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Anemia e Fatigue

Anemia e Fatigue. P Pronzato SC Oncologia & Ematologia, Dip Oncologico La Spezia. Anemia. Anemia in Oncology. Several different factors can contribute to anemia in cancer including CHEMOTHERAPY AND RADIOTHERAPY ERYTHROPOIESIS INHIBITING CYTOKINES BLEEDING, DEFICIENCIES, INFECTIONS

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Anemia e Fatigue

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  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. 1998;25:2-6.

  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 1–4 5–8 9–16 17–25 26–36 37–48 49–50 51–52 FACT-Fatigue subscale scores

  8. Q: While Undergoing Your Most Recent Treatment, How Often Did You Feel Fatigue? Every day30% Don’t know / refused4% Hardly ever21% 76% at least monthly On most days18% Only a few dayseach month17% At least oncea week11% Base: Chemotherapy patients (N=379 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. 61% Fatigue 37% 19% Pain 61% 5% Both 2% Patients and oncologists reporting the major symptom affecting patient’s daily life • Patients (n=419) • Oncologists (n=197) 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 P=0,0057 10,5 g/dl >10,5 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. ECAS

  16. ECASChemo patients - Hb nadir < 11 g/dl (n = 4622) n = 2’287(49%) n = 1’044(23%) n = 1’008(22%) Patients (%) 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. 2004;40:2293-2306.

  17. GUIDE-LINES

  18. 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

  19. 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

  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. EORTC Anaemia GuidelinesSearch 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

  22. EORTC Anaemia GuidelinesSearch 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 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

  24. EORTC Anaemia Guidelines Starting ESP In cancer patients receiving chemo-therapy and/or radiotherapy At a Hb of9–11 g/dL, based on anaemia-related symptoms (grade A)

  25. EORTC Anaemia Guidelines Starting ESP In cancer patients not receiving chemo-therapy and/or radiotherapy At a Hb of9–11 g/dL, based on anaemia-related symptoms (grade B)

  26. EORTC Anaemia Guidelines Starting ESP In asymptomatic anemic cancer patients receiving chemo-therapy and/or radiotherapy At a Hb of9–11 g/dL, to prevent a further decline according to individual factors (type of CT,..) (grade D)

  27. 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.

  28. EORTC Anaemia GuidelinesTarget Treatment should be continued as long as Hb remains  12–13 g/dL and patients show symptomatic improvement (grade B) The target Hb should be12–13 g/dL

  29. 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)

  30. 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)

  31. About Quality of Life

  32. QUALITY OF LIFE DIFFERENCES BY TREATMENT GROUPS Gralla, Semin Oncol 2002

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

  34. 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.

  35. 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

  36. 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

  37. 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

  38. Measurement of fatigue in cancer patients

  39. 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

  40. 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

  41. 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

  42. 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. 2002;94:528-538. 2Cella D, et al. J Pain Symptom Manage. 2002;24:547-561. SD = standard deviation

  43. About Quality of Life & Fatigue

  44. Hb levels FATIGUE HR QOL Despite its logic and supporting evidence this hypothesis has not been finally evaluated with prespecified testing

  45. Five randomized trials FACT Anemia assessment -FACT G physical emotional functional social -FACT A subscale -FACT F subscale Numeric Rating Scale (NRS) -energy -ability to work overall overall

  46. Correlation Hb Response/ Fatigue

  47. Clinically meaningful improvement in FACT F and changes in HRQOL

  48. 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

  49. Cancer-related Anaemia Epoetin Alfa Community-based StudiesIncremental 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

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