Leading the
the Way: Managing
Multiple Myeloma for the Long -Term
Accredited by Medical Education Resources
Suppor
Suppo ted
ted by The Inte
t rn
e at
ation
o al
a Mye
yelom
o a Fou
oundat
dation
o
Grant Funding Provided by Celgene Corporation and
Millennium The Takeda
T
Oncology
Oncology Company
1
Welcome and Introductions
Beth Faiman, MSN, APRN-BC, AOCN
Cleveland Clinic
Clinic Taussig Cancer
Cancer Institute
Cleveland, OH
2
ONS Disclaimer
Meeting space
space has been assigned to
to provide
provide a satellite
satellite
symposium supported by the International Myeloma
Foundation via an unrestricted educational grant during
the Oncology
Oncology Nursing Society
Society's (ONS)
(ONS) 34th Annual
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
the educational content of the symposium.
3
Symposium Accreditation
Accreditation
· This continuing education activity provides
2.0 contact
contact hours.
· Medical Education Resources is an approved provider
of continuing nursing education by the Colorado
Nurses Association, an
an accredited
accredited approver by the
American Nurses Credentialing Center's Commission
on Accreditation.
· Please
l
comp t
e e the CE C t
er ifi
tifi t
ca e R i
eg t
s
t
ra ition
d
an
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
Wl
Welcome
d
an Multi
ltiple M l
ye oma Overview
Bt
Be h
th F i
a man
12:30 pm - 1:00 pm
Update on Novel Therapies
Joseph Tariman
Management and Treatment
Treatment of Long-Ter
Te m
1:00 pm - 1:20 pm
Beth Faiman
Effects on Multiple Myeloma (Case Studies)
Understanding and Optimizing
Tiffany
1:20 pm - 1:40 pm
Survivorship Care
Richards
Focus on the Future and Importance of
1:40 pm - 2:00 pm
Sandra Rome
Health Maintenance
2:00 pm - 2:05 pm
Closing Remarks
Remarks
Beth Faiman
2:05 pm - 2:15 pm
Question & Answer Session
Panel
7
Learning Obj
gjectives
· Describe updated data on novel agents used in the
management of
of patients with multiple
multiple myeloma
myeloma (MM)
· Discuss critical issues in nursing management and
medical implications of major side effect
ti
management w th
ith
l
nove th
th
i
erap es in MM
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
ways to
to improve
improve quality of
of care
care.
8
Multiple Myeloma:
A Current
Current Perspective
· Etiology of multiple myeloma (MM).
·Epidemiology
pgy of MM.
· Current and novel therapies in the
management of MM.
9
What Is Multiple My
pyeloma?
· Cancer of plasma cells.
· Healthy plasma cellls
d
pro uce antib di
o es or
immunoglobulins.
Part of our humoral immunity, they are released
released in
response to foreign body invasion.
·Myeloma cells p
yproduce 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
FN
From Normal Pl
Plasma Cellls by th
the Presence
of Large Nuclei That Are Often Eccentric
11
Vescio R. Multiple Myeloma & Amyloidosis Program,Jonsson Comprehensive Cancer Center/CedarsSinai Medical Center, 2005.
Multiple Myeloma: Abnormal Proliferation
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
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 >ag
pge 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:
Ri k
s
f
o i f
n
ti
ec on
Osteolytic bone lesions
Hypercalcemia
Bone marrow suppression (pancytopenia)
Renal complication risk
risk
· Production of monoclonal M proteins causes:
Decreased levels of normal immunoglobulins
Hyperviscosity
14
http://myeloma.org/pdfs/ph07-eng_f2.pdf
Major Symptoms
Symptoms at
at Diagnosis
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
Bone Involvement
·Skul
· Spine
Thoracic
Lb
Lumbar
Vertebrae
· Pelvis
· Long bones
· Si
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
of a documented
plasmacytoma.
