{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,11,1]],"date-time":"2026-11-01T16:58:04Z","timestamp":1793552284854,"version":"4.5.0"},"reference-count":21,"publisher":"BMJ","license":[{"start":{"date-parts":[[2024,6,19]],"date-time":"2024-06-19T00:00:00Z","timestamp":1718755200000},"content-version":"unspecified","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100001809","name":"National Natural Science Foundation of China","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100001809","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100002858","name":"China Postdoctoral Science Foundation","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100002858","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ"],"accepted":{"date-parts":[[2024,4,30]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Objective<\/jats:title>\n                    <jats:p>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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Design<\/jats:title>\n                    <jats:p>Phase 3, open label, multicentre, randomised trial.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Setting<\/jats:title>\n                    <jats:p>Four hospitals located in China between September 2019 and August 2022.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Participants<\/jats:title>\n                    <jats:p>Adults (\u226518 years) with recurrent or metastatic nasopharyngeal carcinoma.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Interventions<\/jats:title>\n                    <jats:p>\n                      Patients were randomised in a 1:1 ratio to treatment with either nab-paclitaxel (200 g\/m\n                      <jats:sup>2<\/jats:sup>\n                      on day 1), cisplatin (60 mg\/m\n                      <jats:sup>2<\/jats:sup>\n                      on day 1), and capecitabine (1000 mg\/m\n                      <jats:sup>2<\/jats:sup>\n                      twice on days 1-14) or gemcitabine (1 g\/m\n                      <jats:sup>2<\/jats:sup>\n                      on days 1 and 8) and cisplatin (80 mg\/m\n                      <jats:sup>2<\/jats:sup>\n                      on day 1).\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Main outcome measures<\/jats:title>\n                    <jats:p>Progression-free survival was evaluated by the independent review committee as the primary endpoint in the intention-to-treat population.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      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%)\n                      <jats:italic>v<\/jats:italic>\n                      13\/40 (33%); P=0.02), neutropenia (6\/41 (15%)\n                      <jats:italic>v<\/jats:italic>\n                      16\/40 (40%); P=0.01), and anaemia (1\/41 (2%)\n                      <jats:italic>v<\/jats:italic>\n                      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.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration<\/jats:title>\n                    <jats:p>Chinese Clinical Trial Registry ChiCTR1900027112.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/bmj-2023-077890","type":"journal-article","created":{"date-parts":[[2024,6,19]],"date-time":"2024-06-19T06:40:25Z","timestamp":1718779225000},"page":"e077890","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":24,"title":["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"],"prefix":"10.1136","volume":"385","author":[{"given":"Guo-Ying","family":"Liu","sequence":"first","affiliation":[{"name":"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"},{"name":"Department of Oncology, Guangdong Provincial Key Laboratory of Malignant Tumor Epigenetics and Gene Regulation, Medical Research Center, Sun Yat\u2010Sen Memorial Hospital, Sun Yat\u2010Sen University, Guangzhou, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yan-Fang","family":"Ye","sequence":"additional","affiliation":[{"name":"Clinical Research Design Division, Guangdong Provincial Key Laboratory of Malignant Tumor Epigenetics and Gene Regulation, Medical Research Center, Sun Yat\u2010Sen Memorial Hospital, Sun Yat\u2010Sen University, Guangzhou, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yao-Fei","family":"Jiang","sequence":"additional","affiliation":[{"name":"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"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gina Jinna","family":"Chen","sequence":"additional","affiliation":[{"name":"Southern University of Science and Technology, Shenzhen, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Wei-Xiong","family":"Xia","sequence":"additional","affiliation":[{"name":"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"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yi-Sheng","family":"Huang","sequence":"additional","affiliation":[{"name":"Department of Oncology, Maoming People's Hospital, Maoming, 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