Phase II Clinical Trial of Genexol(R) (Paclitaxel) and Carboplatin for Patients with Advanced Non-small Cell Lung Cancer.
- Author:
Han Jo KIM
1
;
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
Author Information
1. Division of Hematology and Oncology, Department of Internal Medicine, Soonchunhyang University Cheonan Hospital, Cheonan, Korea.
- Publication Type:Clinical Trial ; Original Article
- Keywords:
Non-small-cell lung carcinoma;
Chemotherapy;
Carboplatin;
Genexol(R)
- MeSH:
Carboplatin;
Carcinoma, Non-Small-Cell Lung;
Humans;
Lung;
Neutropenia;
Paclitaxel;
Peripheral Nervous System Diseases
- From:Cancer Research and Treatment
2011;43(1):19-23
- CountryRepublic of Korea
- Language:English
-
Abstract:
PURPOSE: This phase II clinical trial was conducted to evaluate the activity and safety of a combination treatment of paclitaxel (Genexol(R)) 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(R) 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(R) 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(R) is needed due to sensory neuropathy.
