Palbociclib in metastatic breast cancer: current evidence and real-life data

Article Details

Authors
Francesco Serra MD, Pietro Lapidari MD, Erica Quaquarini MD, Barbara Tagliaferri MD, Federico Sottotetti MD, Raffaella Palumbo MD, PhD

Article Type
Review

DOI
10.7573/dic.212579

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Abstract

The purpose of this review is to summarize the background and latest evidence for the use of palbociclib, an oral, first-in-class, highly selective cyclin-dependent kinase 4/6 inhibitor, in advanced breast cancer, with a focus on some of the unanswered questions about the performance of this agent in clinical practice. The available clinical data from both controlled clinical trials and real-life experiences concerning palbociclib-based combinations in patients with hormone receptor-positive (HR+)/human epidermal growth factor receptor 2-negative (HER2–) metastatic disease, including patient-reported outcomes and subgroup analyses, have been reviewed and discussed. Palbociclib significantly improved progression-free survival and clinical benefit rates when added to letrozole in postmenopausal women as initial endocrine-based therapy, and it prolonged progression-free survival and overall survival when added to fulvestrant in women who progressed on previous endocrine therapy in randomized clinical trials. Tolerability profile was manageable, with neutropenia occurring most commonly, without detrimental impact on quality of life. Available data from real-life experiences confirm the good performance of palbociclib in unselected, heavily pretreated populations. Palbociclib in combination with endocrine therapy is a valuable emerging option for patients with HR+/HER2– advanced or metastatic breast cancer. Further investigation is needed to provide solutions for palbociclib resistance and to identify the best sequence to use for the best patient benefit with a minimal toxicity.

Keywords: metastatic breast cancer, palbociclib, real-life studies.

Citation: Serra F, Lapidari P, Quaquarini E, Tagliaferri B, Sottotetti F, Palumbo R. Palbociclib in metastatic breast cancer: current evidence and real-life data. Drugs in Context 2019; 8: 212579. DOI: 10.7573/dic.212579

Contributions: Federico Sottotetti and Raffaella Palumbo conceived the content of the article. Francesco Serra and Pietro Lapidari performed the initial searches and wrote the first draft. Erica Quaquariniand Federico Sottotetti had input with the content and reviewing of drafts. Federico Sottotetti and Erica Quaquarini wrote the revision. All authors reviewed and approved the final manuscript. All named authors meet the International Committee of Medical Journal Editors (ICMJE) criteria for authorship for this article, take responsibility for the integrity of the work as a whole, and have given their approval for this version to be published.

Disclosure and potential conflicts of interest: The authors declare that they have no conflicts of interest. The International Committee of Medical Journal Editors (ICMJE) Potential Conflicts of Interests form for the authors is available for download at https://www.drugsincontext.com/wp-content/uploads/2019/06/dic.212579-COI.pdf

Acknowledgments: None.

Funding declaration: There was no funding associated with the preparation of this article.

Copyright: Copyright © 2019 Serra F, Lapidari P, Quaquarini E, Tagliaferri B, Sottotetti F, Palumbo R. https://doi.org/10.7573/dic.212579. Published by Drugs in Context under Creative Commons License Deed CC BY NC ND 4.0 which allows anyone to copy, distribute, and transmit the article provided it is properly attributed in the manner specified below. No commercial use without permission.

Correct attribution: Copyright © 2019 Serra F, Lapidari P, Quaquarini E, Tagliaferri B, Sottotetti F, Palumbo R. Published by Drugs in Context under Creative Commons License Deed CC BY NC ND 4.0.

Article URL: https://www.drugsincontext.com/palbociclib-in-metastatic-breast-cancer:-current-evidence-and-real-life-data/

Correspondence: Federico Sottotetti, MD, Operative Unit of Medical Oncology, IRCCS-ICS Maugeri, Via Maugeri 10, 27100 Pavia, Italy. federico.sottotetti@icsmaugeri.it

Provenance: invited; externally peer reviewed.

Submitted: 10 January 2019; Peer review comments to author: 6 February 2019; Revised manuscript received: 25 May 2019; Accepted: 3 June 2019; Publication date: 16 July 2019.

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