A randomized trial of CDDP+Peolomvcin (PEP)+MTX vs CDDP+ PEP for advanced head and neck cancer

Abstract

To evaluate the efficacy and toxicity of combined chemotherapy for advanced head and neck cancer, a randomized comparative trial carried out at the Head and Neck divisions of 14 cancer centers in Japan. 117 cases were registered from May, 1986 to March, 1988 and they were then divided into two groups according to the following methods.
Regimen A (PPM) CDDP 80mg/m² i. v.(day1) PEP 15mg/body s. c. or I. V. H.(day2-5) MTX 40mg/m2 i. v.(day2) every 3-4 weeks/course
Regimen B (PP) 80mg/m² i. v.(dayl) 15mg/body s. c. or I. V. H.(day2-5) every 3-4 weeks/course
Ninety-eight of the cases were evaluable. In 46 cases given Regimen A the response rate was 61% (CR 2 and PR 26) while in 52 cases given Regimen B it was 23% (CR 2 and PR 10, p<0.01). The response rate in 30 cases of initial treatment with Regimen A was 67% while in 25 cases with Regimen B it was 32%. In the recurrent cases the response rate was 50% in the Regimen A and 15% in Regimen B.(p<0.05) The duration of response in these cases were 13 days to 388 days. No severe side effects were observed in this trial. Therefore Regimen A was found to be more effective than Regimen B in this trail.