1 / 127

Changing Patient Care in Multiple Myeloma: The IMF Nurse Leadership Board’s Long-Term Survivorship Care Plan

Changing Patient Care in Multiple Myeloma: The IMF Nurse Leadership Board’s Long-Term Survivorship Care Plan. May 13, 2010 San Diego. Accredited by Medical Education Resources Supported by The International Myeloma Foundation.

ranger
Télécharger la présentation

Changing Patient Care in Multiple Myeloma: The IMF Nurse Leadership Board’s Long-Term Survivorship Care Plan

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. Changing Patient Care in Multiple Myeloma: The IMF Nurse Leadership Board’s Long-Term Survivorship Care Plan May 13, 2010 San Diego Accredited by Medical Education Resources Supported by The International Myeloma Foundation Grant Funding Provided by Celgene Corporation and Millennium – The Takeda Oncology Company

  2. Welcome and Introductions Elizabeth Bilotti, RN, MSN, APRN, BC The John Theurer Cancer Center at Hackensack University Medical Center Hackensack, NJ

  3. ONS Disclaimer Meeting space has been assigned to provide a satellite symposium supported by the International Myeloma Foundation via an unrestricted educational grant during the Oncology Nursing Society’s (ONS) 35th Annual Congress, May 13 - May 16, 2010, in San Diego, CA. The Oncology Nursing Society’s assignment of meeting space does not imply product endorsement, nor does the Oncology Nursing Society assume any responsibility for the educational content of the symposium.

  4. Symposium Accreditation • This continuing education activity provides 1.5 contact hours. • Medical Education Resources is an approved provider of continuing nursing education by the Colorado Nurses Association, an accredited approver by the American Nurses Credentialing Center’s Commission on Accreditation. • Please complete the CE Certificate Registration and Program Evaluation Form found in your guidebook and return it to the registration desk at the conclusion of this meeting.

  5. Chair: Elizabeth Bilotti, RN, MSN, APRN, BC John Theurer Cancer Center at Hackensack University Medical Center Hackensack, NJ Faculty Faculty: Beth Faiman, MSN, APRN-BC, AOCN® Cleveland Clinic Taussig Cancer Institute Cleveland, OH Teresa Miceli, RN, BSN, OCN® Mayo Clinic- Rochester Rochester, MN Tiffany Richards, MS, ANP, AOCNP® MD Anderson Cancer Center Houston, TX Joseph D. Tariman,PhC, MN, APRN, BC University of Washington Seattle, WA

  6. Agenda

  7. Learning Objectives • Update on current therapies used in the management of patients with multiple myeloma (MM) • Provide new data on emergent therapies in MM • Understand how longer survival may lead to a new care paradigm for MM patients • Understand the rationale and value of a Long-Term Survivorship Care Plan • Outline the role that nurses play in the implementation of a Survivorship Care Plan • Discuss medical implications of major long-term side effects associated with novel therapies in MM

  8. Multiple Myeloma: Epidemiology NCCN Multiple Myeloma Guidelines, v.3.2010; Cancer Facts and Figures, 2009; SEER Stat Fact Sheets, Myeloma (http://seer.cancer.gov/csr/1975_2006/results_merged/sect_18_myeloma.pdf)

  9. Multiple Myeloma: Disease State • Cancer of plasma cells • Healthy plasma cells produce antibodies or immunoglobulins • Part of our humoral immunity, they are released in response to foreign body invasion San Miguel JF, et al. Pathogenesis of Multiple Myeloma: Rationale for New and Novel Therapies. Clinical Care Options:http://clinicaloptions.com/Oncology/Treatment%20Updates/Myeloma/Modules/Pathophysiology/Pages/Page%203.aspx.

