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Anemia e Fatigue P Pronzato SC Oncologia & Ematologia, Dip Oncologico La Spezia.

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Presentation on theme: "Anemia e Fatigue P Pronzato SC Oncologia & Ematologia, Dip Oncologico La Spezia."— Presentation transcript:

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 Genital tract Menstrual problems Loss of libido Vascular system Low skin temperature Pallor of skin, mucous membranes and conjunctivae Adapted from Ludwig H, et al. Semin Oncol. 1998;25:2-6.

6 Fatigue

7 FACT-Fatigue subscale scores: baseline scores from US general population and US anaemic cancer patients FACT-Fatigue subscale scores Percentage of the population US general population (n = 1,010) 01–45–89–1617–2526–3637–4849–5051–52 US anaemic cancer patients (n = 2,292)

8 Q: While Undergoing Your Most Recent Treatment, How Often Did You Feel Fatigue? Don’t know / refused 4% Hardly ever 21% Only a few days each month 17% At least once a week 11% Every day 30% On most days 18% 76% at least monthly Base: Chemotherapy patients (N=379 Curt, 2000

9 Ability to work Physical well-being Ability to enjoy life in the moment Emotional well-being Intimacy with partner Ability to take care of family Relationship with family and friends 44% 42% 38% 51% 57% 60% 61% Impact of Fatigue on Daily Activities for patients on treatment Curt, 2000

10 Patients and oncologists reporting the major symptom affecting patient’s daily life Response (%) nPatients (n=419) nOncologists (n=197) Vogelzang (1997) Fatigue61%37% Pain19%61% Both5%2%

11 Anemia, QoL & ESP

12 Anemia in Oncology Overall P=0,0057 Epoetin alfa Placebo % (n) Patients transfused ,7% 39,5% 28,2% 7,1% 20,0% 10,5 g/dl >10,5 g/dl ,2%

13 Anemia in Oncology weeks Hb (g/dl) ± 2 ESM Epoetin alfa Placebo

14 Effect of epo on QoL: RCT StudyNo. pts QoL impactQoL tools Littlewood JCO YES LASA, FACT-An, FACT-F, SF-36 PCS Osterborg JCO YES FACT-An, FACT-F, FACT-G Vansteenkiste JNCI YESFACT-F Boogaerts Br J Cancer YES VAS, FACT-An, FACT-F, SF- 36 PCS

15

16 ECAS

17 ECAS Chemo patients - Hb nadir < 11 g/dl (n = 4622) Ludwig H, et al. Eur J Cancer. 2004;40: ESP*Transfusion † Iron onlyNo Treatment Patients (%) Treatment Administered n = 1’044 (23%) n = 1’008 (22%) n = 283 (6%) n = 2’287 (49%) *Includes patients who received ESP only, ESP + transfusion, ESP + iron, or ESP + transfusion + iron; † Includes patients who received transfusion only and transfusion + iron

18 GUIDE-LINES

19 Cancer-Related Anaemia 20%–60% 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 Guidelines Search Strategy and Results Strategy –MEDLINE (1996–2003) –PreMEDLINE –Abstract search (2000–2003; AACR, 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 Guidelines Search Strategy and Results Strategy –MEDLINE (1996–2003) –PreMEDLINE –Abstract search (2000–2003; AACR, 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 of 9–11 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 of 9–11 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 of 9–11 g/dL, to prevent a further decline according to individual factors (type of CT,..) (grade D)

28 EORTC Anaemia Guidelines Starting ESP In cancer patients receiving chemo-therapy and/or radiotherapy who have normal Hb value at the start of treatment. The use of ESP is not recommended (grade B)

29 EORTC Anaemia Guidelines Target The target Hb should be 12–13 g/dL Treatment should be continued as long as Hb remains  12–13 g/dL and patients show symptomatic improvement (grade B)

30 EORTC Anaemia Guidelines Target 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 Gralla, Semin Oncol 2002 QUALITY OF LIFE DIFFERENCES BY TREATMENT GROUPS

34 TAX 326: QUALITY OF LIFE Fossella, JCO 2003 DOCETAXEL-BASED REGIMENS BETTER LCSS Euro Qol

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 Emotionalwell-being – coping – distress – enjoyment Functional well-being – ADLs – role performance Social well-being – social activity/support – relationship quality – family well-being QL

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) in 1 –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 points 2 –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 of 0.5 SD 1 Cella D, et al. Cancer. 2002;94: Cella D, et al. J Pain Symptom Manage. 2002;24: 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 Gphysical emotionalfunctionalsocial -FACT A subscale -FACT F subscale overall Numeric Rating Scale (NRS) -energy -ability to work overall

47 Correlation Hb Response/ Fatigue Hb responders Hb NON responders Change in FACT- F (effect size) SOLID TUMORS (0.45) LYMPHO- PROLIFERATIVE (0.39) WITHOUT CT (0.85) ALL (0.50)

48 Clinically meaningful improvement in FACT F and changes in HRQOL ImprovementNO improvement P FACT physical < FACT social FACT emotional < FACT functional < FACT G overall < NRS energy < NRS activity < NRS overall <0.0001

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 Glaspy — Demetri Gabrilove Overall QOL (100-mm LASA) Glaspy 3 x U/WeeK Demetri 3 x U/Week Gabrilove 1 X U/Week Hb (g/dL) Cancer-related Anaemia Epoetin Alfa Community-based Studies Incremental Improvement in Overall QOL

51 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 CLINICAL BENEFIT AND QUALITY OF LIFE CT IN NON SMALL CELL LUNG CANCER

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

53 TAX 317: OPIOIDS ANALGESIC USE CHANGES FROM BASELINE Gralla, Semin Oncol 2002

54 PERCENTAGE OF PATIENTS WITH WEIGHT LOSS >10%

55 FATIGUE, QUALITY OF LIFE AND ANEMIA

56 Pathogenesis of fatigue and cognitive function impairment Musclefunction – lactate – neuromuscular – cytokines Metabolicneeds – hypermetabolic states Reduced substrate – nutrition – anemia – hypoxia Affectivedisorders Fatigue Cognitive Impairment

57 Pathogenesis of fatigue and cognitive function impairment Musclefunction – lactate – neuromuscular – cytokines Metabolicneeds – hypermetabolic states Reduced substrate – nutrition – anemia – hypoxia Affectivedisorders Fatigue Cognitive Impairment Genetics ?

58 Pathogenesis of fatigue and cognitive function impairment Musclefunction – lactate – neuromuscular – cytokines Metabolicneeds – hypermetabolic states Reduced substrate – nutrition – anemia – hypoxia Affectivedisorders Fatigue Cognitive Impairment Anticancer treatments Genetics ?

59 Pathogenesis of fatigue and cognitive function impairment Musclefunction – lactate – neuromuscular – cytokines Metabolicneeds – hypermetabolic states Reduced substrate – nutrition – anemia – hypoxia Affectivedisorders Fatigue Cognitive Impairment Anticancer treatments Genetics ?

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 spesa Agenti 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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