Real-world evidence from a University Hospital system regarding the uptake of adjuvant pertuzumab and/or neratinib before and after their FDA approval.
Real-world evidence from a University Hospital system regarding the uptake of adjuvant pertuzumab and/or neratinib before and after their FDA approval.
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DOI：
10.1007/s10549-021-06132-8
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发表时间：
2021-06
影响因子：
3.8
通讯作者：
Diamond JR
中科院分区：
文献类型：
--
作者：
Stoen E;Kagihara J;Shagisultanova E;Fisher CM;Nicklawsky A;Kabos P;Borges VF;Diamond JR
佐剂pertuzumab和neratinib被FDA独立批准用于联合曲妥珠单抗或曲妥珠单抗治疗早期HER2阳性乳腺癌，疗程分别为一年。这两种药物都可以降低复发的风险；然而，对于许多增加了不良反应风险的患者来说，绝对的好处并不大。本研究的目的是评估早期HER2阳性乳腺癌患者辅助剂pertuzumab和neratinib的临床应用。确定了2016年7月至2019年4月期间在科罗拉多大学四家卫生医院接受曲妥珠单抗治疗的I-III期HER2阳性乳腺癌患者。获得了患者的人口统计数据、癌症分期、治疗情况以及佩尔珠单抗和/或奈拉替尼的使用情况。我们确定了总共350名接受曲妥珠单抗治疗I-III期HER2阳性乳腺癌的患者；253名(73.1%)的肿瘤是 ≥ T2或结节阳性疾病。FDA批准后，辅助剂pertuzumab的使用率增加；pertuzumab用于大多数结节阳性HER2阳性乳腺癌患者。辅助剂pertuzumab的使用与年龄较小、绝经前状态和结节阳性疾病有关。佐剂neratinib的服药率较低，只有15.2%的患者在完成佐剂曲妥珠单抗后的3个月内接受这种治疗。在我们的在不同医疗保健网络中接受治疗的患者队列中，大多数结节阳性HER2阳性乳腺癌患者在FDA批准后接受了Pertuzumab辅助治疗。佐剂neratinib的使用不太常见，可能是由于不良反应、延长治疗时间、以前使用佐剂pertuzumab和不大的益处所致。
Adjuvant pertuzumab and neratinib are independently FDA-approved for treatment of early-stage HER2-positive breast cancer in combination with or following trastuzumab for one year, respectively. Both agents reduce the risk of recurrence; however, the absolute benefit is modest for many patients with added risk of adverse effects. The purpose of this study was to evaluate the clinical use of adjuvant pertuzumab and neratinib in patients with early-stage HER2-positive breast cancer. Patients diagnosed with stage I–III HER2-positive breast cancer treated with trastuzumab at four University of Colorado Health hospitals between July 2016 and April 2019 were identified. Patient demographics, cancer stage, treatment, and administration of pertuzumab and/or neratinib were obtained. We identified a total of 350 patients who received adjuvant trastuzumab for stage I–III HER2-positive breast cancer; 253 (73.1%) had tumors that were ≥ T2 or node-positive disease. The rate of adjuvant pertuzumab use increased following FDA approval; pertuzumab was administered to the majority of patients with node-positive HER2-positive breast cancer. The use of adjuvant pertuzumab was associated with younger age, premenopausal status, and node-positive disease. Rates of administration of adjuvant neratinib were lower, with only 15.2% of patients receiving this therapy within 3 months of completing adjuvant trastuzumab. In our cohort of patients treated within a diverse healthcare network, the majority of patients with node-positive HER2-positive breast cancer received adjuvant pertuzumab following FDA approval. The use of adjuvant neratinib was less common, potentially as a result of adverse effects, prolongation of therapy, previous administration of adjuvant pertuzumab, and modest benefit.
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影响因子：
45.3
作者：
Gonzalez-Angulo, Ana M.;Litton, Jennifer K.;Hortobagyi, Gabriel N.
通讯作者：
Hortobagyi, Gabriel N.
影响因子：
4.6
作者：
Wolff, Antonio C.;Hammond, M. Elizabeth Hale;Dowsett, Mitchell
通讯作者：
Dowsett, Mitchell
影响因子：
45.3
作者：
Burstein, Harold J.;Sun, Yan;Badwe, Rajendra
通讯作者：
Badwe, Rajendra
影响因子：
45.3
作者：
Denduluri, Neelima;Chavez-MacGregor, Mariana;Giordano, Sharon H.
通讯作者：
Giordano, Sharon H.
影响因子：
4.7
作者：
Debiasi M;Polanczyk CA;Ziegelmann P;Barrios C;Cao H;Dignam JJ;Goss P;Bychkovsky B;Finkelstein DM;Guindalini RS;Filho P;Albuquerque C;Reinert T;de Azambuja E;Olopade O
通讯作者：
Olopade O