Metronomic oral vinorelbine as first-line treatment in elderly (>65 year) patients with advanced NSCLC

Introduction: Non-small cell lung cancer (NSCLC) is one of the most frequent malignancies, and the majority of diagnosis are made at an advanced stage (IIIB/IV), with unsatisfactory results. Vinorelbine is a microtubule-targeting agent, with a favorable safety profile, and is currently available also as oral chemotherapeutic agent. Metronomic chemotherapy (MCT) is an attractive strategy for treating cancer, which has been shown to reduce toxicities and to extend duration of treatment, resulting in lower resistances and prolonged survival rates. The aim of our study was to evaluate the role of oral metronomic vinorelbine (mVNR) as first-line treatment in population of elderly unfit-platin patients with advanced NSCLC. Materials and Methods: Twenty patients (13 men and 7 women, median age 78 years, range 66-88) with advanced NSCLC (3 patients stage IIIb, 17 patients stage IV) and a median of 4 major co-morbidities, non-oncogenic addicted and unfit for platin, were treated with oral mVNR as first-line treatment, at a dose of 40 mg (Group 1, 9 patients) or 50 mg (Group 2, 11 patients) as MCT on days Monday, Wednesday and Friday. The ECOG performance status was 1 (PS1) in 11 patients and 2 or 3 (PS2-3) in 9. Results: The median overall survival (OS) was 7.80 months (PS1: 11.27 months; PS2-3: 4.3 months) and time-to-progression (TTP) was 3.07 months (PS1: 3.0 months; PS2-3: 3.5 months). The median OS in Group 1 was 4.5 months and 9.4 months in Group 2. Best response showed stable disease in 5 cases, partial response in 4, progression disease in 7. Low toxicity was reported because grade 1-2 asthenia was the most frequently reported symptom. Conclusions: Metronomic chemotherapy is a new approach that combines good tolerability and acceptable activity. Our preliminary data suggest that oral mVNR in advanced NSCLC may be an effective first-line treatment, even in elderly and unfit patients with major co-morbidities.