnosis of cancer. The aim of our study is to investigate potential differences in lifestyle factors among cancer survivors and cancer-free individuals in a prospective cohort study conducted in the United States. METHODS: Using data from the Prostate, Lung, Colorectal and Ovarian (PLCO) Trial, 10,133 cancer survivors were identified and compared to 81,992 participants without cancer to evaluate differences in body mass index (BMI), smoking, NSAID use, and physical activity. RESULTS: Cancer survivors, compared to the cancer-free, were significantly less likely to engage in physical activity (odds ratio (OR) = 0.82, 95% CI = 0.77-0.88). Compared to those who were obese at baseline, cancer survivors were more likely to be at normal BMI at follow-up compared to the cancer-free (OR = 1.90, 95% CI = 1.42-2.54). Cancer survivors were less likely to report regular aspirin use as compared to the cancer-free population (OR = 0.86, 95 % CI = 0.82-0.92). Of the current smokers, cancer survivors were more likely to be former smokers at follow-up compared to the cancer-free (OR = 1.50, 95% CI = 1.30-1.74). CONCLUSION: Upon stratification by baseline health markers, cancer survivors practice healthier lifestyle habits such as smoking cessation and maintenance of a healthy weight. However, cancer survivors are less likely to be physically active as compared to cancer-free individuals, regardless of baseline practices. IMPLICATIONS FOR CANCER SURVIVORS: For cancer survivors who reported poor health status and behaviors at baseline, a cancer diagnosis may encourage the practice of healthier lifestyle behaviors.

Primary study

Unclassified

Reconciling the Effects of Screening on Prostate Cancer Mortality in the ERSPC and PLCO Trials.

Journal Annals of internal medicine
Year 2017
Liens Pubmed DOI PubMed Central
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<b>BACKGROUND: </b>The ERSPC (European Randomized Study of Screening for Prostate Cancer) found that screening reduced prostate cancer mortality, but the PLCO (Prostate, Lung, Colorectal, and Ovarian Cancer Screening Trial) found no reduction.<b>OBJECTIVE: </b>To evaluate whether effects of screening on prostate cancer mortality relative to no screening differed between the ERSPC and PLCO.<b>DESIGN: </b>Cox regression of prostate cancer death in each trial group, adjusted for age and trial. Extended analyses accounted for increased incidence due to screening and diagnostic work-up in each group via mean lead times (MLTs), which were estimated empirically and using analytic or microsimulation models.<b>SETTING: </b>Randomized controlled trials in Europe and the United States.<b>Participants: </b>Men aged 55 to 69 (ERSPC) or 55 to 74 (PLCO) years at randomization.<b>Intervention: </b>Prostate cancer screening.<b>Measurements: </b>Prostate cancer incidence and survival from randomization; prostate cancer incidence in the United States before screening began.<b>RESULTS: </b>Estimated MLTs were similar in the ERSPC and PLCO intervention groups but were longer in the PLCO control group than the ERSPC control group. Extended analyses found no evidence that effects of screening differed between trials (P = 0.37 to 0.47 [range across MLT estimation approaches]) but strong evidence that benefit increased with MLT (P = 0.0027 to 0.0032). Screening was estimated to confer a 7% to 9% reduction in the risk for prostate cancer death per year of MLT. This translated into estimates of 25% to 31% and 27% to 32% lower risk for prostate cancer death with screening as performed in the ERSPC and PLCO intervention groups, respectively, compared with no screening.<b>Limitation: </b>The MLT is a simple metric of screening and diagnostic work-up.<b>CONCLUSION: </b>After differences in implementation and settings are accounted for, the ERSPC and PLCO provide compatible evidence that screening reduces prostate cancer mortality.<b>Primary Funding Source: </b>National Cancer Institute.

Primary study

Unclassified

Effectiveness of flexible sigmoidoscopy screening in men and women and different age groups: pooled analysis of randomised trials.

Journal BMJ (Clinical research ed.)
Year 2017
Liens Pubmed DOI PubMed Central
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OBJECTIVE:  To compare the effectiveness of flexible sigmoidoscopy in screening for colorectal cancer by patient sex and age. DESIGN:  Pooled analysis of randomised trials (the US Prostate, Lung, Colorectal and Ovarian cancer screening trial (PLCO), the Italian Screening for Colon and Rectum trial (SCORE), and the Norwegian Colorectal Cancer Prevention trial (NORCCAP)). DATA SOURCES:  Aggregated data were pooled from each randomised trial on incidence of colorectal cancer and mortality stratified by sex, age at screening, and colon subsite (distal v proximal). ELIGIBILITY CRITERIA FOR SELECTING STUDIES:  Invited individuals aged 55-74 (PLCO), 55-64 (SCORE), and 50-64 (NORCCAP). Individuals were randomised to receive flexible sigmoidoscopy screening once only (SCORE and NORCCAP) or twice (PLCO), or receive usual care (no intervention). RESULTS:  287 928 individuals were included in the pooled analysis; 115 139 randomised to screening and 172 789 to usual care. Compliance rates were 58%, 63%, and 87% in SCORE, NORCCAP, and PLCO, respectively. Median follow-up was 10.5 to 12.1 years. Screening reduced the incidence of colorectal cancer in men (relative risk 0.76; 95% confidence interval 0.70 to 0.83) and women (0.83; 0.75 to 0.92). No difference in the effect of screening was seen between men younger than 60 and those older than 60. Screening reduced the incidence of colorectal cancer in women younger than 60 (relative risk 0.71; 95% confidence interval 0.59 to 0.84), but not significantly in those aged 60 or older (0.90; 0.80 to 1.02). Colorectal cancer mortality was significantly reduced in both younger and older men, and in women younger than 60. Screening reduced colorectal cancer incidence to a similar extent in the distal colon in men and women, but there was no effect of screening in the proximal colon in older women with a significant interaction between sex and age group (P=0.04). CONCLUSION:  Flexible sigmoidoscopy is an effective tool for colorectal cancer screening in men and younger women. The benefit is smaller and not statistically significant for women aged over 60; alternative screening methods that more effectively detect proximal tumours should be considered for these women.

