PURPOSE: 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). MATERIALS AND 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%). CONCLUSION: 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.
PURPOSE: 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). MATERIALS AND 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%). CONCLUSION: 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: Jung Ae Lee; Keun Seok Lee; Jin Seok Ahn; Jae Ho Byun; Hun Ho Song; Dae Young Zang; Young Iee Park; Young Suk Park; Eun Kyung Mo; Dong Kyu Kim; Myung Goo Lee; In Gyu Hyun; Ki Suck Jung; Soo Mee Bang; Gye Young Park; Jeong Woong Park; Eun Kyung Cho; Seong Hwan Jeong; Dong Bok Shin; Jae Hoon Lee Journal: Cancer Res Treat Date: 2003-06 Impact factor: 4.679
Authors: Joan H Schiller; David Harrington; Chandra P Belani; Corey Langer; Alan Sandler; James Krook; Junming Zhu; David H Johnson Journal: N Engl J Med Date: 2002-01-10 Impact factor: 91.245
Authors: Se Hoon Lee; Keunchil Park; Cheolwon Suh; Hoon Kyo Kim; Jun Suk Kim; Young Hyuck Im; Sang We Kim; Dae Seog Heo; Yung Jue Bang; Noe Kyeong Kim Journal: Cancer Res Treat Date: 2003-02 Impact factor: 4.679
Authors: C J Langer; J C Leighton; R L Comis; P J O'Dwyer; C A McAleer; C A Bonjo; P F Engstrom; S Litwin; R F Ozols Journal: J Clin Oncol Date: 1995-08 Impact factor: 44.544
Authors: Min Kyoung Kim; Kyung Hee Lee; Myung Soo Hyun; Young Rok Do; Hong Suk Song; Won Sik Lee; Keon Uk Park; Jin Ho Baek; Jong Gwang Kim Journal: Cancer Res Treat Date: 2005-12-31 Impact factor: 4.679