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Clinical Trial
. 2024 Jun 19:385:e077890.
doi: 10.1136/bmj-2023-077890.

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

Guo-Ying Liu  1   2 , Yan-Fang Ye  3 , Yao-Fei Jiang  1 , Gina Jinna Chen  4 , Wei-Xiong Xia  1 , Yi-Sheng Huang  5 , Tian-Sheng Gao  6 , Yi-Min Liu  2 , Ya-Ting Hou  5 , Jian-Fei Li  5 , Jia-Hao Liu  6 , Nian Lu  7 , Chang-Long Chen  2 , Liang-Ru Ke  7 , Hu Liang  1 , Wei-Xin Bei  1 , Wang-Zhong Li  1 , Shu-Hui Dong  1 , Qin Liu  1 , Changqing Xie  8 , He-Rui Yao  2   9 , Yan-Qun Xiang  1
Affiliations
Clinical Trial

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

Guo-Ying Liu et al. BMJ. .

Erratum in

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.

Trial registration: Chinese Clinical Trial Registry ChiCTR1900027112.

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Conflict of interest statement

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.

Figures

Fig 1
Fig 1
Consort diagram of study
Fig 2
Fig 2
Kaplan-Meier plots of progression-free survival (top) and duration of response (bottom) assessed by independent review of images from randomly assigned patients. CI=confidence interval; GP=gemcitabine and cisplatin; Nab-TPC=nab-paclitaxel, cisplatin, and capecitabine
Fig 3
Fig 3
Hazard ratio of progression-free survival (nab-TPC over GP) in subgroups according to baseline characteristics. CI=confidence interval; EBV-Epstein-Barr virus; GP=gemcitabine and cisplatin; nab-TPC=paclitaxel, cisplatin, and capecitabine
None
See this image and copyright information in PMC

References

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