title: A 21-day schedule of gemcitabine and cisplatin administration in the treatment of advanced non-small cell lung carcinoma: a phase II study.
abstract: OBJECTIVE
  To evaluate the efficacy and toxicity of gemcitabine and cisplatin combination chemotherapy, we conducted a phase II study of this regimen in patients with advanced non-small cell lung carcinoma (NSCLC).
  
  
  METHODS
  From June 2001 to August 2003, 36 chemotherapy-naive patients with stage IIIB or IV NSCLC were enrolled. The median age was 59 years (range, 42 to 75 years), and performance status was 0 or 1. Eleven patients had stage IIIB disease, and 25 patients had stage IV disease. 1,000 mg/m(2) of gemcitabine was administered on day 1 & 8, and 60 mg/m(2) of cisplatin was administered on day 1. Each cycle was repeated every 21 days.
  
  
  RESULTS
  Everyone subject who participated were assessable. A total of 160 cycles of chemotherapy were delivered, and the median number of chemotherapy courses was 3.5 (range, 2 to 9). Two patients (5.6%) achieved a complete response, and 14 patients (38.9%) achieved a partial response. The overall response rate was 44.5% (95% confidence interval [CI], 32.5 to 56.5%). The median follow-up duration was 9.3 months. The median time to disease progression was 8.6 months (95% CI 7.4 to 9.9 months), and median survival time was 12.2 months (95% CI, 10.5 to 12.9 months). Grade 3/4 neutropenia occurred in 9 patients (25.0%), neutropenic fever occurred in 3 patients (8.3%), and grade 3/4 thrombocytopenia occurred in 7 patients (19.5%). Mild forms of non-hematologic toxicities, such as nausea, vomiting or skin reactions, were observed.
  
  
  CONCLUSIONS
  The combination of gemcitabine and cisplatin in a 21-day schedule is an effective regimen for patients with NSCLC in its advanced stages.
authors.affiliation: Department of Internal Medicine, College of Medicine, Dong-A University, Dong-A Cancer Center, Busan, Korea.
authors.forename: Jong-Sung
authors.initials: JS
authors.lastname: Park
authors.forename: Chang-Min
authors.initials: CM
authors.lastname: Lee
authors.forename: Shin-Ae
authors.initials: SA
authors.lastname: Lee
authors.forename: Chang-Kil
authors.initials: CK
authors.lastname: Jung
authors.forename: Sung-Hyun
authors.initials: SH
authors.lastname: Kim
authors.forename: Hyuk-Chan
authors.initials: HC
authors.lastname: Kwon
authors.forename: Jae-Seok
authors.initials: JS
authors.lastname: Kim
authors.forename: Hyo-Jin
authors.initials: HJ
authors.lastname: Kim
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