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Leading the Way: Managing Multiple Myeloma for the Long -Term

Accredited by Medical Education Resources Supported by The International Myeloma Foundation Grant Funding Provided by Celgene Corporation and Millennium – The Takeda Oncology Company 1

Welcome and Introductions

Beth Faiman

, MSN, APRN-BC, AOCN Cleveland Clinic Taussig Cancer Institute Cleveland, OH 2

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) 34th Annual Congress, April 30 to May 3, 2009, in San Antonio, TX. 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.

Symposium Accreditation

• • • This continuing education activity provides 2.0 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.

Additional Accreditation

Additional 3.8 CEU accreditation opportunity –

Clinical Journal of Oncology Nursing (CJON) June 2008 supplement publication of the International Myeloma Foundation’s (IMF) Nurse Leadership Board (NLB) ‘Consensus Statements’ located at your table

Faculty

Chair: Beth Faiman

Cleveland, OH

MSN, APRN-BC, AOCN Cleveland Clinic Taussig Cancer Institute

Faculty: Joseph D. Tariman ,

PhC, MN, APRN-BC, OCN University of Washington Seattle, WA

Sandra Rome ,

RN, MN, AOCN Cedars-Sinai Medical Center Los Angeles, CA

Tiffany Richards

Houston, TX , MS, ANP, AOCNP MD Anderson Cancer Center

Agenda

Time 12:15 pm - 12:30 pm Discussion Topic Welcome and Multiple Myeloma Overview 12:30 pm - 1:00 pm 1:00 pm - 1:20 pm 1:20 pm - 1:40 pm 1:40 pm - 2:00 pm 2:00 pm - 2:05 pm 2:05 pm - 2:15 pm Update on Novel Therapies Management and Treatment of Long-Term Effects on Multiple Myeloma (Case Studies) Understanding and Optimizing Survivorship Care Focus on the Future and Importance of Health Maintenance Closing Remarks Question & Answer Session Presenter Beth Faiman Joseph Tariman Beth Faiman Tiffany Richards Sandra Rome Beth Faiman Panel 7

Learning Objectives • • • • •

Describe updated data on novel agents used in the management of patients with multiple myeloma (MM) Discuss critical issues in nursing management and medical implications of major side effect management with novel therapies in MM.

Understand the value of Survivorship Care planning, education and care.

Describe known and potential late side effects of MM and its treatment.

Identify ways to improve quality of care.

Multiple Myeloma: A Current Perspective

• Etiology of multiple myeloma (MM).

• Epidemiology of MM.

• Current and novel therapies in the management of MM.

What Is Multiple Myeloma?

• 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.

• Myeloma cells produce abnormal immunoglobulin.

– Overproduce monoclonal protein or paraprotein.

– Ineffective immunoglobulins.

– Leads to decreased bone marrow function. – Destruction of bone tissue.

10 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

Myeloma Cells Are Distinguished From Normal Plasma Cells by the Presence of Large Nuclei That Are Often Eccentric

Vescio R. Multiple Myeloma & Amyloidosis Program,Jonsson Comprehensive Cancer Center/Cedars –Sinai Medical Center, 2005 .

Multiple Myeloma: Abnormal Proliferation of Malignant Plasma Cells

Kyle and Rajkumar, N Engl J Med 2004;351:1860-1873 12

Multiple Myeloma: Epidemiology

• Second most common hematological malignancy.

• Incidence and rates: – 1% of all cancers – US incidence: 19,900 new cases per year – US prevalence: 100,000 patients – Deaths: estimated 10,790 per year • More than 80% of affected patients >age 60.

• Affects slightly more men than women (1.6:1).

Merck Manual Professional. 2005; George ED, et al. Am Fam Phys. 1999;59(7):1401-1405.

Clinical Manifestations of Multiple Myeloma

• Overproliferation of plasma cells can cause: – Risk of infection – Osteolytic bone lesions – Hypercalcemia – Bone marrow suppression (pancytopenia) – Renal complication risk • Production of monoclonal M proteins causes: – Decreased levels of normal immunoglobulins – Hyperviscosity

http://myeloma.org/pdfs/ph07-eng_f2.pdf

Major Symptoms at Diagnosis

• Bone pain - 58% • Fatigue - 32% • Weight loss - 24% • Paresthesias - 5% • Asymptomatic - 11%

Kyle RA. Mayo Clin Proc 2003;78:21 15

Common Sites for Bone Involvement

• Skull • Spine – Thoracic – Lumbar – Vertebrae • Pelvis • Long bones • Spinal cord – compression can occur

http://www.emedicine.com/Radio/topic460.htm#section~Introduction 16

Criteria for Diagnosis of Multiple Myeloma

• Monoclonal plasma cells present in the bone marrow ≥10%, and/or presence of a documented plasmacytoma.

+ • Presence of M component in serum and/or urine.* + • One or more of the following (

CRAB

– criteria):

alcium elevation (serum calcium >11.5 mg/dL) – – –

enal insufficiency (serum creatinine >2 mg/dL)

nemia (hemoglobin <10 g/dL or 2 g/dL

one disease (lytic lesions or osteopenia) *Monoclonal M spike on electrophoresis IgG >3.5 g/dL, IgA >2 g/dL, light chain >1 g/dL in 24-hour urine sample.

17 Durie et al for the International Myeloma Working Group. Leukemia. 2006:1-7.

Diagnostic Evaluation of Multiple Myeloma

Test CBC with differential counts Electrolytes Serum electrophoresis with quantitative immunoglobulins Immunofixation β 2 -microglobulin 24-hour urine protein electrophoresis Bone marrow biopsy Skeletal imaging Serum free light chain MRI Finding (s) With Myeloma ↓ Hgb, ↓ WBC, ↓ platelets ↑ Creat, ↑ Ca+, ↑ Uric acid, ↓ Alb ↑ M protein in serum, may have ↓ levels of normal antibodies Identifies light/heavy chain types M protein ↑ Levels (measure of tumor burden) ↑ Monoclonal protein (

Bence Jones

) ≥ 10% plasma cells Osteolytic lesions, osteoporosis ↑ Free light chains Evaluation of involvement of disease

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. 18

Durie-Salmon Staging System for Multiple Myeloma

I Stage II III Criteria

All of the following:

Hemoglobin >10 g/dL Serum calcium level x-ray IgG <5 g/dL IgA <3 g/dL  12 mg/dL (normal) Normal bone or solitary plasmacytoma on Low M component production rate: Bence Jones protein <4 g/24 hr Not fitting stage I or III

One or more of the following:

Hemoglobin <8.5 g/dL Serum calcium level >12 mg/dL Multiple lytic bone lesions on x-ray High M-component production rate: IgG >7 g/dL IgA >5 g/dL Bence Jones protein >12 g/24 hr Myeloma cell mass (  10 12 cells/m 2 ) <0.6 (low) 0.6 - 1.2 (intermediate) >1.2 (high) Subclassification criteria: A Normal renal function (serum creatinine level <2.0 mg/dL) B Abnormal renal function (serum creatinine level  2.0 mg/dL)

Durie and Salmon, Cancer 1975;36(9):842-854 19

International Staging System for Symptomatic Multiple Myeloma STAGE

Stage 1

VALUES

ß 2 M <3.5 mg/dL ALB  3.5 g/dL Stage 2 Stage 3 Not Stage 1 or 3 ß 2 M >5.5 mg/dL 

2 M=serum



2 microglobulin in mg/dL; ALB=serum albumin in g/dL Greipp PR, et al. Blood 2005; 102: 190a 20

Challenges in MM Management

• Currently incurable in most patients.

