DOCSLIB.ORG

AHRQ Healthcare Horizon Scanning System – Status Update

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
AHRQ Healthcare Horizon Scanning System – Status Update AHRQ Healthcare Horizon Scanning System – Status Update Horizon Scanning Status Update: September 2014 Prepared for: Agency for Healthcare Research and Quality U.S. Department of Health and Human Services 540 Gaither Road Rockville, MD 20850 www.ahrq.gov Contract No. HHSA290201000006C Prepared by: ECRI Institute 5200 Butler Pike Plymouth Meeting, PA 19462 September 2014 Statement of Funding and Purpose This report incorporates data collected during implementation of the Agency for Healthcare Research and Quality (AHRQ) Healthcare Horizon Scanning System by ECRI Institute under contract to AHRQ, Rockville, MD (Contract No. HHSA290201000006C). The findings and conclusions in this document are those of the authors, who are responsible for its content, and do not necessarily represent the views of AHRQ. No statement in this report should be construed as an official position of AHRQ or of the U.S. Department of Health and Human Services. A novel intervention may not appear in this report simply because the System has not yet detected it. The list of novel interventions in the Horizon Scanning Status Update Report will change over time as new information is collected. This should not be construed as either endorsements or rejections of specific interventions. As topics are entered into the System, individual target technology reports are developed for those that appear to be closer to diffusion into practice in the United States. A representative from AHRQ served as a Contracting Officer’s Technical Representative and provided input during the implementation of the horizon scanning system. AHRQ did not directly participate in the horizon scanning, assessing the leads or topics, or provide opinions regarding potential impact of interventions. Disclaimer Regarding 508-Compliance Persons using assistive technology may not be able to fully access information in this report. For assistance contact [email protected]. Financial Disclosure Statement None of the individuals compiling this information has any affiliations or financial involvement that conflicts with the material presented in this report. Public Domain Notice This document is in the public domain and may be used and reprinted without special permission. Citation of the source is appreciated. Suggested citation: ECRI Institute. AHRQ Healthcare Horizon Scanning System Status Update. (Prepared by ECRI Institute under Contract No. HHSA290201000006C) Rockville, MD: Agency for Healthcare Research and Quality. September 2014. http://www.effectivehealthcare.ahrq.gov/reports/final.cfm. i Preface The purpose of the AHRQ Healthcare Horizon Scanning System is to conduct horizon scanning of emerging health care technologies and innovations to better inform patient-centered outcomes research investments at AHRQ through the Effective Health Care Program. The Healthcare Horizon Scanning System provides AHRQ a systematic process to identify and monitor emerging technologies and innovations in health care and to create an inventory of emerging technologies that have the highest potential for impact on clinical care, the health care system, patient outcomes, and costs. It will also be a tool for the public to identify and find information on new health care technologies and interventions. Any investigator or funder of research will be able to use the AHRQ Healthcare Horizon Scanning System to select potential topics for research. The health care technologies and innovations of interest for horizon scanning are those that have yet to diffuse into or become part of established health care practice. These health care interventions are still in the early stages of development or adoption except in the case of new applications of already-diffused technologies. Consistent with the definitions of health care interventions provided by the Institute of Medicine and the Federal Coordinating Council for Comparative Effectiveness Research, AHRQ is interested in innovations in drugs and biologics, medical devices, screening and diagnostic tests, procedures, services and programs, and care delivery. Horizon scanning involves two processes. The first is identifying and monitoring new and evolving health care interventions that are purported to or may hold potential to diagnose, treat, or otherwise manage a particular condition or to improve care delivery for a variety of conditions. The second is analyzing the relevant health care context in which these new and evolving interventions exist to understand their potential impact on clinical care, the health care system, patient outcomes, and costs. It is NOT the goal of the AHRQ Healthcare Horizon Scanning System to make predictions on the future use and costs