1. 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
-
Liu GY, Ye YF, Jiang YF, Chen GJ, Xia WX, Huang YS, Gao TS, Liu YM, Hou YT, Li JF, Liu JH, Lu N, Chen CL, Ke LR, Liang H, Bei WX, Li WZ, Dong SH, Liu Q, Xie C, Yao HR, and Xiang YQ
- Subjects
- Humans, Male, Middle Aged, Female, Adult, Aged, Progression-Free Survival, China, Neoplasm Metastasis, Cisplatin administration & dosage, Cisplatin therapeutic use, Cisplatin adverse effects, Gemcitabine, Nasopharyngeal Carcinoma drug therapy, Nasopharyngeal Carcinoma mortality, Deoxycytidine analogs & derivatives, Deoxycytidine administration & dosage, Deoxycytidine therapeutic use, Antineoplastic Combined Chemotherapy Protocols therapeutic use, Capecitabine therapeutic use, Capecitabine administration & dosage, Nasopharyngeal Neoplasms drug therapy, Nasopharyngeal Neoplasms mortality, Neoplasm Recurrence, Local drug therapy, Paclitaxel administration & dosage, Paclitaxel therapeutic use, Paclitaxel adverse effects, Albumins administration & dosage, Albumins adverse effects, Albumins therapeutic use
- 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/m
2 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., Trial Registration: Chinese Clinical Trial Registry ChiCTR1900027112., Competing Interests: Competing interests: All authors have completed the ICMJE uniform disclosure form at www.icmje.org/disclosure-of-interest/ and declare: support from the Guangdong Basic and Applied Basic Research Foundation, National Natural Science Foundation of China, CPSF, and Postdoctoral Fellowship Program of CPSF for the submitted work; no financial relationships with any organisations that might have an interest in the submitted work in the previous three years; no other relationships or activities that could appear to have influenced the submitted work., (© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)- Published
- 2024
- Full Text
- View/download PDF