Contextualizing pertuzumab approval in the treatment of HER2-positive breast cancer patients. (February 2020)

• Record Type: Journal Article
• Authors: Cortés, Javier; Ciruelos, Eva; Pérez-García, José; Albanell, Joan; García-Estévez, Laura; Ruiz–Borrego, Manuel; Espinosa, Ruth; Gallegos, Isabel; González, Santiago; Álvarez, Isabel; Llombart, Antonio
• Is Part Of: Cancer treatment reviews. Volume 83(2020)
• Publication Date: 2020-02
• Subjects: Breast cancer -- HER2 -- Dual blockade -- Trastuzumab -- Pertuzumab -- Adjuvant therapy; Cancer -- Periodicals; Cancer -- Treatment -- Periodicals; Neoplasms -- therapy -- Periodicals; Cancer -- Périodiques; Cancer -- Traitement -- Périodiques; Cancer -- Treatment; Electronic journals; Periodicals; 616.99406
• DOI: 10.1016/j.ctrv.2019.101944
• Languages: English
• ISSNs: 0305-7372

Abstract

Graphical abstract: Highlights: Despite the apparent favourable prognosis of early-stage breast cancer and the demonstrated efficacy of chemotherapy and trastuzumab in this setting, a considerable number of patients still experience disease progression, the majority in the form of distant metastasis, regardless of optimal postoperative treatments. As metastatic breast cancer remains an incurable disease, any new treatment options that could reduce the risk of recurrence should be considered to treat patients as early as possible. The clinically significant absolute improvement in invasive disease-free survival (i.e., reduced risk of invasive breast cancer recurrence or death) demonstrated for high-risk patients in the APHINITY trial could make pertuzumab, in combination with chemotherapy and trastuzumab, the treatment of choice for HER2-positive early-stage breast cancer, not only in the neoadjuvant, but also in the adjuvant setting. Due to the high expectations generated and probably due to difficulties in correctly interpreting the definition and analysis of the primary endpoint, invasive disease-free survival, the APHINITY study has been questioned by the medical community, due to its clinical relevance. However, the clinical benefit obtained with adjuvant pertuzumab is comparable to those obtained after further improvements of other established adjuvant therapies. Adjuvant pertuzumab was approved in 2017 by the FDA and in 2018 by the European Commission for post-surgery treatment of HER2 positive early breast cancer at high risk of recurrence − lymph node-positive or hormone receptor-negative disease−, in a setting where the goal of treatment is cure. Physicians must be well prepared to place the APHINITY study data in perspective against other add-on therapeutic strategies. This opinion article is intended to help put these results in context, as well as to clarify methodological or statistical doubts about the study, and to define the population of patients with high-risk breast cancer that, in general, we should treat. Abstract: The use of adjuvant pertuzumab in HER2-positive early-stage breast cancer has recently been approved by the EMA on the basis of data from the APHINITY trial. Accordingly, we have produced this opinion article with the aim of putting the study data in perspective against other add-on therapeutic strategies, to clarify methodological or statistical doubts about the study, and to define the population of high-risk patients with hormone receptor-negative breast cancer that we agree, in general, should be treated. With this approval, physicians must be well prepared to place the APHINITY study data in context. It is now up to each country to ratify the EMA-approved indications and to agree on reimbursement, and doctors must optimize their use based on knowledge and discussion with patients.