  10. Multiple Myeloma: Abnormal Plasma Cells Large nuclei (often eccentric) are present in multiple myeloma cells. Multiple Myeloma (bone marrow aspirate) http://www.healthsystem.virginia.edu/internet/hematology/HessEDD/MalignantHematologicDisorders/MultipleMyelomas/Multiple-myeloma.cfm

  11. Multiple Myeloma Cells Overproduce Monoclonal Protein and Abnormal Immunoglobulin • Ineffective immune function • Decreased normal bone marrow function • Impaired renal function Kyle and Rajkumar, N Engl J Med 2004;351:1860-1873

  12. Bone marrow suppression (pancytopenia) Osteolytic bone lesions Renal complications Infection Hypercalcemia Clinical Manifestations of Multiple Myeloma Overproliferation of plasma cells can cause: http://myeloma.org/pdfs/ph07-eng_f2.pdf

  13. Major Symptoms at Diagnosis Kyle RA. Mayo Clin Proc 2003;78:21

  14. Common Sites for Bone Involvement Skull Spine Thoracic Lumbar Vertebrae Pelvis Long bones http://www.emedicine.com/Radio/topic460.htm#section~Introduction

  15. Diagnosing Multiple Myeloma • *Monoclonal M spike on electrophoresis IgG >3.5 g/dL, IgA >2 g/dL, light chain >1 g/dL in 24-hour urine sample. Durie et al for the International Myeloma Working Group. Leukemia. 2006:1-7.

  16. Diagnostic Evaluation of Multiple Myeloma Alb = albumin; CBC = complete blood count; Creat = creatinine; Hgb = hemoglobin; MRI = magnetic resonance imaging; WBC = white blood cell Abella. Oncology News International. 2007;16:27;Barlogie et al. In: Williams Hematology. 7th ed. 2006:1501; Durie et al. Hematol J. 2003;4:379; MMRF. Multiple Myeloma: Disease Overview. 2006. www.multiplemyeloma.org; Rajkumar et al. Blood. 2005;106(3):812.

  17. Durie-Salmon Staging System for Multiple Myeloma Durie and Salmon, Cancer 1975;36(9):842-854

  18. Multiple Myeloma Staging: International Staging System for Symptomatic MM 2M=serum 2 microglobulin in mg/dL; ALB=serum albumin in g/dL • ISS should only be used in patients who meet diagnostic criteria for myeloma since other conditions (renal dysfunction from diabetes or hypertension) may cause elevated B2M levels • ISS is more of a prognostic index; it does not quantify tumor burden or extent of involvement • It is recommended that ISS staging be used along with the Durie-Salmon Staging System Greipp PR, et al. Blood 2005; 102: 190a

  19. Challenges in MM Management Currently incurable in most patients New treatment options are currently in development with the goal to further improve outcomes Long-term complete responses are rare Median overall survival for newly diagnosed patients is ~3.7 years ASCT may prolong progression-free survival, but it’s not curative Newer drugs improved survival to up to ~2.6 years from relapse NCCN Practice Guidelines v.3.2010; Kumar et al, Blood 111(5), 2008

  20. MM Treatment Options

  21. Update on Current Therapies for the Treatment of Multiple Myeloma Beth Faiman,MSN, APRN-BC, AOCN® Cleveland Clinic Taussig Cancer Institute Cleveland, OH

  22. Multi-Drug Combinations in Multiple Myeloma

  23. NCCN Review Categories *Combinations recently reviewed by NCCN Generic Name Trade Name Company Bortezomib Velcade Millennium - Takeda Lenalidomide Revlimid Celgene Thalidomide Thalomid Celgene NCCN Clinical Practice Guidelines in Oncology, v.3.2010

  24. NCCN: Changing Categories of Consensus • Change is a natural process secondary to the constant stream of data from recent clinical studies • Categories 2A and 2B are not indicative of inferiority of the treatment: …non-uniform consensus does not represent a major disagreement, rather it recognizes that given imperfect information, institutions may adopt different approaches. A Category 2B designation should signal to the user that more than one approach can be inferred from the existing data… NCCN, “Categories of Evidence and Consensus”, 2010 NCCN, “Categories of Evidence and Consensus”, 2010

  25. Revised Categories of Evidence and Consensus – NCCN Guidelines, 2010 NCCN Categories of Evidence and Consensus: 1 High-level evidence, uniform consensus 2A Lower-level evidence, uniform consensus 2B Lower-level evidence, non-uniform consensus NCCN Clinical Practice Guidelines in Oncology, v.3.2010

  26. Future of MM Therapy: Recent and Ongoing Clinical Studies Patient Treatment Largely Determined by Transplant Status • Transplant-ineligible patients • VMP – VT vs. VTP – VP • VMPT – VT vs. VMP • MP vs. MPT • MP vs. MPR vs. MPR (continued lenalidomide) • Lenalidomide/dexamethasone in smoldering myeloma • QUIREDEX Study • New combinations and early studies • EVOLUTION Study • Pomalidomide/low dexamethasone • Carfilzomib • Carfilzomib/lenalidomide/dexamethasone • Elotuzumab/lenalidomide/dexamethasone • Transplant-eligible patients • Lenalidomide after ASCT • MPR vs. high-dose melphalan ASCO 2009; ASH 2009

