Long-term results of a randomized trial in locally advanced rectal cancer: no benefit from adding a brachytherapy boost.
Long-term results of a randomized trial in locally advanced rectal cancer: no benefit from adding a brachytherapy boost.
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DOI：
10.1016/j.ijrobp.2014.05.023
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发表时间：
2014-09-01
影响因子：
7
通讯作者：
Jakobsen, Anders
中科院分区：
文献类型：
--
作者：
Appelt, Ane L.;Vogelius, Ivan R.;Ploen, John;Rafaelsen, Soren R.;Lindebjerg, Jan;Havelund, Birgitte M.;Bentzen, Soren M.;Jakobsen, Anders
肿瘤控制和生存率的成熟数据来自于一项随机试验，该试验将近距离放射治疗加至长期新辅助放化疗（CRT）治疗局部晚期直肠癌。2005年3月至2008年11月，248例T3 - 4 N 0 - 2 M0直肠癌患者前瞻性随机接受长期术前CRT（50.4Gy分28次，口服UFT和L-亚叶酸）或相同的CRT方案加近距离放射治疗（10 Gy分2次）。主要试验终点是手术时的病理学完全缓解（pCR）;次要终点包括总生存期（OS）、无进展生存期（PFS）和无局部失败。先前已报告了主要终点的结果。该分析提供了试验丹麦部分224例患者的生存数据。221例患者（对照组111例，近距离放射治疗增强组110例）有数据可供分析，中位随访时间为5.4年。尽管手术时肿瘤缓解显著增加，但未观察到5年OS（70.6% vs 63.6%，HR=1.24，p=0.34）和PFS（63.9% vs 52.0%，HR=1.22，p=0.32）的差异。标准组和近距离放射治疗组5年时无局部失败率分别为93.9%和85.7%（HR=2.60，1.00-6.73，p=0.06）。造口发生率无差异。基于肿瘤消退等级和切缘状态分层的探索性分析表明存在缓解迁移。尽管手术时病理性肿瘤消退增加，但我们观察到晚期结局无获益。当新辅助治疗后进行高质量手术时，改善肿瘤消退并不一定会带来相关的临床获益。
Mature data on tumor control and survival are presented from a randomized trial of the addition of a brachytherapy boost to long-course neoadjuvant chemoradiation (CRT) for locally advanced rectal cancer. Between March 2005 and November 2008, 248 patients withT3-4N0-2M0 rectal cancer were prospectively randomized to either long-course preoperative CRT (50.4Gy in 28 fractions, peroral UFT and L-leucovorin) alone or the same CRT schedule plus a brachytherapy boost (10Gy in 2 fractions). Primary trial endpoint was pathological complete response (pCR) at time of surgery; secondary endpoints included overall survival (OS), progression-free survival (PFS) and freedom from locoregional failure. Results for the primary endpoint have previously been reported. This analysis presents survival data for the 224 patients in the Danish part of the trial. 221 patients (111 control arm, 110 brachytherapy boost arm) had data available for analysis, with a median follow-up of 5.4 years. Despite a significant increase in tumor response at the time of surgery, no differences in 5-year OS (70.6% vs 63.6%, HR=1.24, p=0.34) and PFS (63.9% vs 52.0%, HR=1.22, p=0.32) were observed. Freedom from locoregional failure at 5 years were 93.9% and 85.7% (HR=2.60, 1.00–6.73, p=0.06) in the standard and in the brachytherapy arm, respectively. There was no difference in the prevalence of stoma. Explorative analysis based on stratification for tumor regression grade and resection margin status indicated the presence of response migration. Despite increased pathological tumor regression at the time of surgery, we observed no benefit on late outcome. Improved tumor regression does not necessarily lead to a relevant clinical benefit when the neoadjuvant treatment is followed by high-quality surgery.
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影响因子：
45.3
作者：
Ngan, Samuel Y.;Burmeister, Bryan;Mackay, John
通讯作者：
Mackay, John
影响因子：
9.6
作者：
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影响因子：
45.3
作者：
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通讯作者：
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DOI：
10.1016/j.ijrobp.2011.12.002
发表时间：
2012-06-01
影响因子：
7
作者：
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通讯作者：
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影响因子：
45.3
作者：
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