Estudio primario

No clasificado

Uso compasivo de durvalumab en cáncer de pulmón no microcítico: resultados en vida real

Traducción oficial
Año 2021
Revista O.F.I.L
Enlaces DOI , Virtual Health Library

Este artículo no está incluido en ninguna revisión sistemática

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Objetivos: Durvalumab está financiado en cáncer de pulmón no microcítico (CPNM) localmente avanzado irresecable con expresión PD-L1 ≥1%, sin progresión tras quimiorradioterapia basada en platino y duración del tratamiento de 12 meses. Los pacientes deben presentar buen estado general (PS). Hasta ahora, sólo el uso compasivo ha sido autorizado, sin algunos requisitos de financiación exigidos. El objetivo es describir las condiciones del uso compasivo de durvalumab en CPNM, comparándose con las condiciones de financiación, así como proporcionar resultados en vida real de efectividad y seguridad.Métodos: Se desarrolló un estudio descriptivo retrospectivo entre 01/12/2017-29/02/2020. La efectividad se evaluó con supervivencia global (SG) y supervivencia libre de progresión (SLP) mediante método Kaplan Meier utilizando SPSS Statistics®. La seguridad se evaluó con reacciones adversas (RAs), grado, interrupciones y suspensiones.Resultados: Fueron reclutados 5 pacientes. Se determinó PD-L1 ≥1% en uno. El 80% presentaron PS0. La mediana de seguimiento fue 19 (7-25) meses. Uno de los pacientes (20%) cumplió criterios de financiación. No se registraron fallecimientos, no pudiéndose estimar la media de SG. La media de SLP fue 20,8 (13,6-28,1) meses. Se observaron 17 episodios de RAs, siendo las más frecuentes: 4 (23,5%) infecciones respiratorias, 3 (17,6%) tos y 2 (11,7%) lesiones eritematosas. Se notificaron 16 (94,1%) RAs grado 1, y 8 interrupciones de tratamiento, sin suspensiones.Conclusiones: Existen importantes discrepancias entre el uso compasivo de durvalumab en CPNM localmente avanzado irresecable y las condiciones de financiación. Durvalumab ha demostrado importante efectividad y tolerancia aceptable, aunque estos resultados deben evaluarse con cautela. (AU)

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Estudio primario

No clasificado

Study of Durvalumab and Olaparib or Durvalumab After Treatment With Durvalumab and Chemotherapy in Patients With Lung Cancer

Año 2019
Autores AstraZeneca AB
Registro de estudios Clinical Trials Registry - India
Enlaces CTRI

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Estudio primario

No clasificado

Study of Durvalumab+Olaparib or Durvalumab After Treatment With Durvalumab and Chemotherapy in Patients With Lung Cancer (ORION)

Año 2018
Autores AstraZeneca
Registro de estudios clinicaltrials.gov
Enlaces ClinicalTrials.gov

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Adult patients with a histologically or cytologically documented advanced NSCLC not amenable to curative surgery or radiation with tumors that lack activation EGFR mutations and ALK fusions are eligible for enrollment. During the initial therapy phase, patients will receive treatment with Durvalumab along with the Investigator's choice of platinum‐based doublet therapy for squamous NSCLC (nab‐paclitaxel plus carboplatin or gemcitabine plus carboplatin/cisplatin) and non‐squamous NSCLC (nab‐paclitaxel plus carboplatin or pemetrexed plus carboplatin/cisplatin) for 4 cycles. Patients who have completed 4 cycles and not progressed throughout the initial therapy phase will be randomized in a 1:1 ratio into the maintenance phase of the study to receive either Durvalumab plus placebo or Durvalumab plus Olaparib maintenance therapy. Patients will receive maintenance treatment until specific discontinuation criteria are met, including clinical disease progression (as assessed by the Investigator) or RECIST 1.1‐defined radiological Progressive Disease (PD), unacceptable toxicity, and withdrawal of consent. Tumor evaluation scans will be performed until objective disease progression as efficacy assessments. All patients will be followed for survival until the end of the study.

