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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. WWW.MASCC.ORG 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 WWW.MASCC.ORG 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 ) WWW.MASCC.ORG 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 WWW.MASCC.ORG 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… WWW.MASCC.ORG Progress in Supportive Care A NEGLECTED ISSUE: POLYPHARMACY RISK OF DRUG INTERACTIONS INCREASES BY ABOUT WWW.MASCC.ORG 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 WWW.MASCC.ORG 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 ) WWW.MASCC.ORG 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 WWW.MASCC.ORG 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% WWW.MASCC.ORG 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 WWW.MASCC.ORG 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. WWW.MASCC.ORG See also J Supp Care Cancer February 2005 WWW.MASCC.ORG 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 WWW.MASCC.ORG 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 WWW.MASCC.ORG 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 WWW.MASCC.ORG 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% WWW.MASCC.ORG 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 WWW.MASCC.ORG 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 WWW.MASCC.ORG 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 WWW.MASCC.ORG EORTC 2004 Guidelines Key points Additional causes of anaemia should be corrected prior to erythropoietic protein therapy …iron deficiency, bleeding, nutritional defects or haemolysis WWW.MASCC.ORG 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 WWW.MASCC.ORG 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) WWW.MASCC.ORG 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) WWW.MASCC.ORG 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! WWW.MASCC.ORG 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 WWW.MASCC.ORG 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: This includes all patients on AI treatment Annual BMD measurements Treatment: T-Score > -1.5: Lifestyle, Reassurance T-Score -1.5 to -2.5: Calcium, Vitamin D T-Score <-2.5: Bisphosphonates WWW.MASCC.ORG 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 WWW.MASCC.ORG 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 WWW.MASCC.ORG 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. WWW.MASCC.ORG 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 WWW.MASCC.ORG WWW.MASCC.ORG