title: A Multi-Center, Phase II Clinical Trial of Genexol(R) (Paclitaxel) and Cisplatin for Patients with Non-Small Cell Lung Cancer.
abstract: OBJECTIVE
  A combination of paclitaxel and cisplatin is an effective and safe regimen for advanced non-small cell lung cancer (NSCLC). We conducted a multi-center, phase II trial to evaluate the efficacy and safety of Genexol(R) (paclitaxel) and cisplatin in patients with NSCLC.
  
  
  METHODS
  Chemotherapy-na ve patients having histologically confirmed NSCLC were enrolled. Genexol(R) was administered at 175 mg/m2 as a 3-hour intravenous infusion and cisplatin at 75 mg/m2 as an intravenous infusion on day 1 every 3 weeks.
  
  
  RESULTS
  Twenty-five of 27 patients that were entered from 5 hospitals between Jan 2001 and Aug 2001 received chemotherapy. On an intent-to-treat basis, 9 patients (36%) achieved a partial response, 7 patients (28%) a stable disease, and 5 patients (20%) The overall response rate was 36% (95% CI, 17 to 55%). progressed. The median duration of the response was 7.8 months (95% CI, 6.6 to 9.0 months). The median time to progression was 7.4 months (95% CI, 5.3 to 9.5 months), and median overall survival was 13.3 months (95% CI, 10.8 to 15.9 months) for the intent-to-treat population. The major oxicity was hematological, with grade 3 and 4 neutropenia in 10% (10/106) of the total cycles. The non-hematologic oxicity was mild, and grade 3 emesis was observed in 2 patients (8%). One patient experienced a moderate degree hypersensitivity reaction.
  
  
  CONCLUSIONS
  The results suggest that a combination of Genexol(R) and cisplatin is an effective and well-tolerated regimen for patients with NSCLC.
authors.forename: Se Hoon
authors.initials: SH
authors.lastname: Lee
authors.forename: Keunchil
authors.initials: K
authors.lastname: Park
authors.forename: Cheolwon
authors.initials: C
authors.lastname: Suh
authors.forename: Hoon Kyo
authors.initials: HK
authors.lastname: Kim
authors.forename: Jun Suk
authors.initials: JS
authors.lastname: Kim
authors.forename: Young Hyuck
authors.initials: YH
authors.lastname: Im
authors.forename: Sang We
authors.initials: SW
authors.lastname: Kim
authors.forename: Dae Seog
authors.initials: DS
authors.lastname: Heo
authors.forename: Yung Jue
authors.initials: YJ
authors.lastname: Bang
authors.forename: Noe Kyeong
authors.initials: NK
authors.lastname: Kim
keywords: Chemotherapy; Cisplatin; Genexol; Non-small cell lung neoplasm; Paclitaxel