Gemcitabine and vincristine: an effective outpatient regimen with low myelotoxicity for stage IV non-small cell lung cancer

The activity and tolerability of gemcitabine and the non-overlapping toxici ty of gemcitabine plus vincristine were the basis for testing this regimen patients with non-small cell lung cancer (NSCLC). Forty patients (25 male/15 female, median age 52 years) with stage IV NSCLC and a Karnofsky Performance Status score greater than or equal to 60 enter ed the trial. Patients received gemcitabine 1000 mg/m(2) on days 1, 8 and 1 5 and vincristine 1.4 mg/m(2) on days 1 and 15, every 4 weeks. The overall response rate was 16/40 (40%) (N = 40); with 2 complete and 14 partial resp onses; additional 14 patients had minor responses or stable disease. Median duration of remission was 4.5 months, and the median survival was 9 months . In two patients with grade 2 generalized vesicular rash and severe malais e, respectively, treatment-related toxicity led to early termination of tre atment. Among patients treated for more than two months, vincristine doses were reduced/omitted for 55% of cycles because of grade 1-2 peripheral neur opathy. Myelotoxicity Was frequent but rarely clinically significant. Mean platelet counts on day 1 of cycles 2, 3 and 4 were significantly higher tha n the pre-treatment or post-treatment values. We conclude that vincristine plus gemcitabine is an an active and well tolerated regimen. Its interestin g "platelet-saving" effect deserves further investigation.