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.

中文翻译：

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诱导多西他赛-顺铂-5FU联合顺铂-RT与顺铂-RT在鼻咽癌中的随机试验（GORTEC 2006-02）。

背景技术伴随化疗（CT）放射治疗（RT）是局部晚期鼻咽癌（NPC）的治疗标准，并且尚未确定诱导CT的作用。方法将局部晚期NPC，WHO 2或3型NPC患者随机分为诱导TPF加顺铂-RT或单独顺铂-RT。TPF方案包括第1天3个周期的多西他赛75 mg / m2周期；第1天的顺铂75 mg / m2；5FU 750 mg / m2 /天，第1-5天。RT在7周内由70 Gy加上顺铂40 mg / m2每周组成。结果本研究共纳入83例患者。人口统计学特征和肿瘤特征在两臂之间很平衡。TPF组中的大多数患者（95％）接受了3个周期的诱导CT检查。顺铂-RT期间3-4级毒性反应的发生率和顺应性（NCI-CTCAE v3）在两组之间没有差异。TPF组的中位随访期为43.1个月，三年期PFS率为73.9％，而参考组为37.2％[危险比（HR）= 0.44; 95％置信区间（CI）：0.20-0.97，P = 0.042]。同样，TPF组的3年总生存率为86.3％，而参考组为68.9％（HR = 0.40； 95％CI：0.15-1.04，P = 0.05）。结论总之，可以强调几个重要方面：对诱导TPF的顺应性良好，TPF不会损害伴随的RT-顺铂相的耐受性。PFS和总生存率的提高需要进一步的试验来证实。TPF组为9％，参考组为57.2％[危险比（HR）= 0.44；95％置信区间（CI）：0.20-0.97，P = 0.042]。同样，TPF组的3年总生存率为86.3％，而参考组为68.9％（HR = 0.40； 95％CI：0.15-1.04，P = 0.05）。结论总之，可以强调几个重要方面：对诱导TPF的顺应性良好，TPF不会损害伴随的RT-顺铂相的耐受性。PFS和总生存率的提高需要进一步的试验来证实。TPF组为9％，参考组为57.2％[危险比（HR）= 0.44；95％置信区间（CI）：0.20-0.97，P = 0.042]。同样，TPF组的3年总生存率为86.3％，而参考组为68.9％（HR = 0.40； 95％CI：0.15-1.04，P = 0.05）。结论总之，可以强调几个重要方面：对诱导TPF的顺应性良好，TPF不会损害伴随的RT-顺铂相的耐受性。PFS和总生存率的提高需要进一步的试验来证实。可以强调几个重要方面：诱导TPF的顺应性良好，并且TPF不会损害伴随的顺式-顺铂相的耐受性。PFS和总生存率的提高需要进一步的试验来证实。可以强调以下几个重要方面：诱导TPF的顺应性良好，并且TPF不会损害伴随的RT-顺铂相的耐受性。PFS和总生存率的提高需要进一步的试验来证实。