Originally published as JCO Early Release 10.1200/JCO.2005.10.021 on May 23 2005

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Randomized Phase III Trial of Cisplatin With or Without Topotecan in Carcinoma of the Uterine Cervix: A Gynecologic Oncology Group Study

From the Mayo Clinic College of Medicine, Rochester, MN; Gynecologic Oncology Group Statistical and Data Center, Roswell Park Cancer Institute, Buffalo, NY; Gynecologic Oncology, Northwestern University, Feinberg School of Medicine, Chicago, IL; Departments of Pathology, and Obstetrics and Gynecology, University of Iowa Hospitals and Clinics; University of Iowa Hospitals, Division of Gynecologic Oncology, Iowa City, IA; Fellowship Program in Gynecologic Oncology, University of Oklahoma, Health Sciences Center, Oklahoma City, OK; Dallas Foundation Chair in Gynecologic Oncology, University of Texas Southwestern Medical Center at Dallas, Division of Gynecologic Oncology, Dallas, TX; Division of Gynecologic Oncology, Ohio State University College of Medicine, and James Cancer Hospital and Solove Research Institute, Columbus, OH; Gynecologic Oncology Program, H. Lee Moffitt Cancer Center, University of South Florida, Tampa, FL

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: On the basis of reported activity of methotrexate, vinblastine, doxorubicin, and cisplatin (MVAC) or topotecan plus cisplatin in advanced cervix cancer, we undertook a randomized trial comparing these combinations versus cisplatin alone, to determine whether survival is improved with either combination compared with cisplatin alone, and to compare toxicities and quality of life (QOL) among the regimens.

PATIENTS AND METHODS: Eligible patients were randomly allocated to receive cisplatin 50 mg/m² every 3 weeks (CPT); cisplatin 50 mg/m² day 1 plus topotecan 0.75 mg/m² days 1 to 3 every 3 weeks (CT); or methotrexate 30 mg/m² days 1, 15, and 22, vinblastine 3 mg/m² days 2, 15, and 22, doxorubicin 30 mg/m² day 2, and cisplatin 70 mg/m² day 2 every 4 weeks (MVAC). Survival was the primary end point; response rate and progression-free survival (PFS) were secondary end points. QOL data are reported separately.

RESULTS: The MVAC arm was closed by the Data Safety Monitoring Board after four treatment-related deaths occurred among 63 patients, and is not included in this analysis. Two hundred ninety-four patients enrolled onto the remaining regimens: 146 to CPT and 147 to CT. Grade 3 to 4 hematologic toxicity was more common with CT. Patients receiving CT had statistically superior outcomes to those receiving CPT, with median overall survival of 9.4 and 6.5 months (P = .017), median PFS of 4.6 and 2.9 months (P = .014), and response rates of 27% and 13%, respectively.

CONCLUSION: This is the first randomized phase III trial to demonstrate a survival advantage for combination chemotherapy over cisplatin alone in advanced cervix cancer.

Supported by National Cancer Institute grants to the Gynecologic Oncology Group (GOG) Administrative Office (CA 27469) and the GOG Statistical and Data Center (CA 37517).

Presented in abstract form at the Annual Meeting of the Society of Gynecologic Oncologists, San Diego, CA, February 8, 2004.

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

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