A phase II trial of a new combination chemotherapy (cisplatin, bleomycin, VP-16 and methylprednisolone) in advanced recurrent squamous cell carcinoma of the head and neck.

Abstract

With the aim of increasing complete responses and improving survival in advanced recurrent (after surgery and/or RXT) squamous cell carcinoma of the head and neck, we scheduled 31 patients to receive the following regimen: VP-16, 100 mg/m2 i.v. on days 1, 3 and 5; bleomycin, 10 mg/m2 i.v. on days 4, 11 and 18; cisplatin, 120 mg/m2 on day 6, and 6-methylprednisolone, 40 mg/m2 on days 1-7. Courses were repeated every 21 days. In all, 29 patients were evaluable. complete responses (CR) were achieved in 7 cases (24%); partial responses (PR) in 7 cases (24%); the overall response rate was 48%; stable disease in 7 cases (24%), and progressive disease in 8 cases (27.5%). In 20 cases of the N3 category there were 4 CR (20%) and 6 PR (30%). Survival: entire groups, 32.7 weeks; CR 63.8 (22+28+72+); PR, 30.2; cases of no change, 29 weeks and in nonresponders, 10 weeks. leukopenia, 5/29 (17%); thrombocytopenia, 3/29 (10.3%); anemia, 10/29 (34.4%); nephrotoxicity, 8/29 (10.3%), and alopecia, reversible, 100%. this therapeutic regimen improves the CR rate and survival time with a tolerable toxicity.