肿瘤

节拍式卡培他滨辅助治疗局部晚期鼻咽癌的多中心、随机 III 期临床试验

作者:会飞的大胖纸 来源:医学论坛网 日期:2021-06-30
导读

         背景:局部晚期鼻咽癌(NPC)患者尽管在标准治疗(顺铂同步放疗,加或不加诱导化疗)后临床完全缓解率很高,但通常会出现疾病复发。额外辅助化疗的益处仍不清楚。 Background: Patients suffering from locoregionally advanced nasopharyngeal carcinoma (NPC) commonly develop disease recu

关键字:  肿瘤 

背景:局部晚期鼻咽癌(NPC)患者尽管在标准治疗(顺铂同步放疗,加或不加诱导化疗)后临床完全缓解率很高,但通常会出现疾病复发。额外辅助化疗的益处仍不清楚。

 

Background: Patients suffering from locoregionally advanced nasopharyngeal carcinoma (NPC) commonly develop disease recurrence, despite a high rate of complete clinical remission after standard of care (concurrent cisplatin-radiotherapy, with or without induction chemotherapy). The benefit of additional adjuvant chemotherapy remains unclear.

 

方法:入组患者为具有高风险局部晚期 NPC(III 期~IVA 期,除外 T3-4N0 和 T3N1)且在明确放化疗后无局部复发或远处转移的患者,患者在最后一次放疗完成后的 12~16 周内随机分配(1:1)接受卡培他滨(650mg/m2,bid)持续治疗 1 年(节拍式卡培他滨组,n=204)或仅仅观察(标准治疗组,n=203)。主要终点是无复发生存率(RFS)。

 

Methods: Patients with high-risk locoregionally advanced NPC (stage III to IVA, excluding T3-4N0 and T3N1), and with no locoregional disease or distant metastasis after definitive chemoradiotherapy, were eligible. They were randomly assigned (1:1) within 12 to 16 weeks after the last radiation dose to receive either capecitabine at a dose of 650 mg/m2 twice daily for 1 year (metronomic capecitabine group) or observation (standard-therapy group). The primary end point was recurrence-free survival (RFS). The calculated sample size was 201 per group, with an 80% power (two-sided α 0.05) to detect a target hazard ratio (HR) of 0.52.

 

结果:共有406例患者接受了随机分组,其中节律性卡培他滨组204例,标准治疗组202例。中位随访36个月后(相当于从标准治疗开始算起的43个月),节拍器卡培他滨组的估计3年RFS为85.9%,而标准治疗组为76.5%(意向治疗人群;心率0.51,95%置信区间0.32-0.81;P=0.003)。节律性卡培他滨组3级不良事件发生率为17.4%,标准治疗组为5.5%;手足综合征是卡培他滨最常见的不良反应(9.0%)。节律性卡培他滨组出现1例4级中性粒细胞减少。两组都没有治疗相关的死亡。在治疗期间,使用节拍器辅助剂卡培他滨对健康相关的生活质量没有临床意义的恶化。

 

Results: A total of 406 patients underwent randomization, comprising 204 in the metronomic capecitabine group and 202 in the standard-therapy group. After a median follow-up of 36 months (corresponding to 43 months when calculated from the start of standard therapy), the estimated 3-year RFS was 85.9% in the metronomic capecitabine group, as compared with 76.5% in the standard-therapy group (intention-to-treat population; HR 0.51, 95% confidence interval 0.32–0.81; P = 0.003). The incidence of grade 3 adverse events was 17.4% in the metronomic capecitabine group and 5.5% in the standard-therapy group; hand-foot syndrome was the most common adverse event related to capecitabine (9.0%). One grade 4 neutropenia occurred in the metronomic capecitabine group. Neither group sufferd from treatment-related deaths. During treatment, there was no clinically meaningful deterioration of health-related quality of life associated with the use of metronomic adjuvant capecitabine.

 

结论:在放化疗的基础上加用节律性卡培他滨辅助治疗可显著改善局部晚期鼻咽癌的RFS,安全性可控,且不影响生活质量。

 

Conclusions: The addition of metronomic capecitabine as adjuvant therapy to chemoradiotherapy significantly improved RFS in locoregionally advanced NPC, with a manageable safety profile and no compromise to quality of life.

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