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Estudio primario

No clasificado

A Study of AZD4635 With Durvalumab and With Cabazitaxel and Durvalumab in Patients With mCRPC.

Año 2020
Autores AstraZeneca
Registro de estudios clinicaltrials.gov
Enlaces ClinicalTrials.gov

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This is a Phase II, international, open-label, two-arm, non-randomised study of AZD4635 in participants with metastatic castration-resistant prostate cancer (mCRPC).

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Estudio primario

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Cisplatin + Radiotherapy vs Durvalumab + Radiotherapy Followed by Durvalumab vs Durvalumab + Radiotherapy Followed by Tremelimumab + Durvalumab in Intermediate-Risk HPV-Positive Oropharyngeal SCC

Año 2018
Registro de estudios clinicaltrials.gov
Enlaces ClinicalTrials.gov

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Sometimes, cancer patients receive an initial treatment, followed by additional treatment to lower the chance of cancer coming back. The standard or usual treatment for this type of disease is initially having radiation therapy at the same time as chemotherapy (with a drug called cisplatin), with no additional therapy afterwards

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Revisión sistemática

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Adverse Events and Tolerability of Combined Durvalumab and Tremelimumab versus Durvalumab Alone in Solid Cancers: A Systematic Review and Meta-Analysis.

Año 2022
Revista Biomedicines
Enlaces DOI , Pubmed , PMC

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BACKGROUND:

Recently, the combination of durvalumab and tremelimumab, two immune checkpoint inhibitors, for the treatment of different types of cancers has been considered; however, its overall effects, including its safety, are still unclear and need to be further investigated.

OBJECTIVES:

The aim of the present systematic review and meta-analysis was to investigate the safety and tolerability of this combination of drugs.

METHODS:

A systematic review of the literature, based on the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) statement, was conducted by employing online electronic databases and the American Society of Clinical Oncology (ASCO) Meeting Library. The selection of eligible publications was made following a staged screening and selection process. The software RevMan 5.4 was used to run the quantitative analysis and forest plots, while the Cochrane tool was employed for risk of bias assessment.

RESULTS:

From the retrieved 157 results, 9 randomized controlled trials involving 3060 patients were included. By comparing the combination of durvalumab and tremelimumab vs. durvalumab monotherapy, it was observed that: adverse events (AEs) ≥ Grade 3 incidence was 32.6% (536/1646) vs. 23.8% (336/1414) (Z = 2.80; p = 0.005; risk ratio (RR) = 1.44), reduced appetite incidence was 10.8% (154/1427) vs. 8.3% (108/1305) (Z = 2.26; p = 0.02; RR = 1.31), diarrhea was reported in 15.6% (229/1473) vs. 8.1% (110/1352) (Z = 5.90; p < 0.00001; RR = 1.91), rash incidence was equal to 11.1% (160/1441) vs. 6.5% (86/1320) (Z = 4.35; p <0.0001; RR = 1.75), pruritis was 13.6% (201/1473) vs. 7.7% (104/1352) (Z = 5.35; p < 0.00001; RR = 1.83), fever was 10.5% (42/399) vs. 6.6% (22/330) (Z = 2.27; p = 0.02; RR = 1.77), discontinuation rate was 18% (91/504) vs. 3% (36/434) (Z = 4.78; p < 0.00001; RR = 2.41), and death rate was 2.6% (13/504) vs. 0.7% (3/434) (Z = 1.90; p = 0.06; RR = 2.77).

CONCLUSIONS:

It was observed that the combined (durvalumab and tremelimumab) vs. monotherapy (durvalumab) is associated with a higher risk of treatment discontinuation, mortality, fever, diarrhea, rash, pruritis, and reduced appetite. This information is relevant and should be disclosed, especially to patients that are currently enrolled in clinical trials considering this combined therapy.

