Revisión sistemática

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Cetuximab for metastatic colorectal cancer

Año 2004
Autores [No se listan los autores]
Reporte World Health Organization (WHO)
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Revisión sistemática

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Cetuximab-based therapy versus non-cetuximab therapy for advanced cancer: A meta-analysis of 17 randomized controlled trials

Año 2010
Autores Liu L , Cao Y , Tan A , Liao C , Gao F
Revista Cancer chemotherapy and pharmacology
Enlaces DOI , Pubmed

Este artículo está incluido en 1 Resumen estructurado de revisiones sistemáticas 16 Resúmenes estructurados de revisiones sistemáticas (1 referencia)

Este artículo incluye 17 Estudios primarios 16 Estudios primarios (17 referencias)

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Purpose: To assess the efficacy and safety of cetuximab-based therapy versus non-cetuximab therapy for advanced cancer. Methods: A total of 7,954 patients from 17 randomized controlled trials are identified, with 3,965 patients in the cetuximab group and 3,989 patients in the non-cetuximab group. The outcome was progression-free survival (PFS), overall survival (OS), overall response rate (ORR), and grade 3/4 advent events. Results: There was a significant improvement of PFS (HR 0.83, 95%CI 0.78-0.88), OS (HR 0.89, 0.84-0.95), and ORR in the cetuximab group (OR 1.39, 1.22-1.58). In subgroup analysis, in colorectal cancer, there was a significant improvement of PFS (0.72, 0.66-0.78), OS (0.90, 0.81-1.00), and ORR in the cetuximab group (1.36, 1.15-1.60). In head and neck carcinoma, there was a significant improvement of PFS (0.63, 0.54-0.73), OS (0.78, 0.67-0.91), and ORR in the cetuximab group (1.57, 1.15-2.16). In non-small-cell lung cancer, there was a significant improvement of OS (0.86, 0.76-0.96) in the cetuximab group, and no difference on PFS (0.82, 0.64-1.07) and ORR (1.56, 0.85-2.88). In pancreatic cancer, there was no difference on PFS (1.11, 0.97-1.28), OS (1.07, 0.93-1.25), and ORR (0.94, 0.66-1.33). There were higher incidences of grade 3-4 toxicity (OR 1.84), skin-related toxicity (OR 31.80), acneiform rash (OR 30.14), and hypomagnesemia (OR 6.72) in the cetuximab group. Conclusions: Cetuximab-based therapy improved PFS and OS, and better ORR versus non-cetuximab therapy. The severe adverse events should be predictable and manageable. © 2009 Springer-Verlag.

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Cetuximab monotherapy and cetuximab plus irinotecan in irinotecan-refractory metastatic colorectal cancer.

Año 2004
Revista The New England journal of medicine
Enlaces DOI , Pubmed

Este artículo está incluido en 4 Revisiones sistemáticas Revisiones sistemáticas (4 referencias)

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BACKGROUND:

The epidermal growth factor receptor (EGFR), which participates in signaling pathways that are deregulated in cancer cells, commonly appears on colorectal-cancer cells. Cetuximab is a monoclonal antibody that specifically blocks the EGFR. We compared the efficacy of cetuximab in combination with irinotecan with that of cetuximab alone in metastatic colorectal cancer that was refractory to treatment with irinotecan.

METHODS:

We randomly assigned 329 patients whose disease had progressed during or within three months after treatment with an irinotecan-based regimen to receive either cetuximab and irinotecan (at the same dose and schedule as in a prestudy regimen [218 patients]) or cetuximab monotherapy (111 patients). In cases of disease progression, the addition of irinotecan to cetuximab monotherapy was permitted. The patients were evaluated radiologically for tumor response and were also evaluated for the time to tumor progression, survival, and side effects of treatment.

RESULTS:

The rate of response in the combination-therapy group was significantly higher than that in the monotherapy group (22.9 percent [95 percent confidence interval, 17.5 to 29.1 percent] vs. 10.8 percent [95 percent confidence interval, 5.7 to 18.1 percent], P=0.007). The median time to progression was significantly greater in the combination-therapy group (4.1 vs. 1.5 months, P<0.001 by the log-rank test). The median survival time was 8.6 months in the combination-therapy group and 6.9 months in the monotherapy group (P=0.48). Toxic effects were more frequent in the combination-therapy group, but their severity and incidence were similar to those that would be expected with irinotecan alone.

CONCLUSIONS:

Cetuximab has clinically significant activity when given alone or in combination with irinotecan in patients with irinotecan-refractory colorectal cancer.

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Correlation of cetuximab-induced skin rash and outcomes of solid tumor patients treated with cetuximab: A systematic review and meta-analysis.

