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Palbociclib and breast

Allison Shanks, Julia Choi, Vinit Karur
Neuroendocrine tumors are a rare subset of breast carcinomas. Commonly, platinum-based doublet is used as a systemic treatment option for high-grade neuroendocrine carcinomas from lung, gastrointestinal, and genitourinary origins. In comparison to other breast cancers, neuroendocrine carcinomas have unique genomic features and different treatment strategies. We present a patient with high-grade neuroendocrine carcinoma of the breast who had a successful and durable response to the cyclin D-dependent kinase (CDK) 4/6 inhibitor palbociclib in conjunction with endocrine therapy...
July 2018: Proceedings of the Baylor University Medical Center
Amelia McCartney, Erica Moretti, Giuseppina Sanna, Marta Pestrin, Emanuela Risi, Luca Malorni, Laura Biganzoli, Angelo Di Leo
Until recently, the mainstay of treatment in the majority of hormone receptor (HR)-positive, human epidermal growth factor 2 receptor (HER2)-negative advanced breast cancer (ABC) has consisted of single-agent endocrine therapy (ET). However, as understanding of endocrine resistance has grown, newer targeted agents have come to the fore. Inhibition of cyclin-dependent kinase complexes 4 and 6 (CDK4/6) combined with ET has shown significant activity in HR+ HER2- ABC, with impressive results in terms of progression-free survival (PFS) when compared with ET alone...
2018: Therapeutic Advances in Medical Oncology
L Malorni, G Curigliano, A M Minisini, S Cinieri, C A Tondini, K D'Hollander, G Arpino, A Bernardo, A Martignetti, C Criscitiello, F Puglisi, M Pestrin, G Sanna, E Moretti, E Risi, C Biagioni, A McCartney, L Boni, M Buyse, I Migliaccio, L Biganzoli, A Di Leo
Background: The activity of palbociclib as a single agent in advanced breast cancer has not been extensively studied, with the only available clinical data limited to heavily pre-treated patients. Pre-clinical data suggests palbociclib may partially reverse endocrine resistance, though this hypothesis has not been evaluated in previous clinical studies. This phase II, open-label, multi-center study examined the activity of palbociclib monotherapy, as well as palbociclib given in combination with the same endocrine therapy (ET) that was received prior to disease progression, in post-menopausal women with moderately pre-treated, estrogen receptor-positive, HER2 negative advanced breast cancer...
June 11, 2018: Annals of Oncology: Official Journal of the European Society for Medical Oncology
M Arnedos, M A Bayar, B Cheaib, V Scott, I Bouakka, A Valent, J Adam, V Leroux-Kozal, V Marty, A Rapinat, C Mazouni, B Sarfati, I Bieche, C Balleyguier, D Gentien, S Delaloge, M Lacroix-Triki, S Michiels, F Andre
Background: The CDK4/6 inhibitor Palbociclib is a new standard treatment in hormone-receptor positive breast cancer patients. No predictive biomarkers have been identified and no pharmacodynamics has properly been described so far. Patients and methods: Patients with early breast cancer were randomized 3:1 to oral palbociclib 125mg daily for 14 days until the day before the surgery vs. no treatment. Primary objective was antiproliferative response defined as a natural logarithm of Ki67 expression at day 15 below 1...
June 11, 2018: Annals of Oncology: Official Journal of the European Society for Medical Oncology
Aditya Bardia, Sara Hurvitz
The incidence of advanced breast cancer in premenopausal women is increasing, and breast cancer in younger women is often more aggressive and has a worse prognosis compared with older women. Premenopausal women with hormone receptor-positive (HR+) breast cancer are frequently under-represented in clinical trials, and treatment strategies in the premenopausal setting are usually extrapolated from data from postmenopausal patients, with the addition of ovarian function suppression to endocrine therapy in HR+ disease...