• Long-term complete responses are rare. • Median survival with standard therapy is about 3 years.

• Autologous stem cell transplant may prolong progression free survival, but it’s not curative.

• Treatment of relapse: – No standard therapy. – Existing options inadequate.

New treatment options needed. NCCN Practice Guidelines; Rajkumar et al. Mayo Clin Proc. 2002;77:813-822.

MM Treatment Options

• Conventional chemotherapy: – Melphalan – Doxorubicin – Cyclophosphamide • Steroid therapy: – Dexamethasone – Prednisone • Novel therapeutics: – Thalidomide – Lenalidomide – Bortezomib • Stem cell transplantation: – Autologous – Allogenic • Radiation therapy

Thalomid ® Prescribing Information, Revlimid ® Prescribing Information; Velcade ® Prescribing Information 22

Update on Novel Therapies

•

Joseph Tariman

, PhC, MN, APRN-BC, OCN University of Washington Seattle, WA 23

NCCN Review Categories

Transplant

Dexamethasone L-Doxorubicin/Vincristine/ Dexamethasone (DVD) Thalidomide/Dexamethasone Bortezomib/Dexamethasone Bortezomib/Thalidomide/ Dexamethasone (VTD) Lenalidomide/Dexamethasone Bortezomib/Doxorubicin/ Dexamethasone Bortezomib/Lenalidomide/ Dexamethasone (VRD)*

NCCN Category

2A 2A 2A 2B 2B 2B 2B 2B

Non Transplant

Bortezomib/Melphalan/Prednisone (VMP)* Melphalan/Prednisone/Thalidomide (MPT) Vincristine/Doxorubicin/Dexamethasone (VAD) Dexamethasone Melphalan/Prednisone (MP) Thalidomide/Dexamethasone Lenalidomide/low Dexamethasone* L-Doxorubicin/Vincristine/Dexamethasone (DVD)

*Combinations recently reviewed by NCCN

NCCN Categories of Evidence and Consensus

High-level evidence, uniform consensus

2A 2B

Lower-level evidence, uniform consensus Lower-level evidence, non-uniform consensus

Generic Name

Bortezomib Lenalidomide Thalidomide NCCN Category

1 1 2A 2A 2A 2A 2B 2B

Trade Name

Velcade Revlimid Thalomid 24 NCCN Clinical Practice Guidelines in Oncology, v2 2009

Recent and Ongoing Clinical Studies

• Transplant-eligible patients – Bortezomib/Thalidomide/Dexamethasone (VTD) vs Thalidomide/Dexamethasone (TD) – Bortezomib/dexamethasone – Lenalidomide/low-dose Dexamethasone (Rd) • Transplant-ineligible patients – VISTA: Bortezomib/Melphalan/Prednisone (VMP) vs Melphalan/Prednisone (MP) – Lenalidomide/low-dose Dexamethasone (Rd) • New combinations and early studies – Transplant-eligible patients • Bortezomib/Lenalidomide/Dexamethasone • Bortezomib/Lenalidomide/Dexamethasone vs Bortezomib/Dexamethasone – Transplant-ineligible patients • MTP vs MPR (Phase III) • VMP vs Bortezomib/Thalidomide/Prednisone (VTP) (Phase III) – Early studies • Bortezomib/Vorinostat (Phase I)

VTD vs. TD in Patients Who Are Transplant Eligible

Phase III Bortezomib-Thalidomide-Dexamethasone (VTD) vs Thalidomide-Dexamethasone (TD) Prior to Stem Cell Transplantation (SCT) )

• Study objective – VTD vs TD in preparation for autologous stem cell transplantation (ASCT) • Study design – Randomized trial – Three cycles of induction therapy • Methods – Pts. randomized to either VDT (n=199) or TD (n=200).

– Stem cells were collected.

– Consolidation therapy with same treatment to pts.

– Results drawn from a final analysis of 399 patients.

Cavo et al. Blood 2008 112: Abstract 158 26

Conclusions From VTD vs. TD

• Prophylaxis – Acyclovir prophylaxis against reactivation of VZV.

– TEE prophylaxis with low molecular weight heparin, aspirin, or warfarin; fixed low-dose warfarin is effective.

• Conclusions: – In comparison with TD, 3 21-d cycles of VTD as primary therapy significantly increased CR+nCR rates.

– These response rates translated into significantly higher CR+nCR after first ASCT in the VTD arm.

– Combinations of novel induction agents, such as VTD, can have a remarkable impact on both pre- and post ASCT clinical outcome.

27 Cavo et al. Blood 2008 112: Abstract 158

Bortezomib and Dexamethasone Prior to ASCT in Transplant-Eligible Patients

• Phase III, active control, multicenter, open label, randomized – Objective: compare the CR rate with vincristine/adriamycin/dexamethasone (VAD) and bortezomib/dexamethasone combinations as induction therapy.

• Number of severe AE was similar between the arms:

VAD Bortezomib/ Dexamethasone P-value CR/nCR

Post Induction

≥VGPR 9% 24% ≥PR 71% 22% 0.0085

50% 0.0001

89% NS CR/nCR

Post ASCT

≥VGPR 28% 50% ≥PR 88% 38% 0.127

66% 0.021

87% NS 28 Harousseau et al, Blood 2007 110: Abstract 450.

Conclusions From Bortezomib and Dexamethasone Prior to ASCT

• Post-induction complete remission (CR) was increased by VD compared to VAD.

• One-year PFS and OS rates were 93% and 97% with VD and 90% and 95% with VAD, respectively.

