A Phase Ii Study in Taiwan with Navelbine(Nvb) Oral in Combinatino with Cisplatin (C) in Advanced Non-Small Cell Lung Cancer (Nsclc) Patients

Abstract

Background: ]he combination of intravenous NVB plus C is widely preschbed in m any countd es for the treatment of NSCLC ]he recommended dose chosen ~r this phase II study in Taiwan was C at 80 mg/m 2 on day 1 and NVB ORAL at 60 mg/m 2 on days 1 and 9. every 3 weeks based on the results of a phase I study (Y.M.Chen. IASLC 2003). ]he objectives of tHis phase II study were to define the efficacy and safety of this combination for frst line treatment of advanced/ metastatic NSCLC. Methods: A total of 46 chemotherapy~aive patients (pts) with o/tologically or Histologically confirmed NSCLC. inoperable stage IIIB or IV NSCLC with measurable disease , no cerebral metastasis and Kamofsky score ~>80% were treated with a m~ imum of 8. cycles Results: All patients were evaluaple for salty and 40 for efficacy: median age was 64 (range: 34 7,5): 63% were male: 70% were metastalJc: 63% adenocaroinoma. 22% squamous cell carcinoma. 15% other types: 98% had a Karnofsk'y score 8(~90% ]he median number of cycles received was 3(range: 1 6) for a total of 164 cycles Six patients were still on study at the time of the analysis. After extemal panel re'.'le~,v . 1,5 partial responses were achieved [response rate: 38% (95% confidence interval: 22% to 54%)]. 17 pts had a stable disease and 6 progressive clsease in the eva/cable population.according to WHO crltena The median progressior-, free survival was 5 months(95% confidence interval: 3.9 to 6 .4).