Preoperative versus postoperative chemoradiotherapy for rectal cancer
Preoperative versus postoperative chemoradiotherapy for rectal cancer
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DOI：
10.1056/nejmoa040694
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发表时间：
2004-10-21
影响因子：
158.5
通讯作者：
Raab, R
中科院分区：
文献类型：
--
作者：
Sauer, R;Becker, H;Raab, R
背景：对于局部晚期直肠癌患者，术后放化疗是推荐的标准治疗方法。近年来，术前放射治疗取得了令人鼓舞的结果。我们对局部晚期直肠癌的术前放化疗和术后放化疗进行了比较。方法：我们随机将临床分期为T3或T4或结节阳性的患者随机分为术前或术后放化疗。术前治疗包括5040cGy180cGy1次/d，每周5天；氟尿嘧啶在放疗后第1周和第5周以每平方米体表面积1000 mg/d持续静脉滴注120h。手术在放化疗结束6周后进行。术后1个月给予氟尿嘧啶500 mg/m2/d，5天为1个周期。术后放化疗组的放化疗相同，只是增加了540cGy量。结果：421例患者被随机分成两组，分别接受术前放化疗和术后放化疗。总的5年生存率分别为76%和74%(P=0.80)，5年累计局部复发率分别为6%和13%(P=0.006)，其中27%的患者出现3~4级急性毒性反应，而术后治疗组为40%(P=0.001)；远期毒副反应发生率分别为14%和24%(P=0.01)。结论：与术后放化疗相比，术前放化疗可提高局部控制率，且毒副反应减少，但不能提高总生存率。
BACKGROUND:Postoperative chemoradiotherapy is the recommended standard therapy for patients with locally advanced rectal cancer. In recent years, encouraging results with preoperative radiotherapy have been reported. We compared preoperative chemoradiotherapy with postoperative chemoradiotherapy for locally advanced rectal cancer.METHODS:We randomly assigned patients with clinical stage T3 or T4 or node-positive disease to receive either preoperative or postoperative chemoradiotherapy. The preoperative treatment consisted of 5040 cGy delivered in fractions of 180 cGy per day, five days per week, and fluorouracil, given in a 120-hour continuous intravenous infusion at a dose of 1000 mg per square meter of body-surface area per day during the first and fifth weeks of radiotherapy. Surgery was performed six weeks after the completion of chemoradiotherapy. One month after surgery, four five-day cycles of fluorouracil (500 mg per square meter per day) were given. Chemoradiotherapy was identical in the postoperative-treatment group, except for the delivery of a boost of 540 cGy. The primary end point was overall survival.RESULTS:Four hundred twenty-one patients were randomly assigned to receive preoperative chemoradiotherapy and 402 patients to receive postoperative chemoradiotherapy. The overall five-year survival rates were 76 percent and 74 percent, respectively (P=0.80).The five-year cumulative incidence of local relapse was 6 percent for patients assigned to preoperative chemoradiotherapy and 13 percent in the postoperative-treatment group (P=0.006).Grade 3 or 4 acute toxic effects occurred in 27 percent of the patients in the preoperative-treatment group, as compared with 40 percent of the patients in the postoperative-treatment group (P=0.001); the corresponding rates of long-term toxic effects were 14 percent and 24 percent, respectively (P=0.01).CONCLUSIONS:Preoperative chemoradiotherapy, as compared with postoperative chemoradiotherapy, improved local control and was associated with reduced toxicity but did not improve overall survival.