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吉西他滨和顺铂诱导化疗治疗鼻咽癌的最终总生存分析:一项多中心、随机 III 期试验。

Final Overall Survival Analysis of Gemcitabine and Cisplatin Induction Chemotherapy in Nasopharyngeal Carcinoma: A Multicenter, Randomized Phase III Trial.

机构信息

Department of Radiation Oncology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and Therapy, Guangzhou, People's Republic of China.

Department of Oncology, Cancer Center, Tongji Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.

出版信息

J Clin Oncol. 2022 Aug 1;40(22):2420-2425. doi: 10.1200/JCO.22.00327. Epub 2022 Jun 16.

DOI:10.1200/JCO.22.00327
PMID:35709465
Abstract

JCO We previously reported significantly improved failure-free survival using gemcitabine plus cisplatin induction chemotherapy in locoregionally advanced nasopharyngeal carcinoma. Here, we present the final overall survival (OS) analysis. In this multicenter, randomized trial, patients were assigned to be treated with concurrent chemoradiotherapy alone (standard therapy, n = 238) or gemcitabine and cisplatin induction chemotherapy before concurrent chemoradiotherapy (n = 242). With a median follow-up of 69.8 months, the induction chemotherapy group had a significantly higher 5-year OS (87.9% 78.8%, hazard ratio, 0.51 [95% CI 0.34 to 0.78]; = .001) and a comparable risk of late toxicities (≥ grade 3, 11.3% 11.4%). Notably, the depth of the tumor response to induction chemotherapy correlated significantly and positively with survival (complete response partial response stable/progressive disease, 5-year OS, 100% 88.4% 61.5%, = .005). Besides, patients with a low pretreatment cell-free Epstein-Barr virus DNA load (< 4,000 copies/mL) might not benefit from induction chemotherapy (5-year OS, 90.6% 91.4%, = .77). In conclusion, induction chemotherapy before concurrent chemoradiotherapy improved OS significantly in patients with locally advanced nasopharyngeal carcinoma, without increasing the risk of late toxicities. Tumor response to induction chemotherapy and pretreatment cell-free Epstein-Barr virus DNA might be useful to guide individualized treatment.

摘要

我们之前报道过,在局部晚期鼻咽癌患者中,吉西他滨联合顺铂诱导化疗可显著提高无失败生存率。在此,我们呈现最终的总生存(OS)分析结果。在这项多中心、随机试验中,患者被分配接受单纯同期放化疗(标准治疗组,n=238)或同期放化疗前的吉西他滨和顺铂诱导化疗(n=242)。中位随访 69.8 个月后,诱导化疗组的 5 年 OS 显著更高(87.9% vs. 78.8%,风险比,0.51[95%CI,0.34 至 0.78];P=.001),且晚期毒性的风险相当(≥3 级,11.3% vs. 11.4%)。值得注意的是,肿瘤对诱导化疗的反应深度与生存显著且呈正相关(完全缓解/部分缓解/稳定/进展,5 年 OS,100% vs. 88.4% vs. 61.5%,P=.005)。此外,治疗前细胞游离型 Epstein-Barr 病毒 DNA 载量较低(<4,000 拷贝/mL)的患者可能无法从诱导化疗中获益(5 年 OS,90.6% vs. 91.4%,P=.77)。总之,在局部晚期鼻咽癌患者中,同期放化疗前的诱导化疗显著提高了 OS,且不增加晚期毒性风险。肿瘤对诱导化疗的反应和治疗前细胞游离型 Epstein-Barr 病毒 DNA 可能有助于指导个体化治疗。

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