RADIOTHERAPY, COMBINED WITH SIMULTANEOUS CHEMOTHERAPY WITH MITOMYCIN-C AND BLEOMYCIN FOR INOPERABLE HEAD AND NECK-CANCER - PRELIMINARY-REPORT

Purpose: Prospectively designed randomized clinical study was undertak en to assess the efficacy of simultaneous application of irradiation, Mitomycin C, and Bleomycin in treatment of patients with inoperable he ad and neck carcinoma. Methods and Materials: Between March 1991 and O ctober 1993, 49 patients with inoperable head and neck carcinoma were randomly assigned to receive either radiation therapy alone (group A) or radiotherapy combined with simultaneous application of Mitomycin C and Bleomycin (group B). Patients in both groups were irradiated five times weekly with 2 Gy to the total dose of 66-70 Gy. Chemotherapy reg imen included intramuscular application of Bleomycin 5 units twice a w eek, with the planned dose being 70 units and Mitomycin C 15 mg/m(2) a pplied intravenously after delivery of 9-10 Gy of irradiation. The app lication of Mitomycin C was planned to be repeated on last day of radi otherapy in the dose of 10 mg/m(2). In attempt to enhance the effect o f chemotherapeutic drugs, patients in group B received also Nicotinami de, Chlorpromazine, and Dicoumarol. Results: The difference in complet e response rate between both treatment groups (24% in group A and 63% in group B) was statistically significant (p = 0.015). The difference in response rate was much more pronounced in patients with oropharynge al carcinoma only (18% in group A compared to 81% in group B; p = 0.00 03), while for all other subgroups added together, there was observed no benefit of multidrug therapy. Median follow-up was 18 months. Disea se-free survival of patients in group A (9%) was significantly lower t hen in group B (48%) (p = 0.001). The difference between both treatmen t groups was even greater in patients with oropharyngeal carcinoma onl y: disease-free survival of these patients in group B was 66%, while i n group A, all recurred (p = 0.00001). Conclusion: From results of our prospective randomized study it seems that the group of patients that received multidrug treatment with Mytomycin C, Bleomycin, Nicotinamid e, Chlorpromazine, and Dicoumarol as enhancers of radiotherpy fared be tter than patients treated by radiotherapy alone.