+
· Presence of M component in serum and/or urine.*
+
· Of
One or more of th
the folll
i
ow ng (CRAB criteria):
Calcium elevation (serum calcium >11.5 mg/dL)
Ren
e al
a insuffi
su ciency (serum crea
eatinine >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
ith diff
dif
ti
eren l
a counts
Hb
Hgb, WBC, pltlt
latelets
Electrolytes
Creat, Ca+, Uric acid, Alb
Serum electrophoresis with quantitative
M protein in serum, may have levels of normal
immunoglobulins
g
antibodies
Immunofixation
Identifies light/heavy chain types M protein
2-microglobulin
Levels (measure of tumor burden)
24-hour urine protein electrophoresis
pp
Monoclonal protein (
p(Bence Jones)
Bone marrow biopsy
10% plasma cells
Skeletal imaging
Osteolytic lesions, osteoporosis
Serum free light chain
Free
F
light chains
MRI
Evaluation of involvement of disease
Alb = albumin; CBC = complete blood count; Creat = creatinine; Hgb = hemoglobin; MRI =
magnetic resonance
resonance imaging;
imaging; WBC = wh
white
ite blood
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
Multiple Myeloma
Myeloma
Myeloma cell mass
Stage
Criteria
( 1012 cells/m2)
I
All of the follll
i
ow ng:
06
<0.6 (l(l
)
ow
Hemoglobin >10 g/dL
Serum calcium level 12 mg/dL (normal)
Normal bone or solitary plasmacytoma on
x-ray
Low M component
component production rate:
IgG <5 g/dL
IgA <3 g/dL
Bence Jones protein <4 g/24 hr
II
Not fitting
fitting stage I or
or III
06
0.6 - 1.2 (intermediate)
III
One or more of the following:
>1.2 (high)
Hemoglobin <8.5 g/dL
Serum calcium level >12 mg/dL
Multiple ly
pytic 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
Subclassification criteria:
A
Normal renal function (serum creatinine level <2.0 mg/dL)
B
Abnormal renal function (serum creatinine level 2.0 mg/dL)
19
Durie and Salmon, Cancer 1975;36(9):842-854
International Staging System
for Symptomatic
Symptomatic Multiple Myeloma
STAGE
VALUES
ß
Stage 1
2M <3.5 mg/dL
Stage 1
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
rare.
· Median survival with standard therapy is
about 3 years
years.
· Autologous stem cell transplant may prolong
progression free survival, but it's not curative.
· Treatment of relapse:
No standard therapy
therapy.
Existing options inadequate.
New treatment
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
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
Non Transplant
NCCN
Category
Category
Dexamethasone
2A
Bortezomib/Melphalan/Prednisone (VMP)*
1
L-Doxorubicin/Vincristine/
2A
Melphalan/Prednisone/Thalidomide (MPT)
1
Dexamethasone (DVD)
Thalidomide/Dexamethasone
2A
Vincristine/Doxorubicin/Dexamethasone (VAD)
2A
Bortezomib/Dexamethasone
2B
Dexamethasone
2A
Bortezomib/Thalidomide/
2B
Melphalan/Prednisone (MP)
2A
Dexamethasone (VTD)
Lenalidomide/Dexamethasone
2B
Thalidomide/Dexamethasone
2A
Bortezomib/Doxorubicin/
2B
Lenalidomide/low Dexamethasone*
2B
Dexamethasone
Bortezomib/Lenalidomide/
2B
L-Doxorubicin/Vincristine/Dexamethasone
2B
Dexamethasone (VRD)
(VRD)*
(DVD)
()
*Combinations recently reviewed by NCCN
NCCN Categories of Evidence and Consensus:
Generic Name
Trade Name
1
High-level evidence, uniform consensus
Bortezomib
Velcade
2A
Lower-level evidence, uniform consensus
Lenalidomide
Revlimid
2B
Lower-level evidence, non-uniform consensus
Thalidomide
Thalomid
24
NCCN Clinical Practice Guidelines in Oncology, v2 2009
Recent and Ongoing
Clinical Studies
· Transplant-eligible patients
Bortezomib/Thalidomide/Dexamethasone (VTD) vs
Thalid
id
om
/D
e
th
exame asone (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
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
studies
· Bortezomib/Vorinostat (Phase I)
25
VTD vs. TD in Patients
Who Are
Are Transplant Eligible
Phase III Bortezomib-Thalidomide-Dexamethasone (VTD)
vs Thalidomide-
Thalidomide Dexamethasone (TD) Prior to
to Stem
Stem Cell
Cell
Transplantation (SCT))
· Study objective
VTD vs TD
TD in preparation for autologous t
s em cell
transplantation (ASCT)
· Study design
Rd
Rand
i
om
d
ze ti
tri l
a
Three cycles of induction therapy
· Methods
Pts.
