PDF(Pubmed)
Abstract：
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.
Phase 3, open label, multicentre, randomised trial.
Four hospitals located in China between September 2019 and August 2022.
Adults (≥18 years) with recurrent or metastatic nasopharyngeal carcinoma.
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).
Progression-free survival was evaluated by the independent review committee as the primary endpoint in the intention-to-treat population.
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.
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.
Chinese Clinical Trial Registry ChiCTR1900027112.
Phase 3, open label, multicentre, randomised trial.
Four hospitals located in China between September 2019 and August 2022.
Adults (≥18 years) with recurrent or metastatic nasopharyngeal carcinoma.
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).
Progression-free survival was evaluated by the independent review committee as the primary endpoint in the intention-to-treat population.
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.
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.
Chinese Clinical Trial Registry ChiCTR1900027112.
摘要：
目的：比较nab-紫杉醇的有效性和安全性，顺铂,和卡培他滨（nab-TPC）联合吉西他滨和顺铂作为复发或转移性鼻咽癌的替代一线治疗选择。
方法：阶段3，开放标签，多中心,随机试验。
方法：2019年9月至2022年8月，中国有四家医院。
方法：患有复发性或转移性鼻咽癌的成人（≥18岁）。
方法：患者以1：1的比例随机分配给nab-紫杉醇（第1天200g/m2），顺铂（第1天60mg/m2），和卡培他滨（第1-14天两次1000mg/m2）或吉西他滨（第1天和第8天1g/m2）和顺铂（第1天80mg/m2）。
方法：由独立审查委员会评估无进展生存期作为意向治疗人群的主要终点。
结果：在预设的中期分析中，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，nab-TPC队列的中位无进展生存期为11.3个月(95%置信区间9.7~12.9个月),而吉西他滨和顺铂队列的中位无进展生存期为7.7个月(6.5~9.0个月).风险比为0.43（95％置信区间为0.25至0.73；P=0.002）。nab-TPC组的客观缓解率为83%（34/41），而吉西他滨和顺铂组的客观缓解率为63%（25/40）（P=0.05），nab-TPC队列的缓解持续时间为10.8个月,而吉西他滨和顺铂队列的缓解持续时间为6.9个月(P=0.009).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％）v13/40（33％）;P=0.02），中性粒细胞减少症（6/41（15％）v16/40（40％）；P=0.01），贫血（1/41（2％）v8/40（20％）；P=0.01），吉西他滨和顺铂队列高于nab-TPC队列。在任一治疗组中均未发生与治疗相关的死亡。生存和长期毒性仍在进行长期随访评估。
结论：与吉西他滨和顺铂相比，nab-TPC方案对复发或转移性鼻咽癌具有更高的抗肿瘤疗效和良好的安全性。Nab-TPC应被视为复发性或转移性鼻咽癌的标准一线治疗方法。需要更长时间的随访以确认总体生存的益处。
背景：中国临床试验注册ChiCTR1900027112.
方法：阶段3，开放标签，多中心,随机试验。
方法：2019年9月至2022年8月，中国有四家医院。
方法：患有复发性或转移性鼻咽癌的成人（≥18岁）。
方法：患者以1：1的比例随机分配给nab-紫杉醇（第1天200g/m2），顺铂（第1天60mg/m2），和卡培他滨（第1-14天两次1000mg/m2）或吉西他滨（第1天和第8天1g/m2）和顺铂（第1天80mg/m2）。
方法：由独立审查委员会评估无进展生存期作为意向治疗人群的主要终点。
结果：在预设的中期分析中，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，nab-TPC队列的中位无进展生存期为11.3个月(95%置信区间9.7~12.9个月),而吉西他滨和顺铂队列的中位无进展生存期为7.7个月(6.5~9.0个月).风险比为0.43（95％置信区间为0.25至0.73；P=0.002）。nab-TPC组的客观缓解率为83%（34/41），而吉西他滨和顺铂组的客观缓解率为63%（25/40）（P=0.05），nab-TPC队列的缓解持续时间为10.8个月,而吉西他滨和顺铂队列的缓解持续时间为6.9个月(P=0.009).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％）v13/40（33％）;P=0.02），中性粒细胞减少症（6/41（15％）v16/40（40％）；P=0.01），贫血（1/41（2％）v8/40（20％）；P=0.01），吉西他滨和顺铂队列高于nab-TPC队列。在任一治疗组中均未发生与治疗相关的死亡。生存和长期毒性仍在进行长期随访评估。
结论：与吉西他滨和顺铂相比，nab-TPC方案对复发或转移性鼻咽癌具有更高的抗肿瘤疗效和良好的安全性。Nab-TPC应被视为复发性或转移性鼻咽癌的标准一线治疗方法。需要更长时间的随访以确认总体生存的益处。
背景：中国临床试验注册ChiCTR1900027112.
