Randomized phase III trial of standard timed doxorubicin plus cisplatin versus circadian timed doxorubicin plus cisplatin in stage III and IV or recurrent endometrial carcinoma: A Gynecologic Oncology Group Study
Randomized phase III trial of standard timed doxorubicin plus cisplatin versus circadian timed doxorubicin plus cisplatin in stage III and IV or recurrent endometrial carcinoma: A Gynecologic Oncology Group Study
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DOI：
10.1200/jco.2003.10.083
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发表时间：
2003-10-15
影响因子：
45.3
通讯作者：
Andersen, W
中科院分区：
文献类型：
--
作者：
Gallion, HH;Brunetto, VL;Andersen, W
目的：确定与标准定时 (ST) 化疗相比，昼夜节律定时 (CT) 化疗是否能改善反应、无进展生存期 (PFS)、总生存期 (OS) 和降低毒性。 材料和方法：入选标准为 III、IV 期或复发性子宫内膜癌，通过放射治疗或手术治愈的可能性较差；可测量的疾病；并且之前没有接受过化疗。治疗随机分为 ST 多柔比星 60 mg/m(2) 加顺铂 60 mg/m(2)，或 CT 多柔比星 60 mg/m(2)（上午 6:00）加顺铂 60 mg/m(2)（下午 6:00）。每 3 周重复一次周期，最多 8 个周期。结果：ST 组包括 169 名患者，CT 组包括 173 名患者。 ST 组的客观缓解率（完全缓解加部分缓解）为 46%，而 CT 组为 49%（P = 0.26，一尾）。 ST 组的中位 PFS 和 OS 分别为 6.5 个月和 11.2 个月； CT 组分别为 5.9 个月和 13.2 个月（PFS：P = .31；OS：P = .21，一尾）。 ST组中位总剂量为209 mg/m(2)阿霉素和349 mg/m(2)顺铂，而CT组中位总剂量为246 mg/m(2)阿霉素和354 mg/m(2)顺铂。 ST 组 73% 的患者和 CT 组 63% 的患者出现 3 级或 4 级白细胞减少症。有 8 例与治疗相关的死亡。结论：在这项试验中，在晚期或复发性子宫内膜癌患者中，CT 多柔比星加顺铂在缓解率、PFS 或 OS 或毒性方面没有观察到显着的益处。 (C) 2003 年，美国临床肿瘤学会。
Purpose: To determine if circadian timed (CT) chemotherapy results in improved response, progression-free survival (PFS), overall survival (OS), and lower toxicity, when compared with standard timed (ST) chemotherapy.Materials and Methods: Eligibility criteria were stage III, IV, or recurrent endometrial cancer with poor potential for cure by radiation therapy or surgery; measurable disease; and no prior chemotherapy. Therapy was randomized to schedules of ST doxorubicin 60 mg/m(2) plus cisplatin 60 mg/m(2), or CT doxorubicin 60 mg/m(2) at 6:00 AM Plus cisplatin 60 mg/m(2) at 6:00 Pm. Cycles were repeated every 3 weeks to a maximum of eight cycles.Results: The ST arm included 169 patients, and the CT arm included 173 patients. The objective response rate (complete responses plus partial responses) was 46% in the ST group compared with 49% in the CT group (P = .26, one tail). Median PFS and OS were 6.5 and 11.2 months, respectively, in the ST group; and 5.9 and 13.2 months, respectively, in the CT group (PFS: P = .31; OS: P = .21, one tail). Median total doses were 209 mg/m(2) doxorubicin and 349 mg/m(2) cisplatin in the ST group, versus 246 mg/m(2) doxorubicin and 354 mg/m(2) cisplatin in the CT group. Grade 3 or 4 leukopenia occurred in 73% of patients in the ST arm and in 63% of patients in the CT arm. There were eight treatment-related deaths.Conclusion: In this trial, no significant benefit in terms of response rate, PFS or OS, or toxicity profile was observed with CT doxorubicin plus cisplatin in patients with advanced or recurrent endometrial carcinoma. (C) 2003 by American Society of Clinical Oncology.