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

Abstract

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-naïve patients having histologically confirmed advanced or metastatic non-small cell lung cancer were enrolled. Genexol® was administered at 225 mg/m(2) 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.

• Authors: Han Jo Kim, Kyoung Ha Kim, Jina Yun, Se Hyung Kim, Hyun Jung Kim, Sang-Cheol Lee, Sang Byung Bae, Chan Kyu Kim, Nam Su Lee, Kyu Taek Lee, Do-Jin Kim, Seong-Kyu Park, Jong-Ho Won, Dae Sik Hong, Hee Sook Park
• Journal: Cancer research and treatment (Cancer Res Treat) Vol. 43 Issue 1 Pg. 19-23 (Mar 2011) ISSN: 2005-9256 [Electronic] Korea (South)
• PMID: 21509159 (Publication Type: Journal Article)