OVERVIEW OF ACTIVITY
Each year, thousands of clinicians, basic scientists and other industry professionals sojourn to major international oncology conferences, like the American Society of Hematology (ASH) annual meeting, to hone their skills, network with colleagues and learn about recent advances altering state-of-the-art management in hematologic oncology. As such, these events have become global stages where exciting science, cutting-edge concepts and practice-changing data emerge on a truly grand scale. This massive outpouring of information has enormous benefits for the hematologic oncology community, but the truth is it also creates a major challenge for practicing oncologists and hematologists.
Although original data are consistently being presented and published, the flood of information unveiled during a major academic conference is unprecedented and leaves in its wake an enormous volume of new knowledge that practicing oncologists must try to sift through, evaluate and consider applying. Unfortunately and quite commonly, time constraints and an inability to access these data sets leave many oncologists struggling to ensure that they’re aware of crucial practice-altering findings. This creates an almost insurmountable obstacle for clinicians in community practice because they are not only confronted almost overnight with thousands of new presentations and data sets to consider but they are also severely restricted in their ability to review and interrogate the raw findings.
To bridge the gap between research and patient care, this CME activity will deliver a serial review of the most important emerging data sets on the use of brentuximab vedotin and novel immune checkpoint inhibitors in the treatment of Hodgkin lymphoma (HL) from the latest ASH meeting, including expert perspectives on how these new evidence-based concepts may be applied to routine clinical care. This activity will assist medical oncologists, hematologists, hematology-oncology fellows and other healthcare professionals in the formulation of optimal clinical management strategies and the timely application of new research findings to best-practice patient care.
LEARNING OBJECTIVES
Please see individual web programs for CME program-specific information.
ACCREDITATION STATEMENT
Research To Practice is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians.
CREDIT DESIGNATION STATEMENT
Please see individual web programs for CME program-specific information.
HOW TO USE THIS CME ACTIVITY
Please see individual web programs for CME program-specific information.
CONTENT VALIDATION AND DISCLOSURES
Research To Practice (RTP) is committed to providing its participants with high-quality, unbiased and state-of-the-art education. We assess potential conflicts of interest with faculty, planners and managers of CME activities. Real or apparent conflicts of interest are identified and resolved through a conflict of interest resolution process. In addition, all activity content is reviewed by both a member of the RTP scientific staff and an external, independent physician reviewer for fair balance, scientific objectivity of studies referenced and patient care recommendations.
FACULTY — Please see individual web programs for CME program-specific information.
EDITOR — Dr Love is president and CEO of Research To Practice, which receives funds in the form of educational grants to develop CME activities from the following commercial interests: AbbVie Inc, Amgen Inc, Astellas Scientific and Medical Affairs Inc, AstraZeneca Pharmaceuticals LP, Aveo Pharmaceuticals, Bayer HealthCare Pharmaceuticals, Biodesix Inc, Boehringer Ingelheim Pharmaceuticals Inc, Boston Biomedical Pharma Inc, Bristol-Myers Squibb Company, Celgene Corporation, Clovis Oncology, Daiichi Sankyo Inc, Dendreon Corporation, Eisai Inc, Exelixis Inc, Foundation Medicine, Genentech BioOncology, Genomic Health Inc, Gilead Sciences Inc, Incyte Corporation, Janssen Biotech Inc, Jazz Pharmaceuticals Inc, Lilly, Medivation Inc, Merck, Myriad Genetic Laboratories Inc, NanoString Technologies, Novartis Pharmaceuticals Corporation, Novocure, Onyx Pharmaceuticals, an Amgen subsidiary, Pharmacyclics Inc, Prometheus Laboratories Inc, Regeneron Pharmaceuticals, Sanofi, Seattle Genetics, Sigma-Tau Pharmaceuticals Inc, Sirtex Medical Ltd, Spectrum Pharmaceuticals Inc, Taiho Oncology Inc, Takeda Oncology, Teva Oncology, Tokai Pharmaceuticals Inc and VisionGate Inc.
RESEARCH TO PRACTICE STAFF AND EXTERNAL REVIEWERS — The scientific staff and reviewers for Research To Practice have no real or apparent conflicts of interest to disclose.