Año 2015
Autores Abdel-Rahman O , Fouad M
Revista Critical reviews in oncology/hematology
Enlaces DOI , Pubmed
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BACKGROUND:

We performed a systematic review and meta-analysis of the correlation between cetuximab-induced skin rash and outcomes of solid tumor patients treated with cetuximab.

PATIENTS AND METHODS:

Eligible studies included phase I, II and III trials of patients with solid tumors on cetuximab; describing events of skin rash and correlating skin rash with overall survival (OS), progression free survival (PFS) and/or overall response rate (ORR).

RESULTS:

Our search strategy yielded 409 potentially relevant citations on CETUXIMAB from Pubmed/Medline, CENTRAL Cochrane registry and ASCO meeting library. After exclusion of ineligible studies, a total of 13 clinical trials were considered eligible for the meta-analysis, including 4 phase III trials, 8 phase II trials and one phase I trial. The occurrence of cetuximab-induced rash in patients was highly associated with improvements in PFS (HR=0.74; 95% CI.: 0.63-0.86, P<0.0002), OS (HR=0.60; 95% CI.: 0.47-0.76, P<0.0001), and ORR (RR=1.51, 95% CI.: 1.26-1.81, P<0.00001), as compared to patients without rash. Exploratory subgroup analysis showed no effect of tumor types on the RR of ORR.

CONCLUSIONS:

Our meta-analysis has demonstrated that cetuximab-induced rash is associated with a significantly improved OS, PFS and ORR. Cetuximab-induced skin rash may represent a prognostic factor in patients with advanced solid tumors.

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Revisión sistemática

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Standard chemotherapy with cetuximab for treatment of colorectal cancer

Año 2015
Autores Li XX , Liang L , Huang LY , Cai SJ
Revista World journal of gastroenterology
Enlaces DOI , Pubmed , PMC

Este artículo incluye 8 Estudios primarios 8 Estudios primarios (8 referencias)

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AIM:

To review and assess the evidence related to cetuximab treatment in metastatic colorectal cancer (mCRC) with regard to KRAS status.

METHODS:

PubMed, EMBASE, Cochrane database and American Society of Clinical Oncology meeting abstracts were searched for randomized controlled trials (RCTs) reporting the effect of KRAS status on efficacy of chemotherapy regimen with or without cetuximab in mCRC. Baseline information such as sex and age was summarized from the included studies. Hazard ratios of progression-free survival (PFS) and overall survival (OS) as well as objective response based on KRAS status were extracted for analysis.

RESULTS:

A total of 8 RCTs with 6780 patients were included. The combined analysis showed that cetuximab failed to improve the OS and PFS in patients with mCRC. However, in subgroup analysis, the pooled data showed that addition of cetuximab to irinotecan containing chemotherapy regimen was sufficient to improve OS and PFS in wild-type KRAS mCRC patients, but not in patients with mutant-type KRAS . The addition of cetuximab increased the incidence of adverse events such as diarrhea, rash, skin toxicity/rash, and nausea and vomiting. There was no significant publication bias existing in the included studies.

CONCLUSION:

The clinical benefit of cetuximab was only confirmed in patients with wild-type KRAS . KRAS status could be considered a biomarker of efficacy of cetuximab.

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Bevacizumab in combination with cetuximab and irinotecan after failure of cetuximab and irinotecan in patients with metastatic colorectal cancer.

Año 2011
Revista Acta oncologica (Stockholm, Sweden)
Enlaces DOI , Pubmed

Este artículo está incluido en 1 Revisión sistemática Revisiones sistemáticas (1 referencia)

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BACKGROUND:

The efficacy and safety of concurrent administration of irinotecan with the two monoclonal antibodies cetuximab and bevacizumab as fourth line therapy in heavily pretreated patients with metastatic colorectal cancer were evaluated.

PATIENTS AND METHODS:

Patients with metastatic colorectal cancer who had progressed on therapy with 5-FU, oxaliplatin and irinotecan in the first and second line setting and on the combination of irinotecan and cetuximab in third line setting independent of their KRAS mutation status, were treated with irinotecan and cetuximab combined with bevacizumab in a dosage of 5 mg/kg. All drugs were administered every second week.

RESULTS:

From January 2007 to November 2008 27 patients were treated with cetuximab, irinotecan and bevacizumab. The triple-combination was well tolerated. Progression free survival (PFS) was 8.3 months and median overall survival (mOS) was 12.0 months. Two patients without KRAS mutation (7%) obtained a partial response and 17 (63%) had stable disease for at least two months. A retrospective KRAS mutation analysis revealed that there was a trend toward longer PFS and mOS in patients without KRAS mutations compared to patients with KRAS mutations with a PFS of 8.9 vs. 5.1 months and a mOS of 12.7 vs. 9.0 months.