di
randomi d
ze t
ith
oe er VDT (
199
n=
)
199 or TD (
200
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
vs. TD
TD
· Prophylaxis
Acyclovir prophylaxis against reactivation
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
rates.
These response rates translated into significantly higher
CR+nCR after first ASCT in the VTD arm.
Cb
Com i
bi t
na itions f
o
l
nove i d
n
t
uc ition
t
agen s,
h
suc as VTD
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
in Transplant
Transplant-Eligible Patients
· Phase III, active control, multicenter, open label, randomized
OC
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/
22%
50%
89%
38%
66%
87%
Dexamethasone
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-
Post induction complete
complete remission
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
With Melphalan/Prednisone
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)
p) vs MP arm (oral melphalan and prednisone)
· Primary endpoint:
Time to progression (TTP)
· Sd
Secondary e di
ndpoi t
n s:
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
Ai
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
VISTA: Updated
Updated Results
ts
OS
100
VMP
)
90
MP
%
80
(
70
60
Event
50
/ow 40
Median follow-up: 25.9 mos
30
Pts
VMP: median OS not reached (75 deaths); 3-yr OS rate: 72%
20
MP: median OS not reached (111 deaths); 3-yr OS rate: 59%
10
HR = 0.644; P = .0032
0
0
2 4
6 8 10 12 1416 18 20 22 24 26 28 303234 36 38 40
Months
· VMP associated with ~36% reduced risk of death.
· 43% of pts in
in the
the MP arm who
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%,
y, respectivel
p
y
32
San Miguel JF, et al. Blood 2008 112: Abstract 650.
VISTA
VIST Trial:
Trial: VMP
VMP vs. MP
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 longe
g r 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
25 mg
mg (days
(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
rate at
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%
DVT/PE
25.6%
11.4%
Atrial Fibrillation/Flutter
3.1%
0.0%
Infection/Pneumonia
16.1%
9.0%
Fatigue
11.7%
4.1%
Hyper
yp gl
g ycemia
y
5.8%
2.3%
Neuropathy
0.4%
1.4%
Efficacy
RD
Rd
1-
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%
Deaths
42
16
35
Rajkumar et al, Blood 2007 110: Abstract 74; Jacobus et al., Blood 2008 112: Abstract 1740
Results From
From RD
RD vs
vs Rd
Rd
·Rd
Rd is
is associated
associated with
with superior
superior OS compared
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
Development
·Single ag
ggents are limited in efficacy,
y, likely to be
used in combinations.
Bortezomib, lenalidomide, and thalidomide are being
explored for combination regimens.
· Combining agents directed at different targets
may provide
provide synergistic response without
without an
increase in side effects.
37
ASH 2008 Highlights for Physicians
Bortezomib/Lenalidomide/Dexamethasone
in Patients Who
Who Are Transplant
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%
VRD was efficacious and
CR/nCR 36%
well-tolerated in
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
(g
2008)
Consolidation therapy for patients after dexamethasone-
based induction.
VRD regimen
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
Transplant Ineligible
· Randomized multicenter Phase III ECOG
E1A06 study
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 Wi
With
th 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-
1 4 of
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
on days 1-4 of
of each cycle
· Primary End Point
Overall response rate (ORR)
41
Mateos et al. Blood 2008 112: Abstract 651
Conclusions From VMP vs
vs. VTP
VTP
6 cycles: 31 weeks of treatment)
Rl
Resu t
lts
VMP
VTP
PV
P V l
a ue
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
Treatm
ea ent
e
di
d scontinuation due to AE (pa
(patients)
s)
8
16
p=0.
