Induction chemotherapy followed by concurrent chemoradiotherapy versus concurrent chemoradiotherapy alone in locoregionally advanced nasopharyngeal carcinoma: long-term results of a phase III multicentre randomised controlled trial
Induction chemotherapy followed by concurrent chemoradiotherapy versus concurrent chemoradiotherapy alone in locoregionally advanced nasopharyngeal carcinoma: long-term results of a phase III multicentre randomised controlled trial
复制标题
诱导化疗后同步放化疗与单独同步放化疗治疗局部晚期鼻咽癌：III 期多中心随机对照试验的长期结果
DOI：
10.1016/j.ejca.2019.07.007
复制
发表时间：
2019-09-01
影响因子：
8.4
通讯作者：
Chen, Ming-Yuan
中科院分区：
文献类型：
--
作者：
Yang, Qi;Cao, Su-Mei;Chen, Ming-Yuan
背景：我们对局部区域晚期鼻咽癌患者进行的初步3年临床试验结果显示，用顺铂和氟尿嘧啶诱导化疗(IC)可提高无瘤生存率(DFS)，但对无远处转移生存率(DMFS)影响不大，但IC对局部无复发生存率和总生存率(OS)的影响无显著差异。在此，我们介绍了5年的随访结果。患者和方法：我们的试验是一项随机开放的III期试验，比较同时放化疗(CCRT)和单纯CCRT在III-IVB期(除T3N0-1外)鼻咽癌患者中的疗效。IC+CCRT组在CCRT前给予顺铂(80 mg/m(2)d1)和氟尿嘧啶(800 mg/m(2)d1~5)，每3周1次，共2个周期。两组均在放疗的同时给予顺铂80 mg/m(2)，每3周一次。主要终点是DFS和DMFS。结果：经过82.6月的中位随访期，单纯放疗组和单纯放疗组的5年无病生存率分别为73.4%(95%可信区间67.7-79.1)和63.1%(95%可信区间56.8-69.4)(p=0.007)。化疗后放疗组的5年DMFS率(82.8%，95%CI77.9~87.7)也明显高于单纯放疗组(73.1%，95%CI67.2~79.0，P=0.014)。我们的最新分析显示了IC的OS益处：IC组的5年OS率为80.8%，其次是CCRT组，而单纯CCRT组的OS率为76.8%(p=0.040)。单纯放疗组发生眼部损伤的比例明显高于先放疗组(16.4%[39/238])，后放疗组为9.7%(23/238)，P=0.029。结论：与单纯放疗组相比，单纯放疗组在局部晚期鼻咽癌患者的DFS、DMFS和OS方面均有较好的远期疗效，因此可推荐用于此类患者。(C)2019爱思唯尔有限公司。保留所有权利。
Background: Initial 3-year results from our clinical trial in locoregionally advanced nasopharyngeal carcinoma (NPC) patients showed that induction chemotherapy (IC) with cisplatin and fluorouracil resulted in improved disease-free survival (DFS) with a marginally significant effect on distant metastasis-free survival (DMFS), but the effect of IC on locoregional relapse-free survival and overall survival (OS) did not differ significantly. Here, we present 5-year follow-up results.Patients and methods: Our trial was a randomised, open-label phase III trial comparing IC followed by concurrent chemoradiotherapy (CCRT) versus CCRT alone in patients with stage III-IVB (except T3N0-1) NPC. The IC followed by CCRT group received cisplatin (80 mg/m(2) d1) and fluorouracil (800 mg/m(2) d1-5) every 3 weeks for two cycles before CCRT. Both groups were treated with 80 mg/m(2) cisplatin every 3 weeks concurrently with radiotherapy. The primary end-points were DFS and DMFS. We did efficacy analyses in the 476 randomised patients (intention-to-treat population).Results: After a median follow-up of 82.6 months, the 5-year DFS rate was 73.4% (95% confidence interval [CI] 67.7-79.1) in the IC followed by CCRT group and 63.1% (95% CI 56.8-69.4) in the CCRT alone group (p = 0.007). The 5-year DMFS rate was also significantly higher in the IC followed by CCRT group (82.8%, 95% CI 77.9-87.7) than in the CCRT alone group (73.1%, 95% CI 67.2-79.0, p = 0.014). Our updated analysis revealed an OS benefit of IC: the 5-year OS rate was 80.8% in the IC followed by CCRT group versus 76.8% in the CCRT alone group (p = 0.040). The proportion of patients with eye damage was significantly higher in the CCRT alone group than the IC followed by CCRT group (16.4% [39/238] versus 9.7% [23/238], p = 0.029).Conclusion: IC followed by CCRT provides long-term DFS, DMFS and OS benefits compared with CCRT alone in locoregionally advanced NPC and, therefore, can be recommended for these patients. (C) 2019 Elsevier Ltd. All rights reserved.