Download Matti S. Aapro

Lettura: Terapie di supporto e
qualità della vita: stato
dell'arte 2005
Matti S. Aapro
President
Multinational Association of Supportive Care in Cancer
WWW.MASCC.ORG
Definition of Supportive Care
• Supportive Care is the prevention and
management of the adverse effects of
cancer and its treatment.
• This includes physical and psychosocial
symptoms and side effects across the entire
continuum of the cancer experience
including the enhancement of rehabilitation
and survivorship.
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Importance of Supportive Care
„ Allows patients to tolerate and benefit from active therapy
more easily
„ Alleviates symptoms and complications of cancer
„
Reduces or prevents toxicities of treatment
„
Supports communication with patients about their
disease and prognosis
„
Eases emotional burden of patients and care givers
„
Helps cancer survivors with psychological and social
problems
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SOME AREAS OF SUPPORT
Febrile N…
: but are MASCC guidelines applied?
: remains an issue
„ Hairloss
: underdiagnosed ( this session )
„ Depression
: MASCC guidelines
„ Nausea/V
: guidelines need updating
Ð Wbc’s
: EORTC guidelines ( also this session )
‰ Anemia
: guidelines exist
‰ Diarrhea
: MASCC guidelines ( this session)
‰ Mucositis
‰ Osteoporosis : guidelines need updating
: « WHO guidelines »: but
‰ Pain
morphine is not available worldwide!
„
‰
etc etc ( this session: cachexia; bone pain; fatigue )
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WHAT DO PATIENTS WANT?
155 cancer patients receiving
chemotherapy
„ Australian urban teaching hospital
„ Patients selected symptoms from cards
„ Reported an average of 20 symptoms (13
physical and 7 psychosocial)
„ Key complaints: Nausea followed by
tiredness and loss of hair.
„
Griffin et al, Annals of Oncology 7:189-95, 1996
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WHAT DO PATIENTS WANT?
„
Patient needs and complaints vary
according to
– Treatment
– socio-cultural environment
– early, advanced or terminal disease
– AND WE SHOULD NOT « PRESUME » THAT
WE KNOW…
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Progress in Supportive Care
„A
NEGLECTED
ISSUE:
POLYPHARMACY
RISK OF DRUG INTERACTIONS INCREASES BY ABOUT
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7-13%%
PER DRUG USED, i.e. 100% risk at the 8th drug
Karas S Ann Emerg Med, 1981;10:627–30
CRITERIA DEFINING THE MAJOR
DEPRESSIVE EPISODE (DSM IV, 1994)
A At least five of the following symptoms for nearly two weeks, and marked
change form past functioning
1 Depressed mood all day
2 Loss of interest and pleasure
3 Weight loss or pain
4 Insomnia or hypersomnia
5 Restlessness or psychomotor retardation
6 Fatigue or loss of energy
7 Feeling of worthlessness (guilt)
8 Impaired concentration (indecisiveness)
9 Recurrent thoughts of death or suicide
B Significant impairment in social or occupational (academic) functioning
C and D same as for adjustment disorders
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USE THE GDS FOR SYSTEMATIC SCREENING !
DEPRESSION
IS SIGNIFICANT for at least 20% of
cancer patients
„ More frequent in elderly
„ Apparent ease of use of SSRI’s should not
lead to abuse
„ Use screening tools and consult an
expert; learn to use WELL two SSRIs
„
–
–
–
The Hospital Anxiety and Depression Scale (HADS)
The Beck Depression Inventory (BDI)
The GDS ( Geriatric Depression scale )
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Aapro M, Cull A. Depression in breast cancer patients.Ann Oncol. 1999 ;10:627-36
DEPRESSION is not ANXIETY
„
ANXIETY
LEADS TO BENZODIAZEPINE ABUSE
„
Always consider benzodiazepines as a
cause of « dementification » in an elderly
„
Benzodiazepine withdrawal can lead to servery
psycho-organic disorders
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Perceptions and Reality
Control of Emesis : not as good as one thinks
Physician and
Nurse Estimates
(N = 9)
Actual Patient
Results
(N = 80)
Acute Emesis
83%
72%
Delayed
Emesis
91%
59%
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Patients: 75% women, 90% received agents of moderate emetogenic risk.
Grunberg et al. ASCO; 2002; Abstract 996.
ANTIEMETIC GUIDELINE CONSENSUS
- Official Process Subscribed to by 9 International Oncology Groups International:
MASCC
North America:
- U.S.
