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Kimberly Blackwell

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https://www.readbyqxmd.com/read/27717303/ribociclib-as-first-line-therapy-for-hr-positive-advanced-breast-cancer
#1
Gabriel N Hortobagyi, Salomon M Stemmer, Howard A Burris, Yoon-Sim Yap, Gabe S Sonke, Shani Paluch-Shimon, Mario Campone, Kimberly L Blackwell, Fabrice André, Eric P Winer, Wolfgang Janni, Sunil Verma, Pierfranco Conte, Carlos L Arteaga, David A Cameron, Katarina Petrakova, Lowell L Hart, Cristian Villanueva, Arlene Chan, Erik Jakobsen, Arnd Nusch, Olga Burdaeva, Eva-Maria Grischke, Emilio Alba, Erik Wist, Norbert Marschner, Anne M Favret, Denise Yardley, Thomas Bachelot, Ling-Ming Tseng, Sibel Blau, Fengjuan Xuan, Farida Souami, Michelle Miller, Caroline Germa, Samit Hirawat, Joyce O'Shaughnessy
Background The inhibition of cyclin-dependent kinases 4 and 6 (CDK4/6) could potentially overcome or delay resistance to endocrine therapy in advanced breast cancer that is positive for hormone receptor (HR) and negative for human epidermal growth factor receptor 2 (HER2). Methods In this randomized, placebo-controlled, phase 3 trial, we evaluated the efficacy and safety of the selective CDK4/6 inhibitor ribociclib combined with letrozole for first-line treatment in 668 postmenopausal women with HR-positive, HER2-negative recurrent or metastatic breast cancer who had not received previous systemic therapy for advanced disease...
November 3, 2016: New England Journal of Medicine
https://www.readbyqxmd.com/read/27622023/embracing-rejection-immunologic-trends-in-brain-metastasis
#2
REVIEW
S Harrison Farber, Vadim Tsvankin, Jessica L Narloch, Grace J Kim, April K S Salama, Gordana Vlahovic, Kimberly L Blackwell, John P Kirkpatrick, Peter E Fecci
Brain metastases represent the most common type of brain tumor. These tumors offer a dismal prognosis and significantly impact quality of life for patients. Their capacity for central nervous system (CNS) invasion is dependent upon induced disruptions to the blood-brain barrier (BBB), alterations to the brain microenvironment, and mechanisms for escaping CNS immunosurveillance. In the emerging era of immunotherapy, understanding how metastases are influenced by the immunologic peculiarities of the CNS will be crucial to forging therapeutic advances...
July 2016: Oncoimmunology
https://www.readbyqxmd.com/read/27166393/tbcrc-010-phase-i-ii-study-of-dasatinib-in-combination-with-zoledronic-acid-for-the-treatment-of-breast-cancer-bone-metastasis
#3
Zahi Mitri, Rita Nanda, Kimberly Blackwell, Colleen M Costelloe, Ilona Hood, Caimiao Wei, Abenaa M Brewster, Nuhad K Ibrahim, Kimberly B Koenig, Gabriel N Hortobagyi, Catherine Van Poznak, Mothaffar F Rimawi, Stacy Moulder-Thompson
PURPOSE: Osteoclast-mediated bone resorption through src kinase releases growth factors, sustaining bone metastases. This trial determined the recommended phase II dose (RP2D) and clinical efficacy of the src kinase inhibitor dasatinib combined with zoledronic acid in bone predominant, HER2-negative breast cancer metastases. EXPERIMENTAL DESIGN: A 3+3 lead in phase I design confirmed the RP2D allowing activation of the single-arm, phase II trial. Zoledronic acid was administered intravenously on day 1, and dasatinib was given orally once daily for 28 days each cycle as twice daily administration caused dose-limiting toxicity (DLT)...
