A phase II study of biweekly paclitaxel (P) and gemcitabine (G), followed by maintenance weekly paclitaxel in elderly patients with advanced non-small cell lung cancer (NSCLC)

SummaryBackgroundThis phase II study was conducted to evaluate the efficacy and safety of a novel combination of paclitaxel (P) and gemcitabine (G) in an every 2 weeks schedule followed by weekly paclitaxel (P) as first-line treatment in elderly patients with locally advanced or metastatic NSCLC.MethodsElderly patients (≥65 years of age) with 1997 TNM stage IIIB (pleural effusion)/stage IV NSCLC, performance status (PS) of 0–2 and normal organ function were eligible. Therapy consisted of P at 150 mg/m2 and G at 2000 mg/m2 administered every 2 weeks for 3 cycles followed, in progression-free patients, by P at 80 mg/m2 every week for 6 consecutive weeks every 8 weeks for 2 cycles.ResultsFifty-three eligible patients were enrolled: M/F 51/2; stage IIIB/IV 8/45; PS 0, 40%, PS 1 51%, PS 2 9%; median age, 73 years (range 67–82). The overall response rate was 32% (95% confidence interval [CI]: 19–45). The median overall survival was 7 months (95% CI: 5–9); the median progression-free survival was 5 months (95% CI: 3–6); and the 1- and 2-year survivals were 28.3% and 10.1%, respectively. Both phases of the treatment protocol were well tolerated.ConclusionsBiweekly P/G followed by weekly P is well tolerated and active as first-line therapy for elderly NSCLC patients.