Originally published as JCO Early Release 10.1200/JCO.2004.00.7617 on December 5 2005

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Randomized Phase III Trial of Whole-Abdominal Irradiation Versus Doxorubicin and Cisplatin Chemotherapy in Advanced Endometrial Carcinoma: A Gynecologic Oncology Group Study

From Leo W. Jenkins Cancer Center, Brody School of Medicine at East Carolina University, Greenville, NC; Gynecologic Oncology Group Statistical and Data Center, Roswell Park Cancer Institute, Buffalo, NY; Department of Medicine, University of Vermont-Fletcher Allen Health Care, Burlington, VT; Women's Cancer Center at Community Hospital, Los Gatos, CA; Department of Obstetrics and Gynecology, University of Oklahoma Health Sciences Center, Oklahoma City, OK; Division of Gynecologic Oncology, James Cancer Hospital and Solove Research Institute, Ohio State University, Columbus, OH; Division of Oncology, Department of Medicine, University of Mississippi Medical Center, Jackson, MS; and Departments of Pathology and Obstetrics and Gynecology, University of Iowa Hospitals, IA City, IA

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: To compare whole-abdominal irradiation (WAI) and doxorubicin-cisplatin (AP) chemotherapy in women with stage III or IV endometrial carcinoma having a maximum of 2 cm of postoperative residual disease.

PATIENTS AND METHODS: Four hundred twenty-two patients were entered onto this trial. Of 396 assessable patients, 202 were randomly allocated to receive WAI, and 194 were allocated to receive AP. Irradiation dosage was 30 Gy in 20 fractions, with a 15-Gy boost. Chemotherapy consisted of doxorubicin 60 mg/m² and cisplatin 50 mg/m² every 3 weeks for seven cycles, followed by one cycle of cisplatin.

RESULTS: Most patient and tumor characteristics were well balanced. The median patient age was 63 years; 50% had endometrioid tumors. Median follow-up time was 74 months. The hazard ratio for progression adjusted for stage was 0.71 favoring AP (95% CI, 0.55 to 0.91; P < .01). At 60 months, 50% of patients receiving AP were predicted to be alive and disease free when adjusting for stage compared with 38% of patients receiving WAI. The stage-adjusted death hazard ratio was 0.68 (95% CI, 0.52 to 0.89; P < .01) favoring AP. Moreover, at 60 months and adjusting for stage, 55% of AP patients were predicted to be alive compared with 42% of WAI patients. Greater acute toxicity was seen with AP. Treatment probably contributed to the deaths of eight patients (4%) on the AP arm and five patients (2%) on the WAI arm.

CONCLUSION: Chemotherapy with AP significantly improved progression-free and overall survival compared with WAI. Nevertheless, further advances in efficacy and reduction in toxicity are clearly needed.

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

Presented in part at the 39th Annual Meeting of the American Society of Clinical Oncology, Chicago, IL, May 31-June 3, 2003.

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

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