December 1, 2016: Clinical Cancer Research: An Official Journal of the American Association for Cancer Research
https://www.readbyqxmd.com/read/27154282/in-situ-embryo-rescue-for-generation-of-wide-intra-and-inter-specific-hybrids-of-panicum-virgatum-l
#4
Albert P Kausch, Michael Tilelli, Joel Hague, Christopher Heffelfinger, David Cunha, Maria Moreno, Stephen L Dellaporta, Kimberly Nelson
Wide crosses have been used for decades as a method for transferring novel genetic material and traits in plant breeding. Historically, many products of wide crosses require tedious and inefficient surgical embryo rescue prior to embryo abortion to recover single plantlets. We have utilized transgenic switchgrass (Panicum virgatum L. cv Alamo) as a pollen donor in conjunction with antibiotic or herbicide selection for recovery of intra-and inter-specific F1 crosses by using developing ovules from the female parent and selecting for embryogenic cultures derived from the in situ immature embryo...
May 7, 2016: Plant Biotechnology Journal
https://www.readbyqxmd.com/read/27091420/a-comparison-of-proposed-biosimilar-la-ep2006-and-reference-pegfilgrastim-for-the-prevention-of-neutropenia-in-patients-with-early-stage-breast-cancer-receiving-myelosuppressive-adjuvant-or-neoadjuvant-chemotherapy-pegfilgrastim-randomized-oncology-supportive
#5
Kimberly Blackwell, Roman Donskih, C Michael Jones, Allen Nixon, Maria J Vidal, Roumen Nakov, Pritibha Singh, Gregor Schaffar, Pere Gascón, Nadia Harbeck
BACKGROUND: Pegfilgrastim is widely used for the prevention of chemotherapy-induced neutropenia. In highly regulated markets, there are currently no approved biosimilars of pegfilgrastim. Pegfilgrastim Randomized Oncology (Supportive Care) Trial to Evaluate Comparative Treatment (PROTECT-2) was a confirmatory efficacy and safety study designed to compare proposed biosimilar LA-EP2006 with reference pegfilgrastim (Neulasta, Amgen) in early-stage breast cancer patients receiving adjuvant or neoadjuvant myelosuppressive chemotherapy...
July 2016: Oncologist
https://www.readbyqxmd.com/read/27020170/randomized-double-blind-study-comparing-proposed-biosimilar-la-ep2006-with-reference-pegfilgrastim-in-breast-cancer
#6
Nadia Harbeck, Oleg Lipatov, Mona Frolova, Dmitry Udovitsa, Eldar Topuzov, Doina Elena Ganea-Motan, Roumen Nakov, Pritibha Singh, Anita Rudy, Kimberly Blackwell
AIM: This randomized, double-blind trial compared proposed biosimilar LA-EP2006 with reference pegfilgrastim in women receiving chemotherapy for breast cancer (PROTECT-1). PATIENTS & METHODS: Women (≥18 years) were randomized to receive LA-EP2006 (n = 159) or reference (n = 157) pegfilgrastim (Neulasta(®), Amgen) for ≤6 cycles of (neo)-adjuvant TAC chemotherapy. Primary end point was duration of severe neutropenia (DSN) during cycle 1 (number of consecutive days with absolute neutrophil count <0...
June 2016: Future Oncology
https://www.readbyqxmd.com/read/26908710/increased-fiber-intake-decreases-premenopausal-breast-cancer-risk
#7
COMMENT
Kathleen K Harnden, Kimberly L Blackwell
No abstract text is available yet for this article.
March 2016: Pediatrics
https://www.readbyqxmd.com/read/26834058/translational-breast-cancer-research-consortium-tbcrc-022-a-phase-ii-trial-of-neratinib-for-patients-with-human-epidermal-growth-factor-receptor-2-positive-breast-cancer-and-brain-metastases
#8
MULTICENTER STUDY
Rachel A Freedman, Rebecca S Gelman, Jeffrey S Wefel, Michelle E Melisko, Kenneth R Hess, Roisin M Connolly, Catherine H Van Poznak, Polly A Niravath, Shannon L Puhalla, Nuhad Ibrahim, Kimberly L Blackwell, Beverly Moy, Christina Herold, Minetta C Liu, Alarice Lowe, Nathalie Y R Agar, Nicole Ryabin, Sarah Farooq, Elizabeth Lawler, Mothaffar F Rimawi, Ian E Krop, Antonio C Wolff, Eric P Winer, Nancy U Lin
PURPOSE: Evidence-based treatments for metastatic, human epidermal growth factor receptor 2 (HER2)-positive breast cancer in the CNS are limited. Neratinib is an irreversible inhibitor of erbB1, HER2, and erbB4, with promising activity in HER2-positive breast cancer; however, its activity in the CNS is unknown. We evaluated the efficacy of treatment with neratinib in patients with HER2-positive breast cancer brain metastases in a multicenter, phase II open-label trial. PATIENTS AND METHODS: Eligible patients were those with HER2-positive brain metastases (≥ 1 cm in longest dimension) who experienced progression in the CNS after one or more line of CNS-directed therapy, such as whole-brain radiotherapy, stereotactic radiosurgery, and/or surgical resection...
