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Health-Related Quality of Life During and After Intraperitoneal Versus Intravenous Chemotherapy for Optimally Debulked Ovarian Cancer: A Gynecologic Oncology Group Study

Lari B. Wenzel, Helen Q. Huang, Deborah K. Armstrong, Joan L. Walker, David Cella

From the College of Medicine, University of California at Irvine, Irvine, CA; Gynecologic Oncology Group Statistical and Data Center, Roswell Park Cancer Institute, Buffalo, NY; Johns Hopkins Kimmel Cancer Center, Baltimore, MD; Gynecologic Oncology, University of Oklahoma, Oklahoma City, OK; Psychiatry and Behavioral Science Research, Institute for Health Services Research and Policy Studies, Northwestern University, Chicago; and Center on Outcomes, Research and Education, Evanston Northwestern Healthcare, Evanston, IL

Address reprint requests to Denise Mackey, Gynecologic Oncology Group Administrative Office, Four Penn Center, 1600 JFK Blvd, Ste 1020, Philadelphia, PA 19103; e-mail: dmackey{at}gog.org

Purpose: A Gynecologic Oncology Group (GOG) randomized phase III trial (GOG 172) in optimal stage III epithelial ovarian cancer showed that intravenous (IV) paclitaxel plus intraperitoneal (IP) cisplatin and paclitaxel significantly lengthened progression-free survival and overall survival compared with IV paclitaxel and cisplatin. The purpose of this report is to comprehensively evaluate the patient-reported outcomes associated with IP versus IV therapy.

Patients and Methods: Four hundred fifteen eligible women were enrolled onto GOG 172 at member institutions. The Functional Assessment of Cancer Therapy–Trial Outcome Index (FACT-TOI; which includes physical, functional, and ovarian subscales) and neurotoxicity (Ntx) and abdominal discomfort (AD) subscales were used to assess patient-reported outcomes. Assessments were completed before random assignment, before cycle 4, and 3 to 6 weeks and 12 months after treatment.

Results: Physical and functional well-being and ovarian cancer symptoms were significantly worse in the IP arm before cycle 4 (P < .001) and 3 to 6 weeks after treatment (P = .001 for FACT-TOI). Patients in the IP arm also reported significantly worse AD before cycle 4 (P < .001) and significantly worse Ntx 3 to 6 weeks (P = .001) and 12 months (P = .003) after completing IP treatment. In general, however, the quality of life of both groups improved over time.

Conclusion: During active treatment, patients on the IP arm experienced more health-related quality-of-life disruption, AD, and Ntx compared with patients receiving conventional IV therapy. However, only Ntx remained significantly greater for IP patients 12 months after treatment. This trade-off should be included when discussing treatment options with patients. Future studies to mitigate the added burden associated with IP therapy are planned.

Supported by National Cancer Institute Grant No. CA 27469 to the Gynecologic Oncology Group (GOG) Administrative Office and Grant No. CA 37517 to the GOG Statistical and Data Center. In addition to financial support, the sponsor reviewed and approved the study design and monitored its progress and results.

Presented in part at the 40th Annual Meeting of the American Society of Clinical Oncology, June 5-8, 2004, New Orleans, LA; and the 41st Annual Meeting of the American Society of Clinical Oncology, May 13-17, 2005, Orlando, FL.

H.Q.H. had full access to all the data in the study and takes responsibility for accuracy of the data analysis. L.B.W. and H.Q.H., on behalf of the GOG and its Statistical and Data Center, take responsibility for the integrity of the data.

Authors' disclosures of potential conflicts of interest and author contributions are found at the end of this article.

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