[Randomized trial of initial chemotherapy with cisplatin alone or in combination in 241 advanced carcinomas of the upper respiratory and digestive tract]

Abstract

Two hundred and forty-one patients, with advanced squamous cell carcinoma of head and neck, were randomized to receive three courses of induction chemotherapy. The chemotherapy regimens were delivered every 3 weeks, and consisted in 1) cisplatin, 80 mg/m2 given alone (CDDP regimen), or 2) in combination with vincristine, 1 mg, d 1, methotrexate 10 mg/m2 d 1, 2, 3, and bleomycin 10 mg/m2, d 1, 2, and 3 (MOB-P). Tolerance was significantly better with the CDDP regimen (p less than 0.05); severe side effects, affecting mainly digestive tract, and bone marrow, were encountered in 7% of the patients in the CDDP group, vs 15% in the MOB-P group, without death related to pancytopenia. Short-term results were better for patients treated by the MOB-P regimen, with a 42% response rate (including 9 complete responses) vs 22% with the CDDP regimen (p = 0.01). A superiority of combination chemotherapy was more significant for primary sites than regional lymph nodes. The relapse-free survival was not statistically different in the 2 groups, as well as the 2 years overall survival. Among responders, the survival was found highly correlated with a good initial general status (p less than 0.01), and with the highest total doses of cisplatin (p less than 0.02).(ABSTRACT TRUNCATED AT 250 WORDS)