Prospective phase II trial of a combination of fixed dose rate infusion of gemcitabine with cisplatin and UFT as a first-line treatment in patients with advanced non-small-cell lung carcinoma

被引:7
|
作者
Shin, Su Jin [1 ]
Kim, Hawk [1 ]
Baek, Jin Ho [1 ]
Ahn, Jong-Joon [2 ]
Jegal, Yangjin [2 ]
Seo, Kwang Won [2 ]
Park, Chang Ryul [3 ]
Shin, Je Kyoun [3 ]
Jung, Jong Pil [3 ]
Kim, Jeong Won [3 ]
Cha, Hee Jeong [4 ]
Kwon, Woon Jung [5 ]
Jeong, Ae Kyung [5 ]
Noh, Young Ju [6 ]
Park, Jae-Hoo [1 ]
Min, Young Joo [1 ]
机构
[1] Univ Ulsan, Coll Med, Ulsan Univ Hosp, Dept Internal Med,Div Hematol Oncol, Ulsan 682714, South Korea
[2] Univ Ulsan, Coll Med, Ulsan Univ Hosp, Dept Internal Med,Div Pulmonol, Ulsan, South Korea
[3] Univ Ulsan, Coll Med, Ulsan Univ Hosp, Dept Thorac & Cardiovasc Surg, Ulsan, South Korea
[4] Univ Ulsan, Coll Med, Ulsan Univ Hosp, Dept Pathol, Ulsan, South Korea
[5] Univ Ulsan, Coll Med, Ulsan Univ Hosp, Dept Radiol, Ulsan, South Korea
[6] Univ Ulsan, Coll Med, Ulsan Univ Hosp, Dept Radiat Oncol, Ulsan, South Korea
关键词
non-small-cell lung cancer; gemcitabine; fixed dose rate; uracil-tegafur; cisplatin; chemotherapy;
D O I
10.1016/j.lungcan.2007.09.013
中图分类号
R73 [肿瘤学];
学科分类号
100214 ;
摘要
Purpose: The standard chemotherapy for non-elderly patients with advanced non-small-cell lung cancer (NSCLC) is platinum-based doublet combination therapy. Preclinical and clinical evidence indicates that infusion at the fixed dose rate (FDR) of 10mg/(m(2) min) may be more effective than a standard 30-min infusion of gemcitabine. In addition, oral uracil-tegafur (UFT (R)) was associated with a survival advantage in the adjuvant setting. Therefore, we performed a phase II study using the combination of gemcitabine, cisplatin and LIFT as first-line therapy in patients with advanced NSCLC. Patients and methods: Eligible patients had histologically or cytologically confirmed stage IIIB or IV NSCLC with a performance status of 0-2 and were chemotherapy-naive. Gemcitabine (1250mg/m(2), 10mg/(m(2) min) on days 1 and 8, respectively) and cisplatin (75 mg/m(2) on day 1) were injected intravenously and UFT (400mg/day) was administered orally on days 1-14. Treatment was repeated every 3 weeks for up to six cycles. Primary endpoint was overall response rate and secondary endpoints were overall survival, time to progression and safety profile. Result: Thirty-seven patients were enrolled. The median age was 60 years (range: 44-72 years). The performance status was 0 in 4, 1 in 30, and 2 in 3 patients. Twenty-three patients completed six cycles. Complete response was achieved in one (3%) patient, partial response in 17 (46%) patients, and stable disease in 10 (27%) patients. The overall response rate was 48.6% on an intention-to-treat basis and 54.5% of patients in whom a response evaluation was possible (n = 33). The median survival time was 14.7 months (95% confidence interval [CI] 11.2-18.2), the 1-year survival rate was 54% and the median time to progression was 5.4 months (95% CI 4.3-6.4). Toxicities were moderate and mostly hematological adverse events. Grade 3/4 neutropenia occurred in 37% of patients and four patients experienced febrile neutropenia. Grade 3/4 anemia and thrombocytopenia occurred in 19% and 5% of patients, respectively. Non-hematological toxicities were mild. Conclusion: The combination of gemcitabine, cisplatin and UFT is an active and well-tolerated first-tine regimen in patients with advanced NSCLC. (C) 2007 Elsevier Ireland Ltd. All rights reserved.
引用
收藏
页码:83 / 91
页数:9
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