Il trattamento medico delle neoplasie Il trattamento medico delle ...

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Il trattamento medico delle neoplasie Il trattamento medico delle ...

Il trattamento medico delle neoplasienei pazienti oltre i 70 anni: stato attualee sviluppi probabiliASSOCIAZIONE ITALIANA DI EPIDEMIOLOGIAOstuni,Ottobre 2OO7Silvio MonfardiniIstituto Oncologico Veneto, Padova


NEOPLASIA IN THE ELDERLY:DIMENSION OF THE PROBLEM“Prediction for year 2000 are that approximately 60-70% of the cancer will occur in person aged 65years or older: neoplasia in the elderly is anoncological time bomb”P.Boyle-Joint NCI-EORTC Meeting 1990, Venice


6000500040003000Heart DiseasesCancerStroke20001000045-54 55-64 65-74 75-84 85+Death rates by age for the 3 leading causes of death in 2002National Vital Statistics Report 2004


24Life expectancy at selected ages20161284060 65 70 75 80 85 90 95 100National Vital Statistics Report 2004


PIU’ ANZIANI MALATI DITUMORE>60% di tutti i tumori in persone >65 anni:in Italia 165000/270000 nuovi casi per anno>40% di tutti i tumori in persone >70 anniPiù assistenza per i pazienti anziani con tumore, più informazionesulla diagnosi precoce.


Se il rischio del tumore aumentacon l’età sarebbe importante:1. Che la prevenzione potesse essere fatta anchenegli anziani i ( stile di vita: alimentazione;iattività fisica; fumo;)2. Che la diagnosi precoce potesse essere fatta(esempio ca mammella, ca colon) anche dopo i65 anni;Questo per gli anziani oggi non succede,poiché è più difficile far giungere leinformazioni alla popolazione anziana


Le barriere da rimuovere:• Mancanza d’informazione e di supporto sociale• Mancanza di entusiasmo (anziano e operatoresanitario)• Impressione che età avanzata = breve spettanza divita, tolleranza limitata anche degli esami piùsempliciQuesto atteggiamento può essere responsabile dimolte morti inutili e di sofferenze che potrebberoessere evitabili


ONCOLOGIA MEDICAIOV - PADOVA Novembre 2003Campagna di informazioneo oncologica per gli anzianiLA QUALITA’ DI VITA NON HA ETA’Prof. SILVIO MONFARDINI


Campagna sociale sullaprevenzione “I migliori anni dellanostra vita”• Rivolgersi direttamente agli anziani sani;• Informazioni con piacevole intrattenimento nelBioparco;(Roma)• Entusiasmo e ribaltamento delle posizioni i i disfiducia e pessimismo nel titolo e nei fatti;


Platone “Apologia di Socrate”Capitolo II “La difesa dalle accuse antiche”…ma costui credeva sapere e non sapeva, io invece,come non sapevo,neanche credevo di sapere…Il nucleo centrale del pensiero di Socrateparte dal suo ammettere di non sapere.


Geriatric i Oncology: a retrospective ti look1980Clinical and epidemiological observationsRetrospective studies on selected elderlypatients2000MGA, Prospective studies (selected patients)


Who are Elderly Cancer Patients?( The operational concept of aging in Medical Oncology)They are those with age-associated conditionsinterfering with treatment and possibly leading totreatment limitations and barriers to trials entry:• associated diseases• functional status impairement• mental deterioration and depression• lack of family and social supportBefore trial entry an assessment of these conditionsBefore trial entry an assessment of these conditionsis needed


TREATMENT LIMITATIONS• Interference of age-associated conditions:- comorbidity- neurol. and mental deterioration- functional status t impairmenti - lack of family and social support• Age-associated limitations does not mean:- absence of optimal solutions oftherapeutic problems- clinical trials not feasible


LA SPERIMENTAZIONE CON CHEMIOTERAPIAANTITUMORALE: CONOSCIAMO SOLO LA PUNTADELL’ICEBERGPazienti anziani selezionati pergli studi clinici di fase II: “fit”Pazienti anziani non valutati perl’arruolamento in studi clinici operché fragili o vulnerabili


IS A SPECIFIC CHEMOTHERAPYNEEDED FOR THE MAINNEOPLASIA?Some drugs are better candidates forelderly: vinorelbine, gemcitabine,carboplatin, Caelix, etc.


