Cetuximab plus cisplatin–5-fluorouracil versus cisplatin–5-fluorouracil alone in first-line metastatic squamous cell carcinoma of the esophagus: a randomized phase II study of the Arbeitsgemeinschaft Internistische Onkologie

• Published in: Annals of oncology Vol. 20; no. 10; pp. 1667 - 1673
• Main Authors: Lorenzen, S., Schuster, T., Porschen, R., Al-Batran, S.-E., Hofheinz, R., Thuss-Patience, P., Moehler, M., Grabowski, P., Arnold, D., Greten, T., Müller, L., Röthling, N., Peschel, C., Langer, R., Lordick, F.
• Format: Journal Article
• Language: English
• Published: England Elsevier Ltd 01.10.2009; Oxford University Press; Oxford Publishing Limited (England)
• Subjects: Adult; Aged; Antibodies, Monoclonal - administration & dosage; Antibodies, Monoclonal - adverse effects; Antibodies, Monoclonal, Humanized; Antineoplastic Combined Chemotherapy Protocols - adverse effects; Antineoplastic Combined Chemotherapy Protocols - therapeutic use; Carcinoma, Squamous Cell - drug therapy; Carcinoma, Squamous Cell - pathology; Carcinoma, Squamous Cell - secondary; Cetuximab; chemotherapy; Cisplatin - administration & dosage; Cisplatin - adverse effects; Combined Modality Therapy; Cross-Over Studies; Diarrhea - chemically induced; Disease-Free Survival; Dose-Response Relationship, Drug; esophageal cancer; Esophageal Neoplasms - drug therapy; Esophageal Neoplasms - pathology; Esophageal Neoplasms - secondary; Female; Fluorouracil - administration & dosage; Fluorouracil - adverse effects; Follow-Up Studies; Humans; Kaplan-Meier Estimate; KRAS mutation; Male; Middle Aged; Nausea - chemically induced; Neutropenia - chemically induced; squamous cell carcinoma; Survival Analysis; Time Factors; Treatment Outcome; KRAS mutation; cetuximab; esophageal cancer; chemotherapy; squamous cell carcinoma; mutation
• ISSN: 0923-7534; 1569-8041
• DOI: 10.1093/annonc/mdp069

This study assessed the activity of the mAb cetuximab in combination with cisplatin and 5-fluorouracil (5-FU) in advanced esophageal squamous cell carcinoma. For a maximum of six 29-day cycles, patients received cisplatin 100 mg/m2, day 1, plus 5-FU 1000 mg/m2, days 1–5 (CF), either alone or in combination with cetuximab (CET–CF; 400 mg/m2 initial dose followed by 250 mg/m2 weekly thereafter). The primary end point was tumor response. Tumor material was obtained for analysis of KRAS mutation status. Sixty-two eligible patients were included, 32 receiving CET–CF and 30 CF. Cetuximab did not exacerbate grade 3/4 toxicity, except for rash (6% versus 0%) and diarrhea (16% versus 0%). The overall response rate according to RECIST criteria was 19% and 13% and the disease control rate 75% and 57% for the CET–CF and CF arms, respectively. With a median follow-up of 21.5 months, the median progression-free survival was 5.9 and 3.6 months and median overall survival 9.5 and 5.5 months for CET–CF and CF, respectively. No KRAS codon 12/13 tumor mutations were identified in 37 evaluated samples. Cetuximab can be safely combined with CF chemotherapy and may increase the efficacy of standard CF chemotherapy.