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
Journal of Cancer Research & Clinical Oncology, 07/11/2012
Tibaldi C et al. – The incorporation of cisplatin in a sequential schedule of gemcitabine followed by docetaxel is feasible.Methods
- Patients aged ?70 years and with Eastern Cooperative Oncology Group performance status 0 or 1 received cisplatin 60 mg/m2 on Day 1 and gemcitabine 1,000 mg/m2 on Day 1 and 8 every 3 weeks for 3 courses followed by 3 courses of docetaxel 37.5 mg/m2 on Day 1 and 8 every 3 weeks, 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 8.6 months, respectively; the 1-year survival rate was 30 %.