ARE IN GENERAL CHEMOTHERAPYTREATMENT PLANS SUPERIMPOSABLEFOR ADULTS AND ELDERLY PATIENTS?In general not:- breast cancer- NSLCPartially: - NHL- Ovarian cancer- SLCLAt the moment yes: - colorectal cancer(but improvements - bladder cancerneeded)


WHY CHEMOTHERAPY INBREAST CANCER FOR ELDERLYSHOULD BE DIFFERENT:• Myelodepression is more common• Cardiotoxicity i it is more frequent• Alopecia is less tolerated


ADVANCED BREAST CANCERIN THE ELDERLY• Single agents chemotherapy could be thepreferred option :- vinorelbine- taxotere weekly- infusional 5-FU-Caelix ?- gemcitabine?• In fragile patients single agents shouldprobably be chosen


CURRENT CONTROVERSIES INCANCERShould Adjuvant Chemotherapy be used toTreat Breast Cancer in Elderly Patients (≥70years of age)?EJC 1998L. Balducci & M. Extermann I. Fentiman S. Monfardini & F. Perrone


SPECIFIC REGIMENS FORAGGRESSIVE NHL IN THE ELDERLY1984-1986 : CHOP ?1987 -regimens reducing the dose ofanthracyclines(eg. CAP/BOP, ACOP-B)-regimens reducing the dose intensity ofanthracyclines (eg. weekly chop)-regimens omitting anthracyclines(eg. VP-16/Teniposide)-Mitoxantrone-based regimens1997-Pirarubicin or Idarubicin containg regimens1998 : back to CHOP again


MILES – Conclusions• Polychemotherapy withgemcitabine + vinorelbine does notimprove any outcome as comparedto single-agent vinorelbine orgemcitabine• Single-agent chemotherapy shouldremain a standard for advancedancedNSCLC elderly patients• Role of cisplatin combinations inelderly to be establised


RESULTS FROM CLINICAL TRIALSBEGIN TO BE AVAILABLE FORselected( predominantly fit )ELDERLYWITH-NHL-NSCLC- breast ca.- new drugsand help in the medical decision makingprocess


The Comprehensive GeriatricAssessmentssessment(CGA) The basiccomponents1. Functional status (ADL, IADL)2. Comorbidity (n°, type and rating of comorbid conditions)3. Cognition (Mini-Mental Mental Status Examination)4. Depression (Geriatric Depression Scale)5. Polypharmacy6. Nutrition (Mini-Nutritional Assessment)7. Presence of Geriatric Syndromes (dementia, delirium,depression, failure to thrive, neglect or abuse, osteoporosisfalls, incontinence)8. Socio-economic factors


ADVANTAGES FROM CGA•Recognition of the frail and of the vulnerable person• Gross estimate of individual life-expectancyexpectancy• Estimate of individual treatment tolerance tochemotherapy• Management of underlying comorbid conditions• Prevention and management of malnutrition• Prevention and management of socialinadequacies• Common language for clinical trials


Clinical Definition and Therapeutic Implications of Aging(from L. Balducci et al. Cancer Control 8: 1-25, 2001 and Crit. Rew.Oncol.Haematol. 46: 211-220, 2003)A possible model for future controlled studies( in unselectedpatients)GroupsGroup 1: Fit patientsCGA parameters• Functional independent andwithout relevant comorbidityMortality at2 yearsTherapeutic implication8-12%Full dose treatmentGroup 2:Intermediate orvunerable patientsGroup 3frail patients:• Dependent in one or moreIADLs and/or one or twosignificant comorbid conditions• One or more ADLs dependence,three or more severecomorbidities.• One or more geriatric syndromes(Age > 85)16-25%Special precautions (initialdose reduction, adequatehome care, etc.)> 40% Mainly palliation andsupportive care


RESULTS (1)Classification of Patients according to MGEFollow upInitial VisitTotal pts(79 pts) (154 pts) (233 pts)FIT 17 (21%) 40 (26%) 57 (24%)VULNERABLE 44 (55%) 74 (48%) 118 (51%)FRAIL 18 (22%) 40 (26 %) 58 (25%)


TERAPIE MEDICHE NEI TUMORINELL’ANZIANO NELLA PRATICACLINICA• Farmaci “elderly friendly”• Schemi adatti o modificati• Terapia di supporto & riabilitazione in strettarelazione (es. trattamento dell’anemiariabilitazione funzionale)• Speciale attenzione alla prevenzione e altrattamento di alcune tossicità (es. ematologica,cardiaca, intestinale)


UN PAZIENTE PARTICOLARE


POSSIBILE DISCRIMINAZIONE?• Domanda delicata a chi potrebbeessere in parte accusato• Oltre il 60% dei primari che ilpaziente anziano con tumore siatalvolta discriminato


