First-line chemotherapy with planned sequential administration of cisplatin/gemcitabine followed by docetaxel in elderly ‘unfrail’ patients with advanced non-small-cell lung cancer: a multicenter phase II study

Abstract

The role of cisplatin in the first-line treatment for elderly advanced non-small-cell lung cancer is not completely defined. We previously reported in this subset of patients an interesting efficacy and tolerability of a sequential schedule of gemcitabine followed by docetaxel. Patients aged≥70years and with Eastern Cooperative Oncology Group performance status 0 or 1 received cisplatin 60mg/m(2) on Day 1 and gemcitabine 1,000mg/m(2) on Day 1 and 8 every 3weeks for 3 courses followed by 3 courses of docetaxel 37.5mg/m(2) on Day 1 and 8 every 3weeks, provided there was no evidence of disease progression. Patients were excluded if considered 'frail' according to the Multidimensional Geriatric Assessment. The main objective of the study was the 4-month progression-free survival rate. Simon's two-stage minimax design was applied to calculate the sample size. After 30 patients were enroled into the study, the 4-month progression-free survival rate was 53.3% and the study was closed at the first stage for futility; the overall response rate was 16.7%; the median time to progression and median duration of survival were 5.1 and 8.6months, respectively; the 1-year survival rate was 30%. The incorporation of cisplatin in a sequential schedule of gemcitabine followed by docetaxel is feasible but did not yield a substantial advantage to deserve further investigations.