直肠癌术前与术后放化疗对比

Preoperative versus postoperative chemoradiotherapy for rectal cancer.

作者信息

Sauer Rolf, Becker Heinz, Hohenberger Werner, Rödel Claus, Wittekind Christian, Fietkau Rainer, Martus Peter, Tschmelitsch Jörg, Hager Eva, Hess Clemens F, Karstens Johann-H, Liersch Torsten, Schmidberger Heinz, Raab Rudolf

机构信息

Department of Radiation Therapy, University of Erlangen, Erlangen, Germany.

出版信息

N Engl J Med. 2004 Oct 21;351(17):1731-40. doi: 10.1056/NEJMoa040694.

DOI:10.1056/NEJMoa040694

PMID:15496622

Abstract

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.

摘要

背景

术后放化疗是局部晚期直肠癌患者推荐的标准治疗方法。近年来，有报道称术前放疗取得了令人鼓舞的结果。我们比较了术前放化疗与术后放化疗治疗局部晚期直肠癌的效果。

方法

我们将临床分期为T3或T4或淋巴结阳性疾病的患者随机分配接受术前或术后放化疗。术前治疗包括每天以180 cGy的剂量分多次给予5040 cGy，每周5天，同时给予氟尿嘧啶，在放疗的第一周和第五周期间以每天每平方米体表面积1000 mg的剂量进行120小时持续静脉输注。放化疗完成六周后进行手术。术后一个月，给予四个为期五天的氟尿嘧啶周期（每天每平方米500 mg）。术后治疗组的放化疗相同，只是增加了540 cGy的增强剂量。主要终点是总生存期。

结果

421例患者被随机分配接受术前放化疗，402例患者接受术后放化疗。总体五年生存率分别为76%和74%（P = 0.80）。接受术前放化疗的患者五年局部复发累积发生率为6%，术后治疗组为13%（P = 0.006）。术前治疗组27%的患者出现3级或4级急性毒性反应，而术后治疗组为40%（P = 0.001）；相应的长期毒性反应发生率分别为14%和24%（P = 0.01）。