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Palbociclib and breast

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https://www.readbyqxmd.com/read/29667385/chance-of-reimbursement-for-add-on-therapies-in-poland-and-in-the-world-review-of-the-reimbursement-recommendations
#1
Ewa Borowiack, Magdalena Marzec, Anna Nowotarska, Joanna Jarosz, Agata Orkisz, Patrycja Prząda-Machno
INTRODUCTION: Oncology drugs combined with standard therapies (so-called add-on therapies, e.g. bevacizumab, palbociclib) often receive negative recommendations regarding the legitimacy of public financing, issued by government agencies responsible for their assessment, i.e. health technology assessment agencies. The aim of the study was to estimate the scale of the problem related to the reimbursement of add-on therapies used in the treatment of breast and genitourinary cancers in Poland and in the world...
2018: Przegla̧d Epidemiologiczny
https://www.readbyqxmd.com/read/29623577/use-of-dual-mtor-inhibitor-mln0128-against-everolimus-resistant-breast-cancer
#2
Karineh Petrossian, Duc Nguyen, Chiao Lo, Noriko Kanaya, George Somlo, Yvonne Xiaoyong Cui, Chiun-Sheng Huang, Shiuan Chen
PURPOSE: HR+/HER2- aromatase inhibitor-resistant metastatic breast cancer can be treated with everolimus and a second AI until the cancer recurs. Targeting these everolimus-resistant patients with the latest standard of care, CDK4/6 inhibitors, has not been clearly addressed. Understanding the signaling transduction pathways, which everolimus resistance activates, will elucidate the mechanisms and offer treatment strategies of everolimus resistance. METHODS: To mimic the clinical setting, letrozole-resistant cells were used to generate an everolimus-resistant model (RAD-R)...
April 5, 2018: Breast Cancer Research and Treatment
https://www.readbyqxmd.com/read/29609880/progression-free-survival-with-first-line-endocrine-based-therapies-among-postmenopausal-women-with-hr-her2-metastatic-breast-cancer-a-network-meta-analysis
#3
REVIEW
Rajeev Ayyagari, Derek Tang, Oscar Patterson-Lomba, Zhou Zhou, Jipan Xie, David Chandiwana, Anand A Dalal, Polly Ann Niravath
PURPOSE: The comparative efficacy of endocrine-based therapies (ETs) for hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) metastatic breast cancer (mBC) is not well characterized. This network meta-analysis (NMA) synthesized available evidence on progression-free survival (PFS) with first-line ETs for postmenopausal HR+/HER2- mBC. METHODS: A systematic literature review identified randomized controlled trials of first-line ETs...
March 30, 2018: Clinical Therapeutics
https://www.readbyqxmd.com/read/29581135/er-breast-cancers-resistant-to-prolonged-neoadjuvant-letrozole-exhibit-an-e2f4-transcriptional-program-sensitive-to-cdk4-6-inhibitors
#4
Angel Guerrero-Zotano, Thomas Stricker, Luigi Formisano, Katherine E Hutchinson, Daniel G Stover, Kyung-Min Lee, Luis J Schwarz, Jennifer M Giltnane, Monica V Estrada, Valerie M Jansen, Alberto Servetto, Joaquín Gavilá, José Alejandro Pérez-Fidalgo, Ana Lluch, Antonio Llombart-Cussac, Mohamed Amine Bayar, Stefan Michiels, Fabrice Andre, Monica Arnedos, Vicente Guillem, Amparo Ruiz-Simon, Carlos L Arteaga
PURPOSE: This study aimed to identify biomarkers of resistance to endocrine therapy in ER+ breast cancers (BC) treated with prolonged neoadjuvant letrozole. Experimental Design: We performed targeted DNA and RNA-sequencing in 68 ER+ BC from patients treated with preoperative letrozole (median 7 months). Results:Twenty-four tumors (35%) exhibited a PEPI score ≥4 and/or recurred after a median of 58 months and were considered endocrine resistant. Integration of the 47 most upregulated genes (log FC>1, FDR<0...
March 26, 2018: Clinical Cancer Research: An Official Journal of the American Association for Cancer Research
https://www.readbyqxmd.com/read/29565707/ev-vivo-organ-culture-as-potential-prioritization-tool-for-breast-cancer-targeted-therapy
#5
Albert Grinshpun, Nancy Gavert, Roy Zvi Granit, Hadas Masuri, Ittai Ben-Porath, Shani Breuer, Aviad Zick, Shai Rosenberg, Myriam Maoz, Avital Granit, Eli Pikarsky, Ravid Strausmman, Tamar Peretz, Amir Sonnenblick
The growing use of genomic testing presents new treatment options but also new dilemmas. We describe here a heavily-pretreated metastatic triple negative breast cancer patient who failed to respond to conventional treatment. Genomic analyses were performed that discovered several targetable alterations (e.g. FGFR1, CDK6, INSR) and created a clinical challenge - which target to target first? Our solution to this relatively common scenario was using ex-vivo organ culture (EVOC) system to prioritize treatment directed toward the best molecular target...
