Gemcitabine plus vinorelbine in elderly or unfit patients with non-small cell lung cancer

Cisplatin-based combinations are efficacious in increasing the overall surv ival of patients with non-small cell lung cancer (NSCLC), but their toxicit y makes them unsuitable for elderly and unfit patients. The primary objecti ve of this non-randomized phase II study was to evaluate the feasibility an d activity of the gemcitabine plus vinorelbine combination in previously un treated elderly and/or unfit patients with measurable stage III or IV NSCLC . Forty-three patients aged greater than or equal to 65 years or with contr aindications against cisplatin treatment (36 males and seven females. media n age 66 years; range 48-75: PS 0 = 11, PS 1 = 19, PS 2 = 13) received intr avenous (i.v.) gemcitabine 1000 mg m(-2), followed by vinorelbine 25 mg m(- 2) i.v. on day 1 and 8 every 21 days. Fifteen patients (34.9%) achieved par tial remission (confidence interval: 27.6-42.2%) for a median duration of 6 months; the median survival of these patients has not yet been reached. A further 15 had stable disease for a median of 4 months and a median surviva l of 7 months. The 10 patients (23.2%) who experienced disease progression had a median survival of 4 months. Three patients are not evaluable. The I- year actuarial survival rate is 31.1%. The treatment was well tolerated: on ly 35% of the patients had grade 3 or 4 granulocytopenia on day 14, none ex perienced episodes of neutropenic fever, and there was no evidence of sever e haematological toxicity upon recycling. Only 9% of the patients suffered from gastrointestinal toxicity (grade 3); increased but reversible transami nase levels were observed in 11.6%. In conclusion, the results of this phas e II study show that the combination of gemcitabine and vinorelbine is acti ve and well tolerated in NSCLC, and thus encourage its use in elderly or un fit patients. (C) 2000 Cancer Research Campaign.