March 20, 2016: Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology
https://www.readbyqxmd.com/read/26714199/urinary-exosomes-the-potential-for-biomarker-utility-intercellular-signaling-and-therapeutics-in-urological-malignancy
#9
REVIEW
Carrie A Franzen, Robert H Blackwell, Kimberly E Foreman, Paul C Kuo, Robert C Flanigan, Gopal N Gupta
PURPOSE: Exosomes are small secreted vesicles that contain proteins, mRNA and miRNA with the potential to alter signaling pathways in recipient cells. While exosome research has flourished, few publications have specifically considered the role of genitourinary cancer shed exosomes in urine, their implication in disease progression and their usefulness as noninvasive biomarkers. In this review we examined the current literature on the role of exosomes in intercellular communication and as biomarkers, and their potential as delivery vehicles for therapeutic applications in bladder, prostate and renal cancer...
May 2016: Journal of Urology
https://www.readbyqxmd.com/read/26637834/ascertainment-classification-and-impact-of-neoplasm-detection-during-prolonged-treatment-with-dual-antiplatelet-therapy-with-prasugrel-vs-clopidogrel-following-acute-coronary-syndrome
#10
Matthew T Roe, Derek D Cyr, Debra Eckart, Phillip J Schulte, Michael A Morse, Kimberly L Blackwell, Neal E Ready, S Yousuf Zafar, Anne W Beaven, John H Strickler, Jane E Onken, Kenneth J Winters, Lisa Houterloot, Dmitry Zamoryakhin, Stephen D Wiviott, Harvey D White, Dorairaj Prabhakaran, Keith A A Fox, Paul W Armstrong, E Magnus Ohman
AIMS: Studies have suggested increased cancer incidence associated with long-term dual antiplatelet therapy (DAPT) for acute coronary syndrome (ACS). We evaluated cancer incidence and treatment-related differences in an analysis of DAPT for ACS. METHODS AND RESULTS: The Targeted Platelet Inhibition to Clarify the Optimal Strategy to Medically Manage Acute Coronary Syndromes trial enrolled 9326 participants with ACS, who received aspirin plus clopidogrel or prasugrel...
January 21, 2016: European Heart Journal
https://www.readbyqxmd.com/read/26571496/lapatinib-plasma-and-tumor-concentrations-and-effects-on-her-receptor-phosphorylation-in-tumor
#11
RANDOMIZED CONTROLLED TRIAL
Neil L Spector, Faith C Robertson, Sarah Bacus, Kimberly Blackwell, Deborah A Smith, Kelli Glenn, Leanne Cartee, Jennifer Harris, Carie L Kimbrough, Mark Gittelman, Eli Avisar, Peter Beitsch, Kevin M Koch
PURPOSE: The paradigm shift in cancer treatment from cytotoxic drugs to tumor targeted therapies poses new challenges, including optimization of dose and schedule based on a biologically effective dose, rather than the historical maximum tolerated dose. Optimal dosing is currently determined using concentrations of tyrosine kinase inhibitors in plasma as a surrogate for tumor concentrations. To examine this plasma-tumor relationship, we explored the association between lapatinib levels in tumor and plasma in mice and humans, and those effects on phosphorylation of human epidermal growth factor receptors (HER) in human tumors...