29 Harousseau et al, Blood 2007 110: Abstract 450.

VISTA Trial: VMP vs MP in Transplant-Ineligible Patients

A Phase 3 Study Comparing Bortezomib/Melphalan/Prednisone (VMP) With Melphalan/Prednisone (MP)

• Study objective: – Define the differences in efficacy and outcome between VMP vs MP • Study design and method: – VMP arm (IV Bortezomib in combination with oral prednisone and oral melphalan) vs MP arm (oral melphalan and prednisone) • Primary endpoint: – Time to progression (TTP) • Secondary endpoints: – Progression-free survival (PFS), overall survival (OS), overall response rate (ORR), time to progression (TTP) and duration of response (DOR), and safety

San Miguel et al Blood 2007 110: Abstract 76; San Miguel et al Blood 2008 112: Abstract 650; Harousseau et al Blood 2008 112: Abstract 650 Mateous et al. Haematologica 2008; 93(4), 560-565 30

VISTA Trial: VMP vs. MP

Most Common Adverse Events (in ≥30% Patients) receiving VMP (n=60)

Adverse Event

Anemia Thrombocytopenia Infection Neutropenia Asthenia Nausea Diarrhea Peripheral Neuropathy Constipation Anorexia Vomiting

% Toxicities All Grades

86 93 75 85 63 55 55 55 52 38 30

% Toxicities Grades 3/4

10 51 16 43 5 2 16 17 8 2 2

Mateos, et al. Haematologica 2008; 93(4) 560-565 31

VISTA: Updated Results

100 90 80

VMP MP 70 60 50 40 30 Median follow-up: 25.9 mos VMP: median OS not reached (75 deaths);

3-yr OS rate: 72%

20 10 MP: median OS not reached (111 deaths);

3-yr OS rate: 59%

HR = 0.644;

= .0032

0 0 2 4 6 8 10 12 14 16 18 20 22 24 26 28 30 32 34 36 38 40

Months

• VMP associated with ~36% reduced risk of death.

• 43% of pts in the MP arm who had subsequent therapy received Bortezomib upon disease progression.

• Pts who received >4 cycles of Bortezomib: – 1- and 2-yr OS: 98.5% and 89%, respectively

San Miguel JF, et al. Blood 2008 112: Abstract 650.

VISTA Trial: VMP vs. MP Conclusions

• Adverse events – 46% with VMP – 36% with MP • Patients remained on therapy longer with VMP: – 46 weeks with VMP – 39 weeks with MP • Patients had a longer time to next therapy.

• Patients also had longer treatment-free survival.

These results establish VMP as another option for patients not eligible for SCT.

San Miguel et al Blood 2007 110: Abstract 76; San Miguel et al. Blood 2008 112: Abstract 650.

Lenalidomide/Dexamethasone (RD) vs Lenalidomide/Low-Dose Dexamethasone (Rd) in Transplant-Ineligible Patients • Randomized multicenter Phase III ECOG E4A03 study – RD arm (223 patients) • Lenalidomide 25 mg (days 1-21) • Dexamethasone 40 mg (days 1-4,9-12,17-20) – Rd arm (222 patients) • Lenalidomide 25 mg (days 1-21) • Dexamethasone 40 mg (days 1,8,15,22) – Primary endpoint: response rate at 4 months

Rajkumar et al, Blood 2007 110: Abstract 74 34

Results From Lenalidomide/Dexamethasone (RD) vs Lenalidomide/Low-Dose Dexamethasone (Rd) Toxicity (Grade >3) Neutropenia Thrombocytopenia DVT/PE Atrial Fibrillation/Flutter Infection/Pneumonia Fatigue Hyperglycemia Neuropathy Efficacy 1-year Survival 2-year Survival OS in Pts<65 (1 year) OS in Pts>65 (1 year) Deaths Rajkumar et al, Blood 2007 110: Abstract 74; Jacobus et al., Blood 2008 112: Abstract 1740 RD (N=223) 2.7% 1.8% 25.6% 3.1% 16.1% 11.7% 5.8% 0.4% RD 88% 75% 92% 83% 42 Rd (N=222) 3.2% 1.4% 11.4% 0.0% 9.0% 4.1% 2.3% 1.4% Rd 96% 87% 97% 94% 16 35

Results From RD vs Rd

• Rd is associated with superior OS compared to RD in NDMM patients.

• Increased mortality in RD arm is due to disease progression as well as increased toxicity.

– Prevention of venous thrombotic events is a priority for both combinations.

Rajkumar et al, Blood 2007 110: Abstract 74; Jacobus et al., Blood 2008 112: Abstract 1740 36

Emerging New Treatments in Early Development

• Single agents are limited in efficacy, likely to be used in combinations.

– Bortezomib, lenalidomide, and thalidomide are being explored for combination regimens.

• Combining agents directed at different targets may provide synergistic response without an increase in side effects.

ASH 2008 Highlights for Physicians 37

Bortezomib/Lenalidomide/Dexamethasone in Patients Who Are Transplant Eligible

• First-line Phase I/II study assesses safety and efficacy (66 patients).

– Lenalidomide 15 to 25 mg (days 1-14) – Bortezomib 1.0 to 1.3 mg/m 2 (days 1, 4, 8, 11) – Dexamethasone 40/20-mg (cycles 1-4/5-8) (days 1, 2, 4, 5, 8, 9, 11, 12) – Up to 8 21-day cycles • Manageable toxicities – All G3/4 hematological (3-15%) – G3 hypophosphatemia (8%) – DVT/pulmonary embolism (5% with daily aspirin) – No treatment-related mortality • Overall response rate was 98% (at maximum planned dose – 100%) – VGPR 71%

VRD was efficacious and

– CR/nCR 36%

well-tolerated in NDMM patients.

Richardson et al, Blood 2008 112: Abstract 92 38

Bortezomib/Lenalidomide/Dexamethasone vs Bortezomib/Dexamethasone Study in Transplant-Eligible Patients • Randomized, multicenter Phase III study ECOG E1A05 (initiated in August 2008) – Consolidation therapy for patients after dexamethasone based induction.

– VRD regimen • Bortezomib 1.3 mg/m 2 (days 1, 4, 8, 11) • Lenalidomide 15 mg (days 1-14) • Dexamethasone 40 mg (days 1, 8, 15) – VD regimen • Bortezomib 1.3 mg/m 2 (days 1, 4, 8, 11) • Dexamethasone 40 mg (days 1, 8, 15) • Primary endpoint: PFS – SCT is deferred until relapse • The strategy will further prolong survival.

