Efficacy of gemcitabine--cisplatin treatment in stage IIIA ("bulky"N2), IIIB and IV non-small cell lung cancer.

ABSTRACT

UNLABELLED The objective of the study was to assess the efficacy of a gemcitabine and cisplatin combination for patients with stage IIIA"bulky"N2, IIIB or IV non-small cell lung cancer(NSCLC). PATIENTS AND METHODS: Patients with histological and/or cytological diagnosis of NSCLC were administered gemcitabine 1250 mg/m2 on days 1 and 8, and cisplatin 70 mg/m2 on day 1, every 3 weeks. RESULTS: One hundred and twenty patients with NSCLC, with median age of 53 years, and a WHO performance status of 0 (26%) or 1 (74%), were evaluated. The overall response rate was 40.0% with 37.5% partial response (PR) and 2.5% complete response (CR). Also, 38% of the patients had either minimal response (MR) or stable disease (SD). The median survival was 54.9 weeks. The time to progression was 28.1 weeks. There was no treatment-related death in this series. CTC grade 3/4 neutropenia occurred in 4.4% of the patients, while febrile neutropenia developed in 0,9% of the patients. CTC grade 4 thrombocytopenia occurred in 2.2%, and CTC grade 3/4 anemia developed in 3.3%. CONCLUSION: Our results support that gemcitabine and cisplatin administered as a 3-week cycle is an effective and safe regimen for the treatment of locally advanced or metastatic NSCLC.