of any health care technology. Rather, the reports will help to inform and guide the planning and prioritization of research resources. This edition of the Status Update lists interventions that have been identified and are being monitored. The next edition will be published in 2–3 months. We welcome comments on the list, which may be sent by mail to the Task Order Officer named in this report to: Agency for Healthcare Research and Quality, 540 Gaither Road, Rockville, MD 20850, or by email to: [email protected]. Richard Kronick, Ph.D. Yen-pin Chiang, Ph.D. Director Acting Deputy Director Agency for Healthcare Research and Quality Center for Evidence and Practice Improvement Agency for Healthcare Research and Quality Elise Berliner, Ph.D. Task Order Officer Center for Evidence and Practice Improvement Agency for Healthcare Research and Quality ii Contents Introduction ............................................................................................................................................................................. 1 Section 1. Currently Tracked Interventions: 478 Interventions .............................................................................................. 3 Table 1. AHRQ Priority Condition: 01 Arthritis and Nontraumatic Joint Disease: 13 Interventions ..................... 4 Table 2. AHRQ Priority Condition: 02 Cancer: 179 Interventions ....................................................................... 11 Table 3. AHRQ Priority Condition: 03 Cardiovascular Disease: 47 Interventions ............................................... 99 Table 4. AHRQ Priority Condition: 04 Dementia (including Alzheimer’s: 16 Interventions ............................. 129 Table 5. AHRQ Priority Condition: 05 Depression and Other Mental Health Disorders: 18 Interventions ....... 137 Table 6. AHRQ Priority Condition: 06 Developmental Delays, Attention-Deficit Hyperactivity Disorder, and Autism: 5 Interventions................................................................................................................... 148 Table 7. AHRQ Priority Condition: 07 Diabetes Mellitus: 13 Interventions ...................................................... 152 Table 8. AHRQ Priority Condition: 08 Functional Limitations and Disability: 87 Interventions ....................... 162 Table 9. AHRQ Priority Condition: 09 Infectious Disease, Including HIV-AIDS: 43 Interventions ................. 211 Table 10. AHRQ Priority Condition: 10 Obesity: 7 Interventions ........................................................................ 231 Table 11. AHRQ Priority Condition: 11 Peptic Ulcer Disease and Dyspepsia: 10 Interventions ......................... 236 Table 12. AHRQ Priority Condition: 12 Pregnancy, Including Preterm Birth: 5 Interventions ............................ 241 Table 13. AHRQ Priority Condition: 13 Pulmonary Disease, Asthma: 16 Interventions...................................... 244 Table 14. AHRQ Priority Condition: 14 Substance Abuse: 12 Interventions ....................................................... 252 Table 15. AHRQ Priority Condition: 15 Cross-Cutting: 7 Interventions .............................................................. 258 Section 2. Interventions Added Since Last Update: 25 Interventions ................................................................................ 262 Table 16. AHRQ Priority Condition: 01 Arthritis and Nontraumatic Joint Disease: 0 Interventions ................... 263 Table 17. AHRQ Priority Condition: 02 Cancer: 7 Interventions ......................................................................... 263 Table 18. AHRQ Priority Condition: 03 Cardiovascular Disease: 4 Interventions ............................................... 267 Table 19. AHRQ Priority Condition: 04 Dementia (including Alzheimer’s: 1 Intervention ................................ 269 Table 20. AHRQ Priority Condition: 05 Depression and Other Mental Health Disorders: 0 Interventions ......... 269 Table 21. AHRQ Priority Condition: 06 Developmental Delays, Attention-Deficit Hyperactivity Disorder, and Autism: 0 Interventions................................................................................................................... 270 Table 22. AHRQ Priority Condition: 07 Diabetes Mellitus: 1 Intervention .......................................................... 270 Table 23. AHRQ Priority Condition: 08 Functional Limitations and Disability: 6 Interventions ......................... 271 Table 24. AHRQ Priority Condition: 09 Infectious Disease, Including HIV-AIDS: 2 Interventions ................... 274 Table 25. AHRQ Priority Condition: 10 Obesity: 1 Intervention .......................................................................... 275 Table 26. AHRQ Priority Condition: 11 Peptic Ulcer Disease and Dyspepsia: 0 Interventions ..........................
