Combined intraperitoneal and intravenous chemotherapy for women with optimally debulked ovarian cancer: results from an intergroup phase II trial.

Abstract

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/m(2) IV over 24 hours on days 1 to 2, cisplatin 100 mg/m(2) 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.

• Authors: 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
• Journal: Journal of clinical oncology : official journal of the American Society of Clinical Oncology (J Clin Oncol) Vol. 21 Issue 7 Pg. 1313-9 (Apr 01 2003) ISSN: 0732-183X [Print] United States
• PMID: 12663720 (Publication Type: Clinical Trial, Clinical Trial, Phase II, Comparative Study, Journal Article, Research Support, U.S. Gov't, P.H.S.)

Chemical References

• Paclitaxel
• Cisplatin

Topics

• Adenocarcinoma (drug therapy, mortality, surgery, therapy)
• Administration, Rectal
• Adult
• Aged
• Antineoplastic Combined Chemotherapy Protocols (administration & dosage, adverse effects)
• Cisplatin (administration & dosage, adverse effects)
• Disease-Free Survival
• Drug Tolerance
• Female
• Humans
• Infusions, Intravenous
• Infusions, Parenteral
• Middle Aged
• Ovarian Neoplasms (drug therapy, mortality, surgery, therapy)
• Paclitaxel (administration & dosage, adverse effects)