{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,20]],"date-time":"2026-10-20T14:26:44Z","timestamp":1792506404971,"version":"4.5.0"},"reference-count":32,"publisher":"American Medical Association (AMA)","issue":"11","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JAMA"],"published-print":{"date-parts":[[2025,9,16]]},"abstract":"\n Importance<\/jats:title>\n With the programmed cell death protein 1 (PD-1) blockade toripalimab, omitting highly toxic concurrent cisplatin may be feasible for nasopharyngeal carcinoma (NPC) without compromising survival.<\/jats:p>\n <\/jats:sec>\n \n Objective<\/jats:title>\n To evaluate the efficacy and safety of toripalimab incorporated into induction chemotherapy and radiotherapy, without concurrent cisplatin, for locoregionally advanced NPC.<\/jats:p>\n <\/jats:sec>\n \n Design, Setting, and Participants<\/jats:title>\n Open-label, multicenter, randomized phase 3 clinical trial conducted from August 2021 to July 2022 at 13 hospitals in China, enrolling 532 patients with T4N1M0 or T1-4N2-3M0 NPC; 400 (75.2%) completed the trial per protocol. The final date of follow-up was March 21, 2025.<\/jats:p>\n <\/jats:sec>\n \n Interventions<\/jats:title>\n \n Patients were randomly assigned to either the standard therapy group (n\u2009=\u2009266), receiving toripalimab with gemcitabine-cisplatin induction chemotherapy and concurrent cisplatin-radiotherapy (100 mg\/m\n 2<\/jats:sup>\n triweekly for 2 cycles), or the concurrent cisplatin\u2013sparing group (n\u2009=\u2009266), receiving the same regimen without concurrent cisplatin. The 17 cycles of toripalimab (240 mg triweekly) were distributed across the induction, radiotherapy, and adjuvant phases as 3, 3, and 11 cycles, respectively.\n <\/jats:p>\n <\/jats:sec>\n \n Main Outcomes and Measures<\/jats:title>\n Coprimary end points were failure-free survival (noninferiority margin, 8%) and incidence of all-grade vomiting (superiority design). Secondary end points included overall survival, locoregional recurrence-free survival, distant metastasis\u2013free survival, safety, tumor response, quality of life, and tolerability.<\/jats:p>\n <\/jats:sec>\n \n Results<\/jats:title>\n \n In the 532 patients in the intention-to-treat population (median [IQR] age, 47 [39-54] years; 25.2% women), after a median follow-up of 37.0 (range, 4.0-50.0) months, the concurrent cisplatin\u2013sparing group had a 3-year failure-free survival rate of 88.3% vs 87.6% in the standard therapy group, a difference of 0.7% (lower limit of the 1-sided 95% CI, \u22123.9%;\n P<\/jats:italic>\n \u2009=\u2009.002 for noninferiority; stratified hazard ratio, 0.92 [95% CI, 0.66-1.79]; log-rank\n P<\/jats:italic>\n \u2009=\u2009.73). In the safety analysis, the incidence of all-grade vomiting was significantly lower in the concurrent cisplatin\u2013sparing group vs the standard therapy group (26.2% [68\/260] vs 59.8% [156\/261]; difference, 33.6% [1-sided 95% CI, 26.9%-\u221e];\n P<\/jats:italic>\n \u2009&amp;lt;\u2009.001). Patient-reported quality of life (participation rate, 87.5%) and tolerability (participation rate, 94.7%) were better in the concurrent cisplatin\u2013sparing group, primarily in gastrointestinal, functional, and global health status.\n <\/jats:p>\n <\/jats:sec>\n \n Conclusions and Relevance<\/jats:title>\n In this phase 3 randomized clinical trial, among patients with locoregionally advanced NPC, toripalimab combination therapy without concurrent cisplatin was a feasible treatment with high efficacy in failure-free survival and low toxicity.<\/jats:p>\n <\/jats:sec>\n \n Trial Registration<\/jats:title>\n \n ClinicalTrials.gov Identifier:\n NCT04907370<\/jats:ext-link>\n <\/jats:p>\n <\/jats:sec>","DOI":"10.1001\/jama.2025.13205","type":"journal-article","created":{"date-parts":[[2025,8,21]],"date-time":"2025-08-21T15:00:29Z","timestamp":1755788429000},"page":"973","source":"Crossref","is-referenced-by-count":31,"title":["Toripalimab Combination Therapy Without Concurrent Cisplatin for Nasopharyngeal Carcinoma"],"prefix":"10.1001","volume":"334","author":[{"name":"The DIAMOND Study Group","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Cheng","family":"Xu","sequence":"additional","affiliation":[{"name":"Department of Radiation Oncology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Guangdong Provincial Clinical Research Center for Cancer, Guangzhou, Guangdong, People\u2019s Republic (PR) of China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xiao-Yu","family":"Liang","sequence":"additional","affiliation":[{"name":"Department of Radiation Oncology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Guangdong Provincial Clinical Research Center for Cancer, Guangzhou, Guangdong, People\u2019s Republic (PR) of China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xin-Qiong","family":"Huang","sequence":"additional","affiliation":[{"name":"Department of Radiation Oncology, Xiangya Hospital of Central South University, Changsha, Hunan, PR China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Feng","family":"Jin","sequence":"additional","affiliation":[{"name":"Department of Oncology, Affiliated Hospital of Guizhou Medical University, Affiliated Cancer Hospital of Guizhou Medical University, Guiyang, Guizhou, PR China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kun-Yu","family":"Yang","sequence":"additional","affiliation":[{"name":"Institute of Radiation Oncology, Cancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Hubei Key Laboratory of Precision Radiation Oncology, Wuhan, Hubei, PR China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Guang-Yuan","family":"Hu","sequence":"additional","affiliation":[{"name":"Department of Oncology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, PR China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xiao-Dong","family":"Zhu","sequence":"additional","affiliation":[{"name":"Department of Radiation Oncology, Guangxi Medical University Cancer Hospital, Guangxi Key Laboratory of Early Prevention and Treatment for Regional High-Incidence-Tumor, Nanning, Guangxi, PR China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ying","family":"Wang","sequence":"additional","affiliation":[{"name":"Radiation Oncology Center, Chongqing University Cancer Hospital, Chongqing, PR China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ying","family":"Huang","sequence":"additional","affiliation":[{"name":"Department of Radiation Oncology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Guangdong Provincial Clinical Research Center for Cancer, Guangzhou, Guangdong, People\u2019s Republic (PR) of China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ning","family":"Zhang","sequence":"additional","affiliation":[{"name":"Department of Nasopharyngeal Oncology, First People\u2019s Hospital of Foshan, Foshan, Guangdong, PR China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"De-Sheng","family":"Hu","sequence":"additional","affiliation":[{"name":"Department of Radiation Oncology, Hubei Cancer Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, PR China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ling","family":"Guo","sequence":"additional","affiliation":[{"name":"Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, PR China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Guo-Rong","family":"Zou","sequence":"additional","affiliation":[{"name":"Department of Oncology, The Affiliated Panyu Central Hospital, Guangzhou Medical University, Panyu Institute of Oncology, Guangzhou, Guangdong, PR China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xiao-Zhong","family":"Chen","sequence":"additional","affiliation":[{"name":"Department of Head and Neck Radiotherapy, Zhejiang Cancer Hospital, Hangzhou Institute of Medicine, Chinese Academy of Sciences, Hangzhou, Zhejiang, PR China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shao-Wen","family":"Xiao","sequence":"additional","affiliation":[{"name":"Department of Radiation Oncology, Peking University Cancer Hospital & Institute, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education\/Beijing), Beijing, PR 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