39 Fonseca and Rajkumar, Clin Lymphoma and Myeloma 2008 5: 315-317

MPT vs MPR in Patients Who Are Transplant Ineligible

• Randomized multicenter Phase III ECOG E1A06 study – MPT regimen • Melphalan (days 1-4) • Prednisone (days 1-4) • Thalidomide (days 1-28) – MPR regimen • Melphalan (days 1-4) • Prednisone (days 1-4) • Lenalidomide (days 1-21) – 28 days for up to 12 cycles – Primary objective: PFS, OS

http://clinicaltrials.gov/ct2/show/NCT00602641?term=e1a06&rank=1 40

VMP vs. VTP

Exploring Alkylating (Melphalan) and Immunomodulatory (Thalidomide) Combinations With Bortezomib in Phase III Study in Elderly Transplant-Ineligible Patients

• Study Design – VMP Arm (80 patients): • IV Bortezomib 2x weekly for 1 6-week cycle • IV Bortezomib 1x weekly for 5 5-week cycles + oral Melphalan/Prednisone 1xd on days 1-4 of each cycle – VTP Arm (87 patients): • IV Bortezomib 2x weekly for 1 6-week cycle • IV Bortezomib 1x weekly for 5 5-week cycles + oral Prednisone 1xd and continuous Thalidomide on days 1-4 of each cycle • Primary End Point – Overall response rate (ORR)

41 Mateos et al. Blood 2008 112: Abstract 651

Conclusions From VMP vs. VTP

6 cycles: 31 weeks of treatment) Results

≥G3 Neutropenia ≥G3 Thrombocytopenia Non-hematological AE (total) ≥G3 Non-hematological AE ≥G3 Cardiac toxicity ≥G3 Thromboembolic events ≥G3 Peripheral neuropathy Treatment discontinuation due to AE (patients)

VMP

34% 21% 133 25% 0% <1% 9% 8

VTP

19% 9% 157 32% 7% 3.4% 15% 16

P Value

p=0.009

p=0.01

p<0.005

p=0.04

N/A N/A N/A p=0.08

•

Incidence of non-hematological AE (especially cardiac) was higher in the VTP arm, resulting in more serious AEs and treatment discontinuations

•

Thalidomide may not be a partner of choice for Bortezomib - Lenalidomide should be explored Mateos et al. Blood 2008 112: Abstract 651 42

Bortezomib and Vorinostat in Early Clinical Studies

• Vorinostat (Zolinza): a synthetic inhibitor of the histone deacetylases (HDACs) – Inhibits cell cycle and survival of cancer cells – FDA-approved for some types of lymphoma • Study design: – Non-randomized, open label, parallel assignment, safety study, treatment, uncontrolled – 34 patients with relapsed/refractory MM • Objectives: – Primary: MTD – Secondary: safety and tolerability as measured by disease progression or unacceptable toxicity during each treatment cycle

Weber et al, Blood 2008 112: Abstract 871 43

Vorinostat Plus Bortezomib: Conclusions

Toxicity Nausea Diarrhea Thrombocytopenia Vomiting 61.8% 58.8% 50% 50% Efficacy Partial response (PR) Minimal response (MR) Stable disease (SD) Duration SD (days) 160 26% 21% 53% Range (days) 9 – 369 Combination of Vorinostat plus Bortezomib is active for treatment of multiple myeloma in the early study.

Weber et al, Blood 2008 112: Abstract 871 44

Future Direction of New Therapy Combinations & Protocols of Novel Therapies • New combinations of novel therapies may offer personalized targeted therapy by inhibiting specific pathways in myeloma development – Bortezomib and Thalidomide have moved from the relapsed/refractory indications to first-line therapy positions – Lenalidomide is expected to follow • The trend is to use novel drugs and established chemotherapies in combinations • MM is perceived as a chronic, long-term disease

ASH 2008 Highlights for Physicians 45

Conclusions

• Novel combination therapies have great potentials in improving response rate, time to progression, progression-free survival, and overall survival outcomes.

• Randomized clinical trials are needed to compare which of these novel combinations will offer patients better OS balanced with a good quality of life.

Management and Treatment of Emergent Side Effects and Defining Long-Term Effects of Multiple Myeloma Beth Faiman

, MSN, APRN-BC, AOCN Cleveland Clinic Taussig Cancer Institute Cleveland, OH 47

Five Major Categories of Side Effects for Novel MM Treatments

• Myelosuppression • Thromboembolic events • Peripheral neuropathy • Gastrointestinal side effects • Steroid-associated side effects • Challenge for nursing management of emergent side effects: – Lack of effective practitioner-based guidelines p roduces a barrier to providing optimal patient care

IMF NLB ‘Consensus Statements’ CJON June 2008 48

Myelosuppression: Definition and Symptoms

Red Blood Cells Anemia

–

Fatigue, malaise and SOB Marrow White Blood Cells Lymphocyte Monocyte Eosinophil Basophil Neutrophil Neutropenia

–

Increased risk of bacterial, fungal, and viral infections Platelets Thrombocytopenia

–

Bruising and bleeding 49 http://www.schneiderchildrenshospital.org/peds_html_fixed/peds/transplant/bonetran.htm

; NLB Consensus Recommendations. CJON June 2008

Management of Myelosuppression

Risk of Grade 3 and 4 Myelosuppression With Novel Therapies

Thalidomide/Dexamethasone Lenalidomide/Dexamethasone Bortezomib

Anemia

16% 8% 12%

Neutropenia

13% 21% 14%

Thrombocytopenia

4% 10% 32% • General recommendations: – Monitor signs and symptoms – Monitor CBC – Educate on signs and symptoms • Myelosuppression management: – Growth factor therapy – Dose reduction as appropriate – Transfusion as indicated

50 Adapted from NLB Consensus Recommendations. CJON June 2008 Thalomid ® Prescribing Information, Revlimid ® Prescribing Information, Velcade ® Prescribing Information. http://ctep.cancer.gov/forms/CTCAEv3.pdf

Overview of Thromboembolic Events

• Cancer patients have a higher risk of TE events (blood clots), which may lead to: – Deep vein thrombosis (DVT) – Pulmonary embolism (PE) • MM patients are at an increased risk for blood clots – Patients are at increased risk with high-dose dexamethasone treatment – The risk for DVT/PE is further increased in patients treated with novel therapies: • Thalidomide • Lenalidomide • Measures to prevent novel therapy-associated TE events include: – Mechanical – Myeloma regimen-related – Anticoagulant therapy (clot-preventing)

TE events are serious and potentially life-altering and life-threatening.

Adapted from NLB Consensus Recommendations. CJON June 2008. Amir Qaseem et al., 2007, Ann Fam Med; J. B. Segal et al., 2007, Ann Intern Med. http://www.nhlbi.nih.gov/health/dci/Diseases/Dvt/DVT_WhoIsAtRisk.htm

DVT/PE: Signs/Symptoms

• Slight fever • Tachycardia • Unilateral swelling, erythemia, warm extremity • Cyanosis/cool skin • Distension of superficial venous collateral vessels • Anxiety • Sudden dyspnea • Chest discomfort • Tachycardia, tachypnea • Low-grade fever

PE IS AN EMERGENCY

http://www.nhlbi.nih.gov/health/dci/Diseases/Dvt/DVT_SignsAndSymptoms.html

Adapted from NLB Consensus Recommendations. CJON June 2008 52

Peripheral Neuropathy: Definition, Signs, and Symptoms

Damage to the peripheral nervous system, including any injury, inflammation, or degeneration of peripheral nerve fibers