June 8, 2018: Clinical Cancer Research: An Official Journal of the American Association for Cancer Research
Anand A Dalal, Patrick Gagnon-Sanschagrin, Rebecca Burne, Annie Guérin, Geneviève Gauthier, Tania Small, Polly Niravath
INTRODUCTION: Targeted therapies have revolutionized the treatment of hormone receptor positive/human epidermal growth factor receptor 2 negative (HR+/HER2-) metastatic breast cancer (mBC). However, as for many oncology drugs, the dose of targeted therapies may need to be adjusted over time, leading to drug wastage when a dose modification is needed but the dose cannot be split or saved. This has been shown to be the case for palbociclib and has led to concerns among payers. This study described palbociclib dosing patterns and estimated the economic burden of the drug wastage associated with palbociclib dose modifications in postmenopausal women with HR+/HER2- mBC...
June 4, 2018: Advances in Therapy
Gabriel Tremblay, David Chandiwana, Mike Dolph, Jaclyn Hearnden, Anna Forsythe, Mauricio Monaco
Background: Ribociclib (RIBO) and palbociclib (PALBO), combined with letrozole (LET), have been evaluated as treatments for hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced breast cancer in separate Phase III randomized controlled trials (RCTs), but not head-to-head. Population differences can lead to biased results by classical indirect treatment comparison (ITC). Matching-adjusted indirect comparison (MAIC) aims to correct these differences. We compared RIBO and PALBO in hormone receptor-positive/human epidermal growth factor receptor 2-negative advanced breast cancer using MAIC...
2018: Cancer Management and Research
Makoto Asano, Junji Matsui, Murray J Towle, Jiayi Wu, Sharon McGonigle, Marc Hillairet DE Boisferon, Toshimitsu Uenaka, Kenichi Nomoto, Bruce A Littlefield
BACKGROUND: Eribulin is used in many countries to treat patients with advanced breast cancer or liposarcoma and exerts in vivo anticancer activity under monotherapy conditions against various human tumor xenograft models. Here, eribulin in combination with mechanistically different anticancer agents was evaluated. MATERIALS AND METHODS: Eribulin was combined with cytotoxic agents (capecitabine, carboplatin, cisplatin, doxorubicin, gemcitabine) or targeted agents (bevacizumab, BKM-120, E7449, erlotinib, everolimus, lenvatinib, palbociclib) in tumor xenograft models of breast cancer, melanoma, non-small cell lung cancer (NSCLC), and ovarian cancer...
June 2018: Anticancer Research
Mirat Shah, Maria Raquel Nunes, Vered Stearns
The cyclin-dependent kinase 4 and 6 (CDK4/6) inhibitors palbociclib, ribociclib, and abemaciclib are rapidly transforming the care of patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative (HR+/HER2-) advanced breast cancer. Current clinical questions include how to choose among these agents and how to sequence them with other therapies. Areas of active inquiry include identifying predictive biomarkers for CDK4/6 inhibitors, deciding whether to continue CDK4/6 inhibitors after disease progression, creating novel treatment combinations, and expanding use beyond HR+/HER2- advanced breast cancer...
May 15, 2018: Oncology (Williston Park, NY)
Rohit Mistry, Jessica R May, Gaurav Suri, Kate Young, Diana Brixner, Gary Oderda, Joseph Biskupiak, Derek Tang, Subrata Bhattacharyya, Dinesh Mishra, Devarshi Bhattacharyya, Anand A Dalal
BACKGROUND: U.S. regulatory approvals of the cyclin-dependent kinase 4 and 6 (CDK 4/6) inhibitors ribociclib and palbociclib as add-ons to letrozole greatly enhance the prospects for treating postmenopausal women with hormone receptor-positive (HR+)/human epidermal receptor 2-negative (HER2-) advanced or metastatic breast cancer. Clinical trials have established that the combination of a CDK 4/6 inhibitor with letrozole can significantly improve progression-free survival (PFS) versus letrozole monotherapy and is safe and well tolerated...
