SINGLE-AGENT ACTIVITY OF WEEKLY GEMCITABINE IN ADVANCED NON-SMALL-CELL LUNG-CANCER - A PHASE-II STUDY

Purpose: To evaluate the efficacy and safety of gemcitabine, a pyrimid ine antimetabolite with activity against solid tumours. Patients and M ethods: Eighty-two patients with unresectable state IIIa to IV non-sma ll-cell lung cancer (NSCLC) were entered. The first 54 patients receiv ed gemcitabine 800 mg/m(2), and subsequent patients 1,000 mg/m(2), as a 30-minute intravenous infusion on days 0, 7, and 14. Courses of ther apy were repeated every 28 days. Twenty percent dosage escalation was permitted after course no. 1 if World Health Organization (WHO) toxici ty was less than or equal to 1. Results: Sixteen (20%; 95% confidence interval [CI], 12% to 31%) of 79 patients assessable for response had independently validated partial responses, with a median duration of 7 months. The overall median survival duration was 7 months. Gemcitabin e improved disease-related symptoms (70% patients) and increased WHO p erformance status (44%). Toxicity was generally mild and reversible. P atients experienced little WHO grade 3 and 4 toxicity, with anemia in four (5%), thrombocytopenia in one (1%), leukopenia in six (7%), and n eutropenia in 18 (22%). Infection occurred in nine patients (12%) duri ng the study (four were neutropenic), but there were no episodes of WH O grade 3 or 4 infection. WHO grade 3 and 4 biochemical toxicity occur red with transient elevations of transaminases in 10 patients (12%). T wo patients had transient WHO grade 3 evaluation of serum creatinine l evels, and two developed acute renal failure 4 and 6 weeks after the l ast dose of gemcitabine. There was no WHO grade 4 symptomatic toxicity . WHO grade 3 vomiting occurred in 31 patients (38%) and grade 3 alope cia in one (1%). Flu-like symptoms were associated with gemcitabine ad ministration in 36 patients (44%). Twenty-six patients (32%) experienc ed fever (1% WHO grade 3), 33 (40%) ankle edema not associated with ca rdiac failure, 31 (38%) lethargy, and 11 (13%) dyspnea. Conclusion: Ge mcitabine is an active new agent in the treatment of NSCLC. This sched ule was associated with little alopecia or myelosuppression. Gemcitabi ne warrants further investigation in other malignancies and in combina tion with other agents. (C) 1994 American Society of Clinical Oncology .