Thalidomide/bortezomib can cause peripheral neuropathy • Signs/symptoms: – Temporary Numbness – Tingling – Parasthesias – Sensitivity to touch – Muscle weakness • Severe symptoms: – Burning pain – Muscle wasting – Paralysis – Organ dysfunction

53 Adapted from NLB Consensus Recommendations. CJON June 2008; Thalomid ® Prescribing Information, Velcade ® Prescribing Information; Colson et al., 2004, CJON; S. Lonial, 2007, The American Journal of Hematology/Oncology http://www.ninds.nih.gov/disorders/peripheralneuropathy/detail_peripheralneuropathy.htm

General Strategic Recommendations for the Management of PN

• • • • •

Ongoing evaluation

Dose and schedule modifications

Pharmacological interventions Non-pharmacological interventions Patient education

• • Pharmaceutical

For all patients prior to therapy:

–

B-complex vitamins including B1, B6, B12 (at least 400 mcg)

–

Folic acid 1 mg daily For grades 2 or higher

–

Tricyclic antidepressants

– – –

Amino acids on an empty stomach Neurontin ® , Lyrica ® , Cymbalta ® Lidoderm ® patch 5% to affected area every 12 hours

• • • • Non-Pharmaceutical

Gentle massage of affected areas with cocoa butter, capsaicin cream Home health referral to review safety at home Assistance with ADL Referrals: pain management, neurology, physical/occupational therapy Adapted from NLB Consensus Recommendations. CJON June 2008; NCCN 2007; NINDS, 2007; Tariman, 2003, Clinical Journal of Oncology Nursing; Visovsky et al., 2007, http://www.ons.org/outcomes/volume2/peripheral/pdf/PEPCardDet_peripheral.pdf.

Gastrointestinal Side Effects of Novel Therapies

Drug Lenalidomide/Dexamethasone Thalidomide/Dexamethasone Bortezomib Incidence of Gl AEs (All Grades) Constipation Diarrhea Nausea Vomiting 39% 29% 22% 10% 55% 42% 12% 57% 28% 57% 12% 35% 55 Thalomid ® Prescribing Information, Revlimid ® Prescribing Information, Velcade Adapted from NLB Consensus Recommendations. CJON June 2008 ® Prescribing Information

Management of Diarrhea

• Non-pharmacologic – Increase fluid intake – Avoid caffeinated, carbonated, or heavily sugared drinks – Dietary changes: avoid fiber • Pharmacologic – Caution concerning medications or herbal supplements, which can cause diarrhea – Antidiarrheal agents: • Imodium ® • Lomotil ® • Tincture of opium • Sandostatin ® – Intravenous hydration to correct electrolyte imbalance

56 NLB Consensus Recommendations. CJON 2008; ASCO’s Curriculum Diarrhea 2005; Bush, 2004, Oncology Nursing Forum; Engelking, 2004, Cancer Symptom Management; Mercadante, 2007, Principles & Practice of Palliative Care & Supportive Oncology.

Management of Nausea and Vomiting

• Non-pharmacologic – Dietary intolerance and restrictions – Avoid exercise and do not lie flat for 2 hrs after eating – Fresh air and loose clothing – Relaxation, guided imagery, biofeedback, acupuncture • Pharmacologic – Select anti-emetics based on how strongly the novel agents stimulate N/V and consider type of N/V.

• Nausea: Ativan ® , Compazine ® , Decadron ® , Pepcid ® , Phenergan ® , Reglan ® , or Zantac ® • Vomiting: Emend ® , Zofran ® , Kytril ® , Anzemet ® , or Aloxi ® – Intravenous hydration to correct electrolyte imbalance

Adapted from NLB Consensus Recommendations. CJON 2008; ASCO’s Curriculum Nausea and vomiting 2005; NCI Nausea and vomiting 2007 57

Overview of Steroid Side Effects

• Steroid classes: – Glucocorticosteroids – Corticosteroids – Used as single agents and in combos • Dexamethasone, Prednisone, Prednisolone • Use of steroids can cause multiple system side effects, such as: – Constitutional – Psychiatric – Immune – Musculoskeletal – Bone loss – Body image – Ophthalmic – Gastrointestinal – Endocrine – Cardiovascular – Dermatologic

Adapted from NLB Consensus Recommendations. CJON June 2008; Alexanian, Dimopoulos, Delasalle, & Barlogie, 1992 58

Management of Steroid-Dependent Side Effects: Constitutional

– • Steroids affect every system • Psychological: – Mood alterations, let-down effect, insomnia • GI: flatulence/hiccoughs • Musculoskeltal: proximal myopathy and muscle cramping • Bone: osteonecrosis, osteoporosis • Endocrine: hyperglycemia, hypogonadism, sexual dysfunction • CV: edema

Adapted from NLB Consensus Recommendations. CJON June 2008; Mitchell et al. 2006; Page et al 2006; Badger et al 2006; Cerullo, 2007 59

Overall Recommendations for the 5 Emergent Side Effects of Novel Therapy

• Effective management includes: – Monitoring patients carefully – Educating patients and caregivers about what to expect during treatment – Appropriate prophylaxis – Pharmacologic and non-pharmacologic interventions • Effective management leads to: – Increased adherence to therapy – Improved quality of life – Prevention of serious adverse events that can lead to prolonged hospitalization, and increased morbidity and mortality

60 Adapted from NLB Consensus Recommendations. CJON June 2008; Ghobrial, et al. (2007) Oncology, 21, 785-792.

Lonial, S. (2007) The American Journal of Hematology/Oncology, 6, 194-196.

Developing a Nurse-Centric Model for a Survivorship Care Plan

Evidence-based data for 5 major long-term side effect issues and their management: creation of clinical practice-based consensus documents Functional Mobility Health Bone Health Maintenance Renal Complications Sexuality & Sexual Dysfunction Outcome: Survivorship Care Plan and Manuscript 61

Functional Mobility in Multiple Myeloma

• Multiple myeloma is mainly a disease of the bone.

• Multiple myeloma mostly affects the elderly population, which greatly exacerbates limited motility.

• Factors contributing to high risk of falls in elderly MM patients: – Sensory issues (poor vision and hearing) – Age-related co-morbidities • Cardiovascular • Diabetes • Osteoporosis • Hormonal status • Parkinson’s disease • Dementia • Urinary incontinence (fall-related) • Arthritis – Nutrition (muscle weakness, weight loss) – Psychological issues and lifestyle

Reported Mobility-Affecting Side Effects of Novel MM Treatments

Common SE Peripheral neuropathy – Sensory and motor symptoms – Ataxia Muscle wasting – Tone and mass – Strength and motor function Myelosupression – Thrombocytopenia – Neutropenia – Anemia Gastrointestinal symptoms – Nausea, vomiting, constipation, diarrhea – Dehydration, anorexia, weight loss – Hypercalcemia, hypokalemia, hyponatremia Fatigue and somnolence Cardiovascular issues – Deep vein thrombosis Impact on Functional Mobility Self-limiting mobility due to: – discomfort or prescribed limitations by the health practitioner – pain and/or discomfort Lack of desire to participate in activity and inability to mobilize safety.

