ANZIANI E CANCRO CHE E COME FARE Prof. Roberto Bernabei Università Università Cattolica del Sacro Cuore Roma ANZIANI E CANCRO Future of Cancer Incidence in the United States: Burdens Upon an Aging, Changing Nation Smith B D et al. JCO 2009;27:2758-2765 ©2009 by American Society of Clinical Oncology Projected cases of all invasive cancers in the United States by age and sex. Smith B D et al. JCO 2009;27:2758-2765 ©2009 by American Society of Clinical Oncology Providing Cancer Care to a Graying and Diverse Cancer Population in the 21st Century: Are We Prepared? 2010 2030 By 2030 elderly 70% all cancer diagnosis +45% 1.600.000 cancer patients 2.300.000 cancer patients Influence treatment effectiveness Cancer Demographics Genetic Age Molecular Race Cellular Ethnicity Physiologic effects J. McKoy, A. Samara, C.Bennett; J Clin Oncol 27:1-2, 2009 Gemcitabine and Bevacizumab resulted in a superior response rate, time to progression, and survival than expected with gemcitabine alone. 2 WEEKS 2,020 €/SD Kaplan-Meier Curve of Overall Survival by VEGF Myths & misconceptions • The elderly do not want to be treated (“leave me alone”) • The elderly are not able to cope with chemotherapy – They are too frail to cope with treatment – They would find side‐effects too burdensome – Their QoL would suffer • They may find discussions about treatment options too stressful and want less information • Geriatric assessment...too long! The elderly do not want to be treated (“leave me alone” alone”) The Reality Patient preferences in the elderly are different from those of physicians, nurses, and caregivers French Cancer patients US Non-cancer Cancer patients patients Non-cancer patients Percentage willing to accept strong chemotherapy 77.8 34.0 70.5 73.8 Percentage willing to accept mild chemotherapy 100 67.9 88.5 95.2 Age range: 70–95 years; 29% aged >80 years 1. Extermann et al. J Clin Oncol 2003;21:3214–3219. 2. Slevin M et al. Br Med J 1990;300:1458–1460. 3. Bremnes RM et al. Eur J Cancer 1995;31:1955–1959. Myths & misconceptions • The elderly do not want to be treated (“leave me alone”) • The elderly are not able to cope with chemotherapy – They are too frail to cope with treatment – They would find side‐effects too burdensome – Their QoL would suffer • They may find discussions about treatment options too stressful and want less information • Geriatric assessment...too long! The elderly are not able to cope with chemotherapy • Age is not a contraindication to full‐dose chemotherapy – Chronological age does not reflect functional reserve or frailty of patient • Side‐effect management should be tailored to the individual and based on treatment‐related toxicities and the results of complete geriatric assessment The elderly are not able to cope with chemotherapy ` 407 women > 80 years old ` 50% undertreated – No surgery! or tumourectomy without radiation ` Reasons – Refusal (patients) : 14% – Physician or family decided… ` 5 year survival – « State of the art » : 90% – Lesser therapy : 46% Bouchardy et al. J Clin Oncol 2003;21;3580–3587. Chemotherapy and the elderly ` What are the true limitations? – Renal function – Liver function – Drug distribution and absorption – Drug interactions – Marrow reserves – Neurologic – Multimorbidity (malfunctioning) Multimorbidity Effect of diabetes on disease free-survival in an intergroup adjuvant trial in colon cancer. Meyerhardt JA et col,J Clin Oncol. 2003;21:433-440. Hyperinsulinemia is associated with a worse disease-specific survival in prostate cancer, colon cancer and breast cancer. Meyerhardt JA et col,J Clin Oncol 21:433-440,2003 Hammarsten J, Eur. J Cancer 41:2887-2895, 2005. Goodwin PJ et col., J Clin Oncol 20:42-51, 2002 Obesity is associated with a worse progression-free survival (PFS) in patients with ovarian cancer. Pavelka JC et al, Cancer 107:1520-1524, 2006 Chemotherapy and the elderly Conclusions Standard adjuvant chemotherapy is superior to capecitabine in patients with early-stage breast cancer who are 65 years of age or older. (ClinicalTrials.gov number, NCT00024102 [ClinicalTrials.gov] H.Muss, E.Winer et coll, CALGB investigators; NEJM 360:2055-65 2009 Baseline Characteristics of the Patients Kaplan–Meier Estimates of Relapse-free and Overall Survival According to Treatment Group. H.Muss, E.Winer et coll, CALGB investigators; NEJM 360:2055-65 2009 Kaplan–Meier Estimates of Relapse-free and Overall Survival According to Treatment Group. Outcomes at a