p0 08
08
· Incidence of non-hematological AE (especially cardiac) was higher in the
VTP arm, resulting in more serious AEs and treatment discontinuations
· Thalidomide may
may not be a partner
partner of choice for Bortezomib
Bortezomib
- Lenalidomide should be explored
42
Mateos et al. Blood 2008 112: Abstract 651
Bortezomib and Vorinostat
in Early Clinical
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%
Vom
Vo i
m t
i in
i g
n
50%
Efficacy
Partial response (PR)
26%
Minimal response
response (MR)
(MR)
21%
Stable disease (SD)
53%
Range (days)
Duration SD (days
(y )
160
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
combinations of novel therapies may offer
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
is expected
expected to
to follow
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
response rate
rate, time to
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
Treatment of Emergent
Side Effects and Defining
Long-Term Effects of
of M ltiple
u
M eloma
y
Beth Faiman, MSN,
,, APRN-BC, AOCN
Cleveland Clinic Taussig Cancer Institute
Cleveland, OH
47
Five Major Categories of Side
Effects for
for Novel MM
MM Treatments
Treatments
· Myelosuppression
· Thromboembolic
t
even s
· 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
Lymphoc
yp
yte
y
Marrow
Monocyte
White Blood Cells
Eosinophil
Neutropenia
Increased risk of
Basophil
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
p
Thrombocytopenia
yp
Thalidomide/Dexamethasone
16%
13%
4%
Lenalidomide/Dexamethasone
8%
21%
10%
Bortezomib
12%
14%
32%
· General recommendations:
Monitor signs
signs and symptoms
Monitor CBC
Educate on signs and symptoms
· Ml
Myel
i
osuppress on
t
managemen :
Growth factor therapy
Dose reduction as appro
pp priate
p
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
)y lead to:
Deep vein thrombosis (DVT)
Pulmonary embolism (PE)
· MM patients are at an increased risk for blood clots
Patients are
are at increased risk with high-dose dexamethasone
treatment
The risk for DVT/PE is further increased in patients treated
with novel therapies:
p
· Thalidomide
· Lenalidomide
· Measures to prevent novel therapy-associated TE
events include:
include:
Mechanical
Myeloma regimen-related
Anticoagulant therapy
gpy (clot-preventing)
pg)
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
·Anxiety
· Tachycardia
· Sudden dyspnea
· Unilateral swelling,
· Chest discomfort
erythemia, warm extremity
·Tachycardia,
y,
· Cyanosis/cool skin
tachypnea
· Distension of superficial
· Low-grade fever
venous collateral vessels
vessels
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
nerve fibers
· Signs/symptoms:
Temporary
py Numbness
Tingling
Thalidomide/bortezomib can
Parasthesias
cause perip
ppheral neuropathy
Sensitivity to
to touch
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
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
or higher
higher
Tricyclic antidepressants
Amino acids on an empty stomach
Neurontin®, Lyrica®, Cymbalta®
Lidoderm® patch 5%
p% 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
· A i
ss t
s ance with
ith 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
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® Prescribing Information, Revlimid® Prescribing Information, Velcade® Prescribing Information
Adapted from NLB Consensus Recommendations. CJON June 2008
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
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
sti
l
mu t
a e N/V
d
an consider type f
o N/V.