Load more

Recommended publications
  • A Study of Abemaciclib (LY2835219)
    A Study of Abemaciclib (LY2835219) in Combination With Temozolomide and Irinotecan and Abemaciclib in Combination With Temozolomide in Children and Young Adult Participants With Solid Tumors Status: Not yet recruiting Eligibility Criteria Sex: All Age: up to 18 Years old This study is NOT accepting healthy volunteers Inclusion Criteria: • Body weight ≥10 kilograms and body surface area (BSA) ≥0.5 meters squared. • Participants with any relapsed/refractory malignant solid tumor (excluding lymphoma), including central nervous system tumors, that have progressed on standard therapies and, in the judgment of the investigator, are appropriate candidates for the experimental therapy combination in the study part that is currently enrolling. • Participants must have at least one measurable (per Response Criteria in Solid Tumors [RECIST v1.1; [Eisenhauer et al. 2009] or Response Assessment in Neuro-Oncology (RANO) for central nervous system (CNS) tumors [Wen et al. 2010]) or evaluable lesion. • Participants must have had histologic verification of malignancy at original diagnosis or relapse, except: • Participants with extra-cranial germ-cell tumors who have elevations of serum tumor markers including alpha-fetoprotein or beta- human chorionic gonadotropin (HCG). • Participants with intrinsic brain stem tumors or participants with CNS-germ cell tumors and elevations of CSF or serum tumor markers including alpha-fetoprotein or beta-HCG. • A Lansky score ≥50 for participants ≤16 years of age or Karnofsky score ≥50 for participants >16 years of age. • Participants must have discontinued all previous treatments for cancer or investigational agents and must have recovered from the acute effects to Grade ≤1 at the time of enrollment.
    [Show full text]
  • Cancer Drug Pharmacology Table
    CANCER DRUG PHARMACOLOGY TABLE Cytotoxic Chemotherapy Drugs are classified according to the BC Cancer Drug Manual Monographs, unless otherwise specified (see asterisks). Subclassifications are in brackets where applicable. Alkylating Agents have reactive groups (usually alkyl) that attach to Antimetabolites are structural analogues of naturally occurring molecules DNA or RNA, leading to interruption in synthesis of DNA, RNA, or required for DNA and RNA synthesis. When substituted for the natural body proteins. substances, they disrupt DNA and RNA synthesis. bendamustine (nitrogen mustard) azacitidine (pyrimidine analogue) busulfan (alkyl sulfonate) capecitabine (pyrimidine analogue) carboplatin (platinum) cladribine (adenosine analogue) carmustine (nitrosurea) cytarabine (pyrimidine analogue) chlorambucil (nitrogen mustard) fludarabine (purine analogue) cisplatin (platinum) fluorouracil (pyrimidine analogue) cyclophosphamide (nitrogen mustard) gemcitabine (pyrimidine analogue) dacarbazine (triazine) mercaptopurine (purine analogue) estramustine (nitrogen mustard with 17-beta-estradiol) methotrexate (folate analogue) hydroxyurea pralatrexate (folate analogue) ifosfamide (nitrogen mustard) pemetrexed (folate analogue) lomustine (nitrosurea) pentostatin (purine analogue) mechlorethamine (nitrogen mustard) raltitrexed (folate analogue) melphalan (nitrogen mustard) thioguanine (purine analogue) oxaliplatin (platinum) trifluridine-tipiracil (pyrimidine analogue/thymidine phosphorylase procarbazine (triazine) inhibitor)
    [Show full text]
  • Efficacy and Safety of Abemaciclib, an Inhibitor of CDK4 and CDK6, for Patients with Breast Cancer, Non–Small Cell Lung Cancer, and Other Solid Tumors
