| A Multi-Center, Phase II Clinical Trial of Genexol(R) (Paclitaxel) and Cisplatin for Patients with Non-Small Cell Lung Cancer |
| 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 |
1Department of Internal Medicine, Seoul National UniversityCollege of Medicine, Seoul, Korea. bangyj@plaza.snu.ac.kr
2Department of Medicine, Samsung Medical Center, SungkyunkwanUniversity School of Medicine, Seoul, Korea.
3Department of Internal Medicine, Asan Medical Center, UlsanUniversity College of Medicine, Seoul, Korea.
4Department of Internal Medicine, St. Vincent's Hospital,Catholic University College of Medicine, Suwon, Korea.
5Department of Internal Medicine, Korea University GuroHospital, Korea University College of Medicine, Seoul,Korea.
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Published online: February 28, 2003. |
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| ABSTRACT |
PURPOSE:
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.
MATERIALS AND 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.
CONCLUSION:
The results suggest that a combination of Genexol(R) and cisplatin is an effective and well-tolerated regimen for patients with NSCLC. |
| Key words:
Non-small cell lung neoplasm;Chemotherapy;Genexol;Paclitaxel;Cisplatin |
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