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

Abstract

Background

concomitant CT-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 3 cycles of Docetaxel 75 mg/m² Day 1; cisplatin 75 mg/m² Day 1; 5FU 750 mg/m²/d Day 1-5. RT consisted of 70 Gy in 7 weeks plus concomitant cisplatin 40 mg/m² weekly.

Results

83 patients were included in the study . Demographics and tumor characteristics were well balanced between both arms. Most of the patients (95%) in the TPF arm received 3 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 years PFS rate was 73.9% in the TPF arm versus 57.2% in the reference arm (HR = 0.44; 95% 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.