A randomized trial of CDDP+Peplomycin (PEP)+MTX vs CDDP+PEP+5FU 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 was carried out at the Head and Neck divisions of 16 cancer centers in Japan. 111 cases were registered between April, 1988 and March, 1990 and were then divided into two groups according to the following methods.
Regimen A (PPM) CDDP 80mg/m² i. v.(day1) PEP 10 mg/m² s. c. or I. V. H.(day2-5) MTX 40 mg/m² i. v.(day2) every 3-4 weeks/course
Regimen B (PPF) CDDP 80 mg/m² i. v.(day1) PEP 10 mg/m² s. c. or I. V. H.(day2-5) 5FU 500 mg/m² i. v. or I. V. H.(day2-5) every 3-4 weeks/course
Ninety-eight of the cases were evaluable. In the 44 cases given Regimen A, the response rate was 48% (CR 3 and PR 18) while in the 54 cases given Regimen B, it was 50% (CR 2 and PR 25). The response rate in 24 cases offer the initial treatment with Regimen A was 54% and 39 cases with Regimen B was 56%. In recurrent cases, it was 40% in Regimen A and 33% in Regimen B. No severe side effects were observed in this trial. Therefore combined chemotherapy were found to be useful for advanced head and neck cancer cases and there was no significant differences between Regimen A and B.