  27. VMP vs. VTP Followed by VT vs. VP(ASH 2009 - PLENARY SESSION) A Phase 3 Study of Bortezomib/Melphalan/Prednisone (VMP) vs. Bortezomib/Thalidomide/Prednisone (VTP) Followed by Bortezomib/Thalidomide (VT) vs. Bortezomib/Prednisone (VP) in Elderly Newly Diagnosed Multiple Myeloma (NDMM) Patients • Study objective: • Testing an alkylating agent (melphalan) and an immunomodulatory drug (thalidomide) as a partner for bortezomib • Study design: • Prospective, multicenter, randomized • Induction: patients randomized to 6 cycles of VMP vs. VTP • Maintenance: patients randomized to VT vs. VP for up to 3 years Mateos et al, Blood 114, Abstract 3, 2009

  28. Conclusions from VMP – VT vs. VTP – VP • Both induction schedules are highly effective with similar overall response rate (ORR) and complete response (CR) • More neutropenia but less cardiac toxicity and peripheral neuropathy with VMP • Both maintenance therapies markedly improve responses • Combination of these regimens improves poor prognosis of high-risk cytogenic abnormalities (CA) in elderly MM patients Mateos et al, Blood 114, Abstract 3, 2009

  29. Bortezomib 1.3 mg/m2 Days 1,15Thalidomide 50 mg/day continuously Bortezomib 1.3 mg/m2Melphalan 9 mg/m2 Days 1-4 Prednisone 60 mg/m2 Days 1-4 Thalidomide 50 mg Days 1-42 Bortezomib 1.3 mg/m2 Melphalan 9 mg/m2 Days 1-4 Prednisone 60 mg/m2 Days 1-4 No Maintenance Bortezomib/Melphalan/Prednisone/Thalidomide – Bortezomib/Thalidomide A Phase 3 Study of VMPT Followed by Maintenance With Bortezomib and Thalidomide for Initial Treatment of Elderly Multiple Myeloma Patients • Study Objective: • Compare VMPT with a maintenance regimen including bortezomib and thalidomide to VMP without a maintenance regimen • Study Design: • Prospective, randomized • Both regimens amended to nine 5-week cycles • Bortezomib modified to weekly administration (days 1,8,15,22) Palumbo et al, Blood 114, Abstract 128, 2009

  30. Conclusions from VMPT – VT vs. VMP • VMPT followed by VT was superior to VMP for response rates and PFS. • The weekly infusion of bortezomib significantly reduced the incidence of grade 3-4 peripheral neuropathy • From 18% to 4% (p=0.0002) in VMPT arm • From 13% to 2% (p=0.0003) in VMP arm • This is the first report showing the superiority of a 4-drug regimen followed by maintenance compared to standard therapy (VMP) Palumbo et al, Blood 114, Abstract 128, 2009

  31. Melphalan/Prednisone vs. Melphalan/Prednisone/Thalidomide MP vs. MPT as Initial Therapy for Previously Untreated Elderly and/or Transplant-Ineligible Patients With Multiple Myeloma: A Meta-Analysis of Randomized Controlled Trials • Study objective: • Systemic review of randomized controlled trials to compare efficacy of MP with MP+T • Clinical endpoints are response rate (RR), progression-free survival (PFS), and overall survival (OS) • Study design: • Comprehensive search of database to identify randomized controlled trials • Meta-analysis by pooling results on clinical endpoints Kapoor et al, Blood 114, Abstract 615, 2009

  32. Conclusions from MP vs. MPT • Five prospective randomized controlled trials were identified (1571 patients data analyzed) • The data indicated that MPT was better than MP in achieving at least a partial response. • The pooled hazards ratios for PFS and OS were in favor of MPT • Analyses suggest that MPT is superior to MP in terms of response and survival Kapoor et al, Blood 114, Abstract 615, 2009