This educational activity contains discussion of published and/or investigational uses of agents that are not indicated by the Food and Drug Administration. Research To Practice does not recommend the use of any agent outside of the labeled indications. Please refer to the official prescribing information for each product for discussion of approved indications, contraindications and warnings. The opinions expressed are those of the presenters and are not to be construed as those of the publisher or grantors.
This activity is supported by educational grants from Bristol-Myers Squibb Company, Celgene Corporation, Incyte Corporation, Onyx Pharmaceuticals, an Amgen subsidiary, Seattle Genetics and Takeda Oncology.
Hardware/Software Requirements:
A high-speed Internet connection
A monitor set to 1280 x 1024 pixels or more
Internet Explorer 7 or later, Firefox 3.0 or later, Chrome, Safari 3.0 or later
Adobe Flash Player 10.2 plug-in or later
Adobe Acrobat Reader
(Optional) Sound card and speakers for audio
Last review date: February/March/April/May 2015
Expiration date: February/March/April/May 2016
Overview This 7-part web program is part of an email series designed for dedicated but frenzied oncology professionals attempting to keep up with an exploding clinical research database. Subscribers to this program receive weekly emails that include links to slides from important data sets presented at ASH 2014 along with brief comments from clinical investigators about the significance of these results.
Issue 7 — Current Edition
Issue 6
Read Dr Love’s original email (May 21, 2015)
Novel Agents and Therapeutic Options for Relapsed and/or Refractory Multiple Myeloma (MM), High-Risk Smoldering MM, Waldenström Macroglobulinemia and Newly Diagnosed AL Amyloidosis
Program Description: A summary of results from the Phase I or II trials of monoclonal antibodies elotuzumab, SAR650984 and daratumumab in relapsed or refractory MM, the Phase II PCYC-111 trial of ibrutinib in relapsed/refractory MM, the Phase III QUIREDEX trial of lenalidomide/dexamethasone, the Phase II trial of carfilzomib in combination with lenalidomide/dexamethasone in high-risk smoldering MM, a systemic analysis of the role of CyBorD in AL amyloidosis and Phase I/II trials of lenalidomide or oprozomib in relapsed/refractory Waldenström macroglobulinemia.
Full Abstracts:
Final Efficacy and Safety Results from the 1703 Phase Ib/II Study of Elotuzumab/Lenalidomide/Dexamethasone in Relapsed/Refractory MM
Richardson PG et al. Final results for the 1703 phase 1b/2 study of elotuzumab in combination with lenalidomide and dexamethasone in patients with relapsed/refractory multiple myeloma. Proc ASH 2014; Abstract 302.
Phase I Trial of SAR650984 and Phase I/II Trial of Daratumumab for Patients with Relapsed/Refractory MM
Martin TG et al. A Phase Ib dose escalation trial of SAR650984 (anti-CD-38 mAb) in combination with lenalidomide and dexamethasone in relapsed/refractory multiple myeloma. Proc ASH 2014; Abstract 83.
Plesner T et al. Safety and efficacy of daratumumab with lenalidomide and dexamethasone in relapsed or relapsed, refractory multiple myeloma. Proc ASH 2014; Abstract 84.
Phase II PCYC-1111 Trial of Ibrutinib with or without Dexamethasone in Relapsed/Refractory MM
Vij R et al. Ibrutinib, single agent or in combination with dexamethasone, in patients with relapsed or relapsed/refractory multiple myeloma (MM): Preliminary phase 2 results. Proc ASH 2014; Abstract 31.
Phase III QUIREDEX Trial of Lenalidomide (Len) and Dexamethasone (Dex) and Phase II Trial of Carfilzomib and Len/Dex in High-Risk Smoldering MM
Mateos MV et al. Long term follow-up on the treatment of high risk smoldering myeloma with lenalidomide plus low dose dex (Rd) (phase III Spanish trial): Persistent benefit in overall survival. Proc ASH 2014; Abstract 3465.
Landgren O et al. Carfilzomib, lenalidomide, and dexamethasone in high-risk smoldering multiple myeloma: Final results from the NCI phase 2 pilot study. Proc ASH 2014; Abstract 4746.
A European Collaborative Study of the Role of CyBorD in the Up-Front Treatment of AL Amyloidosis
Palladini G et al. A European collaborative study of 230 patients to assess the role of cyclophosphamide, bortezomib and dexamethasone in upfront treatment of patients with systemic AL amyloidosis. Proc ASH 2014; Abstract 305.
