Randomized trial of postoperative adjuvant chemotherapy with or without radiotherapy for carcinoma of the rectum: National Surgical Adjuvant Breast and Bowel Project Protocol R-02
Randomized trial of postoperative adjuvant chemotherapy with or without radiotherapy for carcinoma of the rectum: National Surgical Adjuvant Breast and Bowel Project Protocol R-02
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DOI：
10.1093/jnci/92.5.388
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发表时间：
2000-03-01
影响因子：
10.3
通讯作者：
Fisher, B
中科院分区：
文献类型：
--
作者：
Wolmark, N;Wieand, HS;Fisher, B
背景资料：认为术后放疗和化疗是Dukes' B B期（II期）和Dukes' C期（III期）直肠癌患者可接受的治疗标准，是在缺乏临床试验数据的情况下发展而来的，这些临床试验旨在确定增加放疗是否会改善无病生存率和总生存率。本研究就是为了解决这个问题而进行的。另一个目的是确定在男性中，亚叶酸（LV）调节的5-氟尿嘧啶（5-FU）是否上级5-FU、司莫司汀和长春新碱（MOF）的组合。患者和方法：从1987年9月至1992年12月，符合条件的Dukes' B或C直肠癌患者（n = 694）被纳入国家外科辅助乳腺和肠道项目（NSABP）方案R-02，并接受随访。他们被随机分配接受术后辅助化疗（n = 348）或化疗与术后放疗（n = 346）。所有女性患者（n = 287）均接受5-FU + LV化疗;男性患者接受MOF（n = 207）或5-FU + LV（n = 200），使用分层对数秩统计进行主要分析; P值为双侧，结果：截至1998年9月30日，存活患者的平均研究时间为93个月。术后放疗对无病生存率（P = 0.90）或总生存率（P = 0.89）没有有益的影响，无论使用哪种化疗，尽管它将局部复发的累积发生率从13%降低到5年随访时的8%（P = 0.02）。接受5-FU加LV治疗的男性患者与接受MOF治疗的患者相比，5年无病生存率有统计学显著性获益（55% vs 37%; P = 0.009），但5年总生存率无统计学显著性获益（65% vs 62%; P = 0.17）。结论：Dukes' B和C直肠癌术后放疗加化疗并不能改变远处转移的发生率，尽管与单纯化疗相比，局部复发率降低。
Background: The conviction that postoperative radiotherapy and chemotherapy represent an acceptable standard of care for patients with Dukes' B (stage II) and Dukes' C (stage III) carcinoma of the rectum evolved in the absence of data from clinical trials designed to determine, whether the addition of radiotherapy results in improved disease-free survival and overall survival. This study was carried out to address this issue. An additional aim was to determine whether leucovorin (LV)-modulated 5-fluorouracil (5-FU) is superior to the combination of 5-FU, semustine, and vincristine (MOF) in men. Patients and Methods: Eligible patients (n = 694) with Dukes' B or C carcinoma of the rectum were enrolled in National Surgical Adjuvant Breast and Bowel Project (NSABP) Protocol R-02 from September 1987 through December 1992 and were followed. They were randomly assigned to receive either postoperative adjuvant chemotherapy alone (n = 348) or chemotherapy with postoperative radiotherapy (n = 346). All female patients (n = 287) received 5-FU plus LV chemotherapy; male patients received either MOF (n = 207) or 5-FU plus LV (n = 200), Primary analyses were carried out by use of a stratified log-rank statistic; P values are two-sided, Results: The average time on study for surviving patients is 93 months as of September 30, 1998. Postoperative radiotherapy resulted in no beneficial effect on disease-free survival (P = .90) or overall survival (P = .89), regardless of which chemotherapy was utilized, although it reduced the cumulative incidence of locoregional relapse from 13% to 8% at 5-year follow-up (P = .02). Male patients who received 5-FU plus LV demonstrated a statistically significant benefit in disease-free survival at 5 years compared with those who received MOF (55% versus 37%; P = .009) but not in 5-year overall survival (65% versus 62%; P = .17). Conclusions: The addition of postoperative radiation therapy to chemotherapy in Dukes' B and C rectal cancer did not alter the subsequent incidence of distant disease, although there was a reduction in locoregional relapse when compared with chemotherapy alone.