Transcript No Slide Title

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.
3
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.
4
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
5
Faculty
Chair:
Beth Faiman, MSN, APRN-BC, AOCN
Cleveland Clinic Taussig Cancer Institute
Cleveland, OH
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, MS, ANP, AOCNP
MD Anderson Cancer Center
Houston, TX
6
Agenda
Time
Discussion Topic
Presenter
12:15 pm - 12:30 pm
Welcome and Multiple Myeloma Overview
Beth Faiman
12:30 pm - 1:00 pm
Update on Novel Therapies
Joseph Tariman
1:00 pm - 1:20 pm
Management and Treatment of Long-Term
Effects on Multiple Myeloma (Case Studies)
Beth Faiman
1:20 pm - 1:40 pm
Understanding and Optimizing
Survivorship Care
Tiffany
Richards
1:40 pm - 2:00 pm
Focus on the Future and Importance of
Health Maintenance
Sandra Rome
2:00 pm - 2:05 pm
Closing Remarks
Beth Faiman
2:05 pm - 2:15 pm
Question & Answer Session
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.
8
Multiple Myeloma:
A Current Perspective
• Etiology of multiple myeloma (MM).
• Epidemiology of MM.
• Current and novel therapies in the
management of MM.
9
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
11
Vescio R. Multiple Myeloma & Amyloidosis Program,Jonsson Comprehensive Cancer Center/Cedars–Sinai Medical Center, 2005.
Multiple Myeloma: Abnormal Proliferation
of Malignant Plasma Cells
12
Kyle and Rajkumar, N Engl J Med 2004;351:1860-1873
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).
13
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
14
http://myeloma.org/pdfs/ph07-eng_f2.pdf
Major Symptoms at Diagnosis
•
•
•
•
•
Bone pain - 58%
Fatigue - 32%
Weight loss - 24%
Paresthesias - 5%
Asymptomatic - 11%
15
Kyle RA. Mayo Clin Proc 2003;78:21
Common Sites
for Bone Involvement
• Skull
• Spine
– Thoracic
– Lumbar
– Vertebrae
• Pelvis
• Long bones
• Spinal cord –
compression can occur
16
http://www.emedicine.com/Radio/topic460.htm#section~Introduction
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):
–
–
–
–
Calcium elevation (serum calcium >11.5 mg/dL)
Renal insufficiency (serum creatinine >2 mg/dL)
Anemia (hemoglobin <10 g/dL or 2 g/dL <normal)
Bone 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
Finding (s) With Myeloma
CBC with differential counts
↓ Hgb, ↓ WBC, ↓ platelets
Electrolytes
↑ Creat, ↑ Ca+, ↑ Uric acid, ↓ Alb
Serum electrophoresis with quantitative
immunoglobulins
↑ M protein in serum, may have ↓ levels of normal
antibodies
Immunofixation
Identifies light/heavy chain types M protein
β2-microglobulin
↑ Levels (measure of tumor burden)
24-hour urine protein electrophoresis
↑ Monoclonal protein (Bence Jones)
Bone marrow biopsy
≥ 10% plasma cells
Skeletal imaging
Osteolytic lesions, osteoporosis
Serum free light chain
↑ Free light chains
MRI
Evaluation of involvement of disease
Alb = albumin; CBC = complete blood count; Creat = creatinine; Hgb = hemoglobin; MRI =
magnetic resonance imaging; WBC = white blood cell.
18
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.
Durie-Salmon Staging System
for Multiple Myeloma
Myeloma cell mass
( 1012 cells/m2)
Stage
Criteria
I
All of the following:
Hemoglobin >10 g/dL
Serum calcium level 12 mg/dL (normal)
Normal bone or solitary plasmacytoma on
x-ray
Low M component production rate:
IgG <5 g/dL
IgA <3 g/dL
Bence Jones protein <4 g/24 hr
<0.6 (low)
II
Not fitting stage I or III
0.6 - 1.2 (intermediate)
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
>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
VALUES
Stage 1
ß2M <3.5 mg/dL
ALB 3.5 g/dL
Stage 2
Not Stage 1 or 3
Stage 3
ß2M >5.5 mg/dL
2M=serum 2 microglobulin in mg/dL; ALB=serum albumin in g/dL
20
Greipp PR, et al. Blood 2005; 102: 190a
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.
