Single agent gemcitabine in pretreated patients with non small cell lung cancer: results of an Argentinean multicentre phase II trial

The activity and mild toxicity profile of single-agent gemcitabine therapy in untreated (chemonaive) patients with non-small-cell lung cancer (NSCLC) is well documented. This phase II trial was conducted to determine the obje ctive tumour response rate and toxicity profile of single-agent gemcitabine in pretreated patients with NSCLC. Patients with histological evidence of advanced NCSLC stage IIIB or IV; at least one prior chemotherapy regimen in cluding a platinum or taxane analogue; an Eastern Cooperative Oncology Grou p (ECOG) performance status of 0-2; clinically measurable disease; adequate bone marrow reserve; and adequate renal function; received 1000 mg m(-2) g emcitabine administered over 30 min on days 1, 8 and 15 of a 28-day cycle d efined as 3 weekly treatments followed by 1 week of rest. Twenty-nine patie nts were evaluated for efficacy and 32 for toxicity. One patient achieved a complete response and five patients had a partial response resulting in a total response rate of 20.6% (95% confidence interval (CI) 6-34). Median re sponse duration was 7 months (range 4-11 months). Twelve (41%) patients rea ched stable disease after two cycles of therapy and 11 (38%) patients had d isease progression. Median progression-free survival time was 3 months and median overall survival time was 5.5 months. Toxicity was generally mild (g rades 0-2). Severe (grade 3 or 4) haematological toxicities included grade 3 anaemia in one patient and grade 3 thrombocytopenia in two patients. Seve re non-haematological toxicities included one patient each with grade 3 liv er transaminase elevations, nausea/vomiting and diarrhoea. This study confi rms the activity and safety of single-agent gemcitabine in pretreated patie nts with advanced NSCLC who are refractory or sensitive to first-line thera py. (C) 1999 cancer Research Campaign.