Gemcitabine and Cisplatin Induction Chemotherapy in Nasopharyngeal Carcinoma
| العنوان: | Gemcitabine and Cisplatin Induction Chemotherapy in Nasopharyngeal Carcinoma |
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| المؤلفون: | Qiong-Fei Su, Na Liu, Mei Shi, Xu Liu, Yu Pei Chen, Lei Chen, Fei Han, Hao-Yuan Mo, Ling Li, Yuan Zhang, Yun Xiao, Weihan Hu, Melvin L.K. Chua, Jian Zang, Guoqing Hu, Jia-Wei Lv, Li Zou, Ying Sun, Jin-Hua Long, Cheng Xu, Jin-Gao Li, Feng Jin, Ye Tian, Ling-Long Tang, Kunyu Yang, Yan Ping Mao, Jun Ma, Rui Guo, Xiao-Jing Du, Xiao-Dong Zhu, Bao-Min Zheng, Guan-Qun Zhou, Qiao-Dan Liu, Yu-Hong Li, Rui Sun, Wen-Fei Li, Shao-Qiang Liang, Zhi-Bin Cheng, Yan Sun, Ying-Qin Li, Guo-Xian Long, Ying Guo, Ning Zhang, Fang-Yun Xie, Jing Huang, Xicheng Wang, Si-Yang Wang |
| المصدر: | New England Journal of Medicine. 381:1124-1135 |
| بيانات النشر: | Massachusetts Medical Society, 2019. |
| سنة النشر: | 2019 |
| مصطلحات موضوعية: | Adult, Male, Oncology, medicine.medical_specialty, Standard of care, Adolescent, 030204 cardiovascular system & hematology, Deoxycytidine, Young Adult, 03 medical and health sciences, 0302 clinical medicine, Internal medicine, Antineoplastic Combined Chemotherapy Protocols, Humans, Medicine, 030212 general & internal medicine, Cisplatin, Nasopharyngeal Carcinoma, business.industry, Induction chemotherapy, Chemoradiotherapy, Induction Chemotherapy, Leukopenia, General Medicine, Middle Aged, medicine.disease, Survival Analysis, Gemcitabine, Concurrent chemoradiotherapy, Nasopharyngeal carcinoma, Multicenter study, Female, business, medicine.drug |
| الوصف: | Platinum-based concurrent chemoradiotherapy is the standard of care for patients with locoregionally advanced nasopharyngeal carcinoma. Additional gemcitabine and cisplatin induction chemotherapy has shown promising efficacy in phase 2 trials.In a parallel-group, multicenter, randomized, controlled, phase 3 trial, we compared gemcitabine and cisplatin as induction chemotherapy plus concurrent chemoradiotherapy with concurrent chemoradiotherapy alone. Patients with locoregionally advanced nasopharyngeal carcinoma were randomly assigned in a 1:1 ratio to receive gemcitabine (at a dose of 1 g per square meter of body-surface area on days 1 and 8) plus cisplatin (80 mg per square meter on day 1), administered every 3 weeks for three cycles, plus chemoradiotherapy (concurrent cisplatin at a dose of 100 mg per square meter every 3 weeks for three cycles plus intensity-modulated radiotherapy) or chemoradiotherapy alone. The primary end point was recurrence-free survival (i.e., freedom from disease recurrence [distant metastasis or locoregional recurrence] or death from any cause) in the intention-to-treat population. Secondary end points included overall survival, treatment adherence, and safety.A total of 480 patients were included in the trial (242 patients in the induction chemotherapy group and 238 in the standard-therapy group). At a median follow-up of 42.7 months, the 3-year recurrence-free survival was 85.3% in the induction chemotherapy group and 76.5% in the standard-therapy group (stratified hazard ratio for recurrence or death, 0.51; 95% confidence interval [CI], 0.34 to 0.77; P = 0.001). Overall survival at 3 years was 94.6% and 90.3%, respectively (stratified hazard ratio for death, 0.43; 95% CI, 0.24 to 0.77). A total of 96.7% of the patients completed three cycles of induction chemotherapy. The incidence of acute adverse events of grade 3 or 4 was 75.7% in the induction chemotherapy group and 55.7% in the standard-therapy group, with a higher incidence of neutropenia, thrombocytopenia, anemia, nausea, and vomiting in the induction chemotherapy group. The incidence of grade 3 or 4 late toxic effects was 9.2% in the induction chemotherapy group and 11.4% in the standard-therapy group.Induction chemotherapy added to chemoradiotherapy significantly improved recurrence-free survival and overall survival, as compared with chemoradiotherapy alone, among patients with locoregionally advanced nasopharyngeal carcinoma. (Funded by the Innovation Team Development Plan of the Ministry of Education and others; ClinicalTrials.gov number, NCT01872962.). |
| تدمد: | 1533-4406 0028-4793 |
| URL الوصول: | https://explore.openaire.eu/search/publication?articleId=doi_dedup___::3d835149110137548644d18be9484b9d https://doi.org/10.1056/nejmoa1905287 |
| حقوق: | OPEN |
| رقم الأكسشن: | edsair.doi.dedup.....3d835149110137548644d18be9484b9d |
| قاعدة البيانات: | OpenAIRE |
| تدمد: | 15334406 00284793 |
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