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Combined Intraperitoneal and Intravenous Chemotherapy for Women With Optimally Debulked Ovarian Cancer: Results From an Intergroup Phase II Trial

Mace L. Rothenberg, P.Y. Liu, Patricia S. Braly, Sharon P. Wilczynski, Edward V. Hannigan, Scott Wadler, Gavin Stuart, Caroline Jiang, Maurie Markman, David S. Alberts

From the Vanderbilt-Ingram Cancer Center, Nashville, TN; Southwest Oncology Group Statistical Center, Seattle, WA; Louisiana State University Medical Center, New Orleans, LA; City of Hope National Medical Center, Duarte, CA; University of Texas Medical Branch, Galveston, TX; Albert Einstein Medical Center, Bronx, NY; National Cancer Institute of Canada Clinical Trials Group, Kingston, ON, Canada; Cleveland Clinic Cancer Center, Cleveland, OH; and University of Arizona Cancer Center, Tucson, AZ.

Address reprint requests to Southwest Oncology Group (S9619), Operations Office, 14980 Omicron Dr, San Antonio, Texas 78245-3217; email: mace.rothenberg{at}vanderbilt.edu.

Purpose: The median survival time for women with optimally debulked adenocarcinoma of the ovary treated with intravenous (IV) chemotherapy is 41 to 52 months, and the 2-year survival rate is 65% to 70%. Recent studies evaluating intraperitoneal (IP) chemotherapy have reported a median survival time of 49 to 63 months and 2-year survival rates of 70% to 80%. This phase II trial was undertaken to evaluate the feasibility of and 2-year survival rate achieved by the combination of IP paclitaxel, IP cisplatin, and IV paclitaxel in women with optimally debulked, stage III ovarian cancer.

Patients and Methods: Treatment consisted of paclitaxel 135 mg/m² IV over 24 hours on days 1 to 2, cisplatin 100 mg/m² IP on day 2, and paclitaxel 60 mg/m² IP on day 8 administered every 21 days for six cycles.

Results: In 68 assessable women with optimal stage III ovarian cancer, the 2-year survival rate was 91%, and the median survival time was 51 months. The 2-year disease-free survival rate was 66%, and median disease-free survival time was 33 months. Ninety-six percent of all patients experienced at least one grade 3 to 4 adverse event during therapy, with the most common events being neutropenia (79%), nausea (50%), vomiting (34%), and fatigue/malaise/lethargy (24%). Seventy-one percent of patients completed all six cycles of IV/IP therapy as planned.

Conclusion: Combined IV and IP chemotherapy with cisplatin and paclitaxel is associated with a very promising 2-year survival rate in women with optimally debulked ovarian cancer. The ultimate impact of this approach on overall survival requires further evaluation in a randomized trial setting.

Supported in part by the following Public Health Service Cooperative Agreements and grants awarded by the National Cancer Institute, Department of Health and Human Services: CA38926, CA32102, CA14958, CA77202, CA58658, CA46368, CA04919, CA45560, CA45450, CA13612, CA42777, CA12644, CA35281, CA35431, CA52386, CA45461, CA96429, CA20319, CA35261, CA35090, CA16385, CA35178, CA58416, CA12213, CA46113, CA22433, CA52654, CA35262, CA35192, and K24 CA82301 (M.L.R.).

Presented, in part, at the Thirty-Eighth Annual Meeting of the American Society of Clinical Oncology, Orlando, FL, May 18–21, 2002.

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