29 P - Gemcitabine: an active well tolerated drug for advanced non small cell lung cancer (NSCLC)

Gemcitabine is a new antimetabolite that has shown activity in a wide range of solid tumours. Until 1994 to January 1996, 16 patients (pis) (M/F = 10/3 median age 57, range 41-73) with advanced NSCLC received Gemcitabine as single agent in an out-patient setting at the Medical Oncology Division of the European Institute of Oncology. Performance status was 0-1 in 15 of them and 2 in one case. Nine were chemonalve, and 7 were previously treated with cisplatin based chemotherapy (3 refractory and 4 responsive and relapsed). The planned schedule was to administer Gemcitabine as 30 minutes infusion on day 1, 8 and 15 q 4 weeks (one cycle) at the starting dose of 1250 mg/sqm in 10 pts, 1000 in 5 and 800 in 1. Overall 159 administrations (for a total of 61 cycles) were given. The worst reported toxicity was: Grade 3 hematological in 11 administrations (4 pts), grade 2 fever in 13 (4 pts), grade 2 nausea or vomiting in 2 (2 pts). The dose has been reduced by 25% in 4 administrations (3 pts). Among the 13 pts with measurable disease there were 3 partial responses, 7 stable diseases (SD) and 3 progressive diseases (PD). We confirm that Gemcitabine Is an active and well tolerated new drug for NSCLC. Further studies in combination with other agents are warranted.