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.

Abstract

BACKGROUND:

This study assessed the activity of the mAb cetuximab in combination with cisplatin and 5-fluorouracil (5-FU) in advanced esophageal squamous cell carcinoma.

PATIENTS AND METHODS:

For a maximum of six 29-day cycles, patients received cisplatin 100 mg/m(2), day 1, plus 5-FU 1000 mg/m(2), days 1-5 (CF), either alone or in combination with cetuximab (CET-CF; 400 mg/m(2) initial dose followed by 250 mg/m(2) weekly thereafter). The primary end point was tumor response. Tumor material was obtained for analysis of KRAS mutation status.

RESULTS:

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.

CONCLUSION:

Cetuximab can be safely combined with CF chemotherapy and may increase the efficacy of standard CF chemotherapy.

• Authors: S Lorenzen, T Schuster, R Porschen, S-E Al-Batran, R Hofheinz, P Thuss-Patience, M Moehler, P Grabowski, D Arnold, T Greten, L Müller, N Röthling, C Peschel, R Langer, F Lordick
• Journal: Annals of oncology : official journal of the European Society for Medical Oncology (Ann Oncol) Vol. 20 Issue 10 Pg. 1667-73 (Oct 2009) ISSN: 1569-8041 [Electronic] England
• PMID: 19549707 (Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Antibodies, Monoclonal
• Antibodies, Monoclonal, Humanized
• Cetuximab
• Cisplatin
• Fluorouracil

Topics

• Adult
• Aged
• Antibodies, Monoclonal (administration & dosage, adverse effects)
• Antibodies, Monoclonal, Humanized
• Antineoplastic Combined Chemotherapy Protocols (adverse effects, therapeutic use)
• Carcinoma, Squamous Cell (drug therapy, pathology, secondary)
• Cetuximab
• Cisplatin (administration & dosage, adverse effects)
• Combined Modality Therapy
• Cross-Over Studies
• Diarrhea (chemically induced)
• Disease-Free Survival
• Dose-Response Relationship, Drug
• Esophageal Neoplasms (drug therapy, pathology, secondary)
• Female
• Fluorouracil (administration & dosage, adverse effects)
• Follow-Up Studies
• Humans
• Kaplan-Meier Estimate
• Male
• Middle Aged
• Nausea (chemically induced)
• Neutropenia (chemically induced)
• Survival Analysis
• Time Factors
• Treatment Outcome