21
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
22
Thalomid® Prescribing
Information,
Revlimid®
Prescribing Information;
Velcade®
Prescribing Information
Update on Novel Therapies
•Joseph Tariman, PhC, MN, APRN-BC, OCN
University of Washington
Seattle, WA
23
NCCN Review Categories
Transplant
NCCN
Category
Non Transplant
NCCN
Category
Dexamethasone
2A
Bortezomib/Melphalan/Prednisone (VMP)*
1
L-Doxorubicin/Vincristine/
Dexamethasone (DVD)
2A
Melphalan/Prednisone/Thalidomide (MPT)
1
Thalidomide/Dexamethasone
2A
Vincristine/Doxorubicin/Dexamethasone (VAD)
2A
Bortezomib/Dexamethasone
2B
Dexamethasone
2A
Bortezomib/Thalidomide/
Dexamethasone (VTD)
2B
Melphalan/Prednisone (MP)
2A
Lenalidomide/Dexamethasone
2B
Thalidomide/Dexamethasone
2A
Bortezomib/Doxorubicin/
Dexamethasone
2B
Lenalidomide/low Dexamethasone*
2B
Bortezomib/Lenalidomide/
Dexamethasone (VRD)*
2B
L-Doxorubicin/Vincristine/Dexamethasone
(DVD)
2B
*Combinations recently reviewed by NCCN
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
Generic Name
Bortezomib
Lenalidomide
Thalidomide
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)
25
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.
26
Cavo et al. Blood 2008 112: Abstract 158
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 postASCT 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:
Post Induction
Post ASCT
CR/nCR
≥VGPR
≥PR
CR/nCR
≥VGPR
≥PR
VAD
9%
24%
71%
28%
50%
88%
Bortezomib/
Dexamethasone
22%
50%
89%
38%
66%
87%
P-value
0.0085
0.0001
NS
0.127
0.021
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
30
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
VISTA Trial: VMP vs. MP
Most Common Adverse Events (in ≥30% Patients) receiving
VMP (n=60)
Adverse Event
% Toxicities All Grades
% Toxicities Grades 3/4
Anemia
86
10
Thrombocytopenia
93
51
Infection
75
16
Neutropenia
85
43
Asthenia
63
5
Nausea
55
2
Diarrhea
55
16
Peripheral Neuropathy
55
17
Constipation
52
8
Anorexia
38
2
Vomiting
30
2
31
Mateos, et al. Haematologica 2008; 93(4) 560-565
Pts w/o Event (%)
VISTA: Updated Results
OS
100
90
80
70
60
50
40
30
20
10
0
VMP
MP
Median follow-up: 25.9 mos
VMP: median OS not reached (75 deaths); 3-yr OS rate: 72%
MP: median OS not reached (111 deaths); 3-yr OS rate: 59%
HR = 0.644; P = .0032
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
32
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.
33
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
34
Rajkumar et al, Blood 2007 110: Abstract 74
Results From Lenalidomide/Dexamethasone (RD) vs
Lenalidomide/Low-Dose Dexamethasone (Rd)
Toxicity (Grade >3)
RD (N=223)
Rd (N=222)
Neutropenia
2.7%
3.2%
Thrombocytopenia
1.8%
1.4%
25.6%
11.4%
3.1%
0.0%
Infection/Pneumonia
16.1%
9.0%
Fatigue
11.7%
4.1%
Hyperglycemia
5.8%
2.3%
Neuropathy
0.4%
1.4%
DVT/PE
Atrial Fibrillation/Flutter
Efficacy
RD
Rd
1-year Survival
88%
96%
2-year Survival
75%
87%
OS in Pts<65 (1 year)
92%
97%
OS in Pts>65 (1 year)
83%
94%
42
16
Deaths
Rajkumar et al, Blood 2007 110: Abstract 74; Jacobus et al., Blood 2008 112: Abstract 1740
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.