Phase I/II RV-WM-0426 Trial of Lenalidomide and Phase I/II Trial of Oprozomib in Relapsed/Refractory Waldenström Macroglobulinemia
Leleu X et al. Lenalidomide is safe and active in Waldenstrom macroglobulinemia (WM). Proc ASH 2014; Abstract 4478.
Siegel DS et al. Updated results from a multicenter, open-label, dose-escalation phase 1b/2 study of single-agent oprozomib in patients with Waldenstrom macroglobulinemia (WM). Proc ASH 2014; Abstract 1715.
Issue 5
Issue 4
Read Dr Love’s original email (May 7, 2015)
Investigational Agents and Therapeutic Options for Chronic Myeloid Leukemia, Myelofibrosis, Polycythemia Vera and Essential Thrombocythemia
Program Description: A summary of the results of the Phase III EPIC, DASISION and SPIRIT 2 trials of tyrosine kinase inhibitors (TKIs) in chronic myeloid leukemia (CML), trials of second-generation TKI discontinuation in CML, Phase III trials of ruxolitinib in polycythemia vera and essential thrombocythemia and recent data on novel investigational agents in myelofibrosis.
Full Abstracts:
Real-World Assessment of Clinical Outcomes in Patients with Lower-Risk Myelofibrosis Receiving Ruxolitinib Therapy
Davis KL et al. Real-world assessment of clinical outcomes in lower-risk myelofibrosis patients receiving treatment with ruxolitinib. Proc ASH 2014; Abstract 1857.
Results from the Phase III RESPONSE Trial of Ruxolitinib versus Best Available Therapy for Patients with Polycythemia Vera
Mesa R et al. Changes in quality of life and disease-related symptoms in patients with polycythemia vera receiving ruxolitinib or best available therapy: RESPONSE trial results. Proc ASH 2014; Abstract 709.
Vannucchi AM et al. Ruxolitinib versus standard therapy for the treatment of polycythemia vera. N Engl J Med 2015;372(5):426-35. Abstract
Kiladjian J-J et al. Clinical benefit of ruxolitinib treatment after crossover from best available therapy in patients with polycythemia vera: Analysis of the RESPONSE trial. Proc ASH 2014; Abstract 3181.
Results from the Phase III RELIEF Trial and a Phase II Trial of Ruxolitinib in Patients with Polycythemia Vera or Essential Thrombocythemia
Mesa R et al. The efficacy and safety of continued hydroxyurea therapy versus switching to ruxolitinib in patients with polycythemia vera: A randomized, double-blind, double-dummy, symptom study (RELIEF). Proc ASH 2014; Abstract 3168.
Verstovsek S et al. Long-term results from a phase II open-label study of ruxolitinib in patients with essential thrombocythemia refractory to or intolerant of hydroxyurea. Proc ASH 2014; Abstract 1847.
Results from a Phase II Trial of PRM-151 and a Pilot Study of Imetelstat for Patients with Primary and Secondary Myelofibrosis
Verstovsek S et al. Phase 2 trial of PRM-151, an anti-fibrotic agent, in patients with myelofibrosis: Stage 1 results. Proc ASH 2014; Abstract 713.
Tefferi A et al. Imetelstat, a telomerase inhibitor, therapy for myelofibrosis: A pilot study. Proc ASH 2014; Abstract 634.
Phase III DASISION and SPIRIT 2 Trials of Dasatinib versus Imatinib in Newly Diagnosed CML in Chronic Phase
Cortes J et al. Final study results of the phase 3 dasatinib versus imatinib in newly diagnosed chronic myeloid leukemia in chronic phase (CML-CP) trial (DASISION, CA180-056). Proc ASH 2014; Abstract 152.
O’Brien SG et al. Spirit 2: An NCRI randomised study comparing dasatinib with imatinib in patients with newly diagnosed CML. Proc ASH 2014; Abstract 517.
Phase III EPIC Trial of Ponatinib versus Imatinib in Newly Diagnosed CML in Chronic Phase
Lipton JH et al. Epic: A Phase 3 trial of ponatinib compared with imatinib in patients with newly diagnosed chronic myeloid leukemia in chronic phase (CP-CML). Proc ASH 2014; Abstract 519.
