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

Abstract

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