    Published OnlineFirst May 23, 2016; DOI: 10.1158/2159-8290.CD-16-0095 RESEARCH ARTICLE Efficacy and Safety of Abemaciclib, an Inhibitor of CDK4 and CDK6, for Patients with Breast Cancer, Non–Small Cell Lung Cancer, and Other Solid Tumors Amita Patnaik1, Lee S. Rosen2, Sara M. Tolaney3, Anthony W. Tolcher1, Jonathan W. Goldman2, Leena Gandhi3, Kyriakos P. Papadopoulos1, Muralidhar Beeram1, Drew W. Rasco1, John F. Hilton3, Aejaz Nasir4, Richard P. Beckmann4, Andrew E. Schade4, Angie D. Fulford4, Tuan S. Nguyen4, Ricardo Martinez4, Palaniappan Kulanthaivel4, Lily Q. Li4, Martin Frenzel4, Damien M. Cronier4, Edward M. Chan4, Keith T. Flaherty5, Patrick Y. Wen3, and Geoffrey I. Shapiro3 ABSTRACT We evaluated the safety, pharmacokinetic profile, pharmacodynamic effects, and antitumor activity of abemaciclib, an orally bioavailable inhibitor of cyclin-dependent kinases (CDK) 4 and 6, in a multicenter study including phase I dose escalation followed by tumor- specific cohorts for breast cancer, non–small cell lung cancer (NSCLC), glioblastoma, melanoma, and colorectal cancer. A total of 225 patients were enrolled: 33 in dose escalation and 192 in tumor-specific cohorts. Dose-limiting toxicity was grade 3 fatigue. The maximum tolerated dose was 200 mg every 12 hours. The most common possibly related treatment-emergent adverse events involved fatigue and the gastrointestinal, renal, or hematopoietic systems. Plasma concentrations increased with dose, and pharmacodynamic effects were observed in proliferating keratinocytes and tumors. Radiographic responses were achieved in previously treated patients with breast cancer, NSCLC, and melanoma. For hormone receptor–positive breast cancer, the overall response rate was 31%; moreover, 61% of patients achieved either response or stable disease lasting ≥6 months.
    [Show full text]
  • New Drug Update: the Next Step in Personalized Medicine
    New Drug Update: The Next Step in Personalized Medicine Jordan Hill, PharmD, BCOP Clinical Pharmacy Specialist WVU Medicine Mary Babb Randolph Cancer Center Objectives • Review indications for new FDA approved anti- neoplastic medications in 2017 • Outline place in therapy of new medications • Become familiar with mechanisms of action of new medications • Describe adverse effects associated with new medications • Summarize dosing schemes and appropriate dose reductions for new medications First-in-Class Approvals • FLT3 inhibitor – midostaurin • IDH2 inhibitor – enasidenib • Anti-CD22 antibody drug conjugate – inotuzumab ozogamicin • CAR T-cell therapy - tisagenlecleucel “Me-too” Approvals • CDK 4/6 inhibitor – ribociclib and abemaciclib • PD-L1 inhibitors • Avelumab • Durvalumab • PARP inhibitor – niraparib • ALK inhibitor – brigatinib • Pan-HER inhibitor – neratinib • Liposome-encapsulated combination of daunorubicin and cytarabine • PI3K inhibitor – copanlisib Drugs by Malignancy AML Breast Bladder ALL FL Lung Ovarian 0 1 2 3 Oral versus IV 46% 54% Oral IV FIRST-IN CLASS FLT3 Inhibitor - midostaurin Journal of Hematology & Oncology 2017;10:93 Midostaurin (Rydapt®) • 717 newly diagnosed FLT3+ AML Patients • Induction and consolidation chemotherapy and placebo maintenance versus chemotherapy + midostaurin and Treatment maintenance midostaurin • OS: 74.7 mo versus 25.6 mo (P=0.009) Efficacy • EFS: 8.2 mo versus 3.0 mo (P=0.002) • Higher grade > 3 anemia, rash, and nausea Safety N Engl J Med 2017;377:454-64 Midostaurin (Rydapt®) • Approved indications: FLT3+ AML, mast cell leukemia, systemic mastocytosis • AML dose: 50 mg twice daily with food on days 8-21 • Of each induction cycle (+ daunorubicin and cytarabine) • Of each consolidation cycle (+ high dose cytarabine) • ADEs: nausea, myelosuppression, mucositis, increases in LFTs, amylase/lipase, and electrolyte abnormalities • Pharmacokinetics: hepatic metabolism, substrate of CYP 3A4; < 5% excretion in urine RYDAPT (midostaurin) [package insert].
