Cancer Res Treat.  2011 Mar;43(1):19-23.

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

• Kim HJ
• Kim KH
• Yun J
• Kim SH
• Kim HJ
• Lee SC
• Bae SB
• Kim CK
• Lee NS
• Lee KT
• Kim DJ
• Park SK
• Won JH
• Hong DS
• Park HS

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.

Keyword

Non-small-cell lung carcinoma; Chemotherapy; Carboplatin; Genexol(R)

MeSH Terms

Carboplatin
Carcinoma, Non-Small-Cell Lung
Humans
Lung
Neutropenia
Paclitaxel
Peripheral Nervous System Diseases
Carboplatin
Paclitaxel

Figure

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  Fig. 1 Kaplan-Meier curve for time-to-progression.

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  Fig. 2 Kaplan-Meier curve for overall survival.

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