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Ann Oncol. 2018 Mar 1;29(3):731-736. doi: 10.1093/annonc/mdx770.

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

Author information

1
Medical Oncology Department, Sfax University Hospital, Sfax, Tunisia.
2
Department of Statistics, Gustave-Roussy, Villejuif, France.
3
Department of Radiation Oncology, Gustave-Roussy, Villejuif, France.
4
Radiation Oncology Department, Sfax University Hospital, Sfax, Tunisia.
5
Radiation Oncology Department, Pitié Salpetrière, Paris, France.
6
Radiation Oncology Department, Centre Hospitalier Montbeliard, Montbeliard, France.
7
Radiation Oncology Department, Centre L. Bérard, Lyon, France.
8
Department of Oncology, Centre A. Lacassagne, Nice, France.
9
Radiation Oncology Department, Clinique St Catherine, Avignon, France.
10
Radiation Oncology Department, Centre C. Papin, Angers, France.
11
Radiation Oncology Department, CHUV, Lausanne, Switzerland.

Abstract

Background:

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.

Methods:

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.

Results:

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).

Conclusion:

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.

PMID:
29236943
DOI:
10.1093/annonc/mdx770
[Indexed for MEDLINE]

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