    [Show full text]
  • Optimizing Binding Kinetics in Medicinal Chemistry: Facts Or Fantasy?
    Optimizing Binding Kinetics in Medicinal Chemistry: facts or fantasy? ‡ -Gon /RT kon e -G‡ /RT ‡ off ΔG on koff e -ΔGd/RT Kd e koff /kon P + L ‡ ΔG off ΔGd PL Gerhard Müller Ex-Head of Med Chem Mercachem, Nijmegen, NL Binding coordinate 11 The topic is hot, complex, and I am just an end-user & controversial “You can’t optimize koff, and you don’t need to optimize koff, you simply need to optimize Kd ! ” Head Med Chem, (top-5 Pharma), West Coast, US, Jan 2016 Optimizing Binding Kinetics in Medicinal Chemistry: facts or fantasy? ‡ -Gon /RT kon e -G‡ /RT ‡ off ΔG on koff e -ΔGd/RT Kd e koff /kon P + L ‡ ΔG off ΔGd PL Gerhard Müller Chief Scientific Officer Gotham Therapeutics, New YorkBinding coordinate 2 confidential Streetlight effect in medicinal chemistry Top-heavy distributions, rich-get-richer mechanisms 5% / 75% J. Med. Chem., 54 ,6405–6416 (2011) Vertex Pharmaceuticals, US J. Org. Chem. 73, 4443-4451 (2008) MW clogP shape clogP flatness Fsp3 flatland J. Med. Chem., 58, 2390−2405 (2015) para meta ortho J. Med. Chem., 59, 4443–4458 (2016) 3 Cheminformatics Analysis – Kinase Family Ligand and target promiscuity (ChEMBL21) Hu, Kunimoto, Bajorath Chemical Biology & Drug Design, 89, 834-845 (2017) quantitative kinome coverage 270 kinases with high-confidence data Top-10 kinases (45% of human kinome still unexplored) VEGFR2 TK 2239 erbB1 TK 1814 22.537 distinct IC50 values p38a CMGC 1509 9191 distinct scaffolds HGFR TK 1411 31.873 kinase-inhibitor combinations PI3a lipid 844 erbB-2 TK 768 GSK3b CMGC 743 SRC TK 709 Chk1 CAMK 693
    [Show full text]
  • New Medicines Decisions APRIL 2019 – MARCH 2020
    NHS Borders: New Medicines Decisions APRIL 2019 – MARCH 2020 Please note: We are happy to consider requests for other languages or formats. Please contact Pharmacy Admin Office [email protected] In Scotland, a newly licensed medicine is routinely available in a health board only after it has been: • accepted for use in NHSScotland by the Scottish Medicines Consortium (SMC), and • accepted for use by the health board’s Area Drug and Therapeutics Committee (ADTC). All medicines accepted by SMC are available in Scotland, but may not be considered ‘routinely available’ within a particular health board because of available services and preferences for alternative medicines. ‘Routinely available’ means that a medicine can be prescribed by the appropriately qualified person within a health board. Each health board has an ADTC. The ADTC is responsible for advising the health board on all aspects of the use of medicines. Medicines routinely available within a health board are usually included in the local formulary. The formulary is a list of medicines for use in the health board that has been agreed by ADTC in consultation with local clinical experts. It offers a choice of medicines for healthcare professionals to prescribe for common medical conditions. A formulary can help improve safety as prescribers are likely to become more familiar with the medicines in it and also helps make sure that standards of care are consistent across the health board. How does the health board decide which new medicines to make routinely available for patients? The ADTC in a health board will consider national and local guidance before deciding whether to make a new medicine routinely available.
