1064 Gemcitabine-cisplatin combination in non-small cell lung cancer (NSCLC). A phase II study

摘要: The clinical efficacy and safety profile of a gemcitabine-cisplatin combination was investigated in 12-centre phase II trial. 48 consecutive previously untreated NSCLC patients were entered. Median age 60 years (range 37–70); performance status 0–1; 21 had locally advanced unresectable stage IIIb disease 27 disseminated IV disease. Gemcitabine 1000 mg/m2 administered weekly (days 1, 8, 15) followed by one week rest cisplatin 100 mg/m2 monthly (day 2) each 28-day cycle. This schedule chosen because experimental evidence synergy when the 2 drugs are given close sequence, to assess separately acute side effects. Forty-six evaluable for response toxicity (≥ 1 measurable lesion ≥ 2 cycles). 1 complete 26 partial responses observed an overall rate 58% (95% CI 44–72%), 11 (52%, 3l–73%) 16 (59%, 41–77%). Thrombocytopenia main effect with 51% grade 3–4 toxicity, usually short-lived responsible omission gemcitabine administration on day IS 90 courses chemotherapy, no serious bleeding episodes. Nonhaematological mild but reversible renal failure. induced significant both IlIb modest regimen deserves further careful evaluation III prospective randomized