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Anemia e Fatigue

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Several different factors can contribute to anemia in cancer including ... D Cella, Ann Oncol 2004. Glaspy 267 740 918 833 308 287 223 ... – PowerPoint PPT presentation

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Title: Anemia e Fatigue


1
Anemia e Fatigue
P Pronzato SC Oncologia Ematologia, Dip
Oncologico La Spezia
2
Anemia
3
Anemia in Oncology
  • Several different factors can contribute to
    anemia in cancer including
  • CHEMOTHERAPY AND RADIOTHERAPY
  • ERYTHROPOIESIS INHIBITING CYTOKINES
  • BLEEDING, DEFICIENCIES, INFECTIONS
  • METASTASES IN BONE MARROW

4
Anemia in Oncology
  • Anemia is highly prevalent
  • Anemia is under-recognized
  • Anemia has an enormous impact on patients and
    their families/ caregivers

5
The symptoms of anaemia affect multiple body
systems
  • CNS
  • Debilitating fatigue
  • Dizziness, vertigo
  • Depression
  • Impaired cognitive function
  • Immune system
  • Impaired T cell and macrophage function
  • Cardiorespiratory system
  • Exertional dyspnoea
  • Tachycardia, palpitations
  • Cardiac enlargement, hypertrophy
  • Increased pulse pressure, systolic ejection
    murmur
  • Risk of life-threatening cardiac failure
  • Gastro-intestinal system
  • Anorexia
  • Nausea
  • Vascular system
  • Low skin temperature
  • Pallor of skin, mucous membranes and conjunctivae
  • Genital tract
  • Menstrual problems
  • Loss of libido

Adapted from Ludwig H, et al. Semin Oncol.
1998252-6.
6
Fatigue
7
FACT-Fatigue subscale scores baseline scores
from US general population and US anaemic cancer
patients
40 32 24 16 8 0
US general population (n 1,010)
US anaemic cancer patients (n 2,292)
Percentage of the population
0 14 58 916 1725 2636 3748 4950 5152
FACT-Fatigue subscale scores
8
Q While Undergoing Your Most Recent Treatment,
How Often Did You Feel Fatigue?
Every day30
Dont know / refused4
Hardly ever21
76 at least monthly
On most days18
Only a few dayseach month17
At least oncea week11
Base Chemotherapy patients (N379
Curt, 2000
9
Impact of Fatigue on Daily Activities for
patients on treatment
Ability to work
61
Physical well-being
60
Ability to enjoy life in the moment
57
51
Emotional well-being
44
Intimacy with partner
42
Ability to take care of family
38
Relationship with family and friends
Curt, 2000
10
Patients and oncologists reporting the major
symptom affecting patients daily life
  • Patients (n419)
  • Oncologists (n197)

0
20
40
60
80
Response ()
Vogelzang (1997)
11
Anemia, QoL ESP
12
Anemia in Oncology
44
43
42
42,2
41
40
Epoetin alfa Placebo
39,5
35
30
25
28,2
24,7
(n) Patients transfused
20
20,0
15
10
5
7,1
0
Overall P0,0057
?10,5 g/dl
gt10,5 g/dl
13
Anemia in Oncology
15
Epoetin alfa Placebo
14
13
12
Hb (g/dl) 2 ESM
11
10
9
8
0
4
8
12
16
20
24
28
weeks
14
Effect of epo on QoL RCT
15
(No Transcript)
16
ECAS
17
ECASChemo patients - Hb nadir lt 11 g/dl (n
4622)
n 2287(49)
n 1044(23)
Patients ()
n 1008(22)
n 283(6)
ESP
Transfusion
Iron only
No Treatment
Treatment Administered
Includes patients who received ESP only, ESP
transfusion, ESP iron, or ESP transfusion
iron Includes patients who received transfusion
only and transfusion iron
Ludwig H, et al. Eur J Cancer. 2004402293-2306.
18
GUIDE-LINES
19
Cancer-Related Anaemia
  • 2060 of patients with cancer will have anaemia
    at presentation
  • Chemotherapy, radiotherapy and the disease itself
    can all worsen the incidence of anaemia
  • Often under-diagnosed and under-recognised by
    physicians
  • Treatment involves watchful waiting, red blood
    cell (RBC) transfusion or erythropoiesis
    stimulating protein (ESP) therapy