Lack of ability to withstand extended activity and may require oxygen.

Inability to participate in activities due to organ-function restrictions as prescribed by health care provider.

Mobility restrictions due to the symptoms and/or cognitive, muscular impact due to imbalance.

Difficulty in desire or ability to participate in activities of daily living, including exercise, diet, etc, and impact on overall quality of life.

Functional Mobility: A Case Study

• Annie is a 68-year-old woman with relapsed myeloma receiving bortezomib and dexamethasone.

• After 6 cycles she is in a near complete remission but developed painful neuropathy in her feet.

– Reported numbness, burning, shooting pain • Doesn’t feel like participating in usual activities due to pain, sits all day.

• Husband is afraid she is “giving up;” she has lost her balance twice this week.

Functional Mobility: A Case Study

What are we most concerned about with Annie? a) Risk of falls due to pain and decreased sensation in her feet can lead to bleeding with low platelets.

b) Risk of pneumonia due to inactivity.

c) Depression. d) Neuropathy may limit the amount of treatment she is able to receive. e) All of the above.

Bone Health and Bone Disease

• Bone disease is a hallmark of multiple myeloma • Caused by defects in the balance between bone formation and resorption – Skeletal events may progress despite an efficacious treatment.

• Main manifestations of bone disease (at diagnosis): – Diffuse osteopenia and/or focal lytic lesions (70-80%) – Pathological fractures • Most common site is spine (55-70%) – Hypercalcemia (30%) – Bony pain (60%)

Bone Health and Bone Disease: A Case Study

• JJ is a 76-year-old man diagnosed in 2001 with IgG Kappa Myeloma. • Prior therapies (3): thalidomide, bortezomib, lenalidomide • Bisphosphonates every 3 months (pamidronate) • While moving furniture he experiences 10/10 pain in his back. • Dx: L2 compression fracture • Balloon kyphoplasty is recommended; patient declines.

• He receives a prescription for pain medication.

Bone Health and Bone Disease: A Case Study

What would be the most important consideration for this elderly patient with a compression fracture? a) Increased risk for DVT while on lenalidomide.

b) Increased risk for pneumonia due to altered skeleton (kyphosis).

c) Pain will decrease his ability to perform ADLs.

d) All of the above.

Renal Complications

One of the common clinical features of symptomatic myeloma.

• 20 to 60% of patients present with renal complications.

– Elevated serum creatinine level – Anemia, fatigue – Fluid and electrolyte imbalances – Light-chain proteinurea • Proteinurea may lead to end-stage renal disease (ESRD) and dialysis.

• Reasons for kidney failure: – Monoclonal immunoglobulin deposition disease (MMID) – Amyloidosis – Light-chain deposition disease (LCCD) – Acute tubular necrosis (ATN)

Renal Complications: A Case Study

• Jane is a 43-year-old woman diagnosed with kappa light chain MM in 1998 • Received 2 stem cell transplants in late 2001 and early 2002; she has been in remission since. • Blood work every 3 months, stable • Called complaining of nausea, vomiting, and fevers in the last 48 hours

Renal Complications: A Case Study

• Labs : – WBC 3.9 k/uL – Hemoglobin 7.9 g/dL – Platelet count 158 K/uL – Creatinine 3.9 g/dL (1.9 last month) – Calcium 11.7 mg/dL – Albumin 3.2 g/dL – Beta-2 M 7.9

• Skeletal survey shows progressive disease: scattered lesions calvarium, pelvis and bilateral femurs

Renal Complications: A Case Study

She is admitted for IV hydration and a blood transfusion She receives a pulse of dexamethasone and pamidronate for hypercalcemia of malignancy (HCM) What would you anticipate next? a) Lenalidomide and Dexamethasone b) Bortezomib and Dexamethasone c) Bortezomib and pegylated liposomal Doxorubicin d) Enroll in a clinical trial with an experimental agent

Sexuality & Sexual Dysfunction

• Sexual dysfunction (SD) is characterized by those psychological and physiological changes that negatively impact sexuality.

• Publications regarding SD in cancer patients are limited • SD is not part of the normal aging process!! It is a result of physical illness and/or psychological factors • Types of SD (according to the DSM IV): – Sexual desire disorder (decreased libido) – Sexual arousal disorder – Orgasm disorder – Sexual pain disorder

The Impact of Myeloma Treatment on Sexuality

• Thalidomide – Reported to induce impotence in male patients • Bortezomib and lenalidomide – Unpublished reports of erectile dysfunction and decreased libido • Sildenafil has positive results in restoring proper functioning • Our knowledge of the effects of novel myeloma treatment on sexuality is very limited – Patients are reluctant to discuss the issue – Sexuality assessments are not performed

74 Murphy and O’Donnell, Haematologica, 92 (10), 2007

Sexual Dysfunction: Communication is Critical

• There is an urgent need for open communication between physicians, nurses, and their patients – Multiple well-established treatments for ED are available for male and female patients • Stressors can lead to depression in men and women • Patients may be unable or unwilling to verbalize this as a side effect • This is often placed on the back burner, as treatment is most important • Ask your patients!!

Sexuality and Sexual Dysfunction: A Case Study

• Mrs. D is a 53-year-old woman diagnosed 3 years ago with MM. After a long remission, she relapsed and is now 2 months post stem cell transplant • Mr. D uncomfortably asks you if he and his wife “will ever be able to have sex again.” • Mrs. D says that she feels no desire and that when they tried to have sex 3 weeks ago, she did not feel stimulated and found it to be painful. Becomes teary eyed; their sexual relationship has been strained since her diagnosis 3 years ago. Mr. D told her that he “can’t take it anymore.”

Sexuality and Sexual Dysfunction: A Case Study

How would you approach this? a) Think of Mr. D as being selfish after all his wife has been through b) Avoid the question because Mrs. D starts crying. It’s a hard topic for her c) Refer the couple to a social worker, who knows more than you d) Pull up a chair and ask Mrs. D, “How do you feel?”

Understanding and Optimizing Survivorship Care

Tiffany Richards:

MS, ANP, AOCNP MD Anderson Cancer Center Houston, TX 78

Definition of Cancer Survivor

“An individual is considered a cancer survivor from the time of diagnosis through the balance of his or her life. Family members, friends, and caregivers impacted by the survivorship experience are included.”

