J Lung Cancer.  2007 Jun;6(1):1-7. 10.6058/jlc.2007.6.1.1.

A Comparison of Gemcitabine in Two Doses for Stage III or IV Non-small Cell Lung Cancer : a Multi-Institutional Phase II Study

• Park HS
• An JY
• Lee YS
• Joung MK
• Lee YJ
• Jung SS
• Yun HJ
• Kim JO
• Kim KS
• Kim YC
• Jung MH
• Ryu JS
• Kim SY

• KMID: 2200107
• DOI: http://doi.org/10.6058/jlc.2007.6.1.1

Abstract

PURPOSE : Since the combination of cisplatin plus gemcitabine (CG) had a significant survival advantage for the treatment of patients with chemotherapynaive advanced or metastatic non-small cell lung cancer (NSCLC), CG combination have been evaluated with different schedules. However, the best schedule is still unclear. We designed to compare the efficacy and toxicity of CG combination chemotherapy in two different doses of gemcitabine (1,000 or 1,250 mg/m2 3-weekly).
MATERIALS AND METHODS
: We randomized patients with stage III or IV NSCLC into either gemcitabine 1,250 mg/m2 or gemcitabine 1,000 mg/m2. Patients received cisplatin 60 mg/m2 intravenously on day1 of each 3-week cycle. Gemcitabine was administered intravenously on days 1 and 8 of each 3-week cycle.
RESULTS
: From April 2002 until July 2004, 125 patients were enrolled from four university hospitals (55 patients in the gemcitabine 1,000 mg/m2 arm and 70 patients in the gemcitabine 1,250 mg/m2 arm). Response rates were not significantly different in both arms (56.4% vs. 55.7%). However, grade 3 neutropenia was significantly lower in gemcitabine 1,000 mg/m2 arm compared to gemcitabine 1,250 mg/m2 arm (11.0% vs. 15.8%). No differences in non-haematologic toxicities in both arms except anorexia were observed. The median survival was 13.4 months for gemcitabine 1,000 mg group compared with 15.8 months for gemcitabine 1,250 mg group. There were no statistically significant differences in survival between the groups.
CONCLUSION
: For stage III or IV non-small cell lung cancer, combination chemotherapy with gemcitabine 1,000 mg/m2 showed equivalent response rate with lesser neutropenia and anorexia compared to treatment with gemcitabine 1,250 mg/m2

Keyword

Cisplatin; Gemcitabine; Non-small cell lung cancer; 3-week cycle; Two different doses; Chemotherapy-naive

MeSH Terms

Anorexia
Appointments and Schedules
Arm
Carcinoma, Non-Small-Cell Lung*
Cisplatin
Drug Therapy, Combination
Hospitals, University
Humans
Neutropenia
Cisplatin

Figure

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  Fig. 1. Kaplan-Meier survival curves for all patients by treatment group.

Reference

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