CONCLUSION:

Bevacizumab is safe to add to irinotecan and cetuximab with a toxicity profile that seems to be similar to what would be expected from the agents alone. The results indicate that adding bevacizumab to irinotecan and cetuximab in a fourth line setting may induce a high rate of disease control in heavily pretreated patients with metastatic colorectal cancer.

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Estudio primario

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Cetuximab for the treatment of colorectal cancer.

Año 2007
Revista The New England journal of medicine
Enlaces DOI , Pubmed

Este artículo está incluido en 11 Revisiones sistemáticas Revisiones sistemáticas (11 referencias) 1 Resúmenes estructurados de estudios primarios Resúmenes estructurados de estudios primarios (1 referencia)

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BACKGROUND:

Cetuximab, an IgG1 chimeric monoclonal antibody against epidermal growth factor receptor (EGFR), has activity against colorectal cancers that express EGFR.

METHODS:

From December 2003 to August 2005, 572 patients who had colorectal cancer expressing immunohistochemically detectable EGFR and who had been previously treated with a fluoropyrimidine, irinotecan, and oxaliplatin or had contraindications to treatment with these drugs underwent randomization to an initial dose of 400 mg of cetuximab per square meter of body-surface area followed by a weekly infusion of 250 mg per square meter plus best supportive care (287 patients) or best supportive care alone (285 patients). The primary end point was overall survival.

RESULTS:

In comparison with best supportive care alone, cetuximab treatment was associated with a significant improvement in overall survival (hazard ratio for death, 0.77; 95% confidence interval [CI], 0.64 to 0.92; P=0.005) and in progression-free survival (hazard ratio for disease progression or death, 0.68; 95% CI, 0.57 to 0.80; P<0.001). These benefits were robust after adjustment in a multivariable Cox proportional-hazards model. The median overall survival was 6.1 months in the cetuximab group and 4.6 months in the group assigned to supportive care alone. Partial responses occurred in 23 patients (8.0%) in the cetuximab group but in none in the group assigned to supportive care alone (P<0.001); the disease was stable in an additional 31.4% of patients assigned to cetuximab and in 10.9% of patients assigned to supportive care alone (P<0.001). Quality of life was better preserved in the cetuximab group, with less deterioration in physical function and global health status scores (both P<0.05). Cetuximab treatment was associated with a characteristic rash; a rash of grade 2 or higher was strongly associated with improved survival (hazard ratio for death, 0.33; 95% CI, 0.22 to 0.50; P<0.001). The incidence of any adverse event of grade 3 or higher was 78.5% in the cetuximab group and 59.1% in the group assigned to supportive care alone (P<0.001).

CONCLUSIONS:

Cetuximab improves overall survival and progression-free survival and preserves quality-of-life measures in patients with colorectal cancer in whom other treatments have failed. (ClinicalTrials.gov number, NCT00079066 [ClinicalTrials.gov].).

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Revisión sistemática

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Relationship between efficacy of cetuximab and skin rashes: A systematic review

Año 2015
Revista Chinese Journal of Evidence-Based Medicine
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Objective To systematically review the relationship between skin rashes and efficacy of cetuximab. Methods Such databases as PubMed, EMbase, The Cochrane Library (Issue 1, 2013), CBM, CNKI and VIP were systemically searched to collect literature on relationship between the severity of skin rashes and efficacy of cetuximab published up to Aug. 2013. According to the inclusion and exclusion criteria, two reviewers independently screened literature, extracted data, and evaluated methodological quality of included studies. Then meta-analysis was performed using RevMan 5.2 software. Results A total of 32 studies involving 1 543 patients were included. The results of meta-analysis showed that: the efficacy of cetuximab in patients with skin rashes was significantly superior to patients without skin rashes (RR=1.53, 95%CI 1.23 to 1.91, P=0.000 2); in addition, the efficacy of cetuximab in patients with severe skin rashes was significantly superior to patients with mild skin rashes (RR=2.42, 95%CI 1.89 to 3.11, P<0.000 01). Conclusion Skin rashes are significantly associated with better efficacy of cetuximab.

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Revisión sistemática

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Cetuximab in refractory squamous cell carcinoma of the anal canal.

Año 2014
Autores Rogers JE , Eng C
Revista Journal of gastrointestinal cancer
Enlaces DOI , Pubmed

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Resumen estructurado de revisiones sistemáticas

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Cetuximab for the treatment of head and neck cancer

Año 2011
Revista HTA Database
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RECORD STATUS:

None

CITATION:

National Institute for Health and Clinical Excellence. Cetuximab for the treatment of head and neck cancer. London: National Institute for Health and Clinical Excellence (NICE). Technology Appraisal Guidance 145. 2008

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