Median Follow-up of 2.4 Years. Adverse Event H.Muss, E.Winer et coll, CALGB investigators; NEJM 360:2055-65 2009 Myths & misconceptions • The elderly do not want to be treated (“leave me alone”) • The elderly are not able to cope with chemotherapy – They are too frail to cope with treatment – They would find side‐effects too burdensome – Their QoL would suffer • They may find discussions about treatment options too stressful and want less information • Geriatric assessment...too long! They may find discussions about treatment options too stressful and want less information Jenkins et al examined the information needs of 2,331 cancer patients, 585 (25%) with breast cancer, 145 (6%) with urological cancer Jenkins V et al. B J Cancer 2001;84:48–51. Myths & misconceptions • The elderly do not want to be treated (“leave me alone”) • The elderly are not able to cope with chemotherapy – They are too frail to cope with treatment – They would find side‐effects too burdensome – Their QoL would suffer • They may find discussions about treatment options too stressful and want less information • Geriatric assessment...too long! What does a CGA bring? Setting Intervention Risk reduction for mortality Elderly Comprehensive geriatric assessment 14% Breast cancer Adjuvant chemotherapy 15.3% Myocardial infarction Beta-blocker 22% Extermann M, Aapro M. Hematol/Oncol Clins North Am 2000;14:63–77. CGA profiles of oncogeriatric population in various settings Assessments Oncogeriatric Outpatient US Oncogeritatric Out/inpatient Itay VA Oncogeriatric Outpatient US IM/Ger Inpatient Canada OACE US Age, years 75 72 68 79 74 ECOG 0-1 83 74 ADL independent,% 79 86 31 44 55 IADL independent,% 44 52 42 34 26 26 (GDS) 40 (GDS) 14 – 26 (HADS) 25 (MMSE<26) 37.8 (MMSE<24) Depression, % Cognitive impairment,% Comorbidity, % Polypharmacy 94 (CIRS) 24 (GDS) Mean MMSE 22 51 (Clock) 5 (OARS) 6 (mean) meds 6 (mean) meds Geriatric syndromes, % Disability, % Extermann M, Hurria A, J Clin Oncol 25:1824-1831, 2007 Elderly patients with cancer: cancer summary • Optimal therapy has the same efficacy in older and younger patients • Treatment tolerance is similar in older and younger patients - exception of haematotoxicity (G-CSF) • Assess first, treat later • Chronological age not have to guide treatment decisions for elderly cancer patients. Tumour biology, patient’s wishes and physical condition should. ANZIANI E CANCRO COME FARE GERIATRIC ONCOLOGY ….IS GERIATRIC? A short history of cancer treatment in the elderly NCCN guidelines US Geriatric Oncology Consortium National Cancer Institute & National Institute in Ageing sponsor a symposium Perspectives on prevention and treatment of cancer in the elderly 1983 1983 International The Venice statement. 1 Cancer in the elderly: why treated so badly? 1988 1988 Dr BJ Kennedy encouraged the study of ageing and cancer during the Presidential Address at 1990 1990 Society of Geriatric Oncology (SIOG) formed 1998 1998 First edition of 2000 2000 Comprehensive Geriatric Oncology released published practice guidelines for senior adult oncology4 founded to initiate trials and raise awareness of problems of elderly patients 2002 2002 2003 2003 First oncogeriatric guidelines published on the use of haematopoietic growth factors in elderly patients receiving cytotoxic chemotherapy2 ASCO 1988 1. Fentiman IS et al. Lancet 1990;335:1020-1022, 2. Bokemeyer C et al. Onkologie 2002; 25: 32–39, 3. Extermann M et al. Crit Rev Oncol Hematol 2005; 55: 241–252, 4. Balducci L. NCCN clinical practice guidelines in oncology. Senior Adult Oncology November 1, 2006, 5. J Clin Oncol 2007;25:1821–1944, 6. Eur J Cancer 2007;15:2141–2306. 2005 2005 CGA guidelines assessed by the SIOG.3 2006 2006 2007 2007 Special supplements in geriatric oncology published in JCO and EJC5,6 The Geriatric evaluation of elderly patients with cancer ` ` ` Is this patient going to die of cancer or with cancer ? Is this patient going to live long enough to suffer the consequences of cancer ? Is my patient able to tolerate the treatment ? ` Are some complications of cancer treatment more common in older individuals? ` Is the social network of my patient adequate to support him or her during the treatment ? How is my patient “functioning” ` Multidisciplinary team All older cancer patients Community Long Term Care Hospital Facility Hospice SCREENING (oncologist or geriatrician) FIT FRAIL FRAIL GERIATRICIAN (CGA) Oncologist Interdisciplinary Team: