Oral vinorelbine for the treatment of metastatic non-small cell lung cancer in elderly patients: a phase II trial of efficacy and toxicity
Oral vinorelbine for the treatment of metastatic non-small cell lung cancer in elderly patients: a phase II trial of efficacy and toxicity
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DOI：
10.1016/j.lungcan.2003.09.012
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发表时间：
2004-03-01
期刊：
影响因子：
5.3
通讯作者：
Kugler, JW
中科院分区：
文献类型：
--
作者：
Kanard, A;Jatoi, A;Kugler, JW
目的：在此之前，口服长春瑞滨尚未在老年晚期非小细胞肺癌患者队列中进行过测试，尽管该药物的静脉注射形式为该组患者提供了合理的治疗选择。本试验旨在确定口服长春瑞滨治疗65岁以上晚期非小细胞肺癌患者的肿瘤缓解率和毒性特征。患者和方法：58例年龄大于或等于65岁的晚期非小细胞肺癌患者入组。中位年龄为73岁（范围：65-87岁）。东部肿瘤协作组（ECOG）体能评分为0、1或2的患者分别为29、59和12%。所有患者均具有足够的器官功能。口服长春瑞滨60 mg/m2/周作为一线治疗。结果：2例患者证实肿瘤缓解，缓解率为3.4%（95%置信区间（CI）：0.4，11.9%）。没有完整的答复。中位无进展生存期为3.5个月（95% CI：2.2，5.4个月），中位总生存期为7.5个月（95% CI：5.0，12个月）。有五人死亡，其中一人可能是。治疗相关，有10起4级事件。结论：在本试验中，口服长春瑞滨治疗年龄≥ 65岁的晚期非小细胞肺癌患者的活性最低。(C)2003爱思唯尔爱尔兰有限公司保留所有权利。
Purpose: Before now oral vinorelbine has not yet been tested in a cohort of elderly, advanced non-small cell lung cancer patients, even though the intravenous form of this drug provides a reasonable therapeutic option for this group. This trial was conducted to determine the tumor response rate and toxicity profile of oral vinorelbine in advanced non-small cell lung cancer patients greater than or equal to65 years of age. Patients and methods: Fifty-eight evaluable patients greater than or equal to65 years of age with advanced non-small cell lung cancer were enrolled. Median age was 73 years (range: 65-87). The Eastern Cooperative Oncology Group (ECOG) performance score was 0, 1, or 2 in 29, 59, and 12% of patients, respectively. All patients had adequate organ function. Ora[ vinorelbine 60 mg/m(2) per week was prescribed weekly as first-Line therapy. Results: Two patients manifested a confirmed tumor response, yielding a response rate of 3.4% (95% confidence interval (Cl): 0.4, 11.9%). There were no complete responses. Median progression-free survival was 3.5 months (95% Cl: 2.2, 5.4 months), and median overall survival was 7.5 months (95% Cl: 5.0, 12 months). There were five deaths, one of which might have been. treatment-related, and there were 10 grade 4 events. Conclusions: Ora[ vinorelbine, as prescribed in this trial, provides minimal activity in the treatment of advanced non-small cell lung cancer in patients greater than or equal to65 years of age. (C) 2003 Elsevier Ireland Ltd. All rights reserved.