    [Show full text]
  • Dual Targeting of CDK4/6 and BCL2 Pathways Augments Tumor Response in Estrogen Receptor–Positive Breast Cancer James R
    Published OnlineFirst April 3, 2020; DOI: 10.1158/1078-0432.CCR-19-1872 CLINICAL CANCER RESEARCH | TRANSLATIONAL CANCER MECHANISMS AND THERAPY Dual Targeting of CDK4/6 and BCL2 Pathways Augments Tumor Response in Estrogen Receptor–Positive Breast Cancer James R. Whittle1,2,3, Francois¸ Vaillant1,3, Elliot Surgenor1, Antonia N. Policheni3,4,Goknur€ Giner3,5, Bianca D. Capaldo1,3, Huei-Rong Chen1,HeK.Liu1, Johanna F. Dekkers1,6,7, Norman Sachs6, Hans Clevers6,7, Andrew Fellowes8, Thomas Green8, Huiling Xu8, Stephen B. Fox8,9, Marco J. Herold3,10, Gordon K. Smyth5,11, Daniel H.D. Gray3,4, Jane E. Visvader1,3, and Geoffrey J. Lindeman1,2,12 ABSTRACT ◥ Purpose: Although cyclin-dependent kinase 4 and 6 (CDK4/6) Results: Triple therapy was well tolerated and produced a super- inhibitors significantly extend tumor response in patients with ior and more durable tumor response compared with single or þ metastatic estrogen receptor–positive (ER ) breast cancer, relapse doublet therapy. This was associated with marked apoptosis, includ- is almost inevitable. This may, in part, reflect the failure of CDK4/6 ing of senescent cells, indicative of senolysis. Unexpectedly, ABT- – inhibitors to induce apoptotic cell death. We therefore evaluated 199 resulted in Rb dephosphorylation and reduced G1 S cyclins, combination therapy with ABT-199 (venetoclax), a potent and most notably at high doses, thereby intensifying the fulvestrant/ selective BCL2 inhibitor. palbociclib–induced cell-cycle arrest. Interestingly, a CRISPR/Cas9 Experimental Design: BCL2 family member expression was screen suggested that ABT-199 could mitigate loss of Rb (and assessed following treatment with endocrine therapy and the potentially other mechanisms of acquired resistance) to palbociclib.
    [Show full text]
  • Abemaciclib (Verzenio) Reference Number: CP.PHAR.355 Effective Date: 10.24.17 Last Review Date: 11.19 Line of Business: Commercial, Medicaid Revision Log
    Clinical Policy: Abemaciclib (Verzenio) Reference Number: CP.PHAR.355 Effective Date: 10.24.17 Last Review Date: 11.19 Line of Business: Commercial, Medicaid Revision Log See Important Reminder at the end of this policy for important regulatory and legal information. Description Abemaciclib (Verzenio®) is an inhibitor of cyclin-dependent kinases 4 and 6 (CDK4/6). FDA Approved Indication(s) Verzenio is indicated: • In combination with an aromatase inhibitor as initial endocrine-based therapy for the treatment of postmenopausal women with HR-positive, HER2-negative advanced or metastatic breast cancer • In combination with fulvestrant for the treatment of women with hormone receptor (HR)- positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer with disease progression following endocrine therapy • As monotherapy for the treatment of adult patients with HR-positive, HER2-negative advanced or metastatic breast cancer with disease progression following endocrine therapy and prior chemotherapy in the metastatic setting Policy/Criteria Provider must submit documentation (such as office chart notes, lab results or other clinical information) supporting that member has met all approval criteria. It is the policy of health plans affiliated with Centene Corporation® that Verzenio is medically necessary when the following criteria are met: I. Initial Approval Criteria A. Breast Cancer (must meet all): 1. Diagnosis of breast cancer; 2. Prescribed by or in consultation with an oncologist; 3. Age ≥ 18 years; 4. Disease has all of the following characteristics (a, b, and c): a. HR-positive (i.e., estrogen receptor (ER) and/or progesterone receptor (PR) positive); b. HER2-negative; c. Advanced (locally recurrent) or metastatic; 5.
