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KMID : 0939920110430010019
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대한암학회지
2011 Volume.43 No. 1 p.19 ~ p.23
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Phase II Clinical Trial of Genexol® (Paclitaxel) and Carboplatin for Patients with Advanced Non-small Cell Lung Cancer
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Kim Han-Jo
Kim Kyoung-Ha
Yun Ji-Na
Kim Se-Hyung
Kim Hyun-Jung
Lee Sang-Cheol
Bae Sang-Byung
Kim Chan-Kyu
Lee Nam-Su
Lee Kyu-Taek
Kim Do-Jin
Park Seong-Kyu
Won Jong-Ho
Hong Dae-Sik
Park Hee-Sook
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Abstract
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Purpose: This phase II clinical trial was conducted to evaluate the activity and safety of a combination treatment of paclitaxel (Genexol®) plus carboplatin in patients with advanced non-small cell lung cancer.
Materials and Methods: Chemotherapy-naive patients having histologically confirmed advanced or metastatic non-small cell lung cancer were enrolled. Genexol® was administered at 225 mg/m2 intravenous (IV) infusion over 3 hours, followed by carboplatin (area under the concentration-time curve=6) IV on day 1 every 3 weeks.
Results: Twenty-eight patients were enrolled between January 2003 and January 2005. A total of 110 cycles of chemotherapy were given. The median number of chemotherapy cycles was 4. A total of 25 study patients were evaluable. On an intent-to-treat basis, there were ten partial responses (response rate 35.7%). The median time-to-progression was 3.2 months (95% confidence interval [CI], 1.5 to 4.9) and the median overall survival was 8.2 months (95% CI, 4.1 to 12.3). The main hematologic grade 3/4 toxicity was neutropenia, which was observed in 14 (50.0%) patients. The main non-hematologic toxicity was peripheral neuropathy, which was observed in 12 patients (42.9%). Grade 3/4 neuropathy occurred in 8 patients (28.6%) and three patients discontinued treatment because of neuropathy.
Conclusion: In this trial, the combination of Genexol® and carboplatin showed significant activity as first line treatment for patients with advanced or metastatic non-small cell lung cancer. However, a modest dose reduction of Genexol® is needed due to sensory neuropathy.
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KEYWORD
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Non-small-cell lung carcinoma, Chemotherapy, Carboplatin, Genexol®
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