· Nausea: Ativan®, Compazine®, Decadron®, Pepcid®,
Phenergan®, Reglan®, or Zantac®
· Vomiting: Emend®, Zofran®, Kytril®, Anzemet®, or Aloxi®
g
,
,y
,
,
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
Side Effects
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:
Ct
Cons it
titutitional
Oh
Op th
hthalmic
Psychiatric
Gastrointestinal
Immune
Endocrine
Ml
Muscul k
os eletal
Cd
Car i
diovascular
Bone loss
Dermatologic
Body image
58
Adapted from NLB Consensus Recommendations. CJON June 2008; Alexanian, Dimopoulos, Delasalle, & Barlogie, 1992
Management of Steroid-Dependent
Side Effects: Constitutional
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
of Novel
Novel Therapy
· Effective management includes:
Mi
Mon titoring
t
pa iti t
en s
f
care l
ully
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
I
d
mprove
lit
qua y f
o 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
Survivorship Care
Care Plan
Plan
Evidence-based data for 5 major long-term side effect
issues and their management:
g
creation of clinical
practice-based consensus documents
Functional
Renal
Bone Health
Mobility
Complications
Sexuality &
Health
Sexual
Maintenance
Df
Dysfuncti
tion
Outcome: Survivorship Care Plan and Manuscript
61
Functional Mobility in Multiple
Myeloma
·Multi
u pl
p e mye
yeloma is mainly a disease of the bo
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
·Dementi
ee a
· Urinary incontinence (fall-related)
· Arthritis
Nutrition (muscle weakness, weight loss)
Psychological issues
issues and lifestyle
62
Reported Mobility-Affecting Side
Effects of
of Novel
Novel MM Treatments
Common SE
Impact on Functional Mobility
Pi
Periph
l
era
t
neuropa h
thy
Sl
Se flf-li i
m ting mobility due to:
Sensory and motor symptoms
discomfort or prescribed limitations by the
Ataxia
health practitioner
Muscle wasting
pain and/or discomfort
Tone
T
and mass
Strength and motor function
Lack of desire to participate in activity and
Myelosupression
inability to mobilize safety.
Thrombocytopenia
Lack of ability to withstand extended activity
Neutropenia
and may require oxygen.
Anemia
Inability to participate in activities due to
Gastrointestinal symptoms
organ-function restrictions as prescribed by
Nausea, vomiting, constipation, diarrhea
Dehydration, anorexia, weight loss
health care provider.
Hypercalcemia, hypokalemia, hyponatremia
Mobility restrictions due to the sy
yymptoms
Fatigue and somnolence
and/or cognitive, muscular impact due to
imbalance.
Cardiovascular issues
Deep vein thrombosis
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
Case Study
Study
· Annie is a 68-year-old woman with relapsed
myeli
loma receiving bortezomib
ib
d
an
dexamethasone.
· After 6 cycles she is
is in
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.
· Hb
Husband is afraid
id she is " i
g i
v ng
"
up; h
s e has l t
os
her balance twice this week.
64
Functional Mobility:
A Case
Case Study
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
of pneumonia due to inactivity.
c) Depression.
d) Neuropathy
py 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 pro
yp gress
g
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
Case Study
Study
· JJ is a 76-year-old man diagnosed in 2001 with
IgG Kappa
Kappa Myeloma.
· Prior therapies (3): thalidomide, bortezomib, lenalidomide
·Bisphosphonates
pp
every 3 months (p
( amidronate
p
)
· 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
Case Study
Study
What would be the most important consideration for
this eld
lderly
ti
pa ent ith
w
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
yp
ADLs.
d) All of the above.
68
Renal Complications
One of the common clinical features of symptomatic myeloma.
· 20 to 60% of patients present
present ith
w
renal
renal complications.
Elevated serum creatinine level
Anemia, fatigue
Fluid and l
e
t
ec rol t
y e i b
m l
a ances
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
Case Study
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; h
s e has been in
i
rem
i
ss on i
s nce.
· Blood work every 3 months, stable
· Called complaining of nausea, vomiting, and
fevers in the last 48 hours
70
Renal Complications:
A Case
Case Study
Study
· Labs:
WBC39k
WBC 3.9 /uL
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
Alb m
u in
min 3 2
. g/dL
Beta-2 M 7.9
· Skeletal survey shows progressive
progressive disease: scattered
lesions calvarium, pelvis and bilateral femurs
71
Renal Complications:
A Case
Case Study
Study
She is admitted for IV hydration and a blood transfusion
She receives
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 B t
or ezomib
d
an pegyl t
a ed li
l
posoma D
bi
oxoru
i
c n
d) Enroll in a clinical trial with an experimental agent
72
Sexuality & Se
S x
e ua
ual Dys
ysfunction
· 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
to the
the DSM IV):
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
to ind
ind ce
u
impotence in
in male
male patients
· Bortezomib and lenalidomide
Unpublished reports of erectile dysfunction and
decreased libido
· Sildenafil has positive results in restoring proper functioning
· Ok
Our knowledge of th
the effffects of novel myeloma
treatment on sexuality is very limited
Patients are
are reluctant to discuss the issue
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
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!!