ASCO, ONS, NCCN
- Canada
CCO
Europe:
ESMO, EONS
Africa:
SASMO
Australia:
COSA
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PERUGIA INTERNATIONAL CANCER CONFERENCE VII
MULTINATIONAL ASSOCIATION FOR SUPPORTIVE
CARE IN CANCER
CONSENSUS CONFERENCE ON ANTIEMETIC THERAPY
PERUGIA, March 29-31, 2004
The original slides ( this set is edited ) are provided to all by the
Multinational Association for Supportive Care in Cancer and can be
used freely provided no changes are made, and the MASCC logo
and date of the information are retained.
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See also J Supp Care Cancer February 2005
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COMMITTEE II and IV
-- Principles
Principles of
of Care
Care for
for Acute
Acute Highly
Highly and
and Moderately
Moderately Emetic
Emetic Settings
Settings --
UNANIMOUS CONSENSUS: CATEGORY I EVIDENCE
- Use the lowest tested fully effective dose
- No schedule is better than a single dose given
before chemotherapy
- The antiemetic efficacy and adverse effects of serotonin
antagonist agents are comparable in controlled trials
- Intravenous and oral formulations are equally effective
and safe*
- Always give dexamethasone with a 5-HT3 antagonist
before chemotherapy
* Palonosetron has only been investigated as an IV formulation.
June 2004 Multinational Association for Supportive Care in Cancer
© MASCC 2004
COMMITTEE V (2/2):
Guideline for prevention of delayed nausea and vomiting in patients
receiving moderately emetic chemotherapy:
Oral dexamethasone is the preferred treatment
MASCC level of confidence: high
MASCC level of consensus: high
ASCO level of evidence: II
ASCO grade of recommendation: A
------------------------------------------------------------------------------------------
A 5-HT3 receptor antagonist may be used as an alternative.
MASCC level of confidence: moderate
MASCC level of consensus: moderate
ASCO level of evidence: II
ASCO grade of recommendation: B
ASCO & ESMO data review
May change these
recommendations
June 2004 Multinational Association for Supportive Care in Cancer
© MASCC 2004
SUPPORTING ADEQUATE CHEMOTHERAPY
ADEQUATE DOSE-INTENSITY
=
ADEQUATE RESPONSE
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Hematopoietic Reserve
Declines With Age
Mean ANC nadir, AC adjuvant chemotherapy for breast cancer
<65 years (n = 32)
≥65 years (n = 11)
350
Nadir ANC (µL–1)
300
270
260
250
P = 0.2
200
179
P < 0.01
150
94
100
50
0
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1
Cycle
4
Dees E, et al. Cancer Invest. 2000;18:521-529.
Undertreatment May Cause Poor
Outcomes in Elderly Patients
„
Aggressive lymphoma
– older patients less likely to be treated for cure,
less likely to survive for 5 years, inspite of all GCSF data
„
Breast cancer
– older women less likely to be invited into clinical
trials, yet G-CSF proven to allow therapy
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Grigg et al Leuk Lymphoma. 2003;44:1503-8; Bouchardy et al J Clin Oncol Sept 2003
Kemeny M, et al. Proc Am Soc Clin Oncol. 2000; 19:602a, Abstract 2371.
St Gallen Breast Adjuvant therapy 2005
consensus
Dose dense for most?
YES
NO
ABSTAIN
6.9 % 86.2 %
6.9 %
„ Growth factors rather than dose reduction
YES
NO
ABSTAIN
48.3 %
37.9 %
13.8%
„
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EORTC guidelines for the use
of colony-stimulating factors
in elderly patients with cancer
Repetto L, Biganzoli L, Koehne CH,
et al. Eur J Cancer.
2003;39:2264-72
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Conclusions
„
In elderly patients with cancer, prophylactic
G-CSF
5 mcg/kg/day is recommended to
reduce the incidence of
– chemotherapy-induced neutropenia
– febrile neutropenia
„
There is insufficient data to make a similar
recommendation for the use of GM-CSF
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EORTC guidelines for the use
of erythropoietic proteins in
anaemic patients with cancer.
