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KMID : 0982820050040020074
Journal of Lung Cancer
2005 Volume.4 No. 2 p.74 ~ p.80
Three-Weekly Gemcitabine Plus Cisplatin Chemotherapy in Patients with Locally Advanced or Metastatic Non-small- cell Lung Cancer: Phase II Study of the Korean Association for the Study of Lung Cancer
Ryu Jeong-Seon

Jung Maan-Hong
Kim Sun-Young
Kim Se-Kyu
Kim Young-Chul
Jeong Eun-Taik
Abstract
Purpose: As one of the new chemotherapeutic agents, gemcitabine is widely used as a four-week schedule in combination with cisplatin in the treatment of advanced non-small-cell lung cancer (NSCLC). In this study, we evaluated the efficacy, tolerance, and survival effect of this combination in a three-week schedule in patients with locally advanced inoperable or metastatic NSCLC.

Materials and Methods: Between January 2000 and September 2002, previously untreated 124 NSCLC patients were enrolled and 118 patients, who completed at least two cycles of chemotherapy, were evaluated. Patients received gemcitabine 1200 mg/m2 on days 1 and 8, cisplatin 75 mg/m2 on day 1 of a 21-day cycle, for a maximum of 6 cycles.
Results: They were 81 men and 37 women. Clinical stage IIIB was present in 56 (47.5%), and stage IV in 62 (52.4%) patients. Sixty-seven patients (56.8%) had a performance status of ECOG grade 0 or 1 and fifty-one patients (43.2%) of grade 2. During the period of chemotherapy, grade 3/4 leukopenia and neutropenia were observed in 19.5% and 31.4%, respectively and grade 3/4 thrombocytopenia in 7.6%. The overall response rate was 52.5% among the 118 patients. Overall median survival time was 12.2 months, and one-year and two-year survival rates were 50.2% and 20.4% respectively. The presence of response to chemotherapy, ECOG performance status of grade 0¡­1, and women showed better survival by the univariate analysis (p=0.010, 0.001 and 0.015, respectively).

Conclusion: A three weekly gemcitabine/cisplatin doublet was relatively well tolerated, with an acceptable response rate and a reasonable median survival in locally advanced inoperable or metastatic NSCLC.
KEYWORD
Non-small-cell lung cancer, Phase II trial, Gemcitabine, Cisplatin
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