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28/11/2016
1
Quality of life management:
yes, we need guidelines!
Florian SCOTTEHôpital Européen Georges Pompidou
Université Paris Descartes
Paris - France
DISCLOSURE SLIDEI declare disclosures with:
Consultant / Advisory Boards / Speaker : Sanofi, Roche, MSD,
TEVA, Norgine, Prostrakan, Leo pharma, Janssen, Hospira,
Boehringer, AMGEN, Pierre Fabre Oncologie, Vifor pharma.
Associations: ESMO, ASCO, MASCC, CKIN, AFSOS, AESCO.
– Randomized trial in metastatic lung cancer
– Compares standard oncological therapy ±
better supportive care
– Supportive care is associated with:
• Longer survival p=0.02 : 11.6 vs 8.9
months
• Better quality of life p=0.03
• Fewer depressive symptoms p=0.02
GLOBAL APPROACH: EARLY PALLIATIVE CARE
SURVIVAL and QOL improvement
Overall survival
Temel J et al. NEJM 2010
PERCEPTION, A ‘PARTIAL’ REALITY …
Perception is not just a product of the stimulus, but also of mental activity
– that we seewith the mind as well as the eye
John F. Kihlstrom
What do you see:
ducks or rabbits ?
Basch et al, The Missing Voice of Patients in Drug-Safety Reporting, NEJM 2010
PERCEPTIONS AND REALITY
WHAT WAS SIMONE’S QOL PERCEPTION ?
6
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QOL GUIDELINES ?
• 1st Step : Assessment
– Scores and Scales
– Frailty
7 8
1 - Do you have any trouble doing strenuous activities,
like carrying a heavy shopping bag or a suitcase?
28 - Has your physical condition or medical treatment
caused you financial difficulties?
Pain, depression, anxiety, tiredness, drowsiness, Appetite,
Nausea, shortness of breath, wellbeing
KARNOFSKY Performance Status : 0 – 100%
Standardised Geriatric Assessment
Items Scales
Functional Status ECOG-PS
ADL (Katz Scale)
IADL (Lawton scale, OARS scale)
Co-Morbidities CIRG-S, Charlson Index, Satariano Index
Medications Number, Drug-Drug interaction
Cognition MMSE, BOMC
Depression GDS, HADS
Nutrition BMI, MNA, PINI, Buzby
Mobility Timed up and go test
Tinetti test
9
• ONCODAGE (G8) Score:
– French NCI : Objective = 100% patients ≥ 75 years
– Completion rate : ? (ex Bretagne = 12% in 2013)
10
Soubeyran P. 2011
INCa 2016
UCOG Bretagne- Rapport Activité 2014
QOL GUIDELINES ?
• 1st Step : Assessment
– Scores and Scales
11
Frailty ?
Complaint ?Supportive care programs integration
���� Global Assessment
PLACE FOR ‘BEST SUPPORTIVE CARE’ TEAMS
TO IMPROVE PATIENT’S ASSESSMENT
Social worker
DieteticianSpecialist
nurse
Kinesitherapist
PsychologistPain
management
Sexologist
Nurses… MDs…
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QOL GUIDELINES ?
• 1st Step : Assessment
– Scores and Scales
– Multidisciplinary discussions
13
Global Assessment
QOL GUIDELINES ?
• 1st Step : Assessment
– Scores and Scales
– Multidisciplinary discussions
• 2nd Step : Prehabilitation
14
Breast Cancer and Cognitive Dysfunction in the
Elderly
– 123 patients included (Control group: 71 patients)
– 41 % had cognitive disorders at baseline
ASCO® 2013 - Joly F et al., abstr. 9510
Incidence of associated troubles
�High Incidence of Cognitive disorders at Baseline
�Correlation with anxiety, depression, fatigue
�Impact on Quality of Life
Pa
tie
nts
wit
h
dy
sfu
nct
ion
s(%
)
05
101520253035
FACT-F Anxiety Depression
0
5
10
15
Patients Control
p = 0,0221
29 %
7 %10 %
Impact of cognitive disorders on QOL
Imp
act
(%
)
Evolution Depending …Habilitation !