March 22, 2018: Cancer Biology & Therapy
https://www.readbyqxmd.com/read/29564742/immunohistochemistry-and-alternative-fish-testing-in-breast-cancer-with-her2-equivocal-amplification
#6
Sally Agersborg, Christopher Mixon, Thanh Nguyen, Sramila Aithal, Sucha Sudarsanam, Forrest Blocker, Lawrence Weiss, Robert Gasparini, Shiping Jiang, Wayne Chen, Gregory Hess, Maher Albitar
PURPOSE: While HER2 testing is well established in directing appropriate treatment for breast cancer, a small percentage of cases show equivocal results by immunohistochemistry (IHC) and fluorescence in situ hybridization (FISH). Alternative probes may be used in equivocal cases. We present a single community-based institution's experience in further evaluating these cases. PATIENTS AND METHODS: Between 2014 and 2016, 4255 samples were submitted for HER2 amplification testing by alternative probes, TP53, RAI1, and RARA...
March 22, 2018: Breast Cancer Research and Treatment
https://www.readbyqxmd.com/read/29564714/preclinical-and-clinical-development-of-palbociclib-and-future-perspectives
#7
REVIEW
E Martínez de Dueñas, J Gavila-Gregori, S Olmos-Antón, A Santaballa-Bertrán, A Lluch-Hernández, E J Espinal-Domínguez, M Rivero-Silva, A Llombart-Cussac
Cyclin-dependent kinases (CDKs) play a key role in cell cycle regulation, which makes them a clear therapeutic target to interfere with cell division and proliferation in cancer patients. Palbociclib, a specific inhibitor of CDK4/6 with outstanding clinical efficacy data and limited toxicity, has been recently approved for the treatment of hormone receptor (HR)-positive human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer, either in combination with an aromatase inhibitor or in combination with fulvestrant in women who have received prior endocrine therapy...
March 21, 2018: Clinical & Translational Oncology
https://www.readbyqxmd.com/read/29557393/breast-cancer-changes-in-clonal-dynamics-predict-response-to-palbociclib
#8
Peter Sidaway
No abstract text is available yet for this article.
March 20, 2018: Nature Reviews. Clinical Oncology
https://www.readbyqxmd.com/read/29527939/different-inhibitors-for-the-same-target-in-metastatic-luminal-breast-cancer-is-there-any-difference
#9
Elie El Rassy, Ziad Bakouny, Tarek Assi, Joseph Kattan
AIM: To determine which of the CDK4/6 inhibitors is the optimal treatment in metastatic luminal breast cancer. MATERIALS & METHODS: A network meta-analysis using the frequentist approach and generalized pairwise modeling was computed. RESULTS: The associations of aromatase inhibitor with ribociclib, palbociclib and abemaciclib were similar in efficacy. Palbociclib-based regimen was associated with significantly lower treatment discontinuation rates compared with the other approved drugs in this indication...
March 12, 2018: Future Oncology
https://www.readbyqxmd.com/read/29523051/verapamil-as-a-culprit-of-palbociclib-toxicity
#10
Jasmine L Gowarty, Jon D Herrington
A promising drug, palbociclib, received accelerated approval as a first line treatment when used with the aromatase inhibitor, letrozole, for postmenopausal women with hormone receptor positive advanced or metastatic breast cancer. We report a case of a patient who presented with febrile neutropenia, grade 3 stomatitis with lip swelling, periorbital edema, and transaminitis while on palbociclib and verapamil. Labs normalized upon discontinuation of verapamil and our patient was able to continue treatment with palbociclib and letrozole...
