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KMID : 0939920030350010030
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대한암학회지
2003 Volume.35 No. 1 p.30 ~ p.34
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A Multi-Center, Phase Ⅱ Clinical Trial of Genexol® (Paclitaxel) and Cisplatin for Patients with Non-Small
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Yung Jue Bang/Se Hoon Lee
Keun Chil Park/Cheol Won Suh/Hoon Kyo Kim/Jun Suk Kim/Young Hyuck Im/Sang We Kim/Dae Seog Heo/Yung Jue Bang/Noe Kyeong Kim
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Abstract
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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.
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KEYWORD
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Non-small cell lung neoplasm, Chemotherapy, Genexol®, Paclitaxel, Cisplatin,
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