Chemotherapy with preoperative radiotherapy in rectal cancer
Chemotherapy with preoperative radiotherapy in rectal cancer
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DOI：
10.1056/nejmoa060829
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发表时间：
2006-09-14
影响因子：
158.5
通讯作者：
Ollier, Jean-Claude
中科院分区：
文献类型：
--
作者：
Bosset, Jean-Francois;Collette, Laurence;Ollier, Jean-Claude
背景：直肠癌患者术前推荐放疗。我们评估了术前放疗加化疗和术后化疗在直肠癌治疗中的应用。方法：将临床分期为T3或T4的可切除直肠癌患者随机分组，分别接受术前放疗、术前放化疗、术前放疗加术后化疗或术前放化疗加术后化疗。放疗为45戈瑞，持续5周。一个疗程的化疗方案为：每日每平方米体表面积给予氟尿嘧啶350 mg，每日每平方米给予亚叶酸素20 mg，疗程均为5天。术前放化疗组和术前放化疗加术后化疗组，术前放疗联合术前放疗2个疗程；术前放疗术后化疗组和术前放化疗术后化疗组术后共规划4个疗程。主要终点为总生存期。结果：我们入组了1011例患者。术前化疗组（P=0.84）与术后化疗组（P=0.12）的总生存率无显著差异。四组患者5年总生存率均为65.2%。术前、术后或同时接受化疗组的5年累积局部复发发生率分别为8.7%、9.6%和7.6%，未接受化疗组的5年累积局部复发发生率为17.1% （P=0.002）。术前化疗依从率为82.0%，术后化疗依从率为42.9%。结论：在术前接受放疗的直肠癌患者中，术前或术后加用氟尿嘧啶为主的化疗对生存率无显著影响。化疗，无论是在手术前还是手术后进行，对局部控制都有显著的好处。
BACKGROUND:Preoperative radiotherapy is recommended for selected patients with rectal cancer. We evaluated the addition of chemotherapy to preoperative radiotherapy and the use of postoperative chemotherapy in the treatment of rectal cancer.METHODS:We randomly assigned patients with clinical stage T3 or T4 resectable rectal cancer to receive preoperative radiotherapy, preoperative chemoradiotherapy, preoperative radiotherapy and postoperative chemotherapy, or preoperative chemoradiotherapy and postoperative chemotherapy. Radiotherapy consisted of 45 Gy delivered over a period of 5 weeks. One course of chemotherapy consisted of 350 mg of fluorouracil per square meter of body-surface area per day and 20 mg of leucovorin per square meter per day, both given for 5 days. Two courses were combined with preoperative radiotherapy in the group receiving preoperative chemoradiotherapy and the group receiving preoperative chemoradiotherapy and postoperative chemotherapy; four courses were planned postoperatively in the group receiving preoperative radiotherapy and postoperative chemotherapy and the group receiving preoperative chemoradiotherapy and postoperative chemotherapy. The primary end point was overall survival.RESULTS:We enrolled 1011 patients in the trial. There was no significant difference in overall survival between the groups that received chemotherapy preoperatively (P=0.84) and those that received it postoperatively (P=0.12). The combined 5-year overall survival rate for all four groups was 65.2%. The 5-year cumulative incidence rates for local recurrences were 8.7%, 9.6%, and 7.6% in the groups that received chemotherapy preoperatively, postoperatively, or both, respectively, and 17.1% in the group that did not receive chemotherapy (P=0.002). The rate of adherence to preoperative chemotherapy was 82.0%, and to postoperative chemotherapy was 42.9%.CONCLUSIONS:In patients with rectal cancer who receive preoperative radiotherapy, adding fluorouracil-based chemotherapy preoperatively or postoperatively has no significant effect on survival. Chemotherapy, regardless of whether it is administered before or after surgery, confers a significant benefit with respect to local control.