2015: PloS One
https://www.readbyqxmd.com/read/26189978/medication-taking-behaviors-among-breast-cancer-patients-on-adjuvant-endocrine-therapy
#12
Gretchen Kimmick, Sara N Edmond, Hayden B Bosworth, Jeffrey Peppercorn, Paul K Marcom, Kimberly Blackwell, Francis J Keefe, Rebecca A Shelby
PURPOSE: To explore how symptoms and psychosocial factors are related to intentional and unintentional non-adherent medication taking behaviors. METHODS: Included were postmenopausal women with hormone receptor positive, stage I-IIIA breast cancer, who had completed surgery, chemotherapy, and radiation, and were taking endocrine therapy. Self-administered, standardized measures were completed during a routine clinic visit: Brief Fatigue Inventory, Brief Pain Inventory, Menopause Specific Quality of Life Questionnaire, Functional Assessment of Cancer Therapy General and Neurotoxicity scales, and Self-Efficacy for Appropriate Medication Use Scale...
October 2015: Breast: Official Journal of the European Society of Mastology
https://www.readbyqxmd.com/read/26098147/occurrence-and-characterization-of-steroid-growth-promoters-associated-with-particulate-matter-originating-from-beef-cattle-feedyards
#13
Brett R Blackwell, Kimberly J Wooten, Michael D Buser, Bradley J Johnson, George P Cobb, Philip N Smith
Studies of steroid growth promoters from beef cattle feedyards have previously focused on effluent or surface runoff as the primary route of transport from animal feeding operations. There is potential for steroid transport via fugitive airborne particulate matter (PM) from cattle feedyards; therefore, the objective of this study was to characterize the occurrence and concentration of steroid growth promoters in PM from feedyards. Air sampling was conducted at commercial feedyards (n = 5) across the Southern Great Plains from 2010 to 2012...
July 21, 2015: Environmental Science & Technology
https://www.readbyqxmd.com/read/25932852/obstetric-and-neonatal-outcomes-after-antipsychotic-medication-exposure-in-pregnancy
#14
REVIEW
Catherine G Coughlin, Katherine A Blackwell, Christine Bartley, Madeleine Hay, Kimberly A Yonkers, Michael H Bloch
OBJECTIVE: Antipsychotic medications are used by increasing numbers of women of reproductive age. The safety of these medications during pregnancy has not been well described. We undertook a systematic review and meta-analysis of the adverse obstetric and neonatal outcomes associated with exposure to antipsychotics during pregnancy. DATA SOURCES: PubMed, Reprotox, and ClinicalTrials.gov were searched to identify potential studies for inclusion. METHODS OF STUDY SELECTION: Case-control or cohort studies estimating adverse birth outcomes associated with antipsychotic exposure during pregnancy were included...
May 2015: Obstetrics and Gynecology
https://www.readbyqxmd.com/read/25870382/routine-use-of-zoledronic-acid-in-early-stage-breast-cancer
#15
REVIEW
Kathleen Harnden, Kimberly Blackwell
Zoledronic acid, a potent nitrogen-containing bisphosphonate, plays a key role in preventing complications of bone metastases in metastatic breast cancer, but its affect on early-stage breast cancer has been unclear. The preclinical data supporting the anticancer effects of zoledronic acid are compelling and several recent clinical trials have suggested that it reduces breast cancer recurrence in certain patient subgroups. Given these anticancer effects and reasonable safety profile, this therapeutic option could be discussed with patients...
April 2015: Journal of the National Comprehensive Cancer Network: JNCCN
https://www.readbyqxmd.com/read/25811737/genomic-profiling-in-locally-advanced-and-inflammatory-breast-cancer-and-its-link-to-dce-mri-and-overall-survival
#16
Sharareh Siamakpour-Reihani, Kouros Owzar, Chen Jiang, Peter M Scarbrough, Oana I Craciunescu, Janet K Horton, Holly K Dressman, Kimberly L Blackwell, Mark W Dewhirst
PURPOSE: We have previously reported that dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) perfusion patterns obtained from locally advanced breast cancer (LABC) patients prior to neoadjuvant therapy predicted pathologic clinical response. Genomic analyses were also independently conducted on the same patient population. This retrospective study was performed to test two hypotheses: (1) gene expression profiles are associated with DCE-MRI perfusion patterns, and (2) association between long-term overall survival data and gene expression profiles can lead to the identification of novel predictive biomarkers...
