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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

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 cetu...

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Autores principales: Chibaudel, Benoist, Lacave, Roger, Lefevre, Marine, Soussan, Patrick, Antoine, Martine, Périé, Sophie, Belloc, Jean-Baptiste, Banal, Alain, Albert, Sébastien, Chabolle, Frédéric, Céruse, Philippe, Baril, Philippe, Gatineau, Michel, Housset, Martin, Moukoko, Rachel, Benetkiewicz, Magdalena, de Gramont, Aimery, Bonnetain, Franck, Lacau St Guily, Jean
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BlackWell Publishing Ltd 2015
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4430265/
https://www.ncbi.nlm.nih.gov/pubmed/25684313
http://dx.doi.org/10.1002/cam4.408
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author Chibaudel, Benoist
Lacave, Roger
Lefevre, Marine
Soussan, Patrick
Antoine, Martine
Périé, Sophie
Belloc, Jean-Baptiste
Banal, Alain
Albert, Sébastien
Chabolle, Frédéric
Céruse, Philippe
Baril, Philippe
Gatineau, Michel
Housset, Martin
Moukoko, Rachel
Benetkiewicz, Magdalena
de Gramont, Aimery
Bonnetain, Franck
Lacau St Guily, Jean
author_facet Chibaudel, Benoist
Lacave, Roger
Lefevre, Marine
Soussan, Patrick
Antoine, Martine
Périé, Sophie
Belloc, Jean-Baptiste
Banal, Alain
Albert, Sébastien
Chabolle, Frédéric
Céruse, Philippe
Baril, Philippe
Gatineau, Michel
Housset, Martin
Moukoko, Rachel
Benetkiewicz, Magdalena
de Gramont, Aimery
Bonnetain, Franck
Lacau St Guily, Jean
author_sort Chibaudel, Benoist
collection PubMed
description 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 months. 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.
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spelling pubmed-44302652015-05-18 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 Chibaudel, Benoist Lacave, Roger Lefevre, Marine Soussan, Patrick Antoine, Martine Périé, Sophie Belloc, Jean-Baptiste Banal, Alain Albert, Sébastien Chabolle, Frédéric Céruse, Philippe Baril, Philippe Gatineau, Michel Housset, Martin Moukoko, Rachel Benetkiewicz, Magdalena de Gramont, Aimery Bonnetain, Franck Lacau St Guily, Jean Cancer Med Cancer Research 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 months. 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. BlackWell Publishing Ltd 2015-05 2015-02-14 /pmc/articles/PMC4430265/ /pubmed/25684313 http://dx.doi.org/10.1002/cam4.408 Text en © 2015 The Authors. Cancer Medicine published by John Wiley & Sons Ltd. http://creativecommons.org/licenses/by/4.0/ This is an open access article under the terms of the Creative Commons Attribution License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited.
spellingShingle Cancer Research
Chibaudel, Benoist
Lacave, Roger
Lefevre, Marine
Soussan, Patrick
Antoine, Martine
Périé, Sophie
Belloc, Jean-Baptiste
Banal, Alain
Albert, Sébastien
Chabolle, Frédéric
Céruse, Philippe
Baril, Philippe
Gatineau, Michel
Housset, Martin
Moukoko, Rachel
Benetkiewicz, Magdalena
de Gramont, Aimery
Bonnetain, Franck
Lacau St Guily, Jean
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
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
title_full 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
title_fullStr 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
title_full_unstemmed 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
title_short 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
title_sort 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
topic Cancer Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4430265/
https://www.ncbi.nlm.nih.gov/pubmed/25684313
http://dx.doi.org/10.1002/cam4.408
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