0
10
20
30
40
50
60
70
80
90
100
0 4 8 12 16 20 24 28 32 36
Health/
Dis
abili
ty
Silver J. - MASCC® 2015 - Plenary Session 2
Poor
Excellent
Diagnosis
No Prehabilitation
Pre
Treatment
Treatment
QOL GUIDELINES ?
• 1st Step : Assessment
– Scores and Scales
– Multidisciplinary discussions
• 2nd Step : Prehabilitation
17
Treatment Choice
QOL GUIDELINES ?
• 1st Step : Assessment
– Scores and Scales
– Multidisciplinary discussions
• 2nd Step : Prehabilitation
• 3d Step : Safety (Elderly specificities ?)
18
Treatment Choice
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Pre-Intervention
1. Numbness and
tingling
2. Hot/coldness in
hands/feet
Post-Intervention
1. Numbness and
tingling
2. Hot/coldness in
hands/feetChemo alone
N = 138
6 weeks
Exercise + chemo
N = 176
ASCO 2016. Abs 10000. Ian Kleckner, PhD, University of Rochester Medical Center, NY
A URCC NCORP Nationwide Randomized Controlled Trial
Exercise Reduces CIPN More For Older Patients
N = 314
ES=0.61p = 0.08
(ANCOVA)
ES=0.60p = 0.10
(ANCOVA)
Demographic Predictors of CIPN
Grade 2-4
OR P-Value
Grade 3-4
OR P-Value
Mean Age 1.04 0.006 1.04 0.03
Race
White
Black
Asian
Ref.
0.84
2.00
0.52
0.16
Ref.
0.86
3.63
0.70
0.02
Taxane
Doxetaxel
Paclitaxel
Ref.
2.20 <0.001
Ref.
2.86 <0.001
Platinum
No
Yes
Ref.
1.68 0.004
Ref.
1.08 0.77
ASCO 2016. Abs 10001 Dawn L. Hershman
No differences in:• Gender
• Ethnicity• Time of Registration
• Cancer Stage
• Planned time on treatment
Comorbidities and Risk of CIPN Among
Participants > 65 in SWOG Clinical Trials
KIDNEY ASSESSMENT
CREATININE VS RENAL FUNCTION
Creatinine
85 µmol/l
GFR
~ 100 ml/mn
GFR
~ 40-50 ml/min
22 y, 63 kg 72 y, 53 kg
Chemotherapy-Induced Nausea and Vomiting
(CINV) - Impact on Quality of Life -
* P = 0.001
Functional Living Index–Emesis (FLIE): Adapted from CM Lindley et al. Qual Life Res. 1992;1:331–340; used with permission
from Kluwer Academic Publishers © 1992.
*
(N = 122)
Patients experiencing CINV Patients without CINV
EMESISCONSIDERING OF INDIVIDUAL RISK FACTORS FOR
THE PROPHYLACTIC TREATMENT ALGORITHM
• Female Gender
• Young age
• History of chemotherapy
• Anxious personality
• Minimal alcohol use (Caveat ≥5 drinks week is protective)
• History of emesis during pregnancy
• History of motion sickness
Roila F, J Clin Oncol 1991; 4: 675-8, Morrow G, Support Care Cancer 2002; 10: 96-105, Warr D, Support Care
Cancer 2010
CONSIDERING OF INDIVIDUAL RISK FACTORS FOR
THE PROPHYLACTIC TREATMENT ALGORITHM
• Female Gender
• Young age
• History of chemotherapy
• Anxious personality
• Minimal alcohol use (Caveat ≥5 drinks week is protective)
• History of emesis during pregnancy
• History of motion sickness
Roila F, J Clin Oncol 1991; 4: 675-8, Morrow G, Support Care Cancer 2002; 10: 96-105, Warr D, Support Care
Cancer 2010
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FEBRILE NEUTROPENIA AND QOL
Impact of FN on Quality Of Life:
- Fatigue
- Fever / Infection
- Complications (mucositis, pain, denutrition…)
Impact of GCSF on QOL (pts with FN)
- Improvement in health, functioning, socio-economic
25
Fazio MT et al. Oncol Nurs Forum 1991; 18:1411-4
Jones EA et al. JAMA 1993; 270: 1132-3.
