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局部晚期头颈部癌同期放化疗与加速超分割放疗的随机 III 期临床试验。

Randomized phase III trial of concurrent chemoradiotherapy vs accelerated hyperfractionation radiotherapy in locally advanced head and neck cancer.

机构信息

Division of Therapeutic Radiology and Oncology, Faculty of Medicine, Chiang Mai University, 110 Intawarorose Road, Chiang Mai, 50200, Thailand.

出版信息

J Radiat Res. 2013 Nov 1;54(6):1110-7. doi: 10.1093/jrr/rrt054. Epub 2013 Jun 5.

DOI:10.1093/jrr/rrt054
PMID:23740894
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC3823777/
Abstract

The aim of this study was to compare the efficacy and safety of concurrent chemoradiotherapy (CCRT) vs accelerated hyperfractionation with concomitant boost (CCB) as a primary treatment for patients with Stage III-IV squamous cell carcinoma of head and neck (SCCHN). A total of 85 non-metastatic advanced SCCHN patients were accrued from January 2003 to December 2007. Of these, 48 and 37 patients received CCRT and CCB, respectively. The patients were randomized to receive either three cycles of carboplatin and 5-fluorouracil plus conventional radiotherapy (CCRT, 66 Gy in 6.5 weeks) or hybrid accelerated radiotherapy (CCB, 70 Gy in 6 weeks). The primary endpoint was determined by locoregional control rate. The secondary endpoints were overall survival and toxicity. With a median follow-up of 43 months (range, 3-102), the 5-year locoregional control rate was 69.6% in the CCRT arm vs 55.0% in the CCB arm (P = 0.184). The 5-year overall survival rate was marginally significantly different (P = 0.05): 76.1% in the CCRT arm vs 63.5% in the CCB arm. Radiotherapy treatment interruptions of more than three days were 60.4% and 40.5% in the CCRT arm and CCB arm, respectively. The median total treatment time was 55.5 days in the CCRT arm and 49 days in the CCB arm. The rate of Grade 3-4 acute mucositis was significantly higher in the CCB arm (67.6% vs 41.7%, P = 0.01), but no high grade hematologic toxicities were found in the CCB arm (27.2% vs 0%). CCRT has shown a trend of improving outcome over CCB irradiation in locoregionally advanced head and neck cancer.

摘要

本研究旨在比较同期放化疗(CCRT)与加速超分割同期加量放疗(CCB)作为局部晚期 III-IV 期头颈部鳞状细胞癌(SCCHN)患者主要治疗手段的疗效和安全性。2003 年 1 月至 2007 年 12 月共纳入 85 例非转移性晚期 SCCHN 患者,其中 48 例和 37 例患者分别接受 CCRT 和 CCB 治疗。患者被随机分为接受三周期卡铂和 5-氟尿嘧啶联合常规放疗(CCRT,66 Gy,6.5 周)或混合加速放疗(CCB,70 Gy,6 周)。主要终点为局部区域控制率。次要终点为总生存率和毒性。中位随访时间为 43 个月(范围,3-102),CCRT 组 5 年局部区域控制率为 69.6%,CCB 组为 55.0%(P=0.184)。5 年总生存率差异有统计学意义(P=0.05):CCRT 组为 76.1%,CCB 组为 63.5%。CCRT 组和 CCB 组放疗中断超过 3 天的比例分别为 60.4%和 40.5%。CCRT 组和 CCB 组的中位总治疗时间分别为 55.5 天和 49 天。CCB 组 3-4 级急性黏膜炎发生率显著高于 CCRT 组(67.6% vs 41.7%,P=0.01),但 CCB 组未发现高等级血液学毒性(27.2% vs 0%)。CCRT 组在局部晚期头颈部癌中的疗效有优于 CCB 照射的趋势。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/47ab/3823777/2706dd7300e0/rrt05403.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/47ab/3823777/753386f9a98b/rrt05401.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/47ab/3823777/1067aa981007/rrt05402.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/47ab/3823777/2706dd7300e0/rrt05403.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/47ab/3823777/753386f9a98b/rrt05401.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/47ab/3823777/1067aa981007/rrt05402.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/47ab/3823777/2706dd7300e0/rrt05403.jpg

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