EPIC: phase III trial of cetuximab plus irinotecan after fluoropyrimidine and oxaliplatin failure in patients with metastatic colorectal cancer.
Abstract | PURPOSE: PATIENTS AND METHODS: This multicenter, open-label, phase III study randomly assigned 1,298 patients with epidermal growth factor receptor-expressing mCRC who had experienced first-line fluoropyrimidine and oxaliplatin treatment failure to cetuximab (400 mg/m(2) day 1 followed by 250 mg/m(2) weekly) plus irinotecan (350 mg/m(2) every 3 weeks) or irinotecan alone. Primary end point was overall survival (OS); secondary end points included progression-free survival (PFS), response rate (RR), and quality of life (QOL). RESULTS: Median OS was comparable between treatments: 10.7 months (95% CI, 9.6 to 11.3) with cetuximab/ irinotecan and 10.0 months (95% CI, 9.1 to 11.3) with irinotecan alone (hazard ratio [HR], 0.975; 95% CI, 0.854 to 1.114; P = .71). This lack of difference may have been due to post-trial therapy: 46.9% of patients assigned to irinotecan eventually received cetuximab (87.2% of those who did, received it with irinotecan). Cetuximab added to irinotecan significantly improved PFS (median, 4.0 v 2.6 months; HR, 0.692; 95% CI, 0.617 to 0.776; P <or= .0001) and RR (16.4% v 4.2%; P < .0001), and resulted in significantly better scores in the QOL analysis of global health status (P = .047). Cetuximab did not exacerbate toxicity, except for acneform rash, diarrhea, hypomagnesemia, and associated electrolyte imbalances. Neutropenia was the most common severe toxicity across treatment arms. CONCLUSION:
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Authors | Alberto F Sobrero, Joan Maurel, Louis Fehrenbacher, Werner Scheithauer, Yousif A Abubakr, Manfred P Lutz, M Eugenia Vega-Villegas, Cathy Eng, Ernst U Steinhauer, Jana Prausova, Heinz-Josef Lenz, Christophe Borg, Gary Middleton, Hendrik Kröning, Gabriele Luppi, Oliver Kisker, Angela Zubel, Christiane Langer, Justin Kopit, Howard A Burris 3rd |
Journal | Journal of clinical oncology : official journal of the American Society of Clinical Oncology
(J Clin Oncol)
Vol. 26
Issue 14
Pg. 2311-9
(May 10 2008)
ISSN: 1527-7755 [Electronic] United States |
PMID | 18390971
(Publication Type: Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial)
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Chemical References |
- Antibodies, Monoclonal
- Antibodies, Monoclonal, Humanized
- Organoplatinum Compounds
- Pyrimidines
- Oxaliplatin
- Irinotecan
- ErbB Receptors
- Cetuximab
- Camptothecin
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Topics |
- Adult
- Aged
- Aged, 80 and over
- Antibodies, Monoclonal
(administration & dosage, adverse effects)
- Antibodies, Monoclonal, Humanized
- Antineoplastic Combined Chemotherapy Protocols
(adverse effects, therapeutic use)
- Camptothecin
(administration & dosage, adverse effects, analogs & derivatives, therapeutic use)
- Cetuximab
- Colorectal Neoplasms
(drug therapy, pathology)
- Disease-Free Survival
- ErbB Receptors
(biosynthesis)
- Female
- Humans
- Irinotecan
- Male
- Middle Aged
- Neoplasm Metastasis
- Organoplatinum Compounds
(administration & dosage, adverse effects)
- Oxaliplatin
- Pyrimidines
(administration & dosage, adverse effects)
- Quality of Life
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