June 2018: Journal of Managed Care & Specialty Pharmacy
Hikmat N Abdel-Razeq
Despite the recent advances in breast cancer early detection and awareness, a significant portion of patients present with an advanced-stage disease and more patients will progress to stage IV despite adequate treatment of their initial early-stage disease. Hormone receptor (HR)-positive, Human Epidermal Growth Factor Receptor-2 (HER2)-negative subtype is the commonest among all breast cancer subtypes. The management of the advanced-stage disease of this subtype has evolved significantly over the past few years...
May 19, 2018: Hematology/oncology and Stem Cell Therapy
Sharon H Giordano, Anthony D Elias, William J Gradishar
The emergence of CDK4/6 inhibitors has changed the treatment algorithm for advanced/metastatic estrogen receptor-positive breast cancer. In pivotal trials of palbociclib, ribociclib, and abemaciclib, doubling in progression-free survival has been seen. All 3 agents in this class are now included in the NCCN Guidelines for Breast Cancer, and clinicians should be incorporating these agents into their treatment algorithms. The other important issue in this breast cancer setting is extended duration of endocrine therapy...
May 2018: Journal of the National Comprehensive Cancer Network: JNCCN
Rajeev Ayyagari, Derek Tang, Oscar Patterson-Lomba, Zhou Zhou, Jipan Xie, David Chandiwana, Anand A Dalal, Polly Ann Niravath
OBJECTIVE: To quantify the comparative efficacy of currently available endocrine-based therapies (ETs) for postmenopausal women with HR+/HER2- mBC after NSAI progression. DESIGN: network meta-analysis (NMA) Methods: Randomized clinical trials of ETs for HR+/HER2- mBC were identified via a systematic literature review using Medline, EMBASE, Cochrane Library, and key conference proceedings. All trials met the following inclusion criteria: 1) included women with HR+/HER2- mBC, 2) previous treatment with ETs or chemotherapy as first-line therapy, 3) treatment with ET as monotherapy or in combination with targeted therapy, 4) PFS was reported, and 5) published in 2007 (when HER2 testing became standardized) or later...
May 21, 2018: Current Medical Research and Opinion
Tingting Zhang, Fubin Feng, Wenge Zhao, Jinhui Tian, Yan Yao, Chao Zhou, Shengjie Dong, Congcong Wang, Chuanxin Zang, Qingliang Lv, Changgang Sun
Background: Endocrine therapy is the cornerstone treatment for patients with hormone receptor-positive advanced breast cancer. We aimed to assess the effectiveness of various first-line endocrine monotherapies or combinations to determine the optimal sequence in a network meta-analysis. Materials and methods: We searched PubMed, EMBASE, and the Cochrane Library for randomized controlled trials (RCTs) from inception up to November 21, 2017. We included only RCTs that assessed the effectiveness of the following treatments as a monotherapy or in combination as the first-line treatment: tamoxifen, anastrozole, letrozole, exemestane, fulvestrant, palbociclib, and ribociclib...
2018: OncoTargets and Therapy
Ajay Dhakal, Christina M Matthews, Ellis Glenn Levine, Kilian Elizabeth Salerno, Fan Zhang, Kazuaki Takabe, Amy P Early, Stephen B Edge, Tracy O'Connor, Thaer Khoury, Jessica S Young, Mateusz Opyrchal
PURPOSE: Outcome data on hormone receptor positive (HR+ ), human epidermal growth factor receptor 2 (HER2) nonamplified (HER2- ) metastatic breast cancer (MBC) treated with palbociclib after treatment with everolimus are lacking. The PALOMA-3 trial, showing benefit of palbociclib plus fulvestrant compared to fulvestrant alone in HR+ HER2- MBC after progression while receiving endocrine therapy excluded women previously treated with everolimus. The objective of this study was to examine outcomes of HR+ HER2- MBC with prior exposure to everolimus while receiving palbociclib-based therapy...
