title: 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: Division of Medical Oncology, Franco-British Hospital Institute, Levallois-Perret, France.|GERCOR (Cooperator Multidisciplinary Oncology Group), Paris, France.|GERCOR-IRC (GERCOR-Innovative Research Consortium), Paris, France.
authors: Benoist
authors: B
authors: Chibaudel
authors: Department of Histology and Tumor Biology, Hospital Tenon, Paris, France.|ER2 Division, University Pierre et Marie Curie, Paris, France.|Clinical Research Group (GRC), Hospital Tenon, Paris, France.
authors: Roger
authors: R
authors: Lacave
authors: Division of Anatomic Pathology, Hospital Tenon, Paris, France.
authors: Marine
authors: M
authors: Lefevre
authors: Unit of Virology, Hospital Tenon, Paris, France.
authors: Patrick
authors: P
authors: Soussan
authors: Division of Anatomic Pathology, Hospital Tenon, Paris, France.
authors: Martine
authors: M
authors: Antoine
authors: Department of Otorhinolaryngology-Cervicofacial Surgery, Hospital Tenon, Paris, France.
authors: Sophie
authors: S
authors: Périé
authors: Department of Otorhinolaryngology-Maxillofacial Surgery, Hospital Simone Veil, Montmorency, France.
authors: Jean-Baptiste
authors: JB
authors: Belloc
authors: Department of Otorhinolaryngology-Head and Neck Surgery, Centre René Huguenin, Saint-Cloud, France.
authors: Alain
authors: A
authors: Banal
authors: Department of Otorhinolaryngology-Head and Neck Surgery, Hospital Bichat-Claude Bernard, Paris, France.
authors: Sébastien
authors: S
authors: Albert
authors: Department of Otolaryngology and Cervicofacial Surgery, Hospital Foch, Suresnes, France.
authors: Frédéric
authors: F
authors: Chabolle
authors: Department of Otorhinolaryngology-Cervicofacial Surgery, Hospital center Lyon-Sud, Lyon, France.
authors: Philippe
authors: P
authors: Céruse
authors: Department of Otorhinolaryngology-Head and Neck Surgery, Hospital Delafontaine, Saint-Denis, France.
authors: Philippe
authors: P
authors: Baril
authors: Medical Oncology Service, Groupe Hospitalier Saint Joseph, Paris, France.
authors: Michel
authors: M
authors: Gatineau
authors: Department of Radiation Oncology, Georges Pompidou European Hospital, Paris, France.
authors: Martin
authors: M
authors: Housset
authors: GERCOR (Cooperator Multidisciplinary Oncology Group), Paris, France.
authors: Rachel
authors: R
authors: Moukoko
authors: GERCOR (Cooperator Multidisciplinary Oncology Group), Paris, France.
authors: Magdalena
authors: M
authors: Benetkiewicz
authors: Division of Medical Oncology, Franco-British Hospital Institute, Levallois-Perret, France.|GERCOR (Cooperator Multidisciplinary Oncology Group), Paris, France.|GERCOR-IRC (GERCOR-Innovative Research Consortium), Paris, France.
authors: Aimery
authors: A
authors: de Gramont
authors: Methodological and Quality of Life in Oncology Unit (EA3181) & Quality of Life and Cancer Clinical Research Platform, Besançon University Hospital, Besançon, France.
authors: Franck
authors: F
authors: Bonnetain
authors: ER2 Division, University Pierre et Marie Curie, Paris, France.|Clinical Research Group (GRC), Hospital Tenon, Paris, France.|Department of Otorhinolaryngology-Cervicofacial Surgery, Hospital Tenon, Paris, France.
authors: Jean
authors: J
authors: Lacau St Guily
mesh_terms: D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology*; D000068818:Cetuximab / Q000008:administration & dosage; D002945:Cisplatin / Q000008:administration & dosage; D000077143:Docetaxel; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage; D006801:Humans; D060828:Induction Chemotherapy; D008297:Male; D008875:Middle Aged; D060787:Neoplasm Grading; D009362:Neoplasm Metastasis; D009367:Neoplasm Staging; D009959:Oropharyngeal Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology*; D043823:Taxoids / Q000008:administration & dosage; D016896:Treatment Outcome
chemical_list: D043823:Taxoids; D000077143:Docetaxel; D000068818:Cetuximab; D002945:Cisplatin; D005472:Fluorouracil
keywords: Cetuximab; chemotherapy; induction therapy; oropharyngeal cancer; papillomavirus