Induction therapy with cetuximab plus docetaxel, cisplatin, and 5-fluorouracil (ETPF) in patients with resectable nonmetastatic stage III or IV squamous cell carcinoma of the oropharynx. A GERCOR phase II ECHO-07 study.

Abstract

Induction TPF regimen is a standard treatment option for squamous cell carcinoma (SCC) of the oropharynx. The efficacy and safety of adding cetuximab to induction TPF (ETPF) therapy was evaluated. Patients with nonmetastatic resectable stage III/IV SCC of the oropharynx were treated with weekly cetuximab followed the same day by docetaxel and cisplatin and by a continuous infusion of 5-fluorouracil on days 1-5 (every 3 weeks, 3 cycles). The primary endpoint was clinical and radiological complete response (crCR) of primary tumor at 3 onths. Secondary endpoints were crCR rates, overall response, pathological CR, progression-free survival, overall survival, and safety. Forty-two patients were enrolled, and 41 received ETPF. The all nine planned cetuximab doses and the full three doses of planned chemotherapy were completed in 31 (76%) and 36 (88%) patients, respectively. Twelve (29%) patients required dose reduction. The crCR of primary tumor at the completion of therapy was observed in nine (22%) patients. ETPF was associated with a tumor objective response rate (ORR) of 58%. The most frequent grade 3-4 toxicities were as follows: nonfebrile neutropenia (39%), febrile neutropenia (19%), diarrhea (10%), and stomatitis (12%). Eighteen (44%) patients experienced acne-like skin reactions of any grade. One toxic death occurred secondary to chemotherapy-induced colitis with colonic perforation. This phase II study reports an interesting response rate for ETPF in patients with moderately advanced SCC of the oropharynx. The schedule of ETPF evaluated in this study cannot be recommended at this dosage.

• Authors: Benoist Chibaudel, Roger Lacave, Marine Lefevre, Patrick Soussan, Martine Antoine, Sophie Périé, Jean-Baptiste Belloc, Alain Banal, Sébastien Albert, Frédéric Chabolle, Philippe Céruse, Philippe Baril, Michel Gatineau, Martin Housset, Rachel Moukoko, Magdalena Benetkiewicz, Aimery de Gramont, Franck Bonnetain, Jean Lacau St Guily
• Journal: Cancer medicine (Cancer Med) Vol. 4 Issue 5 Pg. 721-31 (May 2015) ISSN: 2045-7634 [Electronic] United States
• PMID: 25684313 (Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)
• Copyright: © 2015 The Authors. Cancer Medicine published by John Wiley & Sons Ltd.

Chemical References

• Taxoids
• Docetaxel
• Cetuximab
• Cisplatin
• Fluorouracil

Topics

• Antineoplastic Combined Chemotherapy Protocols (adverse effects, therapeutic use)
• Carcinoma, Squamous Cell (drug therapy, mortality, pathology)
• Cetuximab (administration & dosage)
• Cisplatin (administration & dosage)
• Docetaxel
• Female
• Fluorouracil (administration & dosage)
• Humans
• Induction Chemotherapy
• Male
• Middle Aged
• Neoplasm Grading
• Neoplasm Metastasis
• Neoplasm Staging
• Oropharyngeal Neoplasms (drug therapy, mortality, pathology)
• Taxoids (administration & dosage)
• Treatment Outcome