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

Details

Serval ID
serval:BIB_F9BF3F128D15
Type
Article: article from journal or magazin.
Collection
Publications
Institution
Title
A randomized trial of induction docetaxel-cisplatin-5FU followed by concomitant cisplatin-RT versus concomitant cisplatin-RT in nasopharyngeal carcinoma (GORTEC 2006-02).
Journal
Annals of oncology
Author(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.
Working group(s)
GORTEC
ISSN
1569-8041 (Electronic)
ISSN-L
0923-7534
Publication state
Published
Issued date
01/03/2018
Peer-reviewed
Oui
Volume
29
Number
3
Pages
731-736
Language
english
Notes
Publication types: Clinical Trial, Phase III ; Journal Article ; Multicenter Study ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
Publication Status: ppublish
Abstract
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.
Keywords
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
Create date
14/12/2017 18:03
Last modification date
20/08/2019 17:25
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