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Revisión sistemática

No clasificado

Durvalumab and tremelimumab combination therapy versus durvalumab or tremelimumab monotherapy for patients with solid tumors: A systematic review and meta-analysis.

Año 2020
Autores Wang BC , Li PC , Fan JQ , Lin GH , Liu Q
Revista Medicine
Enlaces DOI , Pubmed , PMC

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BACKGROUND:

The combination of durvalumab and tremelimumab results in clinical benefit, with a tolerable safety profile in patients with solid tumors.

OBJECTIVE:

To evaluate the efficacy and safety of durvalumab in combination with tremelimumab compared with either drug alone.

METHODS:

The online databases (PubMed, Web of Science, EMBASE, and Cochrane Library) were searched for potential clinical studies up to Nov 26, 2019. Eligible studies were prospective and registered clinical trials. Pooled odds ratios for objective response rate and disease control rate and pooled risk ratios for treatment-related adverse events were meta-analyzed. A random-effect model was used due to the synthesis of different cancer types.

RESULTS:

Overall, 5 studies were eligible for systematic review, 3 of which were further meta-analyzed. Durvalumab plus tremelimumab was superior to tremelimumab monotherapy in improving disease control rate in head and neck squamous cell carcinoma. However, there were no significant differences between dual immunotherapy and mono-immunotherapy in pancreatic ductal adenocarcinoma and gastric and gastroesophageal junction adenocarcinoma. Additionally, pooled analyses illustrated that no significant differences in treatment-related adverse events were displayed between the 2 groups.

CONCLUSION:

Durvalumab and tremelimumab combination therapy had a good safety profile and resulted in clinical benefit in head and neck squamous cell carcinoma. Future explorations are needed to further confirm the application of durvalumab plus tremelimumab.

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Estudio primario

No clasificado

Durvalumab in Solid Tumors

Año 2017
Registro de estudios clinicaltrials.gov
Enlaces ClinicalTrials.gov

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The proposal is a phase II clinical study designed to assess the feasibility of durvalumab (MEDI4736) in HIV-1-infected individuals with solid tumors. Additionally, to obtain data that lets understand the possible benefit of this treatment in cancer patients and HIV infection, exploring if activity of durvalumab (MEDI4736) could be higher in cancer that has been produced at least in part due to the chronic immunosupression. Simultaneously, it will allow us to investigate the effect of disrupting this immunoregulatory pathway might have in reversing cancer pathways and HIV-specific T-cell function during persistent chronic HIV infection in humans.

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Estudio primario

No clasificado

Radiotherapy and Durvalumab/Durvalumab Combo (Tremelimumab/Olaparid) for Small Cell Lung Cancer

Año 2019
Registro de estudios clinicaltrials.gov
Enlaces ClinicalTrials.gov

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This is a randomized multi-arm trial evaluating the safety and efficacy of thoracic radiation therapy followed by either durvalumab as monotherapy or in combination with tremelimumab or olaparib in participants with Extensive-Stage Disease Small Cell Lung Cancer (ES-SCLC) who have completed a first-line platinum-based chemotherapy regimen and achieved ongoing complete response (CR), partial response (PR) or stable disease (SD).

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Estudio primario

No clasificado

Durvalumab+ Gemcitabine/Cisplatin (Neoadjuvant Treatment) and Durvalumab (Adjuvant Treatment) in Patients With MIBC

Año 2018
Autores AstraZeneca
Registro de estudios clinicaltrials.gov
Enlaces ClinicalTrials.gov

Este artículo no está incluido en ninguna revisión sistemática

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A Global Study to Determine the Efficacy and Safety of Durvalumab in Combination with Gemcitabine+Cisplatin for Neoadjuvant Treatment and Durvalumab Alone for Adjuvant Treatment in Patients with Muscle‐Invasive Bladder Cancer

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