(NCI, 2004)

3 “Seasons of Survival” (Mullan)

• Acute survival: Diagnosis treatment – Fear and anxiety – Confrontation of mortality – Family needs • Extended survival: watchful waiting, consolidation, or intermittent therapy – Fear of recurrence – Physical limitations adaptation to work and home – Experiences variable • Permanent survival: “cure” – Insurance and employment problems – Long-term effects of therapy

Mullan

NEJM

1985

Comparisons of Patient and Physician Expectations for Cancer Survivorship Care

Investigators from the Harvard School of Public Health, Dana-Farber Cancer Institute, and the Institute of Clinical Evaluative Sciences (Toronto) conducted a study to compare expectations regarding survivorship care among PCPs, oncologists, and patients • The results demonstrated a lack of agreement among these constituents with respect to their roles in ongoing survivor care.

• The discordance was particularly high between patients and their oncologists. The underlying causes for the discrepancies were unclear.

Cancer Survivorship: From Individual to Experience

• Defined as: – A time frame – A stage or phase – An outcome • Must take into account: – Maintenance therapy – Incurable but treatable cancers – Regimen changes – Recurrences – Secondary tumors – Late effects of treatments

Institute of Medicine (IOM) Findings: Survivorship Care

• Survivorship care is neglected.

• Cancer recurrence, second cancers, and late effects of treatment.

• Few guidelines.

• Providers lack education.

Shulman & Ganz ASCO Survivorship Models 2008 83

IOM Findings: Survivorship Care (cont’d)

• Survivors : – Unaware of risk – No plan for follow-up • Missed opportunities • Lack of care coordination

Shulman & Ganz ASCO Survivorship Models 2008 84

IOM Findings: Survivorship Care (cont’d)

• Chronic care model • Essential care components: – Prevention – Surveillance – Intervention – Coordination

Shulman & Ganz ASCO Survivorship Models 2008 85

IOM Findings: Survivorship Care (cont’d) IOM Recommendation:

• “All patients completing Rx should receive a comprehensive treatment summary & care plan.”

Shulman & Ganz ASCO Survivorship Models 2008 86

Reasons for a Survivorship Care Plan

• Summarize treatment • Communicate late effects of treatment • Promote continuous communication between patients and healthcare providers • Promote a healthy lifestyle – Prevent recurrence – Reduce risk of co-morbid conditions

Shulman & Ganz ASCO Survivorship Models 2008 87

Key Elements for an Effective Survivorship Care Plan

• Diagnosis and stage • Treatment plan and dates • Expected short- and long-term effects • Late toxicity monitoring • Surveillance for recurrence or second cancer • Responsibility for survivorship care • Psychosocial and vocational needs • Recommended preventive behaviors and recommendations

Shulman & Ganz ASCO Survivorship Models 2008 88

IOM Recommendations for Quality Healthcare in America

• Care based on continuous healing relationships • Customized care • Patient as source of control • Shared knowledge and information • Evidence-based decision making • Safety as a system property • Transparency • Anticipation of needs • Continuous decrease in waste • Cooperation

Quality Healthcare = Optimal Survivorship Care

• Receipt of optimal survivorship care depends on a patient-centered approach

(Berry et al., 2003)

• Call for such an approach has been made by physician-researchers William Tierney and Elizabeth McKinley in their description of their cancer experience from the patient’s perspective

(Tierney and McKinley, 2002).

Essentials of Survivorship Care

• Prevention and detection of new cancers and recurrence • Intervention for consequences of cancer and its treatment (eg, osteoporosis) • Coordination between specialists and primary care providers

Barriers to Cancer Survivor Care

• For the

Cancer Survivor:

– Fragmented delivery system – Lack of awareness – Barriers to communication • For the

Provider:

– Fragmented delivery system – Lack of education/training – Lack of survivorship standards of care – Capacity to deliver survivorship care

Challenges to Survivorship Care

• As

lives are extended

, so too are the

risks

of developing late or delayed effects. • Major questions - who will be responsible for: – Monitoring patient’s health – Assisting in recovery – Making referrals – Paying for continued care

Leigh, Cancer Survivorship: A Nursing Perspective, in Cancer Survivorship Today and Tomorrow, 2007 93

Why Survivorship Care for Multiple Myeloma?

• 2008 expectations for MM patients: – >90% response upfront – CR + VGPR ≥60% – 3-year survival 80 to 90% – 6-year survival 60 to 70% – >10-year survival 30 to 40% Increased survival leads to the need for new approaches to quality survivorship care

Survivorship Care Continuum

Individuals with chronic or intermittent disease may receive ongoing treatment for their disease, but benefit from survivorship care as they live with their disease

Prevention Initial treatment Continuing care Follow-up Palliative care Diagnosis Maintenance

Survivorship isn’t a stage!!!!

It is a continuum from diagnosis to the end of life

Recurrence Progressive disease 95

ASCO Tools for Survivorship Care

An important component of survivorship care is a patient’s treatment summary www.asco.org/treatmentsummary

Focus on the Future

Sandra Rome

, RN, MN, AOCN Cedars-Sinai Medical Center Los Angeles, CA 98

New Drugs – New Perspective for Multiple Myeloma

• • •

Thalidomide Bortezomib Lenalidomide

Chronic?

OR A Cure??

Longer follow-up required!!

The Future for Transplant-Eligible Patients

VAD Thalidomide

Old standard

Dexamethasone

New standard

New combinations

Lenalidomide/low Dexamethasone Bortezomib + Dexamethasone VTD… NCCN Clinical Practice Guidelines in Oncology, v2 2009

Transplant Harvest

100

The Future for Transplant-Ineligible Patients

MP

MPT

Old standard New standard

VMP MPR Lenalidomide/low Dexamethasone

New options

101 NCCN Clinical Practice Guidelines in Oncology, v2 2009

Impact of Novel Therapies on Survivorship Care

• Unexpected new long-term complications • Second cancers • Long-term maintenance for survivors: quality of life • Family/social problems • Financial/insurance concerns • Other

102

Optimizing Survival: Importance of Health Maintenance

• MM patients are expected to live longer • Proper health maintenance contributes toward longer survival and quality of life

103

Risk Factors Affecting Health Maintenance

• Lifestyle choices • Mental risk factors – Substance abuse – Depression • Fatigue – Depression, pain, and anemia • Cognitive changes – “Chemo brain” effect • Dermatological issues – Immune system weakened by therapy • Transplants • Radiation – Increased risk for skin cancer

104

Shifting Paradigm for Survivorship Care: Nurse Role

Old Model

Survivorship as a stage: • Decreasing contact • Brief check-ups • May not recognize survivorship • Busy clinics – Time constraints – Focus on acutely ill

Emerging Model

Survivorship as a

process

: • Contact along the extended

continuum of care

• Survival plan will be developed shortly after diagnosis • Survivors and families will be supported medically, emotionally, financially.

