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Quality-of-Life Comparisons in a Randomized Trial of Interval Secondary Cytoreduction in Advanced Ovarian Carcinoma: A Gynecologic Oncology Group Study

From the Center for Health Policy Research, Division of General Internal Medicine, College of Medicine, University of California, Irvine, Irvine; Department of Obstetrics and Gynecology, Division of Gynecologic Oncology, University of California-Irvine Medical Center, Orange, CA; Gynecologic Oncology Group Statistical and Data Center, Roswell Park Cancer Institute, Buffalo, NY; Case Western Reserve University; Division of Gynecologic Oncology, MetroHealth Medical Center, Cleveland, OH; and Department of Psychiatry and Behavioral Science, Institute for Health Services Research and Policy Studies, Northwestern University Feinberg School of Medicine, Evanston, IL

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

PURPOSE: To compare self-reported quality of life (QOL) in patients who did versus did not undergo interval secondary cytoreduction after initial surgery and combination chemotherapy for advanced ovarian cancer and to assess the association between baseline QOL scores and survival.

PATIENTS AND METHODS: Consenting patients participating in a Gynecologic Oncology Group (GOG) phase III treatment trial (GOG 152) completed the Functional Assessment of Cancer Therapy–Ovarian (FACT-O) questionnaire and treatment-specific supplemental questions at the third and sixth chemotherapy cycles and at 6 and 12 months after starting treatment.

RESULTS: For all patients, QOL decreased approximately 1 unit from the first to second assessment. Significant improvement observed at 6 months (P < .001) was sustained at 12 months, with no appreciable between-group difference. The baseline FACT-O score was associated with overall survival (P = .048) but not progression-free survival. Less neurotoxicity was reported among patients who did (38.4%) versus did not (54.0%) undergo interval secondary cytoreduction at the third assessment (P = .005), and older patients experienced more long-term effects.

CONCLUSION: This is the first multicenter randomized trial in ovarian cancer to longitudinally examine self-reported QOL and establish a predictive value of baseline QOL on survival, attributed primarily to the lowest-scoring quartile. Although interval secondary cytoreduction resulted in no notable long-term difference, a clinically significant improvement was seen in both arms at 6 and 12 months after starting therapy. Interestingly, there were fewer complaints of neurotoxicity at 6 months among patients who did versus did not undergo interval secondary cytoreduction.

Supported by National Cancer Institute grant No. CA 27469 to the Gynecologic Oncology Group Administrative Office and grant No. CA 37517 to the Gynecologic Oncology Group Statistical and Data Center.

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

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