36
Rajkumar et al, Blood 2007 110: Abstract 74; Jacobus et al., Blood 2008 112: Abstract 1740
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.
37
ASH 2008 Highlights for Physicians
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/m2 (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%
– CR/nCR 36%
VRD was efficacious and
well-tolerated in
NDMM patients.
38
Richardson et al, Blood 2008 112: Abstract 92
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 dexamethasonebased induction.
– VRD regimen
• Bortezomib 1.3 mg/m2 (days 1, 4, 8, 11)
• Lenalidomide 15 mg (days 1-14)
• Dexamethasone 40 mg (days 1, 8, 15)
– VD regimen
• Bortezomib 1.3 mg/m2 (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
40
http://clinicaltrials.gov/ct2/show/NCT00602641?term=e1a06&rank=1
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
VMP
VTP
P Value
≥G3 Neutropenia
34%
19%
p=0.009
≥G3 Thrombocytopenia
21%
9%
p=0.01
Non-hematological AE (total)
133
157
p<0.005
≥G3 Non-hematological AE
25%
32%
p=0.04
≥G3 Cardiac toxicity
0%
7%
N/A
≥G3 Thromboembolic events
<1%
3.4%
N/A
≥G3 Peripheral neuropathy
9%
15%
N/A
8
16
p=0.08
Treatment discontinuation due to AE (patients)
• 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
42
Mateos et al. Blood 2008 112: Abstract 651
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
43
Weber et al, Blood 2008 112: Abstract 871
Vorinostat Plus Bortezomib:
Conclusions
Toxicity
Nausea
61.8%
Diarrhea
58.8%
Thrombocytopenia
50%
Vomiting
50%
Efficacy
Partial response (PR)
26%
Minimal response (MR)
21%
Stable disease (SD)
53%
Duration SD (days)
160
Range (days)
9 – 369
Combination of Vorinostat plus Bortezomib is active for
treatment of multiple myeloma in the early study.
44
Weber et al, Blood 2008 112: Abstract 871
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
45
ASH 2008 Highlights for Physicians
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.
46
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 produces a
barrier to providing optimal patient care
48
IMF-NLB ‘Consensus Statements’ CJON June 2008
Myelosuppression:
Definition and Symptoms
Anemia
Red Blood Cells
– Fatigue, malaise
and SOB
Lymphocyte
Monocyte
Marrow
White Blood Cells
Eosinophil
Neutropenia
Basophil
– Increased risk of
bacterial, fungal,
and viral infections
Neutrophil
Thrombocytopenia
Platelets
– 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
Anemia
Neutropenia
Thrombocytopenia
Thalidomide/Dexamethasone
16%
13%
4%
Lenalidomide/Dexamethasone
8%
21%
10%
Bortezomib
12%
14%
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.
51
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
52
http://www.nhlbi.nih.gov/health/dci/Diseases/Dvt/DVT_SignsAndSymptoms.html
Adapted from NLB Consensus Recommendations. CJON June 2008
Peripheral Neuropathy:
Definition, Signs, and Symptoms
Damage to the peripheral nervous system, including any injury,
inflammation, or degeneration of peripheral nerve fibers
• Signs/symptoms:
–
–
–
–
–
Thalidomide/bortezomib can
cause peripheral neuropathy
Temporary Numbness
Tingling
Parasthesias
Sensitivity to touch
Muscle weakness
• Severe symptoms:
–
–
–
–
Thalomid®
Burning pain
Muscle wasting
Paralysis
Organ dysfunction
Velcade®
53
Adapted from NLB Consensus Recommendations. CJON June 2008;
Prescribing Information,
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
54
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
Incidence of Gl AEs (All Grades)
Constipation
Diarrhea
Nausea
Vomiting
Lenalidomide/Dexamethasone
39%
29%
22%
10%
Thalidomide/Dexamethasone
55%
12%
28%
12%
Bortezomib
42%
57%
57%
35%
55
Thalomid®
Revlimid®
Prescribing Information,
Prescribing Information,
Adapted from NLB Consensus Recommendations. CJON June 2008
Velcade®
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
57
Adapted from NLB Consensus Recommendations. CJON 2008; ASCO’s Curriculum Nausea and vomiting 2005;
NCI Nausea and vomiting 2007
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
58
Adapted from NLB Consensus Recommendations. CJON June 2008; Alexanian, Dimopoulos, Delasalle, & Barlogie, 1992
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
59
Adapted from NLB Consensus Recommendations. CJON June 2008; Mitchell et al. 2006; Page et al 2006; Badger et al 2006; Cerullo, 2007
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
Bone Health
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
62
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.
