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

被引:75
作者
Gallion, HH [1 ]
Brunetto, VL
Cibull, M
Lentz, SS
Reid, G
Soper, JT
Burger, RA
Andersen, W
机构
[1] Univ Pittsburgh, Magee Womens Hosp, Div Gynecol Oncol, Pittsburgh, PA 15213 USA
[2] Roswell Pk Canc Inst, Buffalo, NY 14263 USA
[3] Univ Kentucky, Dept Pathol, Lexington, KY 40506 USA
[4] Wake Forest Univ, Sch Med, Gynecol Oncol Sect, Winston Salem, NC USA
[5] Duke Univ, Med Ctr, Dept Obstet & Gynecol, Div Gynecol Oncol, Durham, NC 27710 USA
[6] Riverside Methodist Hosp, Div Gynecol Oncol, Columbus, OH 43214 USA
[7] Univ Calif Irvine, Irvine Med Ctr, Dept Obstet & Gynecol, Orange, CA 92668 USA
[8] Univ Calif Irvine, Irvine Med Ctr, Clin Res Off, Chao Family Comprehens Canc Ctr, Orange, CA 92668 USA
[9] Univ Virginia, Sch Med, Dept Obstet & Gynecol, Charlottesville, VA 22908 USA
关键词
D O I
10.1200/JCO.2003.10.083
中图分类号
R73 [肿瘤学];
学科分类号
100214 ;
摘要
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.
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页码:3808 / 3813
页数:6
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