A phase II study of gemcitabine and vinorelbine combination followed by sequential gefitinib monotherapy in elderly patients with non-small cell lung cancer

Abstract

e19040 Background: Gemcitabine (GEM) and vinorelbine (VNR) combination have demonstrated activity as a 1st-line treatment in elderly patients with advanced non-small-cell lung cancer (NSCLC). Gefitinib (GEF) is effective as a 2nd-line treatment for NSCLC. We conducted a multicenter phase II trial to evaluate the efficacy and toxicity for treatment of GEM+VNR followed by sequential GEF in elderly patients (pts) with advanced or metastatic NSCLC. Primary endpoint is response rate, secondary endpoints were safety, progression-free survival (PFS), and overall survival (OS). Methods: Eligibility required hitologically or cytologically comfirmed NSCLC, no prior therapy, measurable lesion(s), ECOG PS 0–2, age equal to or over 70 years, and adequate organ functions. Patients were received 3 cycles, each at 4-week intervals, of GEM (1000 mg/m2, d 1, 15) and VNR (25mg/m2 d 1, 15), followed by 250 mg of GEF daily until disease progression or unacceptable toxicity. Results: Between June 2004 and November 2007, 60 pts were enrolled and 2 pts withdrew consent. Fifty-eight pts (35 male and 23 female, median age 77 years) were evaluated. Median number of GEM+VNR administrations was 3 (range 1–3). Median duration of GEF was 101 days (range 9–652 days). Grade 3/4 toxicities included leucopenia (29%), neutoropenia (40%), anemia (12%), febrile neutropenia (9%), and anorexia (9%) during GEM+VNR, anorexia (2%), and constipation (2%) during GEF. Best response rate of GEM+VNR was 17% and that after sequential GEF was 31%. Median PFS and median OS were 4.2 months and 12.6 months, respectively. Response rate, PFS, and OS were significantly favorable in female and never-smoker. Conclusions: Sequential treatment consisted with GEM+VNR and GEF was feasible with acceptable toxicities in elderly patients with NSCLC. [Table: see text]