June 2015: International Journal of Hyperthermia
https://www.readbyqxmd.com/read/25633846/antibiotics-bacteria-and-antibiotic-resistance-genes-aerial-transport-from-cattle-feed-yards-via-particulate-matter
#17
Andrew D McEachran, Brett R Blackwell, J Delton Hanson, Kimberly J Wooten, Gregory D Mayer, Stephen B Cox, Philip N Smith
BACKGROUND: Emergence and spread of antibiotic resistance has become a global health threat and is often linked with overuse and misuse of clinical and veterinary chemotherapeutic agents. Modern industrial-scale animal feeding operations rely extensively on veterinary pharmaceuticals, including antibiotics, to augment animal growth. Following excretion, antibiotics are transported through the environment via runoff, leaching, and land application of manure; however, airborne transport from feed yards has not been characterized...
April 2015: Environmental Health Perspectives
https://www.readbyqxmd.com/read/25348000/endocrine-therapy-with-or-without-inhibition-of-epidermal-growth-factor-receptor-and-human-epidermal-growth-factor-receptor-2-a-randomized-double-blind-placebo-controlled-phase-iii-trial-of-fulvestrant-with-or-without-lapatinib-for-postmenopausal-women-with
#18
RANDOMIZED CONTROLLED TRIAL
Harold J Burstein, Constance T Cirrincione, William T Barry, Helen K Chew, Sara M Tolaney, Diana E Lake, Cynthia Ma, Kimberly L Blackwell, Eric P Winer, Clifford A Hudis
PURPOSE: CALGB 40302 sought to determine whether lapatinib would improve progression-free survival (PFS) among women with hormone receptor-positive metastatic breast cancer treated with fulvestrant. PATIENTS AND METHODS: Eligible women had estrogen receptor-positive and/or progesterone receptor-positive tumors, regardless of human epidermal growth factor receptor 2 (HER2) status, and prior aromatase inhibitor treatment. Patients received fulvestrant 500 mg intramuscularly on day 1, followed by 250 mg on days 15 and 28 and every 4 weeks thereafter, and either lapatinib 1,500 mg or placebo daily...
December 10, 2014: Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology
https://www.readbyqxmd.com/read/25286031/next-generation-sequencing-and-tumor-mutation-profiling-are-we-ready-for-routine-use-in-the-oncology-clinic
#19
Debu Tripathy, Kathleen Harnden, Kimberly Blackwell, Mark Robson
Next generation sequencing (NGS) coupled with sophisticated bioinformatics tools yields an unprecedented amount of information regarding tumor genetics, with the potential to reveal insights into tumor behavior. NGS and other multiplex genomic assays are rapidly spilling from the laboratory into the clinic through numerous commercial and academic entities. This raises the important question as to whether we are ready to use these data in clinical decision-making. While genetic lesions are clearly targeted by a new generation of biological cancer therapies, and certain regulatory approvals are actually coupled to single gene assays, we still do not know if the vast information on other genomic alterations is worth the added cost, or even worse, the inappropriate and unproven assignment of patients to treatment with an unapproved drug carrying potentially serious side effects...
2014: BMC Medicine
https://www.readbyqxmd.com/read/25144817/two-phase-i-dose-escalation-pharmacokinetics-studies-of-low-temperature-liposomal-doxorubicin-ltld-and-mild-local-hyperthermia-in-heavily-pretreated-patients-with-local-regionally-recurrent-breast-cancer
#20
MULTICENTER STUDY
Timothy M Zagar, Zeljko Vujaskovic, Silvia Formenti, Hope Rugo, Franco Muggia, Brigid O'Connor, Robert Myerson, Paul Stauffer, I-Chow Hsu, Chris Diederich, William Straube, Mary-Keara Boss, Alina Boico, Oana Craciunescu, Paolo Maccarini, David Needham, Nicholas Borys, Kimberly L Blackwell, Mark W Dewhirst
PURPOSE: Unresectable chest wall recurrences of breast cancer (CWR) in heavily pretreated patients are especially difficult to treat. We hypothesised that thermally enhanced drug delivery using low temperature liposomal doxorubicin (LTLD), given with mild local hyperthermia (MLHT), will be safe and effective in this population. PATIENTS AND METHODS: This paper combines the results of two similarly designed phase I trials. Eligible CWR patients had progressed on the chest wall after prior hormone therapy, chemotherapy, and radiotherapy...
August 2014: International Journal of Hyperthermia
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