Randomized phase III trial of whole-abdominal irradiation versus doxorubicin and cisplatin chemotherapy in advanced endometrial carcinoma: A gynecologic oncology group study
Randomized phase III trial of whole-abdominal irradiation versus doxorubicin and cisplatin chemotherapy in advanced endometrial carcinoma: A gynecologic oncology group study
复制标题
DOI：
10.1200/jco.2004.00.7617
复制
发表时间：
2006-01-01
影响因子：
45.3
通讯作者：
Benda, JA
中科院分区：
文献类型：
--
作者：
Randall, ME;Filiaci, VL;Benda, JA
目的比较全腹照射（WAI）和阿霉素-顺铂（AP）化疗对术后残留病变最大2cm的III期或IV期子宫内膜癌患者的治疗效果。患者和方法422例患者进入本试验，在396例可评估患者中，202例随机分配接受WAI治疗，194例分配接受AP治疗。照射剂量为30 Gy，分20次，每次15 Gy增强，化疗包括阿霉素60 mg/m(2)和顺铂50 mg/m(2)每3周，共7个周期，随后顺铂1个周期。结果大多数患者与肿瘤的特征得到了很好的平衡。患者年龄中位数为63岁；50%为子宫内膜样肿瘤，中位随访时间为74个月。经分期调整的进展风险比为0.71，有利于AP （95% Cl, 0.55 ~ 0.91 P）
Purpose To compare whole-abdominal irradiation (WAI) and doxorubicin-cisplatin (AP) chemotherapy in women with stage III or IV endometrial carcinoma having a maximum of 2 cm of postoperative residual disease.Patients and Methods Four hundred twenty-two patients were entered onto this trial, Of 396 assessable patients, 202 were randomly allocated to receive WAI, and 194 were allocated to receive AP. Irradiation dosage was 30 Gy in 20 fractions, with a 15-Gy boost, Chemotherapy consisted of doxorubicin 60 mg/m(2) and cisplatin 50 mg/m(2) every 3 weeks for seven cycles, followed by one cycle of cisplatin.Results Most patient and tumor characteristics were well balanced. The median patient age was 63 years; 50% had endometrioid tumors, Median follow-up time was 74 months. The hazard ratio for progression adjusted for stage was 0,71 favoring AP (95% Cl, 0,55 to 0.91 P