yp
75
Sexuality and Sexual
Dysfunction: A Case
Case Study
Study
· Mrs. D is a 53-year-old woman diagnosed 3 years ago
with MM. After a long remission, she relapsed
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
to have sex
sex 3 weeks
weeks ago, she did
did not feel
stimulated and found it to be painful. Becomes teary
eyed; their sexual relationship has been strained since
her di
diagnosis 3 years ago. Mr. D t ld
o her th
th t
a he "
't
can
take it anymore."
76
Sexuality and Sexual
Dysfunction: A Case
Case Study
Study
How would you approach this?
a) Think of Mr. D as being selfish after all his wife has
been through
b) Avoid the
the question because Mrs. D starts
starts crying
crying. It'
It sa
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,
fi
friends, and caregivers impacted by th
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
it
int
i
erm tt
itt t
en th
therapy
Fear of recurrence
Physical limitations
adaptation to work and home
Ei
Experiences
i
var b
a l
ble
· Permanent survival: "cure"
Insurance and employment problems
Long-tf
term e fffects of th
therapy
80
Mullan, NEJM 1985
Comparisons of Patient and Physician
Expectations for Cancer
Cancer Survivorship Care
Investigators from the Harvard School of Public Health,
Dana-Fb
Farber Cancer Instit
tit t
u e,
d
an th
the It
Ins it
tit t
u e
of Clinical Evaluative Sciences (Toronto) conducted a
study to compare expectations regarding survivorship
care among PCPs, oncologi t
s s,
d
an
t
pa iti t
en s
· The results demonstrated a lack of agreement among
these constituents with respect to their roles in ongoing
survivor care.
· The discordance was particularly
py high
g between patients
p
and their oncologists. The underlying causes for the
discrepancies were unclear.
81
Cancer Survivorship:
From Individual to Experience
· Defined as:
A time
time frame
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
Survivorship Care
Care
· Si
Survivorshi
hip care is
l
neg
t
ec ed.
· Cancer recurrence, second
cancers, and late effects of
of
treatment.
· Few guidelines.
· Providers lack education.
83
Shulman & Ganz ASCO Survivorship Models 2008
IOM Findings:
Survivorship Care (cont'
(cont d)
· Survivors:
Unaware of risk
No plan for follow
follow up
-
· Missed opportunities
· Lack of
of care
care coordination
coordination
84
Shulman & Ganz ASCO Survivorship Models 2008
IOM Findings:
Survivorship Care (cont'
(cont d)
· Chronic care
care model
model
· Essential care
components:
Prevention
Surveillance
Intervention
Coordination
85
Shulman & Ganz ASCO Survivorship Models 2008
IOM Findings:
Survivorship Care (cont'
(cont d)
IOM Recommend t
a ition:
· "All patients completing Rx
shl
hou d
ld receive a
comprehensive treatment
summary & care
care plan
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
· Tt
Treatment plan and dates
· Expected short- and long-term effects
· Late toxicity
toxicity monitoring
· Surveillance for recurrence or second cancer
·Responsibility
py for survivorship care
· Psychosocial and vocational needs
· Recommended preventive behaviors and
recommendations
88
Shulman & Ganz ASCO Survivorship Models 2008
IOM Recommendations
for Quality
Quality Healthcare
Healthcare in America
· Care based on continuous healing relationships
· Ct
Cust
id
omized 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
· Ct
Coopera ition
89
Quality Healthcare = Optimal
Survivorship Care
· Receipt of optimal survivorship care depends on
a patient-centered approach (Berry t
e
l
a ., 2003).
· Call for such an approach has been made by
physician-researchers William Tierney
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
to Cancer
Cancer Survivor Care
· For the Cancer Survivor:
Ft
Fragment d
e d l
e ilivery
t
sys em
Lack of awareness
Barriers to
to communication
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
Mk
Ma i
king
f
re
l
erra s
Paying for continued care
93
Leigh, Cancer Survivorship: A Nursing Perspective, in Cancer Survivorship Today and Tomorrow, 2007
Why Survivorship Care
for Multiple
Multiple Myeloma?