IL RAPPORTO CON I GERIATRI• Esiste ma nella minoranza dellestrutture• La Valutazione GeriatricaMultidimensionale è conosciuta maimpiegata di routine in pochi casi


Treatment of elderly cancer patients:weprobably only know the tip of theiceberg,frail are in the baseElderly selected for clinical studies? %Elderly selected for empiricaltreatment? %Elderly not receiving anytreatment because of frailty,lack of family support, otherage-associated conditions


Barriers to the informed consent to be overcomein elderly (frail) cancer patients before trialsentry• Hearing defects• Not easily readable document (small print)• Lack of understanding of the real meaning of the information(cognition deficit and/or very low scientific knowledge)• Family interference(Monfardini S., Prescribing anticancer drugs in elderly cancer patients,Eur. J. Cancer: 2002, 2341-2346)• Physician reluctance to provide full information


L’INFORMAZIONE AL PAZIENTEANZIANO CON TUMORE• accettazione della chemioterapia comenel giovane adultoi f i ò• consenso informato scritto, però,raccolto solo nel 70% dei casi e circa il100% nell’adulto.


IL CAMPO DELLA ONCOLOGIAGERIATRICAOncologia Medica(Clinica) i Epidemiologia,pde oog ricerca sperimentaleGeriatriaTerapie di supporto,riabilitazione,nutrizione iiONCOLOGIAGERIATRICACure palliative


LEVEL I EVIDENCEand GERIATRIC ONCOLOGY7060504030201001990- 1995- 2000- 2004-1991 1996 2001 2005PAPERS ONRCTsSearch terms: Cancer/elderly; title/abstract; +65; RCT( from Matti Aapro, updated)


GOALS (DEFINITION) of a dedicatedGeriatric Oncology Program (GOP):• To provide comprehensive care through amultidisciplinary approach (age-associatedassociatedconditions cancer management) inside andoutside the hospital• To reduce adverse outcomes (e.g. hospitalization,nursing home placement)• To educate health professionals, older patients, theirfamilies and the public•To conduct clinical trials in representative older pts.


SOME STUDIES CAN ONLY BE PLANNED, CARRIEDOUT OR STIMULATED BY THOSE INTERESTED INGERIATRIC ONCOLOGY1. Epidemiology of tumors in the elderly and associatedcomorbidity2. Development of “elderly friendly” drugs3. Trials in vulnerable and frail patients4. Studies on the optimal chemotherapy for breast cancer(primary and metastatic) and other solid tumors5. Study on the prognostic value of MGA6. Development of new models for the organization of theclinical and research activity7. Laboratory studies on senescence and cancer….


SUPPORT TO THE RESEARCH INAGING AND CANCER• Grants to NCI-NIA NIA (National Institute t ofAging)designated Cancer Centers to study Ageintegrated t aspects (2005):2525 million $ in 5 years• INCa – Oncogériatrie Mission- Oncogériatrie Board- Oncogériatrie GEC:- list of research protocols-suggestion, stimulations-advise on grants- 9 Programs of Oncogeriatrie, with a globalgrant of 1.273.000 €


WHY NOT TO THINK IN THE EU OF A NATIONALINSTITUTE DEDICATED TO GERIATRICONCOLOGY? (CONNECTED AND RELATED TO A GENERALHOSPITAL AND/OR A CANCER INSTITUTE)• Epidemiological research;• Clinical activity research;• Laboratory translational research on aging andcancer;• Training i in Geriatric i Oncology;• Geriatric Oncology Programs in the Institute tobe expanded outside• Education of elderly: early diagnosis, therapyetc.


WHY NOT ASK FOR AN EUROPEANCOORDINATED ACTION FOR GERIATRICONCOLOGY?• To coordinate, stimulate and grant - epidemiologicalstudies - laboratory research – clinical research in thefield of Geriatric Oncology• To promote Geriatric Oncology Programs in theEuropean Hospitals and Cancer Institutes• To develop training programs in Europe• To provide educational programs for elderly inEurope


THINK ALSO TO ONCOLOGY WITHINGERIATRICS• Geriatric Oncology Section in a Division ofGeriatry• Geriatricians i i also specialized din MedicalOncology are needed or with support of atrained Medical Oncologist• This Section need to be located in an hospitalwith a Pathology, Medical Oncology and aRadiotherapy Division


CONCLUSIONToward further developments of Geriatric Oncology, infavor of our old patientsGrowth of the clinical activity and researchNeed of recognition as a subspeciality, orat least as a peculiar field of activityNeed of the construction of a better networkInteraction with Epidemiologists,basicInteraction with Epidemiologists,basicscientists,etc.

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