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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.
- Source :
-
BMJ (Clinical research ed.) [BMJ] 2024 Jun 19; Vol. 385, pp. e077890. Date of Electronic Publication: 2024 Jun 19. - Publication Year :
- 2024
-
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.<br />Design: Phase 3, open label, multicentre, randomised trial.<br />Setting: Four hospitals located in China between September 2019 and August 2022.<br />Participants: Adults (≥18 years) with recurrent or metastatic nasopharyngeal carcinoma.<br />Interventions: Patients were randomised in a 1:1 ratio to treatment with either nab-paclitaxel (200 g/m <superscript>2</superscript> on day 1), cisplatin (60 mg/m <superscript>2</superscript> on day 1), and capecitabine (1000 mg/m <superscript>2</superscript> twice on days 1-14) or gemcitabine (1 g/m <superscript>2</superscript> on days 1 and 8) and cisplatin (80 mg/m <superscript>2</superscript> on day 1).<br />Main Outcome Measures: Progression-free survival was evaluated by the independent review committee as the primary endpoint in the intention-to-treat population.<br />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.<br />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.<br />Trial Registration: Chinese Clinical Trial Registry ChiCTR1900027112.<br />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.<br /> (© 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.)
- 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
Subjects
Details
- Language :
- English
- ISSN :
- 1756-1833
- Volume :
- 385
- Database :
- MEDLINE
- Journal :
- BMJ (Clinical research ed.)
- Publication Type :
- Academic Journal
- Accession number :
- 38897625
- Full Text :
- https://doi.org/10.1136/bmj-2023-077890