Myeloma?
· 2008 expectations for MM patients:
>90% response upfront
CR + VGPR 60%
3-year survi l
va 80 to 90%
6-year survival 60 to 70%
>10 year
-
survival 30 to 40%
Increased
Increased surviva
surviv l
a leads
leads to the need
need for
fo new
new
approaches to quality survivorship care
94
Survivorship Care Continuum
Individuals with chronic or intermittent disease may
receive ongoing
gg treatment for their disease, but benefit
from survivorship care as they live with their disease
Initial
Continuing
Palliative
Prevention
treatment
care
Follow-up
care
Diagnosis
Maintenance
Recurrence
Progressive
disease
Survivorship isn't a stage!!!!
It is a continuum from diagnosis to
the end of life
95
ASCO Tools for Survivorship Care
An important component of
survivorship care is a patient's
pp
treatment summary
96
www.asco.org/treatmentsummary
97
Ft
Focus on h
the Future
Sandra Rome, RN, MN, AOCN
Cedars-Sinai Medical Center
Los Angeles, CA
CA
98
New Drugs New Perspective
for Multiple
Multiple Myeloma
Myeloma
· Thalidomide
· Bortezomib
· Lenalidomide
Chronic?
AC
A ure??
OR
Cure??
OR
Longer follow-up required!!
99
The Future for
Transplant-Eligible
-
Patients
VAD
Thalidomide
New
Dexamethasone
combinations
Old
Lenalidomide/low
standard
New
Dexamethasone
standard
Bortezomib +
Dexamethasone
VTD...
Transplant
T
Harvest
100
NCCN Clinical Practice Guidelines in Oncology, v2 2009
The Future for
Transplant-
Transplant Ineligible Patients
MP
MPT
VMP
Old
MPR
standard
New
Lenalido ide/lo
m
w
standard
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
for survivors:
quality of life
· Family/social problems
problems
· Financial/insurance concerns
· Other
102
Optimizing Survival: Importance
of Health Maintenance
· MM patients are expected to live longer
· Proper health
lth
it
maintenance contribt
ibutes 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
brain" effect
· Dermatological issues
Immune system weakened by therapy
· Transplants
· Radiation
Increased risk for skin cancer
104
Shifting Paradigm for
Survivorship Care: Nurse
Nurse Role
Old Model
Survivorship as a stag
pge:
· Decreasing contact
· Brief check-ups
· May not recognize survivorship
· Busy clinics
Time constraints
Focus on acutely ill
Emerging Model
Survivorship as a process:
· Ct
Cont t
ac l
a ong th
the
td
extended continuum of care
· Survival plan will be developed shortly after diagnosis
· Survivors and families will be supported medically,
emotionally, financially.
y
· 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-
Nurse Led Survivorship Care (cont'd)
Barriers:
· Shortage of trained oncology nurses,
especially in outpatient settings
· Lk
Lack of coordi
dinated care
d
an
i
commun
i
cat on
among healthcare providers
· Id
Insurance and
i
re b
m ursement issues
108
Leigh, Cancer Survivorship: A Nursing Perspective, Cancer Survivorship Today and Tomorrow, 2007
National Coalition for Cancer
Survivors (NCCS)
(NCCS) "Imperatives"
NCCS's "Imperatives for Quality Cancer Care: Access,
Advocacy, Action, and Accountability":
· Nurses are major players
· Health promotion and wellness are
are critical in
survivor clinics
· Continued need for supportive
pp
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:"
Initial
Continuing
Palliative
Prevention
treatment
care
Follow-up
care
Diagnosis
Maintenance
Recurrence
Progressive
Survivorship isn't a stage!!!!
disease
It is a continuum from diagnosis to
the end of life
110
Given and Sherwood, 2005; Rutledge, 2005
What is a Survivorship
Care Plan?
