A phase II study of vinorelbine monotherapy in the treatment of advanced non-small cell lung cancer in elderly Chinese population

Abstract

INTRODUCTION: on-small cell lung cancer (NSCLC) has accounted for more than 3,000 new cases each year in Hong Kong with 5-year survival less than 15%. Chemotherapy is currently the “gold standard” treatment for advanced disease in those relatively young (<70 years old) with good performance status. However the benefit of chemotherapy in the elderly has been limited by the concerns about toxicities, which may have ethnic differences. METHOD: A phase II single-centered open-labelled study, using vinorelbine (30mg/m2 ivi on day 1 and 8, every 3 weeks, for 6 cycles) in chemonaive elderly Chinese patients (>70 years old) with cytologically or histologically confirmed stage IIIB/IV NSCLC. RESULTS: There were 18 patients recruited (age 74 ± 3 years, 10 males, 33% never smokers) with good performance status (all in WHO 0 or 1). The majority of cases were adenocarcinomas (56%) and more than two-thirds in stage IIIB. Dose reduction was required because of myelosuppression in 9.9%. The median number of cycles administered was 4, with 6 patients managed to complete 6 cycles of chemotherapy. The objective tumour response rate was 11.1% with 33.3% stable disease. The median survival was 10 months. Significant grade 3/4 toxicities occurred in neutropenia (68%), anaemia (1%), and phlebitis (4%). There was no treatment-related death. CONCLUSION: Vinorelbine as a single agent is active in the treatment of advanced NSCLC in the elderly Chinese with acceptable toxicity profile. Future study comparing with combination chemotherapy is warranted.