Guidelines needed
20
Need for European Guidelines?
  • US guidelines are based on data published up to
    2001
  • Treatment guidelines must be reviewed and updated
    regularly to remain current
  • Several important randomised, controlled trials
    have since been published
  • A new ESP has been approved for use in cancer
    patients with anaemia since 2001

21
Need for European Guidelines?
  • US guidelines are based on data published up to
    2001
  • Treatment guidelines must be reviewed and updated
    regularly to remain current
  • Several important randomised, controlled trials
    have since been published
  • A new ESP has been approved for use in cancer
    patients with anaemia since 2001

22
EORTC Anaemia GuidelinesSearch Strategy and
Results
  • Strategy
  • MEDLINE (19962003)
  • PreMEDLINE
  • Abstract search (20002003AACR, ASCO, ASH,
    ECCO, EHA, ESMO)
  • Results
  • A total of 78 published studies relating to the
    administration of ESPs to anaemic patients with
    cancer were considered to be relevant (from a
    total of 235 studies identified by the search)
  • An additional 50 relevant abstracts were
    identified

AACR American Association for Cancer Research
ECCO European Conference on Clinical Oncology
EHA European Hematology Association ESMO
European Society for Medical Oncology
23
EORTC Anaemia GuidelinesSearch Strategy and
Results
  • Strategy
  • MEDLINE (19962003)
  • PreMEDLINE
  • Abstract search (20002003AACR, ASCO, ASH,
    ECCO, EHA, ESMO)
  • Results
  • A total of 78 published studies relating to the
    administration of ESPs to anaemic patients with
    cancer were considered to be relevant (from a
    total of 235 studies identified by the search)
  • An additional 50 relevant abstracts were
    identified

AACR American Association for Cancer Research
ECCO European Conference on Clinical Oncology
EHA European Hematology Association ESMO
European Society for Medical Oncology
24
EORTC Guidelines
  • Additional causes of anemia should be corrected
    prior to ESP therapy
  • Consider transfusions if the Hb level is 8 or
    below depending on
  • Acuteness or chronicity of anemia
  • Patient specific issues

25
EORTC Anaemia Guidelines Starting ESP
At a Hb of911 g/dL, based on anaemia-related
symptoms (grade A)
In cancer patients receiving chemo-therapy and/or
radiotherapy
26
EORTC Anaemia Guidelines Starting ESP
At a Hb of911 g/dL, based on anaemia-related
symptoms (grade B)
In cancer patients not receiving chemo-therapy
and/or radiotherapy
27
EORTC Anaemia Guidelines Starting ESP
In asymptomatic anemic cancer patients receiving
chemo-therapy and/or radiotherapy
At a Hb of911 g/dL, to prevent a further
decline according to individual factors (type of
CT,..) (grade D)
28
EORTC Anaemia Guidelines Starting ESP
The use of ESP is not recommended (grade B)
In cancer patients receiving chemo-therapy
and/or radiotherapy who have normal Hb value at
the start of treatment.
29
EORTC Anaemia GuidelinesTarget
The target Hb should be1213 g/dL
Treatment should be continued as long as Hb
remains ? 1213 g/dL and patients show
symptomatic improvement (grade B)
30
EORTC Anaemia GuidelinesTarget
For patients who do not respond to the initial
dose of ESP
The decision of dose escalate cannot be generally
recommended and must be individualized (grade B)
31
EORTC Anaemia Guidelines
  • No predictive factors (EPO level in particular
    hematological malignancies) (grade B)
  • Slight increase risk of TE denpending on the
    target (grade B)
  • Addition of ESP in transfusion dependent patients
    (grade D)