· A document:
Si
Summarizes h
w t
a t
i
ransp d
re d i
ur ng cancer t
t
rea
t
men
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
risk of
of co-
co morbid conditions
Ensure adherence to follow-up recommendations
111
Implementing Cancer Survivorship Care Planning http://www.nap.edu/catalog/11739.html
Meeting the
the Unmet Need
Need
Opportunity to leverage the NLB's
experience by identifying relevant long-
long term
side-effects and developing a Survivorship
Care Plan for Multiple Myeloma
112
NLB Developed Consensus Guidelines
for Management
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
effects
113
IMF-NLB `Consensus Statements' supplemCJON June 2008
A New
New Horizon in
in Patient
Patient Care
· Si
Survivorshi
hip Care Pl
Plan off
ffers th
the
opportunity to enhance treatment
outcome and patient
patient quality of
of life
· Survivorship Care Plan will need to be
updated as
as new
new therapies emerge
emerge
114
Goals of NLB
Survivorship Care Plan
How myeloma, treatments, and patient-specific
characteristics affect:
affect:
· Renal disease
· Sexuality and sexual dysfunction
· Bone metabolism
· Safety and functional mobility
yy
· Health maintenance
115
Goals of NLB
Survivorship Care Plan (cont'
(cont d)
Develop recommendations for schedules of
evaluations and evidenced-based interventions:
· Prevention, screening through treatment of sequelae
· Enable clinicians
clinicians and patients to
to optimize therapy
therapy by
preventing or adequately treating co-morbid conditions.
116
Goals of NLB
Survivorship Care Plan (cont'
(cont d)
NLB will disseminate this information to those
within in the community
community who can
can effect the
most change:
· Patients
· Ci
Caregivers
· Healthcare providers
117
Creation of a MM
Survivorship Care Plan
· Co-morbid conditions affect:
Treatment options
p
Survival
Late side effects
· The plan
plan will:
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
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
for survivorship care will be posted on
on the
the site
http://myeloma.org
119
Closing Remarks
· Beth Faiman, MSN,
,, APRN-BC, AOCN
· Cleveland Clinic Taussig Cancer Institute
Cleveland, OH
120
NLB Accomplishments
Accomplishments
PUBLISHED:
Managing the Side Effects of Novel Agents for Multiple
Myeloma: Guidelines and Patient Education Sheets
· Cli i
n
l
ca Journal O
l
nco ogy N
i
urs ng (CJON
(
)S
), S
l
upp
t
emen
12(3), June 2008
· Patient Education Insert
Insert Tear
T
-
ear Out Tools
T
for
for 5 Side
Side Eff
Ef ects
fects
Myelosupression
Thromboembolic events
Pi
Peri h
p
l
era
t
neuropa h
thy
Gastrointestinal side effects
Steroid-associated side effects
121
Patient Education
Tear-
Tear Out
-
Tools
Tools
General format and clilinical utility:
· Side effect description
· Novel therapies that may
py be associated
with the side effect
· Signs and symptoms
· Risk factors
factors
· Healthcare provider recommendations
122
NLB Consensus Statements, CJON June 2008
Future Goals
Goals of
of NLB
NLB
Expand initiative to collaborate with
nurses worldwide
· Ft
Frame h
the importance f
o nursing.
· Management of long-term side effects
associated with MM
MM therapies
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
Hl
Hea th
lth mai t
n enance
Functional mobility
Bone health
Renal complications
Sexual dysfunctions
124
Focus of NLB
Commitment (cont'd)
· Publication of the Survivorship Care Plan
ill
w be immeasurably
l
va
b
ua l
ble to the general
i
nurs ng
community involved in multiple myeloma patient
care
· Communication and dissemination of the
Survivorship Care Plan are imp
pportant 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
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
Foundation
- IMF Myeloma Today Newsletter
- (800) 452 CURE
- IMF Web site
· www.myeloma.org
127
Accreditation
1. Symposium Accreditation Process
Please complete the CE
CE Certificate
Certificate Registration
Registration and
and
Program Evaluation Form found in the guidebook
and return this completed form to the registration
desk to receive 2 0
. CEU credits
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 Rich d
ar s
· Sandra Rome
· Joseph Tariman
· International Myeloma Foundation
Foundation
·MER
129
Question & Answer Session
Faculty Panel
130