The efficacy and safety of Padexol (paclitaxel) and cisplatin for treating advanced non-small cell lung cancer.
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.
Kim
Hoon-Kyo
HK
Department of Internal Medicine, St. Vincent's Hospital, The Catholic Unviersity of Korea, Suwon, Korea.
Kim
Jun Suk
JS
Ryoo
Hun Mo
HM
Shin
Dong Gun
DG
Shim
Byoung Young
BY
Park
Kyong Hwa
KH
Bae
Sung Hwa
SH
Kim
Chi Hong
CH