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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 ?

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QOL GUIDELINES ?

• 1st Step : Assessment

– Scores and Scales

– Frailty

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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

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• ONCODAGE (G8) Score:

– French NCI : Objective = 100% patients ≥ 75 years

– Completion rate : ? (ex Bretagne = 12% in 2013)

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Soubeyran P. 2011

INCa 2016

UCOG Bretagne- Rapport Activité 2014

QOL GUIDELINES ?

• 1st Step : Assessment

– Scores and Scales

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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

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Global Assessment

QOL GUIDELINES ?

• 1st Step : Assessment

– Scores and Scales

– Multidisciplinary discussions

• 2nd Step : Prehabilitation

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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

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Treatment Choice

QOL GUIDELINES ?

• 1st Step : Assessment

– Scores and Scales

– Multidisciplinary discussions

• 2nd Step : Prehabilitation

• 3d Step : Safety (Elderly specificities ?)

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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

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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

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Treatment Choice

« THE CANCER COURSE »

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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

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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

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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