Originally published as JCO Early Release 10.1200/JCO.2005.10.522 on May 23 2005

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Quality of Life Outcomes From a Randomized Phase III Trial of Cisplatin With or Without Topotecan in Advanced Carcinoma of the Cervix: A Gynecologic Oncology Group Study

From the Division of Gynecologic Oncology, Chao Family Comprehensive Cancer Center, University of California Irvine Medical Center, Orange, CA; Gynecologic Oncology Group Statistical and Data Center, Roswell Park Cancer Institute, Buffalo, NY; Department of Psychiatry and Behavioral Science, Institute for Health Services Research and Policy Studies, Northwestern University; Center on Outcomes, Research and Education, Evanston Northwestern Healthcare, Evanston, IL; and Mayo Clinic College of Medicine, Rochester, MN

Address reprint requests to Denise Mackey, GOG Administrative Office, Four Penn Center, Suite 1020, 1600 John F. Kennedy Blvd, Philadelphia, PA 19103; e-mail: dmackey{at}gog.org

PURPOSE: To prospectively assess the impact of treatment with cisplatin alone or in combination with topotecan (CT) on quality of life (QOL) in patients with advanced or recurrent cervical cancer, and to explore the prognostic value of baseline QOL scores.

PATIENTS AND METHODS: Patients entered on Gynecologic Oncology Group (GOG) Protocol 179 were expected to complete QOL assessments at four time points using Functional Assessment of Cancer Therapy–General (FACT-G), Cervix subscale (Cx subscale), FACT/GOG–Neurotoxicity subscale (NTX subscale), Brief Pain Inventory (BPI), and UNISCALE (UNI). Adjusting for patient age, baseline scores, and effects of time, we longitudinally examined treatment effect on QOL during and after chemotherapy.

RESULTS: Among patients randomly allocated to receive cisplatin (n = 146) or CT (n = 147), there were no statistically significant differences in QOL up to 9 months after randomization despite more hematologic toxicity in the combination arm. QOL assessments were completed at rates of 98%, 85%, 68%, and 59%, respectively, for the four time points, with similar rates and reasons for nonparticipation between regimens. Baseline FACT-G (P = .0016) and BPI (P = .0001) scores were significantly associated with patient age; older patients had better QOL and less pain. Baseline UNI was positively correlated with FACT-G (r = 0.66; P < .001) and Cx subscale (r = 0.29; P < .001), and negatively related to BPI (r = –0.41; P < .0001). Baseline FACT-Cx (FACT-G + Cx subscale) was associated with survival.

CONCLUSION: Despite increased toxicity, CT did not significantly reduce patient QOL when compared with cisplatin alone. Patient-reported QOL measures may be an important prognostic tool in advanced cervix cancer.

Supported by National Cancer Institute grants to the Gynecologic Oncology Group Administrative Office (CA 27469), the Gynecologic Oncology Group Statistical and Data Center (CA 37517), and Bradley J. Monk, Principal Investigator (CA 87558-04).

Presented in abstract form at the Annual Meeting of the Society of Gynecologic Oncologists, San Diego, CA, 2004.

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

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