title: The efficacy and safety of Padexol (paclitaxel) and cisplatin for treating advanced non-small cell lung cancer.
abstract: OBJECTIVE
  The authors conducted a multicenter study to evaluate the efficacy and safety of combination chemotherapy with Padexol and cisplatin for treating patients with advanced non-small cell lung cancer (NSCLC).
  
  
  METHODS
  From November 2003 to April 2005, 42 chemo-naive patients with advanced NSCLC were enrolled into this study from 4 hospitals. The treatment consisted of Padexol 175 mg/m(2) as a 3-hr infusion, and this was followed by cisplatin 75 mg/m(2) administered as an intravenous infusion with standard premedication. The treatment was repeated every 3 weeks.
  
  
  RESULTS
  Among the 42 patients (pts), 33 pts were evaluable for response. On the per protocol analysis, 1 patient (pt) (3.0%) achieved complete response (CR), 17 pts (51.5%) achieved partial response (PR), 6 pts (18.2%) achieved stable disease (SD), and 9 pts (27.3%) progressed; therefore, the overall response rate was 54.6% (95% CI: 37.6 approximately 71.5%). On the intention-to-treat analysis, 1 pt (2.4%) achieved CR, 18 pts (42.9%) achieved PR, 11 pts (26.2%) achieved SD, and 9 pts (21.4%) progressed; therefore, the overall response rate was 45.2% (95% CI: 30.2 approximately 60.3%). The response, as evaluated by the investigators, was independently reviewed by 2 external radiologists and it was as follows; 13 PR (43.3%), 14 SD (46.7%) and 3 progressive disease (10%). The median duration of response was 5.9 months. The median follow-up duration was 10.3 months (range: 1.3 to 22.1 months). The median time to progression was 5.8 months (95% CI: 4.7 to 7.4 months). The median survival time on the intention-to-treat analysis was 10.5 months (95% CI: 8.1 to 18.8 months). The most common grade 3 or 4 hematologic toxicities were neutropenia (26/180 cycles, 14.4%), anemia (7/180 cycles, 3.9%) and febrile neutropenia (2/180 cycles, 1.1%). The most frequent grade 3 or 4 non-hematologic toxicities were nausea (14/42 patients, 14.3%), anorexia (3/42 patients, 7.1%) and myalgia (3/42 patients, 7.1%).
  
  
  CONCLUSIONS
  The authors observed that Padexol was as good as the other paclitaxel (Taxol or Genexol) formulations when combined with cisplatin for treating patients with advanced NSCLC.
authors.affiliation: Department of Internal Medicine, St. Vincent's Hospital, The Catholic Unviersity of Korea, Suwon, Korea.
authors.forename: Hoon-Kyo
authors.initials: HK
authors.lastname: Kim
authors.forename: Jun Suk
authors.initials: JS
authors.lastname: Kim
authors.forename: Hun Mo
authors.initials: HM
authors.lastname: Ryoo
authors.forename: Dong Gun
authors.initials: DG
authors.lastname: Shin
authors.forename: Byoung Young
authors.initials: BY
authors.lastname: Shim
authors.forename: Kyong Hwa
authors.initials: KH
authors.lastname: Park
authors.forename: Sung Hwa
authors.initials: SH
authors.lastname: Bae
authors.forename: Chi Hong
authors.initials: CH
authors.lastname: Kim