Oncologist, Geriatrician, Physical therapist, Usual Care Geriatric palliative care Professional Nurse, Psycho‐oncologist, Social Worker………. Modified approach Palliative Oncology Piano Oncologico Nazionale 2010/12 Integrazione/coordinamento dell’assistenza intra ed extraospedaliera al paziente anziano. E’ necessario garantire una presa in carico globale del paziente anziano con cancro dall’inizio del percorso diagnostico e terapeutico, attraverso un approccio multidisciplinare e multidimensionale sostenuto da un’organizzazione dipartimentale che garantisca il coordinamento dell’assistenza e delle cure oncologiche e geriatriche sia ospedaliere sia territoriali, Unità di Coordinamento di Onco-Geriatria. Tali Unità, da istituirsi presso le Aziende Ospedaliere e IRCCS di riferimento regionale, devono avere al loro interno le competenze oncologiche e geriatriche e devono essere in grado di gestire direttamente le prestazioni sanitarie erogate al paziente anziano. 2010 Workgroup oncologia geriatrica InterRAI-cancer unica VMD per il paziente anziano oncologico Survey per gli oncologi Survey per i geriatri SURVEY 2010 Quanti pazienti di eta’ >80 anni affetti da neoplasia sono stati visti presso la tua struttura nell’ultimo anno? Quale percentuale rappresentano? Ritieni che un paziente neoplastico di eta’ >70 anni vada trattato, se le sue condizioni generali lo consentano, con gli stessi protocolli terapeutici utilizzati per gli adulti di eta’ inferiore a 70 anni? Ritieni utile la creazione di protocolli terapeutici dedicati ai pazienti con neoplasia di eta’ > 70 anni? E’ necessaria una sezione di oncologia che si interessi dei pazienti con eta’ superiore ai 70 anni? SURVEY 2010 Quante consulenze geriatriche ti sono state richieste dagli oncologi in quest’ultimo mese? Ritieni utile frequentare programmi formativi aventi per argomento la gestione del paziente oncologico anziano? L’assistenza del paziente oncologico anziano rappresenta per te un problema? Ritieni utile uno strumento di screening per il paziente oncologico anziano? INTERRAI-CANCER Journal of Clinical Oncology Vol 21,April 2003: 1383-1389 Participation of Patients 65 Years of Age or Older in Cancer Clinical Trials Joy H. Lewis, Meredith L. Kilgore, Dana P. Goldman, Edward L. Trimble, Richard Kaplan, Michael J. Montello, Michael G. Housman, José J. Escarce From RAND Health, Santa Monica; the University of California Los Angeles and the West Los Angeles Veterans Affairs Medical Center, Los Angeles, CA; and the National Institutes of Health, National Cancer Institute, Bethesda, MD. Purpose: Although 61% of new cases of cancer occur among the elderly, recent studies indicate that the elderly comprise only 25% of participants in cancer clinical trials. Further investigation into the reasons for low elderly participation is warranted. Our objective was to evaluate the participation of the elderly in clinical trials sponsored by the National Cancer Institute (NCI) and assess the impact of protocol exclusion criteria on elderly participation. Patients and Methods: We conducted a retrospective analysis using NCI data, analyzing patient and trial characteristics for 59,300 patients enrolled onto 495 NCI-sponsored, cooperative group trials, active from 1997 through 2000. Our main outcome measure was the proportion of elderly patients enrolled onto cancer clinical trials compared with the proportion of incident cancer patients who are elderly. Results: Overall, 32% of participants in phase II and III clinical trials were elderly, compared with 61% of patients with incident cancers in the United States who are elderly. The degree of underrepresentation was more pronounced in trials for early-stage cancers than in trials for late-stage cancers (P < .001). Furthermore, protocol exclusion criteria on the basis of organ-system abnormalities and functional status limitations were associated with lower elderly participation. We estimate that if protocol exclusions were relaxed, elderly participation in cancer trials would be 60%. Conclusion: The elderly are underrepresented in cancer clinical trials relative to their disease burden. Older patients are more likely to have medical histories that make them ineligible for clinical trials because of protocol exclusions. Insurance coverage for clinical trials is one step toward improvement of elderly access to clinical trials. Without a change in study design or requirements, this step may not be sufficient.