    [Show full text]
  • Cyclin-Dependent Kinase Inhibitors in Brain Cancer: Current State and Future Directions
    Juric et al. Cancer Drug Resist 2020;3:48-62 Cancer DOI: 10.20517/cdr.2019.105 Drug Resistance Review Open Access Cyclin-dependent kinase inhibitors in brain cancer: current state and future directions Viktorija Juric, Brona Murphy Department of Physiology and Medical Physics, Royal College of Surgeons in Ireland, Dublin D02, Ireland. Correspondence to: Dr. Brona Murphy, Department of Physiology and Medical Physics, Royal College of Surgeons in Ireland, 39A York Street, Dublin D02, Ireland. E-mail: [email protected] How to cite this article: Juric V, Murphy B. Cyclin-dependent kinase inhibitors in brain cancer: current state and future directions. Cancer Drug Resist 2020;3:48-62. http://dx.doi.org/10.20517/cdr.2019.105 Received: 5 Nov 2019 First Decision: 4 Dec 2019 Revised: 11 Dec 2019 Accepted: 20 Dec 2019 Published: 19 Mar 2020 Science Editor: Lee M. Graves Copy Editor: Jing-Wen Zhang Production Editor: Jing Yu Abstract Cyclin-dependent kinases (CDKs) are important regulatory enzymes in the normal physiological processes that drive cell-cycle transitions and regulate transcription. Virtually all cancers harbour genomic alterations that lead to the constitutive activation of CDKs, resulting in the proliferation of cancer cells. CDK inhibitors (CKIs) are currently in clinical use for the treatment of breast cancer, combined with endocrine therapy. In this review, we describe the potential of CKIs for the treatment of cancer with specific focus on glioblastoma (GBM), the most common and aggressive primary brain tumour in adults. Despite intense effort to combat GBM with surgery, radiation and temozolomide chemotherapy, the median survival for patients is 15 months and the majority of patients experience disease recurrence within 6-8 months of treatment onset.
    [Show full text]
  • Standard Oncology Criteria C16154-A
    Prior Authorization Criteria Standard Oncology Criteria Policy Number: C16154-A CRITERIA EFFECTIVE DATES: ORIGINAL EFFECTIVE DATE LAST REVIEWED DATE NEXT REVIEW DATE DUE BEFORE 03/2016 12/2/2020 1/26/2022 HCPCS CODING TYPE OF CRITERIA LAST P&T APPROVAL/VERSION N/A RxPA Q1 2021 20210127C16154-A PRODUCTS AFFECTED: See dosage forms DRUG CLASS: Antineoplastic ROUTE OF ADMINISTRATION: Variable per drug PLACE OF SERVICE: Retail Pharmacy, Specialty Pharmacy, Buy and Bill- please refer to specialty pharmacy list by drug AVAILABLE DOSAGE FORMS: Abraxane (paclitaxel protein-bound) Cabometyx (cabozantinib) Erwinaze (asparaginase) Actimmune (interferon gamma-1b) Calquence (acalbrutinib) Erwinia (chrysantemi) Adriamycin (doxorubicin) Campath (alemtuzumab) Ethyol (amifostine) Adrucil (fluorouracil) Camptosar (irinotecan) Etopophos (etoposide phosphate) Afinitor (everolimus) Caprelsa (vandetanib) Evomela (melphalan) Alecensa (alectinib) Casodex (bicalutamide) Fareston (toremifene) Alimta (pemetrexed disodium) Cerubidine (danorubicin) Farydak (panbinostat) Aliqopa (copanlisib) Clolar (clofarabine) Faslodex (fulvestrant) Alkeran (melphalan) Cometriq (cabozantinib) Femara (letrozole) Alunbrig (brigatinib) Copiktra (duvelisib) Firmagon (degarelix) Arimidex (anastrozole) Cosmegen (dactinomycin) Floxuridine Aromasin (exemestane) Cotellic (cobimetinib) Fludara (fludarbine) Arranon (nelarabine) Cyramza (ramucirumab) Folotyn (pralatrexate) Arzerra (ofatumumab) Cytosar-U (cytarabine) Fusilev (levoleucovorin) Asparlas (calaspargase pegol-mknl Cytoxan (cyclophosphamide)
    [Show full text]
  • Targeted Neoadjuvant Therapies in HR+/HER2-Breast Cancers
