A randomized trial of induction docetaxel-cisplatin-5FU followed by concomitant cisplatin-RT versus concomitant cisplatin-RT in nasopharyngeal carcinoma (GORTEC 2006-02).

Détails

ID Serval
serval:BIB_F9BF3F128D15
Type
Article: article d'un périodique ou d'un magazine.
Collection
Publications
Titre
A randomized trial of induction docetaxel-cisplatin-5FU followed by concomitant cisplatin-RT versus concomitant cisplatin-RT in nasopharyngeal carcinoma (GORTEC 2006-02).
Périodique
Annals of oncology
Auteur(s)
Frikha M., Auperin A., Tao Y., Elloumi F., Toumi N., Blanchard P., Lang P., Sun S., Racadot S., Thariat J., Alfonsi M., Tuchais C., Cornely A., Moussa A., Guigay J., Daoud J., Bourhis J.
Collaborateur(s)
GORTEC
ISSN
1569-8041 (Electronic)
ISSN-L
0923-7534
Statut éditorial
Publié
Date de publication
01/03/2018
Peer-reviewed
Oui
Volume
29
Numéro
3
Pages
731-736
Langue
anglais
Notes
Publication types: Clinical Trial, Phase III ; Journal Article ; Multicenter Study ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
Publication Status: ppublish
Résumé
Concomitant chemotherapy (CT)-radiotherapy (RT) is a standard of care in locally advanced nasopharyngeal carcinoma (NPC) and a role for induction CT is not established.
Patients with locally advanced NPC, WHO type 2 or 3, were randomized to induction TPF plus concomitant cisplatin-RT or concomitant cisplatin-RT alone. The TPF regimen consisted of three cycles of Docetaxel 75 mg/m2 day 1; cisplatin 75 mg/m2 day 1; 5FU 750 mg/m2/day days 1-5. RT consisted of 70 Gy in 7 weeks plus concomitant cisplatin 40 mg/m2 weekly.
A total of 83 patients were included in the study. Demographics and tumour characteristics were well balanced between both arms. Most of the patients (95%) in the TPF arm received three cycles of induction CT. The rate of grade 3-4 toxicity and the compliance (NCI-CTCAE v3) during cisplatin-RT were not different between both arms. With a median follow-up of 43.1 months, the 3-year PFS rate was 73.9% in the TPF arm versus 57.2% in the reference arm [hazard ratio (HR) = 0.44; 95% confidence interval (CI): 0.20-0.97, P = 0.042]. Similarly the 3 years overall survival rate was 86.3% in the TPF arm versus 68.9% in the reference arm (HR = 0.40; 95% CI: 0.15-1.04, P = 0.05).
In conclusion, several important aspects can be emphasized: the compliance to induction TPF was good and TPF did not compromise the tolerance of the concomitant RT-cisplatin phase. The improved PFS and overall survival rates needs to be confirmed by further trials.
Mots-clé
Adult, Aged, Antineoplastic Combined Chemotherapy Protocols/administration & dosage, Antineoplastic Combined Chemotherapy Protocols/adverse effects, Chemoradiotherapy/methods, Cisplatin/administration & dosage, Cisplatin/adverse effects, Docetaxel/administration & dosage, Docetaxel/adverse effects, Female, Fluorouracil/administration & dosage, Fluorouracil/adverse effects, Humans, Induction Chemotherapy/adverse effects, Induction Chemotherapy/methods, Kaplan-Meier Estimate, Male, Middle Aged, Nasopharyngeal Carcinoma/drug therapy, Nasopharyngeal Carcinoma/mortality, Nasopharyngeal Carcinoma/radiotherapy, Nasopharyngeal Neoplasms/drug therapy, Nasopharyngeal Neoplasms/mortality, Nasopharyngeal Neoplasms/radiotherapy
Pubmed
Web of science
Création de la notice
14/12/2017 18:03
Dernière modification de la notice
23/04/2019 6:26
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