Primary study

Unclassified

Effect of flexible sigmoidoscopy screening on colorectal cancer incidence and mortality: long-term follow-up of the randomised US PLCO cancer screening trial.

Journal The lancet. Gastroenterology & hepatology
Year 2019
Liens Pubmed DOI PubMed Central
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BACKGROUND: Screening flexible sigmoidoscopy reduces incidence and mortality of colorectal cancer. Previously reported results from the Prostate, Lung, Colorectal, and Ovarian Cancer (PLCO) screening trial had a median follow-up of 12 years. Whether the benefit is sustained over the long term and remains so in both sexes and all age groups is uncertain. We report long-term results after an additional 5 years of follow-up. METHODS: Participants in the PLCO trial were recruited from the general population in the catchment areas of ten screening centres across the USA, without previous diagnosis of a prostate, lung, colorectal, or ovarian cancer or current cancer treatment. From 1993 to 2001, participants aged 55-74 years were randomly assigned to usual care or flexible sigmoidoscopy at baseline and again at 3 years or 5 years. Randomisation was done within blocks and stratified by centre, age, and sex. The primary endpoint was cause-specific mortality and secondary endpoints included incidence and tumour staging; cause of death was determined without knowledge of study arm. In this analysis, we assessed incidence and mortality rates overall, by time-period, and by combinations of sex, age at baseline (55-64 years/65-74 years), location (distal/proximal), and stage, on an intent-to-treat basis. This trial is registered with ClinicalTrials.gov, number NCT00002540. FINDINGS: After a median follow-up of 15·8 years (IQR 13·2-18·0) for incidence and 16·8 years (14·4-18·9) for mortality, the incidence of colorectal cancer was significantly lower in the intervention arm (1461 cases; 12·55 per 10 000 person-years) than with usual care (1761 cases; 15·33 per 10 000 person-years; relative risk [RR] 0·82, 95% CI 0·76-0·88). Similarly, mortality was lower in the intervention arm (417 deaths; 3·37 per 10 000 person-years) than the usual care arm (549; 4·48 per 10 000 person-years; RR 0·75, 95% CI 0·66-0·85). The reduction in mortality was limited to the distal colon, with no significant effect in the proximal colon. Reductions in incidence were significantly larger in men than women (pinteraction=0·04) and reductions in mortality were significantly larger in the older age group (65-74 years vs 55-64 years at baseline; pinteraction=0·01). INTERPRETATION: Reductions in colorectal cancer incidence and mortality from flexible sigmoidoscopy screening are sustained over the long term. Differences by sex and age should be examined in other ongoing trials of colorectal cancer screening to help clarify if different screening strategies would achieve greater risk reduction. FUNDING: Extended follow-up was funded under NIH contract HHSN261201600007I.

Primary study

Unclassified

Overall mortality in men and women in the randomized Prostate, Lung, Colorectal, and Ovarian Cancer Screening Trial.

Auteurs Pinsky PF , Miller EA , Zhu CS , Prorok PC
Journal Journal of medical screening
Year 2019
Liens Pubmed DOI
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OBJECTIVE: To assess the secondary outcome of overall mortality in the randomized Prostate, Lung, Colorectal, and Ovarian cancer screening trial. METHODS: In the Prostate, Lung, Colorectal, and Ovarian trial, subjects were randomized to usual care or intervention. In the intervention arm, men and women received annual chest radiographs and two sigmoidoscopy exams. Men also received annual prostate-specific antigen tests and digital rectal exams, and women also received annual CA125 tests and trans-vaginal ultrasounds. Poisson regression and Cox proportional hazards models were used to assess differences across trial arms in overall mortality and overall mortality excluding deaths from trial cancers (OM<sub>EX</sub>). Due to slight age imbalances in later trial years, age-adjusted rate ratios and hazard ratios were computed. RESULTS: There were 76,678 men and 78,209 women randomized, with median follow-up of 17 years. In men there was a significant reduction in both overall mortality (age-adjusted rate ratio = 0.966; 95% CI: 0.943–0.989; p = 0.004) and OM<sub>EX</sub> (age-adjusted rate ratio = 0.970, 95% CI: 0.946–0.995; p = 0.02) in the intervention versus usual care arm. In women, no reduction was seen in either overall mortality (age-adjusted rate ratio = 1.002) or OM<sub>EX</sub> (age-adjusted rate ratio = 1.006). In both sexes combined, there was a significant reduction in overall mortality (age-adjusted rate ratio = 0.980; 95% CI: 0.963–0.999; p = 0.036) but not OM<sub>EX</sub> (age-adjusted rate ratio = 0.985; 95% CI: 0.965–1.004; p = 0.13). Results were similar using age-adjusted hazard ratios. CONCLUSION: In the Prostate, Lung, Colorectal, and Ovarian trial, there was a small but significant reduction in overall mortality in men, and in both sexes combined, and a small but significant reduction in overall mortality excluding trial cancer deaths in men.