  33. Cycles 10+ Nine 28-day cycles Melphalan 0.18 mg/kg Days 1-4 Prednisone 2 mg/kg Days 1-4 Lenalidomide 10 mg QD PO Days 1-21 Lenalidomide Lenalidomide Melphalan 0.18 mg/kg Days 1-4 Prednisone 2 mg/kg Days 1-4 Lenalidomide 10 mg QD PO Days 1-21 Placebo Progression Melphalan 0.18 mg/kg Days 1-4 Prednisone 2 mg/kg Days 1-4 Placebo Days 1-21 Placebo MP vs. MPR vs. MPR – R A Phase 3 Study to Determine the Efficacy and Safety of Lenalidomide in Combination With Melphalan and Prednisone (MPR) in Elderly Patients With NDMM • Study objective: • In previous studies lenalidomide was effective in relapsed/refractory MM • Compare safety and efficacy of MPR in NDMM patients • Study design: Palumbo et al, Blood 114, Abstract 613, 2009

  34. Conclusions From MP vs. MPR vs. MPR – R • MPR – R regimen reduced risk of progression by 50% vs. MP alone • MPR followed by lenalidomide maintenance is a new therapeutic option • This regimen can be considered a new standard for elderly patients Palumbo et al, Blood 114, Abstract 613, 2009

  35. Lenalidomide After ASCT First Analysis of a Phase 3 Study of the Intergroupe Francophone Du Myelome (IFM 2005 02) • Study objective: • Controlling the residual disease after high-dose therapy • Neuropathy a major limiting factor in previous study • Lenalidomide evaluated (has lower neurological toxicity) • Study design: • Prospective, randomized, placebo-controlled • 1st line ASCT less than 6 months before enrollment • Consolidation with lenalidomide, 25 mg/day, po, 21 days/month, 2 months • Maintenance until relapse • Lenalidomide, 10-15 mg/day Attal et al, Blood 114, Abstract 529, 2009

  36. Conclusions From Lenalidomide After ASCT 2-month consolidation with lenalidomide: • 80% of patients were able to receive the planned 2 cycles of consolidation • Significantly improved the sCR/CR rate Attal et al, Blood 114, Abstract 529, 2009

  37. Melphalan/Prednisone/Lenalidomide vs. High-Dose Melphalan MPR vs. Melphalan (200 mg/m2) and Autologous Transplantation in Newly Diagnosed Myeloma Patients: An Interim Analysis • Study objective: • To compare melphalan/prednisone/lenalidomide (MPR) with tandem melphalan (200 mg/m2) in patients younger than 65 years • Study design: • Induction: four 28-day cycles • Lenalidomide 25 mg days 1-21 • Low-dose dexamethasone 40 mg days 1,8,15,22 • Consolidation: • MPR arm: six 28-days cycles • Melphalan 0.18 mg/kg days 1-4 • Prednisone 2 mg/kg days 1-4 • Lenalidomide 10 mg days 1-21 • Melphalan arm: tandem melphalan 200 mg/m2 with stem cell support Palumbo et al, Blood 114, Abstract 350, 2009

  38. Conclusions From MPR vs. MEL200 • Rd is an effective and safe induction regimen • Both MPR and MEL200 improved the quality of response. • At one-year follow-up, PFS and OS are similar in both groups. • Longer follow-up is needed Palumbo et al, Blood 114, Abstract 350, 2009

  39. Lenalidomide/Dexamethasone in Smoldering Myeloma Phase 3 Trial of Lenalidomide/Dexamethasone vs. Therapeutic Abstention in Smoldering Multiple Myeloma (sMM) at High Risk of Progression to Symptomatic MM • Study objective: • To investigate whether early treatment prolongs the time to progression (TTP) in sMM patients at high risk • Study design: • Multicenter, randomized, open-label • High-risk population defined by plasma cells ≥10% and M-component ≥3 g/dL • Len/dex arm, nine 4-week cycles: • Lenalidomide: 25 mg/daily, days 1-21 • Dexamethasone: 20 mg/daily, days 1-4 and 12-15 (total dose 160 mg) • Maintenance with lenalidomide, 10 mg on days 1-21 every 2 months until progression Mateos et al, Blood 114, Abstract 614, 2009

  40. Conclusions From Lenalidomide/Dexamethasone in Smoldering Myeloma In sMM patients, lack of treatment is associated with early progression (17.5 months) with bone disease Lenalidomide/dexamethasone treatment prolonged TTP and induced CRs with a manageable and acceptable toxicity profile Mateos et al, Blood 114, Abstract 614, 2009

