A Multi-Center, Phase II Clinical Trial of Genexol(R) (Paclitaxel) and Cisplatin for Patients with Non-Small Cell Lung Cancer.
- Author:
Se Hoon LEE
1
;
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
Author Information
1. Department of Internal Medicine, Seoul National University College of Medicine, Seoul, Korea. bangyj@plaza.snu.ac.kr
- Publication Type:Clinical Trial ; Multicenter Study ; Original Article
- Keywords:
Non-small cell lung neoplasm;
Chemotherapy;
Genexol;
Paclitaxel;
Cisplatin
- MeSH:
Carcinoma, Non-Small-Cell Lung*;
Cisplatin*;
Drug Therapy;
Humans;
Hypersensitivity;
Infusions, Intravenous;
Neutropenia;
Paclitaxel;
Vomiting
- From:Cancer Research and Treatment
2003;35(1):30-34
- CountryRepublic of Korea
- Language:English
-
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.
