中山大学肿瘤防治中心马骏教授及其研究团队，开展了一项利用吉西他滨+顺铂（简称GP）方案诱导化疗治疗鼻咽癌局部晚期的大型前瞻性Ⅲ期临床试验。该研究发表在2019年9月18日出版的《新英格兰医学杂志》上。

在这项平行组、多中心、随机、对照、临床3期试验中，研究组共招募了480例鼻咽癌局部晚期患者，按1：1随机分组，其中242名接受吉西他滨和顺铂治疗，每3周一次，共化疗3个周期，进行同步放化疗，3个周期中每3周给予100 mg/m²的顺铂以加强放化疗；238名接受标准治疗，即单纯进行放化疗。

中位随访42.7个月后，诱导化疗组中3年无复发生存率为85.3%，显著高于标准治疗组（76.5%）。诱导化疗组的3年总生存率为94.6%，标准治疗组为90.3%。共有96.7%的患者完成了3个周期的诱导化疗。诱导化疗组中3、4级急性不良反应的发生率为75.7%，标准治疗组为55.7%，诱导化疗组中性粒细胞减少、血小板减少、贫血、恶心和呕吐的发生率较高。诱导化疗组3、4级晚期毒性反应发生率为9.2%，标准治疗组为11.4%。

总之，对于鼻咽癌局部晚期患者，诱导化疗联合同步放化疗与单纯的放化疗相比，可显著提高患者的无复发生存率与总生存率。

据了解，基于铂的同步放化疗是鼻咽癌局部晚期患者的标准治疗方法。

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马骏，男，1963年出生于湖南长沙，中共党员。现任中山大学肿瘤防治中心常务副主任、常务副院长，教授/主任医师、博士研究生导师。专长：肿瘤放射治疗，头颈部肿瘤/鼻咽癌综合治疗。（据中山大学肿瘤防治中心）

附：英文原文

Title: Gemcitabine and Cisplatin Induction Chemotherapy in Nasopharyngeal Carcinoma

Author: Yuan Zhang, Lei Chen, Guo-Qing Hu, Ning Zhang, Xiao-Dong Zhu, Kun-Yu Yang, Feng Jin, Mei Shi, Yu-Pei Chen, Wei-Han Hu, Zhi-Bin Cheng, Si-Yang Wang, Ye Tian, Xi-Cheng Wang, Yan Sun, Jin-Gao Li, Wen-Fei Li, Yu-Hong Li, Ling-Long Tang, Yan-Ping Mao, Guan-Qun Zhou, Rui Sun, Xu Liu, Rui Guo, Guo-Xian Long, Shao-Qiang Liang, Ling Li, Jing Huang, Jin-Hua Long, Jian Zang, Qiao-Dan Liu, Li Zou, Qiong-Fei Su, Bao-Min Zheng, Yun Xiao, Ying Guo, Fei Han, Hao-Yuan Mo, Jia-Wei Lv, Xiao-Jing Du, Cheng Xu, Na Liu, Ying-Qin Li, Melvin L. K. Chua, Fang-Yun Xie, Ying Sun, Jun Ma

Issue&Volume: Vol 381 No 12

Abstract:

Background

Platinum-based concurrent chemoradiotherapy is the standard of care for patients with locoregionally advanced nasopharyngeal carcinoma. Additional gemcitabine and cisplatin induction chemotherapy has shown promising efficacy in phase 2 trials.

Methods

In a parallel-group, multicenter, randomized, controlled, phase 3 trial, we compared gemcitabine and cisplatin as induction chemotherapy plus concurrent chemoradiotherapy with concurrent chemoradiotherapy alone. Patients with locoregionally advanced nasopharyngeal carcinoma were randomly assigned in a 1:1 ratio to receive gemcitabine (at a dose of 1 g per square meter of body-surface area on days 1 and 8) plus cisplatin (80 mg per square meter on day 1), administered every 3 weeks for three cycles, plus chemoradiotherapy (concurrent cisplatin at a dose of 100 mg per square meter every 3 weeks for three cycles plus intensity-modulated radiotherapy) or chemoradiotherapy alone. The primary end point was recurrence-free survival (i.e., freedom from disease recurrence [distant metastasis or locoregional recurrence] or death from any cause) in the intention-to-treat population. Secondary end points included overall survival, treatment adherence, and safety.

Results

A total of 480 patients were included in the trial (242 patients in the induction chemotherapy group and 238 in the standard-therapy group). At a median follow-up of 42.7 months, the 3-year recurrence-free survival was 85.3% in the induction chemotherapy group and 76.5% in the standard-therapy group (stratified hazard ratio for recurrence or death, 0.51; 95% confidence interval [CI], 0.34 to 0.77; P=0.001). Overall survival at 3 years was 94.6% and 90.3%, respectively (stratified hazard ratio for death, 0.43; 95% CI, 0.24 to 0.77). A total of 96.7% of the patients completed three cycles of induction chemotherapy. The incidence of acute adverse events of grade 3 or 4 was 75.7% in the induction chemotherapy group and 55.7% in the standard-therapy group, with a higher incidence of neutropenia, thrombocytopenia, anemia, nausea, and vomiting in the induction chemotherapy group. The incidence of grade 3 or 4 late toxic effects was 9.2% in the induction chemotherapy group and 11.4% in the standard-therapy group.

Conclusions

Induction chemotherapy added to chemoradiotherapy significantly improved recurrence-free survival and overall survival, as compared with chemoradiotherapy alone, among patients with locoregionally advanced nasopharyngeal carcinoma.

DOI: 10.1056/NEJMoa1905287

Source: https://www.nejm.org/doi/full/10.1056/NEJMoa1905287