• It is not just about

and

HOW LONG

, but

HOW WELL

Leigh, Cancer Survivorship: A Nursing Perspective, Cancer Survivorship Today and Tomorrow, 2007 105

Nurse-Centric Model of Survivorship Care*

Patient Monitoring Nurses are Central to Patient Management and Healthcare Resource Coordination Patient Management Patient Counseling Patient Research Nursing Roles Emerge as Central to Survivorship Care Patient Advocacy * Developed by ScienceFirst, LLC; All Rights Reserved ( www.science-first.com

)

Patient Education 106

Nurse-Led Survivorship Care

Nurses:

• Expert knowledge • Close relationships with patients and families • Understand psychosocial issues • Recommend referral • Work within a model of wellness promotion rather than disease management

Leigh, Cancer Survivorship: A Nursing Perspective, Cancer Survivorship Today and Tomorrow, 2007 107

Nurse Led Survivorship Care (cont’d)

Barriers:

• Shortage of trained oncology nurses, especially in outpatient settings • Lack of coordinated care and communication among healthcare providers • Insurance and reimbursement issues

Leigh, Cancer Survivorship: A Nursing Perspective, Cancer Survivorship Today and Tomorrow, 2007 108

National Coalition for Cancer Survivors (NCCS) “Imperatives”

NCCS’s “Imperatives for Quality Cancer Care: Access, Advocacy, Action, and Accountability”: • Nurses are major players • Health promotion and wellness are critical in survivor clinics • Continued need for supportive care • Critical value of education and rehabilitation for symptoms: – Fatigue, chronic pain, weight changes, decreased stamina

109 NCCS. Imperatives for Quality Cancer Care: Access, Advocacy, Action, and Accountability, 1996

Nursing-Sensitive Patient Outcomes (NSPO)

• ONS defined nursing-specific outcomes for cancer patients: – changes in symptom management, functional status, safety, psychological status, costs • NSPO describes “continuum of care:”

Prevention Initial treatment Continuing care Follow-up Palliative care Diagnosis Maintenance

Survivorship isn’t a stage!!!!

It is a continuum from diagnosis to the end of life

Given and Sherwood, 2005; Rutledge, 2005 Recurrence Progressive disease 110

What is a Survivorship Care Plan?

• A document: – Summarizes what transpired during cancer treatment – Gives recommendations for follow-up care • It needs to: – Be prospective – Identify known and potential long-term effects • It aims to : – Promote a healthy lifestyle – Prevent recurrence of cancer – Reduce risk of co-morbid conditions – Ensure adherence to follow-up recommendations

Implementing Cancer Survivorship Care Planning http://www.nap.edu/catalog/11739.html

111

Meeting the Unmet Need

Opportunity to leverage the NLB’s experience by identifying relevant long-term side-effects and developing a Survivorship Care Plan for Multiple Myeloma 112

NLB Developed Consensus Guidelines for Management of Acute Side-Effects

NLB determined the 5 most common emergent side effects requiring clinical “Consensus Statement” development Peripheral neuropathy DVT and PE Myelosuppression GI effects Steroid effects IMF NLB ‘Consensus Statements’ supplemCJON June 2008 113

A New Horizon in Patient Care

•

Survivorship Care Plan offers the opportunity to enhance treatment outcome and patient quality of life

•

Survivorship Care Plan will need to be updated as new therapies emerge 114

Goals of NLB Survivorship Care Plan

How myeloma, treatments, and patient-specific characteristics affect: • Renal disease • Sexuality and sexual dysfunction • Bone metabolism • Safety and functional mobility • Health maintenance

115

Goals of NLB Survivorship Care Plan (cont’d)

Develop recommendations for schedules of evaluations and evidenced-based interventions: • Prevention, screening through treatment of sequelae • Enable clinicians and patients to optimize therapy by preventing or adequately treating co-morbid conditions.

116

Goals of NLB Survivorship Care Plan (cont’d)

NLB will disseminate this information to those within in the community who can effect the most change: • Patients • Caregivers • Healthcare providers

117

Creation of a MM Survivorship Care Plan

• Co-morbid conditions affect: – Treatment options – Survival – Late side effects • The plan will: – Prevent and control • Other cancer diagnosis • Treatment-related outcomes – Late effects of treatment – Second cancers – Suboptimal quality of life – Provide a knowledge base for follow-up care and surveillance – Optimize health after cancer treatment

118

Multiple Myeloma Survivorship Care Plan

• IMF Web site is a source for support and education in all aspects of MM • Resources for survivorship care will be posted on the site

http://myeloma.org

119

Closing Remarks

•

Beth Faiman , MSN, APRN-BC, AOCN Cleveland Clinic Taussig Cancer Institute Cleveland, OH

120

NLB Accomplishments

PUBLISHED:

Managing the Side Effects of Novel Agents for Multiple Myeloma: Guidelines and Patient Education Sheets •

Clinical Journal Oncology Nursing

(

CJON

), Supplement 12(3), June 2008 • Patient Education Insert Tear-Out Tools for 5 Side Effects – Myelosupression – Thromboembolic events – Peripheral neuropathy – Gastrointestinal side effects – Steroid-associated side effects

121

Patient Education Tear-Out Tools

General format and clinical utility: • Side effect description • Novel therapies that may be associated with the side effect • Signs and symptoms • Risk factors • Healthcare provider recommendations

NLB Consensus Statements, CJON June 2008 122

Future Goals of NLB

Expand initiative to collaborate with nurses worldwide

• Frame the importance of nursing.

• Management of long-term side effects associated with MM therapies

Develop Survivorship Care Plan 123

Focus of NLB Commitment

Nurse-Centric Survivorship Care Plan

• Five major long-term health risks identified • Five NLB focus groups are created to investigate the five risk categories and develop recommendation manuscripts

Health maintenance Functional mobility Bone health Renal complications Sexual dysfunctions 124

Focus of NLB Commitment (cont’d)

• Publication of the Survivorship Care Plan will be immeasurably valuable to the general nursing community involved in multiple myeloma patient care • Communication and dissemination of the Survivorship Care Plan are important next steps.

• Develop new educational materials/tools: - Patient related - Nurse related

125

Communication and Dissemination

• Patient and nurse educational slide set development • NLB Speaker’s Bureau • Oncology conference presentations • ONS Web site: www.ons.org

• IMF Web site: www.myeloma.org

126

Educational Resources

• American Cancer Society • National Cancer Institute • International Myeloma Foundation IMF

Myeloma Today

Newsletter - (800) 452 CURE - IMF Web site • www.myeloma.org

127

Accreditation

1. Symposium Accreditation Process

Please complete the CE Certificate Registration and Program Evaluation Form found in the guidebook and return this completed form to the registration desk to receive 2.0 CEU credits

2. CJON Supplement Accreditation Opportunity

Please visit www.cjon.org

and complete the online

tests for a maximum of 3.8 additional CEU credits

128

Acknowledgements

• Tiffany Richards • Sandra Rome • Joseph Tariman • International Myeloma Foundation • MER

129

Question & Answer Session

Faculty Panel

130