Cetuximab, docetaxel, and cisplatin as first-line treatment in patients with recurrent or metastatic head and neck squamous cell carcinoma: a multicenter, phase II GORTEC study.

Détails

ID Serval
serval:BIB_29534AACA585
Type
Article: article d'un périodique ou d'un magazine.
Collection
Publications
Titre
Cetuximab, docetaxel, and cisplatin as first-line treatment in patients with recurrent or metastatic head and neck squamous cell carcinoma: a multicenter, phase II GORTEC study.
Périodique
Annals of oncology : official journal of the European Society for Medical Oncology
Auteur(s)
Guigay J., Fayette J., Dillies A.F., Sire C., Kerger J.N., Tennevet I., Machiels J.P., Zanetta S., Pointreau Y., Bozec Le Moal L., Henry S., Schilf A., Bourhis J.
ISSN
1569-8041 (Electronic)
ISSN-L
0923-7534
Statut éditorial
Publié
Date de publication
09/2015
Volume
26
Numéro
9
Pages
1941-1947
Langue
anglais
Notes
Publication types: Clinical Trial, Phase II ; Journal Article ; Multicenter Study ; Research Support, Non-U.S. Gov't
Publication Status: ppublish
Résumé
Cetuximab in combination with platinum and 5-fluorouracil is the standard of care in the first-line treatment of patients with recurrent/metastatic head and neck squamous cell carcinoma (HNSCC). Cetuximab and taxane combinations have shown promising activity. This study evaluated the efficacy and safety of four cycles of docetaxel associated with cisplatin and cetuximab (TPEx), followed by maintenance with cetuximab every 2 weeks.
Patients with a histologically confirmed HNSCC with metastasis or recurrence unsuitable for locoregional curative treatment received docetaxel and cisplatin (75 mg/m(2) both) at day 1 and weekly cetuximab 250 mg/m(2) (loading dose of 400 mg/m(2)), repeated every 21 days for four cycles, followed by maintenance cetuximab 500 mg/m(2) every 2 weeks until progression or unacceptable toxicity. Prophylactic administration of granulocyte colony-stimulating factor was done systematically after each chemotherapy cycle. Patients had a good general status (performance status ≤1) and were under 71 years. Prior total doses of cisplatin exceeding 300 mg/m(2) were not allowed. The primary end point was objective response rate (ORR) after four cycles.
Fifty-four patients were enrolled. The primary end point was met with an ORR of 44.4% (95% CI 30.9-58.6). Median overall and progression-free survivals were, respectively, 14 months (95% CI 11.3-17.3) and 6.2 months (95% CI 5.4-7.2). The most common grade 3/4 adverse events were skin rash (16.6%) and non-febrile neutropenia (20.4%). There were one pulmonary embolism and two infectious events leading to death.
The TPEx regimen showed promising activity as first-line treatment in fit patients with recurrent/metastatic HNSCC. Further studies are needed to compare the TPEx versus EXTREME regimen in this population.
NCT01289522.

Mots-clé
Adult, Aged, Antineoplastic Combined Chemotherapy Protocols/adverse effects, Antineoplastic Combined Chemotherapy Protocols/therapeutic use, Carcinoma, Squamous Cell/drug therapy, Cetuximab/adverse effects, Cetuximab/therapeutic use, Cisplatin/adverse effects, Cisplatin/therapeutic use, Disease Progression, Disease-Free Survival, Drug Administration Schedule, Female, Granulocyte Colony-Stimulating Factor/therapeutic use, Head and Neck Neoplasms/drug therapy, Humans, Male, Middle Aged, Neoplasm Recurrence, Local/drug therapy, Taxoids/adverse effects, Taxoids/therapeutic use
Pubmed
Création de la notice
13/02/2017 17:30
Dernière modification de la notice
20/08/2019 13:09
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