Journal
JOURNAL OF CLINICAL ONCOLOGY
Volume 21, Issue 7, Pages 1313-1319Publisher
AMER SOC CLINICAL ONCOLOGY
DOI: 10.1200/JCO.2003.07.031
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Funding
- NCI NIH HHS [CA52386, CA52654, CA35262, CA42777, CA35261, CA38926, CA35431, CA35281, CA35192, CA45450, CA45461, CA45560, CA46113, CA46368, CA35178, CA35090, CA32102, CA22433, CA58416, CA20319, CA58658, CA04919, CA12213, CA12644, CA13612, K24 CA82301, CA96429, CA77202, CA14958, CA16385] Funding Source: Medline
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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 11 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/m(2) IV over 24 hours on days 1 to 2, cisplatin 100 mg/m2 IP on day 2, and paclitaxel 60 mg/m(2) 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. (C) 2003 by American Society of Clinical Oncology.
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