P2-295: Phase II trial a 2-h infusion of Gemcitabine-carboplatin combination as first-line therapy for stage IIIB or IV non-small cell lung cancer

Abstract

19%:81%. 312 cycles of treatment were administered and 14 patients had dose reductions (26.4%); median number of doses was 5 for both G and P, and median dose intensity was 98.05% for both G and P. Confirmed responses were 0 CRs, 11 PRs, (20.8%), 23 SDs (43.4%), and 14 PDs (26.4%), with a median duration of response of 10.3 mos (95%CI, 3.2, 20.0). Patient-based G3/4 hematologic events included febrile neutropenia (9.4%), neutropenia (28.3%), and thrombocytopenia (5.7%). Grade 3/4 nonhematologic events included fatigue (22.6%), dyspnea (7.5%), dehydration (7.5%), diarrhea (5.7%), constipation (3.8%), nausea (3.8%), ALT elevation (3.8%), and pneumonia (1.9%). Median TTP was 4.6 mos (95%CI, 2.8, 6.2; 30.2% censored) and median OS was 10.1 mos (95%CI, 6.0, 14.1; 41.0% 1-yr survival; 20.8% censored). Conclusion: Biweekly G and P appear to be well tolerated in advanced NSCLC. A median OS of 10.1 mos and clinical benefit rate (ORR + SD) of 64.2% indicates activity in patients with advanced NSCLC. The dose intensity for biweekly G and P is higher than a previously reported 6-cycle, 21-day regimen with median dose intensity of 83.2% for P and 82.2% for G (West, et al. Proc ASCO 2005; 7117).