A phase II trial of biweekly administration of vinorelbine (V) and gemcitabine (G) in elderly patients (Pts) with advanced non-small cell lung cancer (NSCLC)

Abstract

7331 Objective: The purpose of this phase II trial was to evaluate the activity and the toxicity in elderly NSCLC pts of biweekly administration of this combination. Pts and Methods: 45 elderly pts with advanced NSCLC were treated with V 25mg/m2 intravenously and G 1000mg/m2 intravenously every 2 weeks. Eligible pts had: age ≥ 70 yrs; measurable or evaluable disease; ECOG PS 0–2; adequate bone marrow, liver and renal function; no previous chemo- or radiotherapy; life expectancy ≥12 weeks; written informed consent. Results: From August 2001 to November 2003, 46 pts were enrolled and 44 pts were eligible: males/females 27/17; median age 76(range 71–84); PS 0/1/2 25/16/3; stage IIIA/IIIB/IV 5/14/25; adeno/squamous 31/13. A total of 194 cycles(median 6/pt, range 1–12) were given. Tumor response and safety were analysed by December 2003. Of the 40 pts evaluable for response, 11(27.5%) had partial response and 19(47.5%) had stable disease. At this writing, median time to progression is 160 days and median survival is 397 days and 21 pts(47.7%) are still alive. All pts were evaluable for toxicity. Toxicity was mild and mainly hematologic. Grade 3/4 toxicities were neutropenia in 35.3/17.6% of pts, leukopenia in 29.4/2.3%, anemia in 0/0% and thrombocytopenia in 0%/2.9%, respectively. 2 pts(4.5%) had febrile neutropenia. Only 5(11.6%) pts had grade 3 or 4 non-hematological toxicities which were mainly constipation. There was one death from sepsis with neutropenia. At 40th Annual Meeting, we will demonstrate the final results of this trial. Conclusions: This VG biweekly schedule shows an acceptable activity in elderly. The toxicity profile is favorable with mild myelotoxicity. No significant financial relationships to disclose.