STOP 2G-TKI and EURO-SKI Trials of Discontinuation of Tyrosine Kinase Inhibitor Therapy for Patients with CML
Rea D et al. Dasatinib or nilotinib discontinuation in chronic phase (CP)-chronic myeloid leukemia (CML) patients (pts) with durably undetectable BCR-ABL transcripts: Interim analysis of the STOP 2G-TKI study with a minimum follow-up of 12 months — On behalf of the French CML group Filmc. Proc ASH 2014; Abstract 811.
Mahon FX et al. Interim analysis of a pan European stop tyrosine kinase inhibitor trial in chronic myeloid leukemia: The EURO-SKI study. Proc ASH 2014; Abstract 151.
Issue 3
Read Dr Love’s original email (April 9, 2015)
Management of Chronic Lymphocytic Leukemia
Program Description: A summary of recent data on the safety and efficacy of rituximab-based therapies, BTK, Bcl-2 and selective PI3 kinase inhibitors, third-generation anti-CD20 antibodies and the value of minimal residual disease-negative status at response evaluation in patients with chronic lymphocytic leukemia.
Full Abstracts:
Final Analysis of the Phase III CLL10 Study: FCR versus BR in Physically Fit Patients with Previously Untreated, Advanced CLL
Eichhorst B et al. Frontline chemoimmunotherapy with fludarabine (F), cyclophosphamide (C), and rituximab (R) (FCR) shows superior efficacy in comparison to bendamustine (B) and rituximab (BR) in previously untreated and physically fit patients (pts) with advanced chronic lymphocytic leukemia (CLL): Final analysis of an international, randomized study of the German CLL Study Group (GCLLSG) (CLL10 study). Proc ASH 2014; Abstract 19.
Value of Minimal Residual Disease-Negative Status at Response Evaluation in CLL
Kovacs G et al. Value of minimal residual disease (MRD) negative status at response evaluation in chronic lymphocytic leukemia (CLL): Combined analysis of two phase III studies of the German CLL Study Group (GCLLSG). Proc ASH 2014; Abstract 23.
GREEN: Preliminary Results of a Phase IIIb Trial of Obinutuzumab Alone or in Combination with Chemotherapy for CLL
Bosch F et al. Preliminary safety results from the phase IIIb GREEN study of obinutuzumab (GA101) alone or in combination with chemotherapy for previously untreated or relapsed/refractory chronic lymphocytic leukemia (CLL). Proc ASH 2014; Abstract 3345.
CLL11: Salvage Therapy with Obinutuzumab and Chlorambucil (Clb) After Failure of Clb Alone for Patients with CLL and Comorbidities
Goede V et al. Salvage therapy with obinutuzumab (GA101) plus chlorambucil (Clb) after treatment failure of Clb alone in patients with chronic lymphocytic leukemia (CLL) and comorbidities: Results of the CLL11 study. Proc ASH 2014; Abstract 3327.
Efficacy of Maintenance Therapy with Rituximab or Ofatumumab in CLL
Greil R et al. Rituximab maintenance after chemoimmunotherapy induction in 1st and 2nd line improves progression free survival: Planned interim analysis of the international randomized AGMT-CLL8/a Mabtenance trial. Proc ASH 2014; Abstract 20.
van Oers MHJ et al. Ofatumumab (OFA) maintenance prolongs PFS in relapsed CLL: Prolong study interim analysis results. Proc ASH 2014; Abstract 21.
Ibrutinib for Patients with Relapsed/Refractory CLL and Association of Complex Karyotype with Outcomes
O’Brien S et al. Efficacy and safety of ibrutinib in patients with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic leukemia with 17p deletion: Results from the phase II RESONATE-17 trial. Proc ASH 2014; Abstract 327.
Thompson PA et al. Complex karyotype, rather than del(17p), is associated with inferior outcomes in relapsed or refractory CLL patients treated with ibrutinib-based regimens. Proc ASH 2014; Abstract 22.
Second Interim Analysis of a Phase III Study of Idelalisib and Rituximab for Patients with Relapsed CLL with Del(17p) and Other Adverse Cytogenetics
Sharman J et al. Second interim analysis of a phase 3 study of idelalisib (Zydelig) plus rituximab for relapsed chronic lymphocytic leukemia: Efficacy analysis in patient subpopulations with del(17p) and other adverse prognostic factors. Proc ASH 2014; Abstract 330.
