ORAL CHEMOTHERAPY IN ELDERLY PATIENTS WITH ADVANCED NON SMALL CELL LUNG CARCINOMA

ABSRACT ‐ Background: Improving quality of life (QoL) is a main goal of treatment in the man agement of elderly patients with advanced stage non-small cell lung cancer (NSCLC). Oral cytotoxic agents may offer advantages in terms of patient preference and QoL. We compared the effects of oral vinorelbine and intravenous (i.v.) gemcitabine on QoL of elderly patients with advanced NSCLC. Patients and methods : In this observational, non-interventional, prospective, multicenter study we enrolled 128 elderly (age ≥70 years) patients with advanced (IIIB-IV) NSCLC who were candidates for first-line treatment with i.v. gemcitabine (1000 mg/m 2 ) or oral vinorelbine (60 mg/m 2 ) both on days 1 and 8, every 21 days. The primary endpoint was the change from baseline in global health status/QoL after three cycles. Secondary endpoints included change from baseline in other parameters of QoL, accept ability and satisfaction with oral vinorelbine. At baseline and every 3 cycles patients were administered the EORTC QLQ-C30 v 3.0 and QLQ-LC13 to evaluate QoL. A specifically designed questionnaire was used to estimate the satisfaction with treatment among patients receiving oral vinorelbine. Results: 106 patients (80 males and twenty-six females, mean age 77.1 years) were evaluable for this study. Global health status/QoL significantly improved only in the oral vinorelbine group (p < 0.05). Significant improvements were also observed in the Physical Functioning scale with both treat ments, in the Cognitive Functioning scale with i.v. gemcitabine only (p < 0.05) and in the Role Func tioning, Emotional Functioning and Social Functioning scales with oral vinorelbine only (p < 0.01 for all). Vinorelbine also improved several symptom scales of the QLQ-C30 and dyspnoea (p < 0.01), sore mouth (p < 0.05) and pain in chest (p < 0.01) assessed by the QLQ-LC13. Treatment with oral vi norelbine was well tolerated and associated with high patient satisfaction rates. Conclusions: Owing to comparable efficacy to traditional chemotherapy and an acceptable tox icity profile, oral vinorelbine may represent an effective first-line therapeutic option in elderly pa tients with NSCLC, and may also provide improvements in quality of life.