Bokemeyer C, Aapro MS, Courdi A,
et al
Eur J Cancer. 2004; 40:2201-16
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EORTC 2004 Guidelines
Key points
„
Additional causes of anaemia should be
corrected prior to erythropoietic protein
therapy
„
…iron deficiency, bleeding, nutritional
defects or haemolysis
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Bokemeyer et al. Eur J Cancer 2004; 40: 2201–2216
EORTC 2004 Guidelines
Patients
Additional facts for
consideration
Initiate
treatment (Hb
level)
Grade
Cancer
Undergoing CT
and/or RT
9–11 g/dl
A
Cancerrelated
anaemia
NOT undergoing CT
and/or RT
9–11 g/dl
B
Asymptomatic
anaemia
To prevent decline in
Hb according to
individual factors (eg
type/intensity of CT
or RT, baseline Hb)
9–11 g/dl
D
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CT=chemotherapy; RT=radiotherapy
Bokemeyer et al. Eur J Cancer 2004; 40: 2201–2216
EORTC 2004 Guidelines
They do NOT recommend
„
the prophylactic use of EPOs to prevent
anaemia in patients undergoing
chemotherapy and/or radiotherapy who
have normal Hb values at the start of
treatment (Grade B)
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Bokemeyer et al. Eur J Cancer 2004; 40: 2201–2216
EORTC 2004 Guidelines
„
„
The decision to dose-escalate cannot be
generally recommended and must be
individualised (Grade B)
Treatment should be continued as long as Hb
levels remain ≤12–13 g/dl and patients show
symptomatic improvement. For patients
reaching the target Hb, individualised titration
to lowest effective maintenance dose should be
made repeatedly (Grade D)
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Bokemeyer et al. Eur J Cancer 2004; 40: 2201–2216
EORTC 2004 Guidelines
„ ARE
THE BASIS FOR THE
SOON TO BE RELEASED
EMEA/CHMP harmonized SPC’s
for ESPs!
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Bokemeyer et al. Eur J Cancer 2004; 40: 2201–2216
World Health Organization Criteria for
Bone Loss: T-Score Calculation
Diagnosis
Lower limit of normal*
Osteopenia
Osteoporosis≥ –2.5
Severe osteoporosis
„
T score, SD
–1
–1 to –2.5
≥ –2.5 and ≥ 1 fracture
For every 1 SD ⇓ from normal, the relative risk
of fracture ⇑ by 1.5- to 2.5-fold
* Reference standard for “normal” BMD is a 30-year-old healthy
woman with optimal or peak BMD
WWW.MASCC.ORG
Kanis JA, et al. J Bone Miner Res. 1994;9:1137-1141.
National Osteoporosis Foundation, 2003.
Treatment of Osteoporosis
Estimated BMD
increase
„
Supplementation
0% - 4%
– Calcium (1,000 to 1,300 mg/day)
– Vitamin D (400 to 800 IU/day)
„
„
„
„
Hormone replacement therapy
SERMs (tamoxifen or raloxifene)
Calcitonin (intranasal)
Bisphosphonates
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National Osteoporosis Foundation, 2003.
*Reginster JY et al., Am J Med 1995;98(5):452-458
3% - 5%
1% - 2%
1% - 2%*
10%
Recommendations
ASCO, American Osteoporosis Society:
„ For all „High Risk“ patients:
„
ƒ This includes all patients on AI treatment
ƒ Annual BMD measurements
„
Treatment:
ƒ
ƒ
ƒ
T-Score > -1.5: Lifestyle, Reassurance
T-Score -1.5 to -2.5: Calcium, Vitamin D
T-Score <-2.5: Bisphosphonates
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Gnant M et al., SABCS 2004
ESO Bisphosphonates Task Force
COMPOSITION
M. Aapro (moderator)
J.J. Body
A. Paterson (Canada)
R. Coleman
I. Diel
M. Gnant
K. Albain (USA)
T. Howell
J. Gralow (USA)
R. Jakesz
E. McCloskey
T. Powles
R. Rizzoli
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BISPHOSPHONATES TASK FORCE
PROVISIONAL Recommendations for BrCa patients
„
„
Measurement of bone mineral density (BMD) in
all patients
- Before starting adjuvant chemotherapy, and
again after 1 year
- Before starting AIs, and again after 1 year
Treatment of bone loss tailored to
baseline BMD
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BISPHOSPHONATES TASK FORCE
PROVISIONAL Recommendations for BrCa patients
„
„
„
While awaiting the results of ongoing
trials:
- one may consider bisphosphonate treatment for all
premenopausal women becoming amenorrheic after
chemotherapy
- and preventative treatment of all women starting nonsteroidal AI therapy.
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Progress in Supportive Care
„
Supportive care is NOT only palliative care
Supportive care allows delivery of OPTIMAL
cancer therapy from all perspectives: first those
of the patient, then of the caregiver and the
health professional, and finally of the payer
„
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