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HER2-Positive Metastatic Breast Cancer Patients Receiving Pertuzumab in a Community Oncology Practice Setting: Treatment Patterns and Outcomes

机译:在社区肿瘤学实践场所接受帕妥珠单抗治疗的HER2阳性转移性乳腺癌患者:治疗方式和结果

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BackgroundPertuzumab (Perjeta?), a HER2/ neu receptor antagonist, was approved by the US Food and Drug Administration in June 2012 for use in the first-line setting for patients with HER2-positive metastatic breast cancer (mBC). ObjectiveThis retrospective study investigated the clinical and demographic characteristics, treatment patterns, safety, and clinical outcomes for patients with HER2-positive mBC who received pertuzumab in the first-line setting in US community oncology practices. MethodsPatients with HER2-positive mBC, who initiated pertuzumab within 60 days of mBC diagnosis between June 2012 and June 2014, followed through December 2014, had ≥2 visits within the McKesson Specialty Health/US Oncology Network, and were not on clinical trials during the study period, were eligible. This study utilized iKnowMed electronic health records, Claims Data Warehouse, and Social Security Death Index. Progression-free survival (PFS) was assessed by Kaplan–Meier methods. ResultsA total of 266 patients met the selection criteria. A vast majority of the patients (249/266, 93.6%) received a trastuzumab + pertuzumab + taxane (H + P + T) regimen. The number of patients with prior adjuvanteoadjuvant therapy was higher than the CLEOPATRA trial, but age (median 57 years) and percentage of visceral disease (74.8%) were similar. The most common adverse events were fatigue (50.8%), diarrhea (44.7%), nausea (35.3%), peripheral neuropathy (33.5%), neutropenia (24.9%), and rash (24.4%). The median PFS was 16.9 months (95% CI 14.2–19.7). ConclusionsIn this retrospective study of patients with HER2-positive mBC receiving pertuzumab in the first-line setting, most patients were treated with H + P + T. The safety and PFS of H + P + T were consistent with those observed in the pivotal trial.
机译:背景:Pertuzumab(Perjeta ?)是一种HER2 / neu受体拮抗剂,于2012年6月获得美国食品和药物管理局的批准,可用于HER2阳性转移性乳腺癌患者的一线治疗( mBC)。目的这项回顾性研究调查了在美国社区肿瘤学实践中在一线治疗中接受帕妥珠单抗治疗的HER2阳性mBC患者的临床和人口统计学特征,治疗模式,安全性和临床结局。方法HER2阳性mBC的患者在2012年6月至2014年6月的mBC诊断后60天内开始进行帕妥珠单抗治疗,随后一直持续到2014年12月,在McKesson Speciality Health / US Oncology Network内进行了≥2次就诊,并且在此期间未进行临床试验学习期间,均合格。这项研究利用了iKnowMed电子健康记录,理赔数据仓库和社会保障死亡指数。无进展生存期(PFS)通过Kaplan-Meier方法进行评估。结果共有266例患者符合入选标准。绝大多数患者(249/266,93.6%)接受曲妥珠单抗+帕妥珠单抗+紫杉烷(H + P + T)方案。先前接受辅助/新辅助治疗的患者人数高于CLEOPATRA试验,但年龄(中位57岁)和内脏疾病百分比(74.8%)相似。最常见的不良事件是疲劳(50.8%),腹泻(44.7%),恶心(35.3%),周围神经病变(33.5%),中性粒细胞减少症(24.9%)和皮疹(24.4%)。 PFS中位数为16.9个月(95%CI 14.2–19.7)。结论在这项对一线治疗中接受帕妥珠单抗治疗的HER2阳性mBC患者的回顾性研究中,大多数患者接受了H + P + T治疗。H+ P + T的安全性和PFS与关键试验中观察到的一致。 。

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