Phase II, multicentre, open label, non randomized trial on safety of first line chemotherapy with oral metronomic vinorelbine in the elderly subgroup of NSCLC patients

Background: More than 50% of patients (pts)affected by NSCLC are close to 70 years old. Platinum-based chemotherapy is the cornerstone of treatment of advanced NSCLC, but in elderly pts, the balance between efficacy and toxicity of adding cisplatin to single- agent chemotherapy remains uncertain.Vinorelbine is one of the most studied drugs.An oral formulation of vinorelbine has been developed. Several studies have demonstrated that the pharmacokinetic parameters of the oral form were similar to those of the injectable formulation, but the compliance of patients may be higher.Oral administration at fixed doses of Vinorelbine might be a new way of administration of these drugs. So we designed a phase II, multicentre, open label, non- randomized trial on safety and efficacy of first line chemotherapy with oral metronomic vinorelbine in the elderly (age > 70) subgroup of advanced (stage IIIb - IV) NSCLC pts with PS 0-2. Methods: 76 patients were enrolled and oral vinorelbine at the dose of 50 mg three times a week was administered until progression or toxicity. Safety is the primary end point: if G3/4 toxicity after 3 months will affect more than 20% of patients the treatment will not be feasible. Toxicity were be recorded according to CTC-NCI 3.0. Secondary end points were OS, PFS, RR according to RECIST criteria. Results: median age was 79 (70-92). 80% were male. 84% of pts had 1- 4 co-morbidities. 41% of pts had adenocarcinoma, 46% squamous carcinoma. 90% of pts were actual or former smokers. PS was 2 or more in 41% of pts, 1 in 33%. 15% of pts responded to therapy, 36% has stable disease and 45% had disease progression.70% pts showed G1-2 toxicity. G3-4 toxicity was present in 11% of pts.Median OS e PFS were 8 (95%CI 6.6-9.4) and 3 (95%CI 2.6-3.5) months respectively. Conclusions: Our data indicate that metronomic treatment seems feasible in this population of old and frail patients. Toxicity is manageable. OS and PFS are very interesting and claim for new larger studies.