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,The BMJ

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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
The BMJ ( IF 93.6 ) Pub Date : 2024-06-19 , DOI: 10.1136/bmj-2023-077890
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

Affiliation

Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of NPC Diagnosis and Therapy, Guangzhou, China.
Department of Oncology, Guangdong Provincial Key Laboratory of Malignant Tumor Epigenetics and Gene Regulation, Medical Research Center, Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University, Guangzhou, China.
Clinical Research Design Division, Guangdong Provincial Key Laboratory of Malignant Tumor Epigenetics and Gene Regulation, Medical Research Center, Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University, Guangzhou, China.
Southern University of Science and Technology, Shenzhen, China.
Department of Oncology, Maoming People's Hospital, Maoming, China.
Department of Radiation Oncology, Wuzhou Red Cross Hospital, Wuzhou, China.
Department of Medical Imaging, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of NPC Diagnosis and Therapy, Guangzhou, China
Thoracic and GI Malignancies Branch, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, MD, USA
Medical Research Center, Guangdong Provincial Key Laboratory of Malignant Tumor Epigenetics and Gene Regulation, Medical Research Center, Sun Yat‐Sen Memorial Hospital, Sun Yat‐Sen University, Guangzhou, China

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. Taking into account patient privacy and relevant regulations in China, we have decided against making the database publicly accessible to all. However, the raw database will be securely deposited on the Research Data Deposit public platform ([www.researchdata.org.cn][1]). Researchers interested in using the raw data for scientific research purposes may request access through our corresponding author and database administrator. [1]: http://www.researchdata.org.cn

更新日期：2024-06-19

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