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在印度使用纳米紫杉醇(Nanoxel)的临床和经济意义。

Clinical and economic implications of the use of nanoparticle paclitaxel (Nanoxel) in India.

机构信息

Department of Medical Oncology, Deenananth Mangeshkar Hospital, Pune, Maharashtra, India.

出版信息

Ann Oncol. 2013 Sep;24 Suppl 5:v6-12. doi: 10.1093/annonc/mdt322.

DOI:10.1093/annonc/mdt322
PMID:23975704
Abstract

Paclitaxel (Taxol), one of the most commonly used chemotherapeutic agents, is poorly soluble in water and requires cremophor, which often causes infusion reactions, as a solvent. Nanoxel, a nanoparticle formulation of the taxane, has been approved by the Indian regulatory authority. In the present article, we aim to describe the experience with the use of Nanoxel in India and its clinical and economic implications. We present three retrospective series in a common practice environment and an economic model. The first series shows no reactions in 596 Nanoxel infusions; the second series shows comparable adverse events other than infusion reactions between 83 patients who received Nanoxel and 32 treated with conventional paclitaxel. The third reveals comparable clinical outcomes for 51 patients treated with Nanoxel or conventional paclitaxel for gastroesophageal tumors. Finally, we describe an economic model which estimates savings of 21 580 Indian rupees per cycle with Nanoxel vis-à-vis conventional paclitaxel in the treatment of solid tumors in India. In conclusion, in an era in which the greatest challenge we face as medical oncologists is how to conciliate hard-won and incremental--but small--improvements in survival with exponentially rising drugs costs, it is refreshing to see a potential new formulation of a commonly used drug that may actually generate cost-savings while improving clinical outcomes and patient well-being. Further studies are clearly warranted to determine the optimal dose and schedule for Nanoxel as well as its comparative effectiveness to cremophor-based paclitaxel.

摘要

紫杉醇(泰素)是最常用的化疗药物之一,在水中溶解度差,需要 Cremophor 作为溶剂。纳米紫杉醇是一种紫杉醇的纳米颗粒制剂,已获得印度监管机构的批准。在本文中,我们旨在描述印度使用纳米紫杉醇的经验及其临床和经济意义。我们在常规实践环境中呈现了三个回顾性系列和一个经济模型。第一个系列显示 596 次纳米紫杉醇输注中无反应;第二个系列显示接受纳米紫杉醇治疗的 83 例患者和接受常规紫杉醇治疗的 32 例患者除输注反应外,不良事件相似。第三个系列揭示了 51 例接受纳米紫杉醇或常规紫杉醇治疗胃食管肿瘤的患者的临床结局相似。最后,我们描述了一个经济模型,该模型估计在印度治疗实体瘤时,与常规紫杉醇相比,纳米紫杉醇每个周期可节省 21580 印度卢比。总之,在我们作为肿瘤内科医生面临的最大挑战是如何调和来之不易的、略有改善的生存获益与药物成本呈指数级增长的时代,看到一种常用药物的潜在新制剂可能会带来成本节约,同时改善临床结局和患者福祉,这令人耳目一新。显然需要进一步研究来确定纳米紫杉醇的最佳剂量和方案,以及它与基于 Cremophor 的紫杉醇的比较效果。

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