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Randomized Trial of Cisplatin and Ifosfamide With or Without Bleomycin in Squamous Carcinoma of the Cervix: A Gynecologic Oncology Group Study

From the Division of Gynecologic Oncology, Ellis Fischel Cancer Center, University of Missouri Health Sciences Center, Columbia; Department of Obstetrics and Gynecology, Division Gynecologic Oncology, Washington University School of Medicine, St Louis, MO; Gynecologic Oncology Group, Roswell Park Cancer Institute, Buffalo, NY; Columbus Oncology Associates, Columbus; The Cleveland Clinic Taussig Cancer Center, Department of Hematology/Medical Oncology, The Cleveland Clinic Foundation, Cleveland, OH; Department of Obstetrics & Gynecology, University of Oklahoma Health Sciences Center, Oklahoma City, OK; Division of Gynecologic Oncology, University of Iowa Hospitals and Clinics; and Departments of Pathology, and Obstetrics and Gynecology, University of Iowa, Iowa City, IA.

Address reprint requests to Gynecologic Oncology Group Administrative Office, 1234 Market St, Suite 1945, Philadelphia, PA 19107.

PURPOSE: Phase II trial reports have suggested that the addition of bleomycin to the combination of cisplatin and ifosfamide may improve response rates and possible survival in squamous carcinoma of the cervix. This study prospectively evaluates the combination of bleomycin to this regimen in women with histologically proven advanced recurrent or persistent squamous cell carcinoma of the cervix.

PATIENTS AND METHODS: Eligible women were randomized to receive either cisplatin (50 mg/m²), ifosfamide (5 g/m² over 24 hours), and mesna (6 g/m² during ifosfamide infusion and the following 12 hours) (CI) versus bleomycin 30 units over 24 hours on day 1 followed by cisplatin (50 mg/m²), ifosfamide (5 g/m² over 24 hours), and mesna (6 g/m² during ifosfamide infusion and the following 12 hours) (CIB). Three hundred three women were enrolled onto this trial, of which 287 were assessable.

RESULTS: There were no significant differences between CI and CIB with regard to response rates (32% v 31.2%, respectively), progression-free survival (PFS), or overall survival. PFS and survival were associated with initial performance status (PS). Patients with a PS of 0 experienced a lower rate of failure (P = .013) and a lower risk of death (P = .009) compared with patients with PS of 2. The most frequent grade 3/4 toxicities were leukopenia, neutropenia, anemia, thrombocytopenia, and nausea and vomiting. Neither regimen was associated with a significant increase in incidence of these toxicities.

CONCLUSION: The CI regimen was virtually identical to CIB with regard to response rate, PFS, survival, and toxicity profile. Thus, the addition of bleomycin in the dose-schedule employed to cisplatin and ifosfamide did not improve outcome in patients with advanced cervical cancer.

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