April 28, 2018: Clinical Breast Cancer
Balasaheb B Chavan, Shristy Tiwari, Shankar G, Rakesh D Nimbalkar, Prabha Garg, Srinivas R, M V N Kumar Talluri
Palbociclib (PAB) is a CDK4/6 inhibitor and U. S Food and Drug Administration (FDA) granted regular approval for the treatment of hormone receptor (HR) positive, metastatic breast cancer in combination with an aromatase inhibitor in postmenopausal women. Metabolite identification is a crucial aspect during drug discovery and development as the drug metabolites may be pharmacologically active or possess toxicological activity. As there are no reports on the metabolism studies of the PAB, the present study focused on investigation of the in vitro and in vivo metabolic fate of the drug...
May 14, 2018: Journal of Pharmaceutical and Biomedical Analysis
G Hoste, K Punie, H Wildiers, B Beuselinck, I Lefever, E Van Nieuwenhuysen, S N Han, P Berteloot, N Concin, R Salihi, I Vergote, P Neven
PURPOSE: We aimed to investigate the role of palbociclib, a first-in-class cyclin-dependent kinase 4 and 6 inhibitor, in postmenopausal women with highly pretreated endocrine therapy-resistant metastatic breast cancer (MBC). METHODS: Between 28 September 2015 and 14 March 2017, a compassionate use program was established in the University Hospitals Leuven in which 82 postmenopausal women with estrogen receptor-positive, HER2-negative MBC were included after at least four lines of systemic treatment...
May 16, 2018: Breast Cancer Research and Treatment
Renee de Leeuw, Christopher McNair, Matthew J Schiewer, Neermala P Neupane, Lucas J Brand, Michael A Augello, Zhen Li, Larry C Cheng, Akihiro Yoshida, Sean M Courtney, Starr Hazard, Gerald Hardiman, Maha Hussain, J Alan Diehl, Justin M Drake, William K Kelly, Karen E Knudsen
PURPOSE: Loss of cell cycle control is a hallmark of cancer, which can be targeted with agents, including Cyclin Dependent Kinase-4/6 (CDK4/6) kinase inhibitors that impinge upon the G1-S cell cycle checkpoint via maintaining activity of the retinoblastoma tumor suppressor (RB). This class of drugs is under clinical investigation for various solid tumor types, and has recently been FDA-approved for treatment of breast cancer. However, development of therapeutic resistance is not uncommon...
May 8, 2018: Clinical Cancer Research: An Official Journal of the American Association for Cancer Research
Ahrum Min, Jung Eun Kim, Yu-Jin Kim, Jee Min Lim, Seongyeong Kim, Jin Won Kim, Kyung-Hun Lee, Tae-Yong Kim, Do-Youn Oh, Yung-Jue Bang, Seock-Ah Im
Palbociclib is a specific inhibitor of CDK4/6 and has been shown to provide a survival benefit in hormone receptor-positive advanced breast cancer. TCGA database reported that about half of gastric cancers exhibit abnormalities in cell-cycle-related molecules, suggesting that gastric cancer is a good candidate for palbociclib treatment; however, the antitumor effects and predictive markers of palbociclib in gastric cancer remain incompletely described. Herein, the effect and predictive markers of palbociclib on gastric cancer cells were investigated...
May 2, 2018: Cancer Letters
S Parylo, A Vennepureddy, V Dhar, P Patibandla, A Sokoloff
Cyclin-dependent kinase 4/6 inhibitors, which act by inhibiting progression from the G1 to S phases of the cell cycle, include palbociclib, ribociclib, abemaciclib, and trilaciclib. Palbociclib and ribociclib are currently food and drug administration-approved for use in combination with aromatase inhibitors in postmenopausal women with metastatic hormone receptor-positive, human epidermal growth factor receptor 2-negative breast cancer. Palbociclib is also food and drug administration-approved for use in combination with fulvestrant in hormone receptor-positive, human epidermal growth factor receptor 2-negative breast cancer progressing after endocrine therapy...
January 1, 2018: Journal of Oncology Pharmacy Practice
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