A summary of vinorelbine (Navelbine) safety data from North American clinical trials.

A summary of vinorelbine (Navelbine) safety data from North American clinical trials.
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北美临床试验的长春瑞滨 (Navelbine) 安全性数据摘要。

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发表时间:
1994
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通讯作者:
Hohneker Ja
Hohneker Ja
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作者:
Hohneker Ja

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抗肿瘤药物vinorelbine (Navelbine; Burroughs Wellcome Co, Research Triangle Park, NC; Pierre Fabre Medicament, Paris, France)在欧洲和其他地方获得了丰富的临床经验。最近在北美进行的三个晚期非小细胞肺癌或乳腺癌患者的临床试验补充了这一经验。这些试验的数据表明长春瑞滨在门诊人群中是安全且耐受性良好的。粒细胞减少是剂量限制性毒性。虽然这种情况在长春瑞滨治疗的患者中发病率很高,但它很少与严重的并发症相关。大多数患者碱性磷酸酶水平升高,但这种影响可能部分是由于肝和骨转移所致。非血液学毒性大多为轻度或中度。注射部位的反应已在一些患者中被注意到,但改进的给药技术可能有助于减少这种影响的发生率。胃肠道和呼吸系统的影响很少严重,通常对治疗有反应。与其他常用的长春花生物碱化合物相比,药物相关的神经毒性较少发生。总的来说,长春瑞滨与一些严重的毒性有关,这些毒性在大多数情况下很容易控制。因此,这种药物似乎很适合用于非小细胞肺癌和乳腺癌的门诊治疗。
Extensive clinical experience has been obtained with the antineoplastic agent vinorelbine (Navelbine; Burroughs Wellcome Co, Research Triangle Park, NC; Pierre Fabre Medicament, Paris, France) in Europe and elsewhere. This experience recently has been supplemented by three clinical trials of patients with advanced non-small cell lung cancer or breast cancer conducted in North America. Data from these trials indicate that vinorelbine is safe and well tolerated in the outpatient population. Granulocytopenia is the dose-limiting toxicity. Although the incidence of this condition is high among vinorelbine-treated patients, it is uncommonly associated with severe complications. Elevations in alkaline phosphatase levels are seen in the majority of patients, but this effect may be due in part to liver and bone metastases. Nonhematologic toxicities are mostly mild or moderate. Injection site reactions have been noted in some patients, but improved administration techniques may help reduce the incidence of this effect. Gastrointestinal and respiratory effects are seldom severe and usually respond to treatment. Drug-associated neurotoxicity occurs less often than with other commonly used vinca alkaloid compounds. Overall, vinorelbine is associated with few severe toxicities, which for the most part, are easily managed. Thus, this agent seems well suited for use in the outpatient treatment of non-small cell lung and breast cancers.