1259PPHASE II TRIAL OF METRONOMIC ORAL VINORELBINE AS FIRST-LINE TREATMENT IN ELDERLY PATIENTS WITH ADVANCED NON-SMALL CELL LUNG CANCER (MOVE TRIAL)

ABSTRACT Aim: Metronomic oral vinorelbine could be a safe option for elderly patient with advanced non small cell lung cancer (NSCLC). Metronomic administration of chemotherapy leads to a cytostatic action shifting treatment target from cancer cell to tumor angiogenesis. Methods: 43 chemotherapy naive elderly (≥70 yrs) PS 0-2 patients with stage IIIB-IV NSCLC were prospectively recruited. Median age was 80 yrs (M/F 36/7) with predominantly squamous histology. PS distribution was 0-1(16)/2(27) with a median of 3 serious co-morbid illnesses. Study treatment consisted of oral vinorelbine 50mg three times weekly (Monday-Wednesday-Friday) continuously. Primary endpoints were overall response rate (ORR), clinical benefit (CB – disease response + stabilization >12 weeks) and safety. Health-related QoL (HRQoL) was also assessed. We conducted an exploratory time-course analysis of VEGF and thrombospondin-1 (TSP1) serum levels in a subgroup of patients. Results: Patients received a median of 5 (range 1-21) cycles with a total of 272 cycles delivered. ORR was 18.6% with 7 partial and 1 complete responses; 17/43 experienced stable disease lasting more than 12 weeks leading to an overall CB of 58.1%. Median time to progression was 5 (range 2-21) and median overall survival 9 (range 3-29) months. Treatment was well tolerated with rare G3/4 toxicity. Regardless of severity main toxicities observed were anemia in 44%, fatigue in 32.4%, and diarrhoea 10.5%. HRQoL scores did not significantly vary. Baseline VEGF levels were lower and showed a rapid increase during treatment in non-responders pts only while TSP1 levels did not change. Conclusions: Metronomic oral vinorelbine is safe in elderly patients with advanced NSCLC with an interesting activity mainly consisting in long-term disease stabilization coupled with an optimal patient compliance. Disclosure: All authors have declared no conflicts of interest.