Preoperative radiotherapy versus selective postoperative chemoradiotherapy in patients with rectal cancer (MRC CR07 and NCIC-CTG C016): a multicentre, randomised trial.
Preoperative radiotherapy versus selective postoperative chemoradiotherapy in patients with rectal cancer (MRC CR07 and NCIC-CTG C016): a multicentre, randomised trial.
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DOI：
10.1016/s0140-6736(09)60484-0
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发表时间：
2009-03-07
期刊：
影响因子：
168.9
通讯作者：
Parmar, Mahesh
中科院分区：
文献类型：
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作者：
Sebag-Montefiore, David;Stephens, Richard J.;Steele, Robert;Monson, John;Grieve, Robert;Khanna, Subhash;Quirke, Phil;Couture, Jean;de Metz, Catherine;Myint, Arthur Sun;Bessell, Eric;Griffiths, Gareth;Thompson, Lindsay C.;Parmar, Mahesh
术前或术后放疗可降低可手术直肠癌患者局部复发的风险。然而，手术和组织病理学评估的改进意味着放疗的作用需要重新评估。我们比较了短期术前放疗与初始手术和术后选择性放化疗。我们在四个国家的80个中心进行了一项随机试验。1350例可手术的直肠腺癌患者被随机分配，通过最小化程序，进行短期术前放疗（25 Gy分5次，n=674）或初始手术后选择性放化疗（45 Gy分25次，同时使用5-氟尿嘧啶），仅限于累及环切缘的患者（n=676）。主要观察指标为局部复发率。分析的目的是治疗。本次研究已注册，注册号为ISRCTN 28785842。在分析时，包括所有参与者，330例患者死亡（术前放疗组157例，术后选择性放化疗组173例），存活患者的中位随访时间为4年。99例发生局部复发（术前放疗27例，术后选择性放化疗72例）。我们注意到，接受术前放疗的患者局部复发的相对风险降低了61%（风险比[HR] 0.39, 95% CI 0.27 - 0.58, p< 0.0001）， 3年后的绝对差异为6.2% (95% CI 5.3 - 7.1)（术前放疗4.4% vs术后选择性放化疗10.6%）。我们记录了接受术前放疗的患者无病生存率的相对改善为24% (HR 0.76, 95% CI 0.62 - 0.94, p= 0.013)， 3年后的绝对差异为6.0% (95% CI 5.3 - 6·8)（77.5% vs 71.5%）。两组间总生存率无差异（HR 0.91, 95% CI 0.73 - 1.13, p= 0.40）。结合其他随机试验的结果，我们的研究结果提供了令人信服和一致的证据，证明短期术前放疗是可手术直肠癌患者的有效治疗方法。医学研究理事会（联合王国）和加拿大国家癌症研究所。
Preoperative or postoperative radiotherapy reduces the risk of local recurrence in patients with operable rectal cancer. However, improvements in surgery and histopathological assessment mean that the role of radiotherapy needs to be reassessed. We compared short-course preoperative radiotherapy versus initial surgery with selective postoperative chemoradiotherapy. We undertook a randomised trial in 80 centres in four countries. 1350 patients with operable adenocarcinoma of the rectum were randomly assigned, by a minimisation procedure, to short-course preoperative radiotherapy (25 Gy in five fractions; n=674) or to initial surgery with selective postoperative chemoradiotherapy (45 Gy in 25 fractions with concurrent 5-fluorouracil) restricted to patients with involvement of the circumferential resection margin (n=676). The primary outcome measure was local recurrence. Analysis was by intention to treat. This study is registered, number ISRCTN 28785842. At the time of analysis, which included all participants, 330 patients had died (157 preoperative radiotherapy group vs 173 selective postoperative chemoradiotherapy), and median follow-up of surviving patients was 4 years. 99 patients had developed local recurrence (27 preoperative radiotherapy vs 72 selective postoperative chemoradiotherapy). We noted a reduction of 61% in the relative risk of local recurrence for patients receiving preoperative radiotherapy (hazard ratio [HR] 0·39, 95% CI 0·27–0·58, p<0·0001), and an absolute difference at 3 years of 6·2% (95% CI 5·3–7·1) (4·4% preoperative radiotherapy vs 10·6% selective postoperative chemoradiotherapy). We recorded a relative improvement in disease-free survival of 24% for patients receiving preoperative radiotherapy (HR 0·76, 95% CI 0·62–0·94, p=0·013), and an absolute difference at 3 years of 6·0% (95% CI 5·3–6·8) (77·5% vs 71·5%). Overall survival did not differ between the groups (HR 0·91, 95% CI 0·73–1·13, p=0·40). Taken with results from other randomised trials, our findings provide convincing and consistent evidence that short-course preoperative radiotherapy is an effective treatment for patients with operable rectal cancer. Medical Research Council (UK) and the National Cancer Institute of Canada.