OBJECTIVE:Cisplatin and ifosfamide are two most active agents in patients with recurrent and metastatic cervical cancer. Combination of bleomycin, ifosfamide and cisplatinum (BIP) was compared with cisplatinum alone. PATIENTS AND METHODS: One hundred and six patients with recurrent/persistent and metastatic cervical cancer received either a combination of bleomycin, ifosfamide and cisplatinum, (Group A, n = 50) or cisplatinum alone (Group B, n = 56) every 3 weeks for up to 6 courses. Ninety-seven patients were evaluable and were analysed for response and survival. RESULTS: Patients receiving BIP (Group A) had a higher response rate (complete and partial responses), 52.2% vs 29.4%, p < 0.01 with overall median survival, 8 months (1 to 92+ months) vs 6 months (1 to 40+ months), p = 0.18. Chemotherapy responders had a significantly higher survival in both groups compared to the non-responders (Group A: 17 vs 6 months, p < 0.001, Group B: 20.5 months vs 5 months, p < 0.001). Patients in good performance status (ECOG, 0-2) had a significantly higher response rate to chemotherapy (Group A: 70.3% vs 26.3%, p < 0.01, Group B: 38.2% vs 11.7%, p < 0.05). In Group A, patients with extrapelvic disease responded better compared to pelvic disease (83.3% vs 34.5%, p < 0.01). Chemotherapy side effects were mainly nausea/vomiting, alopecia, myelosuppression, reversible encephalopathy (in Group A), and impaired renal functions. Chemotherapy toxicity was higher for patients receiving BIP, 2 patients died of BIP toxicity. Currently, in 'Group A' 8 patients are alive, 7 disease-free and one with disease at a median interval of 51 months after chemotherapy treatment. While in Group B, 3 patients are alive, 2 disease-free and one with disease. CONCLUSIONS:Bleomycin, ifosfamide and cisplatin improved the response rate in recurrent and metastatic cervical cancer compared with cisplatinum alone. However, the toxicity was moderate and survival was not significantly improved. These results need to be confirmed in a phase III, randomized study in larger number of patients.
RCT Entities:
OBJECTIVE:Cisplatin and ifosfamide are two most active agents in patients with recurrent and metastatic cervical cancer. Combination of bleomycin, ifosfamide and cisplatinum (BIP) was compared with cisplatinum alone. PATIENTS AND METHODS: One hundred and six patients with recurrent/persistent and metastatic cervical cancer received either a combination of bleomycin, ifosfamide and cisplatinum, (Group A, n = 50) or cisplatinum alone (Group B, n = 56) every 3 weeks for up to 6 courses. Ninety-seven patients were evaluable and were analysed for response and survival. RESULTS:Patients receiving BIP (Group A) had a higher response rate (complete and partial responses), 52.2% vs 29.4%, p < 0.01 with overall median survival, 8 months (1 to 92+ months) vs 6 months (1 to 40+ months), p = 0.18. Chemotherapy responders had a significantly higher survival in both groups compared to the non-responders (Group A: 17 vs 6 months, p < 0.001, Group B: 20.5 months vs 5 months, p < 0.001). Patients in good performance status (ECOG, 0-2) had a significantly higher response rate to chemotherapy (Group A: 70.3% vs 26.3%, p < 0.01, Group B: 38.2% vs 11.7%, p < 0.05). In Group A, patients with extrapelvic disease responded better compared to pelvic disease (83.3% vs 34.5%, p < 0.01). Chemotherapy side effects were mainly nausea/vomiting, alopecia, myelosuppression, reversible encephalopathy (in Group A), and impaired renal functions. Chemotherapy toxicity was higher for patients receiving BIP, 2 patients died of BIP toxicity. Currently, in 'Group A' 8 patients are alive, 7 disease-free and one with disease at a median interval of 51 months after chemotherapy treatment. While in Group B, 3 patients are alive, 2 disease-free and one with disease. CONCLUSIONS:Bleomycin, ifosfamide and cisplatin improved the response rate in recurrent and metastatic cervical cancer compared with cisplatinum alone. However, the toxicity was moderate and survival was not significantly improved. These results need to be confirmed in a phase III, randomized study in larger number of patients.