63
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.
64
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.
65
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%)
66
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.
67
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.
68
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)
69
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
70
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
71
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
72
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
73
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!!
75
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.”
76
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?”
77
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)
79
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
– Experiences variable
adaptation to work and home
• Permanent survival: “cure”
– Insurance and employment problems
– Long-term effects of therapy
80
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.
81
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
82
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.
83
Shulman & Ganz ASCO Survivorship Models 2008
IOM Findings:
Survivorship Care (cont’d)
• Survivors:
– Unaware of risk
– No plan for follow-up
• Missed opportunities
• Lack of care coordination
84
Shulman & Ganz ASCO Survivorship Models 2008
IOM Findings:
Survivorship Care (cont’d)
• Chronic care model
• Essential care
components:
–
–
–
–
Prevention
Surveillance
Intervention
Coordination
85
Shulman & Ganz ASCO Survivorship Models 2008
IOM Findings:
Survivorship Care (cont’d)
IOM Recommendation:
• “All patients completing Rx
should receive a
comprehensive treatment
summary & care plan.”
86
Shulman & Ganz ASCO Survivorship Models 2008
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
87
Shulman & Ganz ASCO Survivorship Models 2008
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
88
Shulman & Ganz ASCO Survivorship Models 2008
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
89
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).
90
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
91
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
92
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
93
Leigh, Cancer Survivorship: A Nursing Perspective, in Cancer Survivorship Today and Tomorrow, 2007
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
94
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
Diagnosis
Continuing
care
Follow-up
Maintenance
Survivorship isn’t a stage!!!!
It is a continuum from diagnosis to
the end of life
Palliative
care
Recurrence
Progressive
disease
95
ASCO Tools for Survivorship Care
An important component of
survivorship care is a patient’s
treatment summary
96
www.asco.org/treatmentsummary
97
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!!
99
The Future for
Transplant-Eligible Patients
VAD
Old
standard
Thalidomide
Dexamethasone
New
standard
New
combinations
Lenalidomide/low
Dexamethasone
Bortezomib +
Dexamethasone
VTD…
Transplant
Harvest
100
NCCN Clinical Practice Guidelines in Oncology, v2 2009
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 IF and HOW LONG, but HOW WELL??
105
Leigh, Cancer Survivorship: A Nursing Perspective, Cancer Survivorship Today and Tomorrow, 2007
Nurse-Centric Model
of Survivorship Care*
Nurses are Central to
Patient Management and
Healthcare Resource
Coordination
Patient Monitoring
Patient Management
Patient Counseling
Patient Research
Nursing Roles Emerge
as Central to
Survivorship Care
Patient Advocacy
Patient Education
106
* Developed by ScienceFirst, LLC; All Rights Reserved (www.science-first.com)
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
107
Leigh, Cancer Survivorship: A Nursing Perspective, Cancer Survivorship Today and Tomorrow, 2007
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
108
Leigh, Cancer Survivorship: A Nursing Perspective, Cancer Survivorship Today and Tomorrow, 2007
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
Diagnosis
Continuing
care
Follow-up
Maintenance
Survivorship isn’t a stage!!!!
It is a continuum from diagnosis to
the end of life
Palliative
care
Recurrence
Progressive
disease
110
Given and Sherwood, 2005; Rutledge, 2005
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
111
Implementing Cancer Survivorship Care Planning http://www.nap.edu/catalog/11739.html
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
113
IMF-NLB ‘Consensus Statements’ supplemCJON June 2008
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
122
NLB Consensus Statements, CJON June 2008
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