突尼斯仿制药多西他赛对早期乳腺癌的耐受性:一项前瞻性研究。

IF 0.9 4区 医学 Q4 ONCOLOGY
Wala Ben Kridis, Rim Sahnoun, Chadha Maalej, Rim Atheymen, Serria Hammami, Nabil Toumi, Khaled Zeghal, Afef Khanfir
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引用次数: 0

摘要

多西紫杉醇是非转移性乳腺癌化疗的关键成分。在突尼斯,自2017年以来一直使用当地生产的多西他赛仿制制剂Cytotere®。人们对某些紫杉烷仿制药的安全性提出了担忧,但Cytotere®的前瞻性数据仍然缺乏。我们的目的是评估Cytotere®在接受非转移性乳腺癌辅助化疗的患者中的安全性,并确定与毒性相关的因素。方法:我们进行了一项前瞻性、单中心观察性研究,纳入了her2阴性、非转移性乳腺癌患者,接受Cytotere®(100 mg/m²/ 21天)治疗。不良事件(ae)采用CTCAE v5.0分级,因果关系采用法国b高德法评估。采用卡方检验分析患者特征与毒性之间的关系。结果共纳入60例患者。虚弱(90%)、关节痛/肌痛(71.7%)、粘膜炎(50%)和手足综合征(36.7%)是最常见的不良事件。3级毒性很少,发生在16.7%的患者中,最常见的是手足综合征和中性粒细胞减少症。8.3%的病例报告发热性中性粒细胞减少。尽管有标准化的预用药,但仍观察到1例过敏反应(1.7%)。23.3%的患者需要减少剂量,并且与3级毒性的发生显著相关(p®与历史数据中与原用药多西他赛相当的毒性相关)。这些发现支持在仔细监测的情况下继续使用Cytotere®辅助化疗。有必要进行更大规模的多中心研究来证实这些结果,并指导资源匮乏地区的药物警戒策略。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Tolerability of a Tunisian generic Docetaxel in early breast cancer: A prospective study.

BackgroundDocetaxel is a key component of chemotherapy for non-metastatic breast cancer. In Tunisia, Cytotere®, a local produced generic formulation of Docetaxel, has been used since 2017. Concerns have been raised regarding the safety of certain generic of taxanes, but prospective data on Cytotere® remain lacking. We aimed to evaluate the safety profile of Cytotere® in patients receiving adjuvant chemotherapy for non-metastatic breast cancer and to identify factors associated with toxicity.MethodsWe conducted a prospective, monocentric observational study including patients with HER2-negative, non-metastatic breast cancer treated with Cytotere® (100 mg/m² every 21 days). Adverse events (AEs) were graded using CTCAE v5.0 and assessed for causality using the French Bégaud method. Associations between patient characteristics and toxicities were analyzed using Chi-square tests.Results60 patients were included. Asthenia (90%), arthralgia/myalgia (71.7%), mucositis (50%), and hand-foot syndrome (36.7%) were the most frequent adverse events. Grade 3 toxicities were rare, occurring in 16.7% of patients, most commonly hand foot syndrome and neutropenia. Febrile neutropenia was reported in 8.3% of cases. One hypersensitivity reaction (1.7%) was observed despite standardized premedication. Dose reduction was required in 23.3% of patients, and significantly associated with the occurrence of grade 3 toxicities (p < 0.001) and HFS (p = 0.008).ConclusionCytotere® was associated with a toxicity profile comparable to that of originator Docetaxel in historical data. These findings support the continued use of Cytotere® in adjuvant chemotherapy, with careful monitoring. Larger multicenter studies are warranted to confirm these results and guide pharmacovigilance strategies in low-resource settings.

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来源期刊
CiteScore
2.70
自引率
7.70%
发文量
276
期刊介绍: Journal of Oncology Pharmacy Practice is a peer-reviewed scholarly journal dedicated to educating health professionals about providing pharmaceutical care to patients with cancer. It is the official publication of the International Society for Oncology Pharmacy Practitioners (ISOPP). Publishing pertinent case reports and consensus guidelines...
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