January 1, 2018: Journal of Oncology Pharmacy Practice
https://www.readbyqxmd.com/read/29497091/early-circulating-tumor-dna-dynamics-and-clonal-selection-with-palbociclib-and-fulvestrant-for-breast-cancer
#11
Ben O'Leary, Sarah Hrebien, James P Morden, Matthew Beaney, Charlotte Fribbens, Xin Huang, Yuan Liu, Cynthia Huang Bartlett, Maria Koehler, Massimo Cristofanilli, Isaac Garcia-Murillas, Judith M Bliss, Nicholas C Turner
CDK4/6 inhibition substantially improves progression-free survival (PFS) for women with advanced estrogen receptor-positive breast cancer, although there are no predictive biomarkers. Early changes in circulating tumor DNA (ctDNA) level may provide early response prediction, but the impact of tumor heterogeneity is unknown. Here we use plasma samples from patients in the randomized phase III PALOMA-3 study of CDK4/6 inhibitor palbociclib and fulvestrant for women with advanced breast cancer and show that relative change in PIK3CA ctDNA level after 15 days treatment strongly predicts PFS on palbociclib and fulvestrant (hazard ratio 3...
March 1, 2018: Nature Communications
https://www.readbyqxmd.com/read/29474991/endocrine-therapy-and-palbociclib-within-a-compassionate-use-program-in-heavily-pretreated-hormone-receptor-positive-her2-negative-metastatic-breast-cancer
#12
Christian Maurer, Arlindo R Ferreira, Samuel Martel, Matteo Lambertini, Noam Pondé, Philippe Aftimos, Evandro de Azambuja, Martine Piccart
This is a single center retrospective analysis of patients with hormone receptor-positive, HER2-negative metastatic breast cancer progressing after ≥ 4 treatment lines treated with palbociclib in combination with endocrine therapy within a compassionate use program. Thirty-four patients were included between 10/2015 and 02/2017, the majority (82.4%) being previously treated with mTOR inhibitors. Disease control rate was 52.9% and 24.4% at week 12 and 24. Overall progression-free survival was 3.1 months with no difference between mTOR inhibitor-pretreated (3...
February 20, 2018: Breast: Official Journal of the European Society of Mastology
https://www.readbyqxmd.com/read/29470723/cyclin-dependent-kinase-4-6-inhibitors-as-first-line-treatment-for-post-menopausal-metastatic-hormone-receptor-positive-breast-cancer-patients-a-systematic-review-and-meta-analysis-of-phase-iii-randomized-clinical-trials
#13
Allan Ramos-Esquivel, Hellen Hernández-Steller, Marie-France Savard, Denis Ulises Landaverde
BACKGROUND: To compare the efficacy and toxicity of the combination of cyclin-dependent kinase 4/6 (CDK 4/6) inhibitors and nonsteroidal aromatase inhibitors (AI) versus AI alone as first-line therapy for patients with advanced hormone receptor-positive breast cancer. MATERIALS AND METHODS: Phase III randomized clinical trials (RCT) were identified after a systematic review of electronic databases. A random-effect model was used to determine the pooled hazard ratio (HR) for progression-free survival (PFS) using the inverse-variance method...
February 22, 2018: Breast Cancer: the Journal of the Japanese Breast Cancer Society
https://www.readbyqxmd.com/read/29452249/expression-and-therapeutic-implications-of-cyclin-dependent-kinase-4-cdk4-in-osteosarcoma
#14
Yubing Zhou, Jacson K Shen, Zujiang Yu, Francis J Hornicek, Quancheng Kan, Zhenfeng Duan
Overexpression and/or hyperactivation of cyclin-dependent kinase 4 (CDK4) has been found in many types of human cancers, and a CDK4 specific inhibitor, palbociclib, has been recently approved by the FDA for the treatment of breast cancer. However, the expression and the therapeutic potential of CDK4 in osteosarcoma remain unclear. In the present study, CDK4 was found to be highly expressed in human osteosarcoma tissues and cell lines as compared with normal human osteoblasts. Elevated CDK4 expression correlated with metastasis potential and poor prognosis in osteosarcoma patients as determined by immunohistochemical analysis in a human osteosarcoma tissue microarray (TMA)...
February 13, 2018: Biochimica et Biophysica Acta
https://www.readbyqxmd.com/read/29436583/antiproliferative-effects-of-the-cdk6-inhibitor-pd0332991-and-its-effect-on-signaling-networks-in-gastric-cancer-cells
#15
Daguang Wang, Yabin Sun, Wei Li, Fei Ye, Yang Zhang, Yuchen Guo, David Y Zhang, Jian Suo
PD0332991 (palbociclib/Ibrance®) is a cyclin-dependent kinase (CDK)4/6 inhibitor that has recently been approved for the treatment of estrogen receptor‑positive advanced breast cancer. The present study investigated the antiproliferative effects of PD0332991 on gastric cancer (GC) cells and the underlying molecular mechanisms. The activity of PD0332991 was tested in several GC cell lines, including AGS, KATO‑Ⅲ, NCI‑N87 and HS746T. Growth inhibitory activity of PD0332991, alone or in combination with fluorouracil (5‑FU), was measured by MTT assay...