FEBRILE NEUTROPENIA MASCC/EORTC Guidelines
FN: Febrile neutropenia
Aapro MS, et al. EORTC guidelines. Eur J Cancer 2011;47:8-32
Updated by Flowers CR, et al. J Clin Oncol. 2013;31(6):794-810
Step 1Assess frequency of FN associated with the planned chemotherapy regimen
Step 1Assess frequency of FN associated with the planned chemotherapy regimen
FN risk ≥20% FN risk 10–20% FN risk <10%
Step 3Define the patient’s overall FN risk for planned chemotherapy regimen
Step 3Define the patient’s overall FN risk for planned chemotherapy regimen
Overall FN risk ≥20% Overall FN risk <20%
Prophylactic G-CSF recommendedProphylactic G-CSF recommended Prophylactic G-CSF not indicatedProphylactic G-CSF not indicated
Reassess at each cycle
Reassess at each cycle
Step 2Assess factors that increase the frequency/risk of FN
High risk Age >65 years
Increased risk (level I and II evidence)
Advanced disease
History of prior FN
No antibiotic prophylaxis, no G-CSF use
Other factors (level III and IV evidence)
Poor performance and/or nutritional status
Female gender
Hemoglobin <12g/dL
Liver, renal or cardiovascular disease
G-CSF: A NEW ALGORITHM?
FN risk between 10 and
20%
FN risk <10%FN risk >20%
Evaluation of
individual risk factors
NoYes
Long-acting G-CSF
(ex: pegfilgrastim)(+/- prophylactic antibiotherapy?)
Short acting G-CSF
(ex: filgrastim)(+/- prophylactic antibiotherapy?)
Klastersky JA, et al. MASCC 2012
In 1962, 91% of
patients with leukemia
died from FN
In 2007, FN-related
death rate was 13% in
solid tumors and 9%
in hematological
malignancies
HospitalMedical Call Center
Patient1- Physician sends
patient enrollment
form to call center
nurse 2- Call center
nurse calls patient
to collect toxicity
data
4- Call center
nurse sends patient
data to the
pharmacy3- Call center receives
lab work results5- After physician’’’’s
validation, pharmacist
prepares the chemotherapy
6- Oncology team is ready for patient arrival.
Chemotherapy is waiting for patient
PROCHE Program : PRO programs ?
Period = 01.2009 – 02.2011
1037 pts = prospective inclusion
513 pts = standard of care cohort
P=0,003
P<0,0001
Wait before treatmentEvolution of incidence
Fatigue (A) and Pain (B)
PROCHE Program
Scotté F. et al. Eur J Cancer 2013.
Scotté F. Oncologist 2012.
Scotté F et al. Supportive Care Cancer 2014.
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QOL GUIDELINES ?
• 1st Step : Assessment
– Scores and Scales
– Multidisciplinary discussions
• 2nd Step : Prehabilitation
• 3d Step : Safety
– Prevention / Follow Up
31
Treatment Choice
« THE CANCER COURSE »
32
Supportive care
Palliative care
Hospice care
No Disease Curable Cancer Uncurable Cancer
Survivorship
Dying
EVOLUTION DEPENDING …HABILITATION !
0
10
20
30
40
50
60
70
80
90
100
0 4 8 12 16 20 24 28 32 36
Health/
Dis
abili
ty
Silver J. - MASCC® 2015 - Plenary Session 2
Poor
Excellent
Diagnosis
Rehabilitation
No Prehabilitation
Pre
Treatment
Treatment Survivorship
QOL GUIDELINES ?
• 1st Step : Assessment
– Scores and Scales
– Multidisciplinary discussions
• 2nd Step : Prehabilitation
• 3d Step : Safety
– Prevention / Follow Up
• 4th Step : Survivorship / Disability - Palliative
34
Treatment Choice
Take Home Message
YES WE NEED GUIDELINES
“Supportive care makes excellent
cancer care possible”
Dorothy M.K. Keefe, past MASCC president
Save the Date 2017
28/11/2016
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For the most comprehensive online source on all QoL in oncology issues please visit:
http://qualityoflife.elsevierresource.com/http://qualityoflife.elsevierresource.com/http://qualityoflife.elsevierresource.com/http://qualityoflife.elsevierresource.com/
� Editor-in-chief Dr. Matti Aapro
� Original research and review articles
� Opinion pieces and interviews with key opinion leaders
� News from conferences and meetings
Supported by an educational grant from Helsinn Healthcare SA