A phase II trial of three sequential doublets for the treatment of advanced mullerian malignancies

被引:8
作者
Matulonis, U
Campos, S
Duska, L
Fuller, A
Berkowitz, R
Gore, S
Roche, M
Colella, T
Lee, H
Seiden, MV
机构
[1] Massachusetts Gen Hosp, Div Med Oncol, Boston, MA 02114 USA
[2] Dana Farber Canc Inst, Div Med Oncol, Boston, MA 02115 USA
[3] Massachusetts Gen Hosp, Div Gynecol Oncol, Boston, MA 02114 USA
[4] Brigham & Womens Hosp, Div Gynecol Oncol, Boston, MA 02115 USA
关键词
ovarian cancer; topotecan; gemcitabine; adriamycin; paclitaxel; cisplatin; Neupogen treatment;
D O I
10.1016/S0090-8258(03)00496-7
中图分类号
R73 [肿瘤学];
学科分类号
100214 ;
摘要
Objective. In an effort to improve the results of primary chemotherapy for mullerian malignancies a novel chemotherapy program was piloted that delivered three sequential chemotherapy doublets. The primary endpoints were surgically defined response rates and evaluation of toxicity. Methods. After primary cytoreductive surgery patients were treated with three sequential doublets including three initial cycles of carboplatin and paclitaxel (doublet 1) and then two cycles of cisplatin (day 1) and gemcitabine (days I and 8; doublet 2), and finally two cycles of doxorubicin (day 1) and topotecan (days 3,4, and 5; doublet 3). Cycles 4 through 7 were given with G-CSF (Neupogen) support at a dose of 5 mcg/kg/day. After therapy, all women were clinically staged and evaluated by second-look laparoscopy/laparotomy (SLO) if clinical staging was negative for residual disease. Results. A total of 49 eligible patients were enrolled with a median age of 52 (SD 9). Forty-four women had either ovarian cancer or primary peritoneal carcinoma with 3 women diagnosed with fallopian tube carcinoma and 2 with papillary serous carcinoma of the uterus. Eighty-four percent of patients had stage lIIc/IV tumors, with 29% having > I cm residual disease after primary cytoreductive surgery. Thirty-nine of 49 (80%) patients completed therapy. A total of 283 cycles of chemotherapy were delivered with acceptable toxicities. There were no toxic deaths. Five women were withdrawn from trial (3 for Taxol hypersensitivity, I for gemcitabine pulmonary hypersensitivity, and I for serious line infection). Neutropenia, typically without fever, was relatively frequent in the first doublet. Nausea and thrombocytopenia were the predominant toxicities in doublet 2. Thirty-nine women completed all cycles of treatment. Thirty-six women had restaging results consistent with a clinical complete response (CR) and underwent SLO. The pathologic CR rate of the patients undergoing SLO was 38%. Conclusions. Treatment with this sequential doublet regimen is feasible with a 38% pathologic CR rate. (C) 2003 Elsevier Inc. All rights reserved.
引用
收藏
页码:293 / 298
页数:6
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