    cancers Review Targeted Neoadjuvant Therapies in HR+/HER2−Breast Cancers: Challenges for Improving pCR Nandini Dey, Jennifer Aske and Pradip De * Translational Oncology Laboratory, Avera Cancer Institute, Sioux Falls, SD 57105, USA; [email protected] (N.D.); [email protected] (J.A.) * Correspondence: [email protected]; Tel.: +1-605-322-3297; Fax: +1-605-322-6901 Simple Summary: A high pathological complete response in the neoadjuvant setting is directly associated with a better overall response. A favorable prognosis is achieved when preoperative chemo or endocrine therapy succeeds in achieving a high pathological complete response (total eradication of tumors in the breast and the lymph nodes). Approximately 70% of breast cancers are ER-positive. The growth and progression of ER-positive breast cancers are critically dependent on estrogen receptor signaling. Although endocrine therapies (tamoxifen, an aromatase inhibitor, and fulvestrant) in ER-positive breast cancers are the backbone of adjuvant setting, the efficacy of such therapies in terms of achieving a pathological complete response is not encouraging in the neoadjuvant setting. Similar results are observed following targeted therapies in a neoadjuvant setting. Reviewing the literature in the context of different therapies of ER-positive breast cancers in the neoadjuvant setting, here we propose two hypothetical strategies to induce apoptosis based on the background of genomic alterations in the tumor tissues. Abstract: A strong association of pCR (pathological complete response) with disease-free survival or overall survival is clinically desirable. The association of pCR with disease-free survival or Citation: Dey, N.; Aske, J.; De, P. overall survival in ER+/HER2−breast cancers following neoadjuvant systemic therapy (NAT) or Targeted Neoadjuvant Therapies in neoadjuvant endocrine therapy (NET) is relatively low as compared to the other two subtypes of HR+/HER2−Breast Cancers: breast cancers, namely triple-negative and HER2+ amplified.
    [Show full text]
  • New Drug Updates in Solid Tumors: PARP Inhibitors in Ovarian Cancer, Immunotherapeutics, and Other Agents
    New Drug Updates in Solid Tumors: PARP Inhibitors in Ovarian Cancer, Immunotherapeutics, and Other Agents Edward Li, PharmD, MPH, BCOP University of New England College of Pharmacy Learning Objectives 1. Discuss the pharmacology and indications of medications approved in the year 2016–2017 for the management of patients with solid tumors 2. Recall the pivotal clinical trial data considered by the FDA when approving new oncologics 3. Identify the signs and symptoms of serious or life-threatening adverse effects of newly approved oncology drugs 4. Describe the impact of these agents in advanced practice Financial Disclosure • Edward Li, PharmD, MPH, BCOP, declares that he has served on the speakers bureau for Pfizer and ApoBiologiX and on advisory boards for Pfizer, Eli Lilly, and Mylan. History of Cancer Drug Approvals in the United States 1942: Goodman and Gilman 1975: CMF for 1992: Paclitaxel use nitrogen mustard for NHL breast cancer FDA approved Targeted 1959: FDA approves therapies cyclophosphamide 1940s 1950s 1960s 1970s 1980s 1990s 2000s 1948: Farber 1965: 1978: 1998: 2001: Imatinib uses antifolate in Combination Cisplatin Trastuzumab FDA approved ALL chemo for ALL approved FDA approved ALL = acute lymphoblastic leukemia; CMF = cyclophosphamide, methotreXate and fluorouracil; FDA = US Food and Drug Administration; NHL = non-Hodgkin lymphoma. Adapted from Chabner BA, et al. Nat Rev Cancer 2005;5:65-72. Drug Approvals Impact the Practice Paradigm 1942: Goodman Combination and Gilman use chemo Commercialized Ta rg e te d nitrogen Expansion of regimens chemo era therapy era mustard for oral oncolytics invented begins begins NHL 1960 // 1980 1990 2000 2010 Cancer treatment paradigm Cisplatin (1978) Supportive care management: CINV Filgrastim (1991) Supportive care management: febrile neutropenia Trastuzumab (1998), imatinib (2000), gefitinib (2003), etc.
    [Show full text]