The Addition of Bleomycin and Dose-Escalated Ifosfamide to the Combination of Cisplatin Plus Ifosfamide Does Not Improve Survival in Advanced or Recurrent Cervical Carcinoma

Twenty patients with advanced or recurrent cervical cancer were treated with bleomycin 30 U, ifosfamide 5 g/m2, and cisplatin 50 mg/m2 (BIP) every 28 days in a phase II trial. The primary purpose of this study was to compare response rate, survival, and toxicity of this regimen with results obtained in a similar group of patients treated with cisplatin 1 mg/kg per week for six courses followed by cisplatin, 20 mg/m2, plus ifosfamide 1.2 g/m2 daily for 3 days every 28 days. Four of 17 evaluable patients (23.5%) treated with BIP demonstrated a response to therapy (complete response 11.7%; partial response 11.7%). The median duration of response was 8.5+ months (range, 6+ to 24 months). These data do not differ significantly (P = 0.76) from a response rate of 27.5% among patients treated with cisplatin plus ifosfamide (PI). A significant (P = 0.003) increase in myelotoxicity was observed among patients treated with BIP versus those treated with PI. The median survival of patients treated with BIP of 13.5+ months (range, 8+ to 24 months) does not differ significantly from the median survival of 9+ months (3 to 26+ months) among patients treated with PI. The addition of bleomycin and dose-escalated ifosfamide did not significantly improve response rate or survival among patients with advanced or recurrent cervical cancer and resulted in a significant increase in myelotoxicity.