Determination of Recommended Phase II Dose of Venetoclax (ABT-199) and Rituximab for Relapsed/Refractory CLL
Roberts AW et al. Determination of recommended phase 2 dose of ABT-199 (GDC-0199) combined with rituximab (R) in patients with relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL). Proc ASH 2014; Abstract 325.
Issue 2
Read Dr Love’s original email (March 20, 2015)
Therapeutic Options for Newly Diagnosed and Relapsed/Refractory Multiple Myeloma
Program Description: A summary of the Phase III ASPIRE and FIRST trial results and of recent data on novel proteasome inhibitor and/or immunomodulatory agent combination regimens as first-line, maintenance or later-line therapies for newly diagnosed or relapsed multiple myeloma. Modalities of response evaluation in the management of multiple myeloma will also be discussed.
Full Abstracts:
Efficacy and Safety of Carfilzomib, Lenalidomide and Dexamethasone in MM
Stewart AK et al. Carfilzomib, lenalidomide, and dexamethasone vs lenalidomide and dexamethasone in patients (pts) with relapsed multiple myeloma: Interim results from ASPIRE, a randomized, open-label, multicenter phase 3 study. Proc ASH 2014; Abstract 79.
Stewart AK et al. Carfilzomib, lenalidomide, and dexamethasone for relapsed multiple myeloma. N Engl J Med 2015;372(2):142-52. Abstract
Rosenthal AC et al. The cardiovascular impact of carfilzomib in multiple myeloma. Proc ASH 2014; Abstract 4748.
Phase II Trials of Pomalidomide and Dexamethasone in Combination with Either Cyclophosphamide or Bortezomib in Relapsed or Refractory MM
Baz R et al. Pomalidomide, cyclophosphamide, and dexamethasone is superior to pomalidomide and dexamethasone in relapsed and refractory myeloma: Results of a multicenter randomized phase II study. Proc ASH 2014; Abstract 303.
Lacy MQ et al. Pomalidomide, bortezomib and dexamethasone (PVD) for patients with relapsed lenalidomide refractory multiple myeloma (MM). Proc ASH 2014; Abstract 304.
A Prospective Head-to-Head Assessment of Cell-Based, Molecular and Molecular-Imaging Modalities of Testing Minimal Residual Disease in MM
Korde N et al. Minimal residual disease (MRD) testing in newly diagnosed multiple myeloma (MM) patients: A prospective head-to-head assessment of cell-based, molecular, and molecular-imaging modalities. Proc ASH 2014; Abstract 2105.
Phase I/II Study of Weekly Carfilzomib, Cyclophosphamide and Dexamethasone in Patients with Newly Diagnosed MM
Palumbo A et al. Weekly carfilzomib, cyclophosphamide and dexamethasone (wCCd) in newly diagnosed multiple myeloma patients: A phase I-II study. Proc ASH 2014; Abstract 175.
FIRST Trial: Effect of Age on Efficacy and Safety Outcomes in Patients with Newly Diagnosed MM Receiving Rd
Hulin C et al. Effect of age on efficacy and safety outcomes in patients (Pts) with newly diagnosed multiple myeloma (NDMM) receiving lenalidomide and low-dose dexamethasone (Rd): The First trial. Proc ASH 2014; Abstract 81.
Clinical Profile of Oprozomib and Ixazomib in Relapsed or Refractory MM
Kumar S et al. Long-term ixazomib maintenance is tolerable and improves depth of response following ixazomib-lenalidomide-dexamethasone induction in patients (pts) with previously untreated multiple myeloma (MM): Phase 2 study results. Proc ASH 2014; Abstract 82.
Vij R et al. Clinical profile of single-agent oprozomib in patients (Pts) with multiple myeloma (MM): Updated results from a multicenter, open-label, dose escalation Phase 1b/2 study. Proc ASH 2014; Abstract 34.
Utility of Serum Free Light Chains in the Evaluation of Response in Light Chain MM: Results from the IFM/DFCI 2009 Trial
Corre J et al. Serum free light chains should be the target of response evaluation in light chain multiple myeloma rather than urines: Results from the IFM/DFCI 2009 trial. Proc ASH 2014; Abstract 180.
Issue 1
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