Adjuvant bi-weekly schedule of gemcitabine (G) plus carboplatin (Cb) in resected stage IA (>2cm) to IIIA non-small cell lung cancer: A phase II study.

7598 Background: Gemcitabine (G) plus carboplatin (Ca) chemotherapy has shown to have activity against non-small cell lung cancer (NSCLC) and to be a well-tolerated treatment. Our aim was to evaluate the feasibility and clinical efficacy of adjuvant bi-weekly GCa in completely resected NSCLC.,Eligibility required completely resected stage IA (>2cm) to IIIA NSCLC, no prior chemotherapy or radiotherapy, ECOG PS 0-1, age under 76 years. Patients were to receive four cycles, each at 4-week intervals, of G (1,000 mg/m, d 1, 15) and Ca (AUC 2.5, d 1, 15). Cycles were repeated until 4 treatments.,Between 03/2005 and 10/2006, 54 pts were enrolled and 53 pts were eligible, 2 pts withdrawn informed consent. 51 pts (32 male and 19 female, median age 64) were evaluated. Median number of GCa treatments was 4(1-4) and median dose intensity was 94% for both G and Ca. Grade 3/4 hematologic events included leucopenia (7%), neutoropenia (7%), and anemia (4%). Grade 3/4 non-hematologic events included nausea (2%), infection (4%). 1-year disease-free survival was 90%.,Adjuvant bi-weekly schedule of GCa was feasible with acceptable level of toxicity in completely resected stage IA (>2cm) to IIIA non-small cell lung cancer. A phase III trial is now warranted. No significant financial relationships to disclose.