HIGH-DOSE CISPLATIN WITH DIPYRIDAMOLE IN ADVANCED NONSMALL CELL LUNG-CANCER - A GRUPO-ONCOLOGICO-COOPERATIVO-DEL-SUR STUDY

From March 1991 to October 1992, 41 patients with advanced non-small c ell lung cancer (NSCLC) (20 stage IIIB and 21 stage IV) received a reg imen consisting of cisplatin (CP) 100 mg/m(2) i.v. days 1 and 8, and d ipyridamole (DPD) 100 mg p.o. 75 minutes before CP, and then at hours 6, 12, and 18 as first-line chemotherapy. Cycles were repeated every 2 8 days for a total of 3. Median age was 56 years (range: 40-70). All p atients had a performance status 0 to 1 and a weight-loss less than or equal to 10%. Squamous-cell carcinoma was diagnosed in 19 patients; a denocarcinoma in 16, and large-cell carcinoma in 6. A total of 37 pati ents were fully evaluable for response, whereas 39 were assessable for toxicity. No complete responses were observed: 5 patients (14%) achie ved partial response; 23 patients (62%) showed no change, and progress ive disease was observed in 9 (24%). The median time to treatment fail ure was 4 months, whereas median survival was 8 months. The average do se intensity received at the end of the third course of therapy was 46 mg/m(2)/week. There were no drug-related deaths. Toxicity was mild to moderate, with a high incidence of ototoxicity (54%) and emesis (67%) . In conclusion, these results failed to demonstrate any significant a dvantage from a high-dose CP regimen modulated by DPD in patients with advanced NSCLC.