February 6, 2018: International Journal of Molecular Medicine
https://www.readbyqxmd.com/read/29399694/mechanisms-of-the-cdk4-6-inhibitor-palbociclib-pd-0332991-and-its-future-application-in-cancer-treatment-review
#16
Minghui Liu, Hongyu Liu, Jun Chen
An uncontrolled cell cycle is an obvious marker of tumor cells. The G1‑S phase is an important restriction point in the normal cell cycle, but in cancer cells the restriction function is reduced, leading to uncontrolled cell proliferation. Two cyclin‑dependent kinases (CDKs), CDK4 and CDK6, play a crucial role in the G1‑S phase transition. Inhibitors of CDK4/6 are presently the subjects of numerous studies, and PD 0332991, an inhibitor of CDK4/6, has been used to treat hormone receptor (HR)‑positive, advanced‑stage breast cancer...
March 2018: Oncology Reports
https://www.readbyqxmd.com/read/29398467/complete-response-to-single-agent-palbociclib-in-metastatic-breast-cancer-a-case-report
#17
Sri Lakshmi Hyndavi Yeruva, Mehrbod Som Javadi, Vered Stearns
No abstract text is available yet for this article.
December 21, 2017: Clinical Breast Cancer
https://www.readbyqxmd.com/read/29374415/-inhibitors-of-cyclin-dependent-kinases-cdk-a-new-group-of-medicines-in-therapy-of-advanced-breast-cancer
#18
EDITORIAL
Tomasz Sarosiek
Cyclin-dependent kinases (CDKs) are a family of enzyme proteins present in cell nuclei that regulate the various stages of the cell cycle. They act as proto-oncogens, and increased expression of some of these proteins (CDK4 and CDK6) is observed in breast cancer cells and associated with decreased sensitivity to anti-estrogen therapy. CDK inhibitors are chemicals that inhibit the enzymatic activity of specific CDKs. Currently three drugs in this group are available on the market and are registered for the treatment of advanced HR-positive, HER2-negative breast cancer...
January 23, 2018: Polski Merkuriusz Lekarski: Organ Polskiego Towarzystwa Lekarskiego
https://www.readbyqxmd.com/read/29360932/impact-of-palbociclib-plus-letrozole-on-patient-reported-health-related-quality-of-life-results-from-the-paloma-2-trial
#19
H S Rugo, V Diéras, K A Gelmon, R S Finn, D J Slamon, M Martin, P Neven, Y Shparyk, A Mori, D R Lu, H Bhattacharyya, C Huang Bartlett, S Iyer, S Johnston, J Ettl, N Harbeck
Background: Patient-reported outcomes are integral in benefit-risk assessments of new treatment regimens. The PALOMA-2 study provides the largest body of evidence for patient-reported health-related quality of life (HRQOL) for patients with metastatic breast cancer receiving first-line endocrine-based therapy (palbociclib plus letrozole and letrozole alone). Patients and Methods: Treatment-naïve postmenopausal women with estrogen receptor-positive (ER+)/human epidermal growth factor receptor 2-negative (HER2-) metastatic breast cancer were randomized 2:1 to palbociclib plus letrozole (n=444) or placebo plus letrozole (n=222)...
January 19, 2018: Annals of Oncology: Official Journal of the European Society for Medical Oncology
https://www.readbyqxmd.com/read/29360661/palbociclib-has-no-clinically-relevant-effect-on-the-qtc-interval-in-patients-with-advanced-breast-cancer
#20
Chandrasekar Durairaj, Ana Ruiz-Garcia, Eric R Gauthier, Xin Huang, Dongrui R Lu, Justin T Hoffman, Richard S Finn, Anil A Joy, Johannes Ettl, Hope S Rugo, Jenny Zheng, Keith D Wilner, Diane D Wang
The aim of this study was to assess the potential effects of palbociclib in combination with letrozole on QTc. PALOMA-2, a phase 3, randomized, double-blind, placebo-controlled trial, compared palbociclib plus letrozole with placebo plus letrozole in postmenopausal women with estrogen receptor-positive, human epidermal growth factor receptor 2-negative advanced breast cancer. The study included a QTc evaluation substudy carried out as a definitive QT interval prolongation assessment for palbociclib. Time-matched triplicate ECGs were performed at 0, 2, 4, 6, and 8 h at baseline (Day 0) and on Cycle 1 Day 14...
January 22, 2018: Anti-cancer Drugs
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