%0 Journal Article
%T 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.
%A Liu GY
%A Ye YF
%A Jiang YF
%A Chen GJ
%A Xia WX
%A Huang YS
%A Gao TS
%A Liu YM
%A Hou YT
%A Li JF
%A Liu JH
%A Lu N
%A Chen CL
%A Ke LR
%A Liang H
%A Bei WX
%A Li WZ
%A Dong SH
%A Liu Q
%A Xie C
%A Yao HR
%A Xiang YQ
%J BMJ
%V 385
%N 0
%D 2024 06 19
%M 38897625
暂无%R 10.1136/bmj-2023-077890
%X 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.<BR>Phase 3, open label, multicentre, randomised trial.<BR>Four hospitals located in China between September 2019 and August 2022.<BR>Adults (≥18 years) with recurrent or metastatic nasopharyngeal carcinoma.<BR>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).<BR>Progression-free survival was evaluated by the independent review committee as the primary endpoint in the intention-to-treat population.<BR>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.<BR>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.<BR>Chinese Clinical Trial Registry ChiCTR1900027112.