Oral vinorelbine (NVBO) and gemcitabine (GEM) in elderly patients with advanced non-small-cell lung cancer (NSCLC): A phase II study conducted by the Galician Lung Cancer Group (GLCG)

Abstract

19068 Background: The non-platin doublet GEM-vinorelbine is one of the most effective treatment regimens for elderly patients (PTS) with advanced NSCLC. NVBO has been employed in NSCLC treatment with similar bioavailability and response rates and a more favourable toxicity profile compared to the i.v. form. The GLCG conducted a phase II study to determine the efficacy and safety of NVBO- GEM regimen in elderly patients with advanced NSCLC. The primary objective was response rate (RR). Secondary objectives included time to progression (TTP) overall survival (OS) and toxicity. Methods: Beetween July 2005 and November 2007, 43 chemo-naïve pts aged >70 years, histologically confirmed NSCLC, stage IIIB/IV, ECOG 0–1, measurable lesions according to RECIST criteria and adecuate bone marrow, renal and hepatic function were included. The NVBO-GEM regimen consisted of GEM 1000 mg/m2/i.v., followed by NVBO 60 mg/m2 days 1 and 8 every 3 weeks, for a maximum of 6 cycles. Results: To date, 43 pts were included and 170 cycles were administrated. Male/Female 39/4; median age 78 years (range 71–84), all ECOG 1, 28 squamous cell carcinoma, 11 adenocarcinoma and 4 large cell. Stage IIIB/IV 11/32. 35 pts were evaluable (4 non evaluable and 4 in treatment) for response and 43 for toxicity. The RR was 40%; PR: 40%; SD: 20% and PD: 40%. The median TTP was 4.6 months (95% CI: 2.9–6.2) and the median OS was 9.3 months (95% CI: 6.2–12.4). The main toxicities were anemia grade 3–4 in 4 pts, neutropenia grade 3–4 in 4 and plaquetopenia grade 3 in 2; non- haematological grade 3–4 toxicities included grade 3 asthenia in 3 pts and grade 3 emesis in one. Conclusions: This trial confirms that a NVBO-GEM regimen is effective and well tolerated in elderly pts with advanced NSCLC. No significant financial relationships to disclose.