  41. Emerging New Treatments in Early Development • EVOLUTION phase 2 study • Novel 3- and 4-drug combinations: VDR, VDC, VDCR • Exploring the combination of bortezomib and dexamethasone with lenalidomide and cyclophosphamide in NDMM patients • Development of a novel proteosome inhibitor, carfilzomib • Appears to work in patients that are resistant to bortezomib • Prior therapy with bortezomib doesn’t preclude a good response • Minimal neuropathy and myelosuppression • Development of pomalidomide, an immunomodulatory drug • Evidence of efficacy in heavily pretreated patients with relapsed disease • Acceptable safety profile • Development of elotuzumab, a monoclonal antibody against a glycoprotein that is highly and uniformly expressed in MM • Manageable toxicity profile in combinations with other agents • Promising preliminary efficacy data ASCO 2009; Kumar et al, Blood 114, Abstract 127, 2009; Lonial et al, Blood 114, Abstract 432, 2009; Richardson et al, Blood 114, Abstract 301, 2009; Siegel et al, Blood 114, Abstract 303, 2009; Wang et al, Blood 114, Abstract 302, 2009; Niesvizky et al, Blood 114, Abstract 304, 2009

  42. Future Direction of Combinations & Protocols With Novel Therapies • Evolving role of the new drug combinations for transplant-eligible and -ineligible patients • New 4-drug aggressive regimen (VMPT) • New strategy for bortezomib: weekly dose with much better tolerability Treatment of smoldering MM patients provided first evidence of efficacy in preventing progression. • Two new clinical paradigms are emerging: • Control option • Careful use of drugs, using agents sequentially • Cure option • Aggressive treatment ASCO 2009; ASH 2009

  43. Conclusions • Novel combination therapies exhibit great potential in improving RR, TTP, PFS, and OS outcomes • Randomized clinical trials are underway to compare which of these novel combinations will offer patients better OS balanced with a good quality of life

  44. Joseph Tariman, PhC, MN, APRN, BCUniversity of WashingtonSeattle, WA The NLB’s Long-Term Survivorship Care Plan

  45. Why Survivorship Care for Multiple Myeloma? • Increased survival leads to the need for new approaches to quality survivorship care • Long-term care management offers the opportunity to enhance the patient’s treatment outcome and quality of life

  46. Multiple Myeloma Patients Are Living Longer Post Diagnosis Brenner et al, Blood, 2008

  47. Individuals Diagnosed With MM Are Living Longer • The Kaplan-Meier curves for overall survival from diagnosis: • Groups are divided based on the time of diagnosis: • After 12-31-1996 • On or before 12-31-1996 • Grouped into 6-year intervals based on the date of diagnosis Kumar et al, Blood, 2008 Reprinted by permission from the American Society of Hematology

  48. Post-Transplantation Relapsed Patients Are Also Living Longer The Kaplan-Meier curves for overall survival from the time of post-transplantation relapse: • Grouped into 2-year intervals based on the date of relapse • Grouped by whether the patients were treated with one or more newer drugs • Thalidomide • Lenalidomide • Bortezomib Kumar et al, Blood, 2008 Reprinted with permission from the American Society of Hematology

  49. Assessment of Early Overall Survival 1-year survival steadily improving R/low-dexamethasone 96% Total therapy 2 92% VMP (VISTA) 90% R/dexamethasone 88% ASCT 88% MPT 87% Thalidomide/dexamethasone 80–83% Increased survival leads to the need for new approaches to quality survivorship care Barlogie et al. N Engl J Med 2006; Facon et al. Lancet 2007; Palumbo et al, Lancet 2006; Rajkumar et al J Clin Oncol 2006; Rajkumar et al J Clin Oncol 2008; Rajkumar et al ASH 2008; San Miguel et al N Engl J Med 2008;

  50. Nurses are central to patient management and healthcare resource coordination. Patient Management Patient Monitoring Patient Counseling Patient Research Nursing roles emerge as central to survivorship care. Patient Advocacy Patient Education Nurse-Centric Model of Survivorship Care* * Developed by ScienceFirst, LLC; All Rights Reserved (www.science-first.com)

More Related