32
About Quality of Life
33
QUALITY OF LIFE DIFFERENCES BY TREATMENT GROUPS
Gralla, Semin Oncol 2002
34
TAX 326 QUALITY OF LIFE
LCSS
Euro Qol
DOCETAXEL-BASED REGIMENS BETTER
Fossella, JCO 2003
35
QUALITY OF LIFE DEFINITION
Health-related quality of life represents the
functional effect of an illness and its therapy
upon a patient, as perceived by a patient itself.
36
QUALITY OF LIFE DIMENSIONS
Physical well-being disease symptoms
treatment side effects
Emotional well-being coping distress
enjoyment
Functional well-being ADLs role performance
QL
Social well-being social activity/support
relationship quality family well-being
37
Appropriate measures are essential for
documenting HRQOL benefits
  • It is essential to demonstrate the psychometric
    properties (feasibility, reliability and
    validity) of questionnaires used to assess HRQOL
  • Three methods used most often
  • reliability internal consistency reliability
    (Cronbach ?) and test-retest reliability
    (reproducibility over time in the absence of
    changes in patients health/clinical status)
  • validity relationship between HRQOL scores and
    other independent measures of patient health
    status and outcomes (eg, hospitalisation)
  • responsiveness changes in HRQOL scores
    corresponding to clinically relevant changes

38
FACT
  • Extensively validated and used in many
    multinational studies
  • The general FACT measure (FACT-G) consists of 27
    questions that comprise four scales
  • physical well-being scale (seven questions)
    measures nausea, pain, vitality, general malaise
    and problems meeting family needs due to physical
    condition
  • social/family well-being scale (seven questions)
    measures emotional support, isolation and sexual
    function
  • emotional well-being scale (six questions)
    measures coping, hopelessness, health-related
    worry and depression
  • functional well-being scale (seven questions)
    measures ability to work, acceptance of illness,
    sleep and enjoyment of life

39
Measurement of fatigue in cancer patients
40
Measuring anaemia-related fatigue
  • A supplement to the 27-question FACT-G was
    developed to capture the symptoms of anaemia ?
    FACT-An assessment
  • The supplement includes 20 questions
  • 13 questions are fatigue-related
  • seven questions are non-fatigue, anaemia-related
    symptoms
  • The 13 questions are combined to form the
    FACT-Fatigue subscale
  • All 20 questions are combined to form the FACT-An
    subscale
  • The sum of the FACT-G and FACT-An subscales is
    called the FACT-An total scale

41
FACT-An subscale non-fatigue, anaemia-related
symptoms
  • Seven questions answered on a 5-point scale (0
    not at all to 4 very much)
  • I have trouble walking
  • I feel lightheaded (dizzy)
  • I get headaches
  • I have been short of breath
  • I have pain in my chest
  • I am interested in sex
  • I am motivated to do my usual activities

42
FACT-Fatigue subscale items
  • Below is a list of statements that other people
    with your illness have said are important. Please
    indicate how true each statement has been for you
    during the past week

R reverse for scoring NR no reverse for
scoring
43
Interpretation of FACT-Fatigue subscale scores
  • Mean (SD) of FACT-Fatigue scores (on a scale of
    52) in1
  • general population 43.6 (9.4)
  • non-anaemic cancer patients 40.0 (9.8)
  • anaemic cancer patients 23.9 (12.6)
  • Minimally clinically important difference 3/52
    points2
  • based on observed FACT-Fatigue scale scores
    across groups of patients with meaningful
    differences in
  • disease response
  • performance status
  • Hb
  • verified from observed shifts in FACT-Fatigue
    scale scores of0.5 SD

1Cella D, et al. Cancer. 200294528-538. 2Cella
D, et al. J Pain Symptom Manage. 200224547-561.
SD standard deviation
44
About Quality of Life Fatigue
45
Hb levels
FATIGUE
HR QOL
Despite its logic and supporting evidence this
hypothesis has not been finally evaluated with
prespecified testing
46
Five randomized trials
FACT Anemia assessment -FACT G physical emotio
nal functional social -FACT A
subscale -FACT F subscale
Numeric Rating Scale (NRS) -energy -ability to
work overall
overall
47
Correlation Hb Response/ Fatigue
48
Clinically meaningful improvement in FACT F and
changes in HRQOL
49
Conclusions
  • Patients with Hb response reported greater
    increases in FACT F subscale (also in patients
    off chemotherapy)
  • Clinically meaningful improvement in
    self-reported fatigue is associated with HRQOL
    improvement

