Park SH et al. – Weekly docetaxel and gemcitabine has modest activity with an acceptable toxicity profile in advanced NSCLC; however, a high frequency of early discontinuation is observed Methods
Prospective phase II study of whether weekly docetaxel and gemcitabine administration offers better tolerance and increased dose intensity
Review of 35 pts with stage IIIB/IV NSCLC and performance status 0–2
First-line chemotherapy with docetaxel 35 mg/m2 and gemcitabine 600 mg/m2 administered on days 1, 8 and 15
Treatment repeated every 4 wks, for up to 4 cycles; total of 85 chemotherapy cycles (median, 2; range, 1–4)
Results
Main reasons for treatment discontinuation: completion of all 4 planned cycles (6 pts), toxicity (15), progressive disease (14)
Most frequently encountered toxic effects: anemia (52% of pts), nausea/vomiting (60%), fatigue (71%), anorexia (57%)
Mortality in 1 pt due to bilateral pneumonitis after administration of second cycle
Disease control (objective response and stable disease) in the intent-to-treat (ITT) population was achieved in 60% of pts; overall response rate was 29%
At 13-mo median follow-up, median progression-free survival and overall survival were 2.8 and 10.6 mo, respectively