中山大学肿瘤防治中心向燕群主任团队研究了nab-紫杉醇、顺铂和卡培他滨治疗复发或转移性鼻咽癌的疗效与安全性。该项研究成果发表在2024年6月19日出版的《英国医学杂志》上。

为了比较nab-紫杉醇、顺铂和卡培他滨（nab-TPC）与吉西他滨和顺铂作为复发或转移性鼻咽癌替代一线治疗方案的有效性和安全性，2019年9月至2022年8月，研究组在中国四家医院进行了一项3期临床、开放标签、多中心、随机试验，招募复发或转移性鼻咽癌的成年人（≥18岁）。将患者按1:1的比例随机接受nab-紫杉醇（第1天200 g/m²）、顺铂（第1天达60 mg/m²）和卡培他滨（第1-14天两次1000 mg/m²）或吉西他滨（第1和第8天1 g/m²）和顺铂（第一天80 mg/m²）的治疗。独立审查委员会将无进展生存率评估为意向治疗人群的主要终点。

在预先指定的中期分析中，中位随访时间为15.8个月（2022年10月31日）。根据独立审查委员会的评估，与吉西他滨和顺铂队列的7.7（6.5至9.0）个月相比，nab-TPC队列的中位无进展生存期为11.3个月（95%置信区间9.7至12.9）。风险比为0.43（95%置信区间0.25至0.73；P=0.002）。nab-TPC队列的客观有效率为83%（34/41），而吉西他滨和顺铂队列为63%（25/40）（P=0.005），nab-TPP队列的缓解持续时间为10.8个月，而吉希他滨和铂队列为6.9个月（P=0.009）。

与治疗相关的3级或4级不良事件，包括白细胞减少症（4/41（10%）vs 13/40（33%）；P=0.02）、中性粒细胞减少症（6/41（15%）vs 16/40（40%）；P=0.01）和贫血（1/41（2%）vs 8/40（20%）；P＝0.01），吉西他滨和顺铂队列的不良事件率均高于nab-TPC队列。两个治疗组均未发生与治疗相关的死亡。存活率和长期毒性仍在评估中，随访时间更长。

研究结果表明，与吉西他滨和顺铂相比，nab-TPC方案对复发或转移性鼻咽癌显示出优越的抗肿瘤疗效和良好的安全性。Nab-TPC应被视为复发或转移性鼻咽癌的标准一线治疗，但仍需要更长的随访时间来确认整体生存的益处。

附：英文原文

Title: Nab-paclitaxel, cisplatin, and capecitabine versus cisplatin and gemcitabine as first line chemotherapy in patients with recurrent or metastatic nasopharyngeal carcinoma: randomised phase 3 clinical trial

Author: Guo-Ying Liu, Yan-Fang Ye, Yao-Fei Jiang, Gina Jinna Chen, Wei-Xiong Xia, Yi-Sheng Huang, Tian-Sheng Gao, Yi-Min Liu, Ya-Ting Hou, Jian-Fei Li, Jia-Hao Liu, Nian Lu, Chang-Long Chen, Liang-Ru Ke, Hu Liang, Wei-Xin Bei, Wang-Zhong Li, Shu-Hui Dong, Qin Liu, Changqing Xie, He-Rui Yao, Yan-Qun Xiang

Issue&Volume: 2024/06/19

Abstract:

Objective To compare the effectiveness and safety of nab-paclitaxel, cisplatin, and capecitabine (nab-TPC) with gemcitabine and cisplatin as an alternative first line treatment option for recurrent or metastatic nasopharyngeal carcinoma.

Design Phase 3, open label, multicentre, randomised trial.

Setting Four hospitals located in China between September 2019 and August 2022.

Participants Adults (≥18 years) with recurrent or metastatic nasopharyngeal carcinoma.

Interventions Patients were randomised in a 1:1 ratio to treatment with either nab-paclitaxel (200 g/m2 on day 1), cisplatin (60 mg/m2 on day 1), and capecitabine (1000 mg/m2 twice on days 1-14) or gemcitabine (1 g/m2 on days 1 and 8) and cisplatin (80 mg/m2 on day 1).

Main outcome measures Progression-free survival was evaluated by the independent review committee as the primary endpoint in the intention-to-treat population.

Results The median follow-up was 15.8 months in the prespecified interim analysis (31 October 2022). As assessed by the independent review committee, the median progression-free survival was 11.3 (95% confidence interval 9.7 to 12.9) months in the nab-TPC cohort compared with 7.7 (6.5 to 9.0) months in the gemcitabine and cisplatin cohort. The hazard ratio was 0.43 (95% confidence interval 0.25 to 0.73; P=0.002). The objective response rate in the nab-TPC cohort was 83% (34/41) versus 63% (25/40) in the gemcitabine and cisplatin cohort (P=0.05), and the duration of response was 10.8 months in the nab-TPC cohort compared with 6.9 months in the gemcitabine and cisplatin cohort (P=0.009). Treatment related grade 3 or 4 adverse events, including leukopenia (4/41 (10%) v 13/40 (33%); P=0.02), neutropenia (6/41 (15%) v 16/40 (40%); P=0.01), and anaemia (1/41 (2%) v 8/40 (20%); P=0.01), were higher in the gemcitabine and cisplatin cohort than in the nab-TPC cohort. No deaths related to treatment occurred in either treatment group. Survival and long term toxicity are still being evaluated with longer follow-up.

Conclusion The nab-TPC regimen showed a superior antitumoural efficacy and favourable safety profile compared with gemcitabine and cisplatin for recurrent or metastatic nasopharyngeal carcinoma. Nab-TPC should be considered the standard first line treatment for recurrent or metastatic nasopharyngeal carcinoma. Longer follow-up is needed to confirm the benefits for overall survival.

DOI: 10.1136/bmj-2023-077890

Source: https://www.bmj.com/content/385/bmj-2023-077890