D Cella, Ann Oncol 2004
50
Cancer-related Anaemia Epoetin Alfa
Community-based Studies Incremental Improvement
in Overall QOL
Glaspy 3 x 10.000 U/WeeK
Demetri 3 x 10.000 U/Week
Gabrilove 1 X 40.000 U/Week
70
65
60
Overall QOL (100-mm LASA)
55
50
45
40
7
8
9
10
11
12
13
14
Hb (g/dL)
Glaspy 267
740 918 833
308 287 223 Demetri
59 352
770 753 547
391 313 160 Gabrilove
156 466 1134
1426 844 544
410 168
51
CT IN NON SMALL CELL LUNG CANCER
CLINICAL BENEFIT AND QUALITY OF LIFE
  • Clinical Benefit
  • Subjective or palliative control of common
    problems
  • Previously defined to evaluate
  • pain control
  • weight loss
  • performance status
  • Quality of Life
  • Multidimensional
  • Includes many areas not likely to be affected by
    chemotherapy

52
FACT-L AND LCS
Social well-being
Physicalwell-being
FACT-L
Emotional well-being
Functionalwell-being
Symptoms(LCS)
Seven-item LCS
  • Shortness of breath
  • Weight loss
  • Clear thinking
  • Coughing
  • Appetite
  • Tightness in chest
  • Ease of breathing

53
TAX 317 OPIOIDS ANALGESIC USE CHANGES FROM
BASELINE
Gralla, Semin Oncol 2002
54
PERCENTAGE OF PATIENTS WITH WEIGHT LOSS gt10
Gralla, Semin Oncol 2002
55
FATIGUE, QUALITY OF LIFE AND ANEMIA
56
Pathogenesis of fatigue and cognitive function
impairment
  • Reduced substrate
  • nutrition
  • anemia
  • hypoxia
  • Metabolic
  • needs
  • hypermetabolic
  • states
  • Muscle
  • function
  • lactate
  • neuromuscular
  • cytokines

Affective disorders
Fatigue Cognitive Impairment
57
Pathogenesis of fatigue and cognitive function
impairment
Genetics ?
  • Reduced substrate
  • nutrition
  • anemia
  • hypoxia
  • Metabolic
  • needs
  • hypermetabolic
  • states
  • Muscle
  • function
  • lactate
  • neuromuscular
  • cytokines

Affective disorders
Fatigue Cognitive Impairment
58
Pathogenesis of fatigue and cognitive function
impairment
Genetics ?
  • Reduced substrate
  • nutrition
  • anemia
  • hypoxia
  • Metabolic
  • needs
  • hypermetabolic
  • states
  • Muscle
  • function
  • lactate
  • neuromuscular
  • cytokines

Affective disorders
Anticancer treatments
Fatigue Cognitive Impairment
59
Pathogenesis of fatigue and cognitive function
impairment
Genetics ?
  • Reduced substrate
  • nutrition
  • anemia
  • hypoxia
  • Metabolic
  • needs
  • hypermetabolic
  • states
  • Muscle
  • function
  • lactate
  • neuromuscular
  • cytokines

Affective disorders
Anticancer treatments
Fatigue Cognitive Impairment
60
Il razionamento esplicito come strumento di
contenimento della spesa
STUDI CLINICI RANDOMIZZATI LINEE GUIDA
Razionamento
61
Il razionamento esplicito come strumento di
contenimento della spesaAgenti eritropoietici
Hb 9-11 g/dL (sintomi!!)
8-10 g/dL
62
The Practice of Medicine
  • The practice of medicine combines both science
    and art .. skill in the most sophisticated
    application of laboratory technology or the use
    of the latest therapeutic alone does not make a
    good physician ..combination of medical
    knowledge, intuition and judgement is the art of
    medicine
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