使用多西他赛和环磷酰胺方案辅助治疗乳腺癌时,发热性中性粒细胞减少症的发生率以及多西他赛品牌药和仿制药之间的毒性差异。

IF 1.1 Q2 MEDICINE, GENERAL & INTERNAL
Einstein-Sao Paulo Pub Date : 2023-12-22 eCollection Date: 2023-01-01 DOI:10.31744/einstein_journal/2023AO0486
Flávia Viécili Tarcha, Ana Luísa de Castro Baccarin, Lilian Arruda do Rêgo Barros, Erika Bushatsky Andrade de Alencar, Auro Del Giglio, Felipe José Silva Melo Cruz
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引用次数: 0

摘要

目的评估接受多西他赛和环磷酰胺辅助化疗的患者在未使用粒细胞集落刺激因子预防的情况下发生发热性中性粒细胞减少症的情况,并评估品牌多西他赛(Taxotere ®)和普通制剂的毒性概况:这项回顾性研究使用的数据来自巴西一家癌症中心治疗患者的电子病历。研究选取了 2016 年 1 月至 2019 年 6 月期间接受辅助治疗的乳腺癌患者。数据采用卡方和费雪变量相关性分析,多变量分析采用倾向评分调整:研究共纳入231名患者,治疗时平均年龄为55.9岁。大多数(93.9%)患者为腔隙组织学,84.8%的患者处于临床I期,98.2%的患者表现良好。研究人群中发热性中性粒细胞减少症的总发生率为13.4%(31例)。使用品牌多西他赛(Taxotere ®)是唯一与发热性中性粒细胞减少症发生率相关的因素(OR=3.55,95%CI=1.58-7.94,P=0.002):对于需要使用多西他赛和环磷酰胺辅助疗法的乳腺癌患者,品牌多西他赛和普通多西他赛的毒性情况有所不同。无论使用哪种制剂,发热性中性粒细胞减少症的发生率都低于20%,因此在这种情况下可以不使用初级预防性粒细胞集落刺激因子。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Febrile neutropenia incidence and the variable toxicity profile between brand and generic docetaxel in the adjuvant treatment of breast cancer with docetaxel and cyclophosphamide regimen.

Objective: To assess the incidence of febrile neutropenia without primary granulocyte colony-stimulating factor prophylaxis in patients undergoing chemotherapy with adjuvant docetaxel and cyclophosphamide, and to evaluate the toxicity profile of brand-name docetaxel (Taxotere ® ) and the generic formulation.

Methods: This retrospective study was conducted using data obtained from electronic medical records of patients treated at a Brazilian cancer center. Patients with breast cancer who underwent adjuvant treatment between January 2016 and June 2019 were selected. Data were analyzed using chi-square and Fisher correlation of variables, and multivariate analyses were adjusted for propensity score.

Results: A total of 231 patients with a mean age of 55.9 years at the time of treatment were included in the study. The majority (93.9%) had luminal histology, 84.8% were at clinical stage I, and 98.2% had a good performance status. The overall incidence of febrile neutropenia in the study population was 13.4% (31 cases). The use of brand-name docetaxel (Taxotere ® ) was the only factor associated with febrile neutropenia occurrence (OR= 3.55, 95%CI= 1.58-7.94, p=0.002).

Conclusion: In patients with breast cancer who require treatment with adjuvant docetaxel and cyclophosphamide regimen, the toxicity profile differs between brand-name and generic docetaxel. Regardless of the formulation used, the incidence of febrile neutropenia was less than 20%, which may allow for the omission of primary prophylactic granulocyte colony-stimulating factor use in this setting.

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Einstein-Sao Paulo
Einstein-Sao Paulo MEDICINE, GENERAL & INTERNAL-
CiteScore
2.00
自引率
0.00%
发文量
210
审稿时长
38 weeks
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