PURPOSE: Lung cancer is a disease with a great incidence in older people. About two thirds of patients present at diagnosis with advanced disease requiring chemotherapy. Survival benefit and quality of life improvement of patients with non-small cell lung cancer (NSCLC) can be achieved with chemotherapy. Its value is still disputed in geriatric patients. Vinorelbine is a highly active drug for NSCLC registered for use as a single agent in the 1st line NSCLC. In this phase II study, we evaluate the feasibility and activity of oral vinorelbine monochemotherapy for geriatric NSCLC patients.
METHODS: Geriatric chemotherapy naive patients age > 70 years with newly diagnosed locally advanced or metastatic NSCLC in performance status (PS) 0-1 were involved. Patients received monochemotherapy with oral vinorelbine 60 mg/m2, on day 1, 8, and 15, in 28 days cycles. The soft gelatine vinorelbine capsules had to be swallowed with a glass of water during a meal. Chemotherapy was administred till chest X-ray progression or patients intolerance was found, fully on outpatient basis. The best response was recorded for each patient by the WHO RECIST criteria.
RESULTS: We involved 18 pts (9 male/9 female), median age 80 (70-86) with newly diagnosed NSCLC, clinical stage III/IV (10/8), PS 0-1 (7/11). The overall response rate was 78% (4 partial response, 10 stable and 4 progressive disease). Median progression free survival was 15 weeks (5-47), median survival was 32 weeks (12-136). 61 cycles were administred with the median number of 3 cycles (1-9). 1-year survival was 33%. The most frequent hematological toxicities were neutropenia (grade 3-4 in 28% of patients) and anemia (grade 3-4 in 17% of patients). Grade 3-4 infection and non-hematological toxities occurred occasionally.
CONCLUSION: The overall response rate was 78%, median progression free survival was 15 weeks, median survival was 32 weeks. The most frequent hematological toxicities were neutropenia and anemia. Serious infection and non-hematological toxities occurred occasionally.
CLINICAL IMPLICATIONS: Oral vinorelbine monochemotherapy is a reasonable option for geriatric patients with advanced NSCLC in PS 0-1.
DISCLOSURE: Irena Spasova, No Financial Disclosure Information; No Product/Research Disclosure Information