Phase II study of oral vinorelbine in first-line advanced breast cancer chemotherapy
Phase II study of oral vinorelbine in first-line advanced breast cancer chemotherapy
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DOI：
10.1200/jco.2003.09.057
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发表时间：
2003-01-01
影响因子：
45.3
通讯作者：
Trillet-Lenoir, V
中科院分区：
文献类型：
--
作者：
Freyer, G;Delozier, T;Trillet-Lenoir, V
目的：进行了一项11期试验，以评估口服长春瑞滨（诺维本）的疗效、耐受性和药代动力学特征。口服诺维本（NVB;皮埃尔法布尔药物，布洛涅，法国）作为一线化疗局部晚期或转移性乳腺癌（ABC）。患者和方法：64例患者进入接受口服诺维本每周的基础上，共8周，除非发生进展或毒性。前三次口服NVB的剂量为60 mg/m2，每周一次，如果没有4级中性粒细胞减少或3级中性粒细胞减少不超过1次，则随后的剂量增加到10 mg/m2。客观反应或病情稳定的患者继续治疗，共12周或以上。结果：58个可评估的患者被纳入我们的研究。4例患者（6.9%）完全缓解，14例（24.1%）部分缓解，总缓解率为31%（95% CI，19%-43%）。中位无进展生存期为17.4周。中位总生存期尚未达到。无治疗相关死亡。主要毒性为中性粒细胞减少：17.2%的患者发生4级，1.8%的给药和4例患者（6.2%）发生相关临床严重事件。分别在3.1%和4.6%的患者中观察到3级和4级恶心和/或呕吐。只有1例患者发生了3级神经性便秘。生活质量问卷C30形式的分析显示，基线和第8周和第16周之间没有显着的改变，在全球quality of life.Conclusion：口服诺维本在这个时间表是一种有效的和耐受性良好的代理ABC的治疗，并提供了一个有前途的替代静脉途径。联合用药研究正在进行中。(C)2003年，美国临床肿瘤学会。
Purpose : A phase 11 trial was performed to evaluate the efficacy, tolerance, and pharmacokinetic profiles of oral vinorelbine (Navelbine). Oral Navelbine (NVB; Pierre Fabre Medicament, Boulogne, France) was given as first-line chemotherapy for locally advanced or metastatic breast carcinoma (ABC).Patients and Methods: Sixty-four patients were entered to receive oral NVB on a weekly basis for a total of 8 weeks unless progression or toxicity occurred. Oral NVB was given at 60 mg/m(2) weekly for the first three administrations and was increased to go mg/m(2) for the subsequent administrations if there was no grade 4 neutropenia or no more than one episode of grade 3 neutropenia. Patients with objective response or stable disease continued treatment up to a total of 12 weeks or more.Results: Fifty-eight evaluable patients were included in our study. Four patients (6.9%) had complete responses, and 14 (24.1%) had partial responses, for an overall response rate of 31% (95% Cl, 19% to 43%). Median progression-free survival was 17.4 weeks. Median overall survival is not yet reached. There were no treatment-related deaths. The main toxicity was neutropenia: grade 4 in 17.2% of the patients, and 1.8% of administrations and associated clinical serious events in 4 patients (6.2%). Grade 3 and 4 nausea and/or vomiting were noted in 3.1% and 4.6% of the patients, respectively. Only one patient developed grade 3 neuroconstipation. An analysis of Quality of Life Questionnaire C30 forms revealed no significant alteration between baseline and weeks 8 and 16 in global quality of life.Conclusion: Oral NVB at this schedule is an effective and well-tolerated agent in the treatment of ABC and offers a promising alternative to the intravenous route. Combination studies are ongoing. (C) 2003 by American Society of Clinical Oncology.