Phase II Clinical Trial of Genexol¢ç (Paclitaxel) and Carboplatin for Patients with Advanced Non-small Cell Lung Cancer

Cancer Research and Treatment 2011³â 43±Ç 1È£ p.19 ~ p.23

±èÇÑÁ¶(Kim Han-Jo) - Soonchunhyang University College of Medicine Department of Internal Medicine
±è°æÇÏ(Kim Kyoung-Ha) - Soonchunhyang University College of Medicine Department of Internal Medicine
À±Áö³ª(Yun Ji-Na) - Soonchunhyang University College of Medicine Department of Internal Medicine
±è¼¼Çü(Kim Se-Hyung) - Soonchunhyang University College of Medicine Department of Internal Medicine
±èÇöÁ¤(Kim Hyun-Jung) - Soonchunhyang University College of Medicine Department of Internal Medicine
ÀÌ»óö(Lee Sang-Cheol) - Soonchunhyang University College of Medicine Department of Internal Medicine
¹è»óº´(Bae Sang-Byung) - Soonchunhyang University College of Medicine Department of Internal Medicine
±èÂù±Ô(Kim Chan-Kyu) - Soonchunhyang University College of Medicine Department of Internal Medicine
À̳²¼ö(Lee Nam-Su) - Soonchunhyang University College of Medicine Department of Internal Medicine
À̱ÔÅÃ(Lee Kyu-Taek) - Soonchunhyang University College of Medicine Department of Internal Medicine
±èµµÁø(Kim Do-Jin) - Soonchunhyang University College of Medicine Department of Internal Medicine
¹Ú¼º±Ô(Park Seong-Kyu) - Soonchunhyang University College of Medicine Department of Internal Medicine
¿øÁ¾È£(Won Jong-Ho) - Soonchunhyang University College of Medicine Department of Internal Medicine
È«´ë½Ä(Hong Dae-Sik) - Soonchunhyang University College of Medicine Department of Hematology-Oncology
¹ÚÈñ¼÷(Park Hee-Sook) - Soonchunhyang University College of Medicine Department of Internal Medicine

Abstract

Purpose: This phase II clinical trial was conducted to evaluate the activity and safety of a combination treatment of paclitaxel (Genexol¢ç) 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¢ç 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¢ç 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¢ç is needed due to sensory neuropathy.

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Non-small-cell lung carcinoma, Chemotherapy, Carboplatin, Genexol¢ç
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