Phase III Randomized Trial of 12 Versus 3 Months of Maintenance Paclitaxel in Patients With Advanced Ovarian Cancer After Complete Response to Platinum and Paclitaxel-Based Chemotherapy: A Southwest Oncology Group and Gynecologic Oncology Group Trial
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- 1 July 2003
- journal article
- clinical trial
- Published by American Society of Clinical Oncology (ASCO) in Journal of Clinical Oncology
- Vol. 21 (13) , 2460-2465
- https://doi.org/10.1200/jco.2003.07.013
Abstract
Purpose: To determine whether continuing paclitaxel for an extended time period in women with advanced ovarian cancer who had achieved a clinically defined complete response to a platinum/paclitaxel-based chemotherapy could prolong subsequent progression-free survival (PFS) and affect ultimate survival. Patients and Methods: Patients were randomly assigned to either three or 12 cycles of single-agent paclitaxel administered every 28 days and were then followed up for progression-free and overall survival. Results: As of September 6, 2001, 277 patients (262 assessable) had entered the trial, with a total of 54 PFS events having developed among 222 patients with follow-up data. With the exception of peripheral neuropathy, there were no major differences in toxicity between the regimens. The median PFS was 21 and 28 months in the three-cycle and 12-cycle paclitaxel arms, respectively. One-sided P values from an unadjusted log-rank test and an adjusted Cox model analysis (for stratification factors) were .003...Keywords
This publication has 18 references indexed in Scilit:
- Treatment of Relapsed Carcinoma of the Ovary with Single-Agent Paclitaxel Following Exposure to Paclitaxel and Platinum Employed as Initial TherapyGynecologic Oncology, 2000
- Randomized Intergroup Trial of Cisplatin-Paclitaxel Versus Cisplatin-Cyclophosphamide in Women With Advanced Epithelial Ovarian Cancer: Three-Year ResultsJNCI Journal of the National Cancer Institute, 2000
- Phase III Randomized Study of Cisplatin Versus Paclitaxel Versus Cisplatin and Paclitaxel in Patients With Suboptimal Stage III or IV Ovarian Cancer: A Gynecologic Oncology Group StudyJournal of Clinical Oncology, 2000
- Polychemotherapy for early breast cancer: an overview of the randomised trialsThe Lancet, 1998
- A randomized trial of five versus eight courses of cisplatin or carboplatin in advanced epithelial ovarian carcinomaAnnals of Oncology, 1997
- Intraperitoneal Cisplatin plus Intravenous Cyclophosphamide versus Intravenous Cisplatin plus Intravenous Cyclophosphamide for Stage III Ovarian CancerNew England Journal of Medicine, 1996
- Cyclophosphamide and Cisplatin Compared with Paclitaxel and Cisplatin in Patients with Stage III and Stage IV Ovarian CancerNew England Journal of Medicine, 1996
- A Prospective Randomized Comparison of 6 and 12 Cycles of Cyclophosphamide, Adriamycin, and Cisplatin in Advanced Epithelial Ovarian Cancer: A Danish Ovarian Study Group Trial (DACOVA)Gynecologic Oncology, 1993
- Randomized prospective trial of 5 versus 10 cycles of cyclophosphamide, doxorubicin, and cisplatin in advanced ovarian carcinomaGynecologic Oncology, 1992
- Evaluation of optimal duration of chemotherapy in favorable-prognosis disseminated germ cell tumors: a Southeastern Cancer Study Group protocol.Journal of Clinical Oncology, 1989