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诺维本(长春瑞滨)治疗非小细胞肺癌的II期研究。

A phase II study of Navelbine (vinorelbine) in the treatment of non-small-cell lung cancer.

作者信息

Depierre A, Lemarie E, Dabouis G, Garnier G, Jacoulet P, Dalphin J C

机构信息

Service de Pneumologie, CHR de Besançon, France.

出版信息

Am J Clin Oncol. 1991 Apr;14(2):115-9. doi: 10.1097/00000421-199104000-00004.

DOI:10.1097/00000421-199104000-00004
PMID:1851385
Abstract

Navelbine (vinorelbine, NVB) is the first semisynthetic 5'-nor-vinca-alkaloid selected for clinical trial. NVB has been shown to have a good level of activity against different experimental solid tumors in animals, with low neurotoxicity. In the phase II study, 78 patients with an inoperable non-small-cell lung cancer (NSCLC) were treated with NVB at a weekly dose of 30 mg/m2. No patient had previously received chemotherapy. Twenty-three of the 78 eligible patients showed a partial response (29.4% with a 95% confidence limits: 19.5-39.5). Eight patients were not evaluable and the percentage of partial response were 32.8% in the evaluable patients group. The median response duration was 34 weeks, and the median survival time for the overall population reached 33 weeks. Grade 3-4 leukopenia was seen in 12.5% of cycles. No thrombocytopenia occurred. At the dosage schedule used, NVB seems a very promising agent in the treatment of NSCLC.

摘要

诺维本(长春瑞滨,NVB)是首个被选用于临床试验的半合成5'-去甲长春花生物碱。已证明NVB对动物体内不同的实验性实体瘤具有良好的活性水平,且神经毒性较低。在II期研究中,78例无法手术的非小细胞肺癌(NSCLC)患者接受了每周剂量为30mg/m²的NVB治疗。此前所有患者均未接受过化疗。78例符合条件的患者中有23例出现部分缓解(29.4%,95%置信区间:19.5 - 39.5)。8例患者无法评估,可评估患者组的部分缓解率为32.8%。中位缓解持续时间为34周,总体人群的中位生存时间达33周。12.5%的周期出现3 - 4级白细胞减少。未发生血小板减少症。在所使用的剂量方案下,NVB在NSCLC治疗中似乎是一种非常有前景的药物。

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