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Multidimensional Geriatric Asses

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					Evaluation of the Frail Old Cancer
             Patient

            Silvio Monfardini
      Division of Medical Oncology
       Istituto Oncologico Veneto
                   Italy
          THE FRAIL PATIENT
           No broadly accepted definition

• Combination of aging, disease and other
  factors that make some people vulnerable
  to stress

• Poor tolerance to stress and at high risk of
  loss of independence
Causes of frailty
                    Fried et al.
Frailty in older adults. Evidence for a phenotype.
             J Gerontol. Med. Sci. 2001

• Loss of 10% or more of body weight in over 1
  year
• low energy level
• difficulty in initiating movements
• slow movements
• decreased grip strenght

Frailty is defined by three or more of these criteria
        Is frailty a disease?
By the Fried definition,
frailty is not a disease
but rather a sort of being in the middle
state
between being functional and
nonfunctional,
and between being healthy and being sick.
   Who are Elderly Frail Cancer
            Patients?
( The operational concept of aging in Medical Oncology)

They are those with age-associated conditions interfering
with treatment and possibly leading to no treatment and
barriers to trials entry such as:
• associated diseases
• functional status impairement
• mental deterioration and depression
• lack of family and social support
How to measure these age-associated conditions?
     Activity of daily living(ADL)


Based on 6 criteria

1.   Dressing
2.   Toilet Use
3.   Bathing with sponge, bath, or shower
4.   Transferring (in and out of bed or chair)
5.   Urine and Bowel Continence
6.   Eating
   Cumulative illness rating scale for geriatrics (CIRS-G)*
Rating:
0- No problem
1- Current mild problem or past significant problem
2- Moderate disability or morbidity/requires “first line” therapy
3- Severe/constant significant disability/ “uncontrollable” chronic problems
4- Extremely severe / immediate treatment required/end organ failure/severe
impairment in function

Organ system: Heart, Vascular, Haematopoietic, Respiratory, Eyes/ENT,
Larynx, Upper GI, Lower GI, Liver, Renal, Genitourinary,
Musculoskeletal/Integument, Neurological, Endocrine/Metabolic, Psychiatric
Illness
* Miller MD, Paradis CF. HoucK PR, Mazumdar S, Stack JA, Rifai AH et al., Rating
chronic mediacal illness burden in geropsychiatric practice and research: an application
of the Cumulative Illness rating scale, Psychiatry Res. 1992 41: 237-348
       The basic components of the
        Comprehensive Geriatric
           Assessment(CGA)
1.   Functional status ADL (Activity of Daily Living),
     IADL (Instrumental Activity of Daily Living)
2.   Comorbidity (number, type and rating of comorbid
     conditions)
3.   Cognition (Mini-Mental Status Examination)
4.   Depression (Geriatric Depression Scale)
5.   Polypharmacy
6.   Nutrition (Mini-Nutritional Assessment)
7.   Presence of Geriatric Syndromes (dementia,
     delirium, depression, failure to thrive, neglect or
     abuse, osteoporosis, falls, incontinence)
8.   Socio-economic factors
An operational definition of frailty for the
        Elderly Cancer Patient

              What defines a frail patient?


 • Dependence in one or more ADL
 • 3 or more severe comorbidities (CIRS)
 • Presence of one or more geriatric syndromes
 • Age> 85 years ?
     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
Groups              CGA parameters               Mortality Therapeutic
                                                 at 2 years implication
Group 1: Fit        • Functional independent     8-12%     Full dose treatment
patients              and without relevant
                      comorbidity
Group 2:            • Dependent in one or more   16-25%    Special precautions
Intermediate or       IADLs and/or one or two              (initial dose reduction,
vunerable             significant comorbid                 adequate home care,
                      conditions                           etc.)
patients
Group 3             • One or more ADLs           > 40%     Mainly palliation and
                    dependence, three or more              supportive care
frail patients:
                    severe comorbidities.
                    • One or more geriatric
                    syndromes
                    (Age > 85)
    CLINICAL VALUE OF SUBDIVIDING ELDERLY CANCER
    PATIENTS AS FIT, VULNERABLE AND FRAIL IN A GERIATRIC
    ONCOLOGY CLINIC.
                       Vamvakas L,Monfardini S.et.al. SIOG 2005


INTRODUCTION AND AIMS
The aim of this work was to
determine the relative amount of Fit,
Frail and Vulnerable patients and to
verify the therapeutic approach for
each subgroup in a Geriatric
Oncology Clinic.
               RESULTS
    Frail Patients according to MGE

           Follow up   Initial Visit   Total pts
            (79 pts)    (154 pts)      (233 pts)




FRAIL
           18 (22%) 40 (26 %)          58 (25%)
                       RESULTS
       Subdivision of Causes of Frailty
Age only                      9 (15.5 %)
ADL only                     16 (27.6 %)
Comorbidities only            7 (12.1 %)
Ger. Syndromes only           2 (3.4 %)

ADL + Age                     5 (8.6%)
ADL + Comorbidities           8 (13.8%)
ADL + Ger. Syndromes          8 (13.8%)
ADL + Comorbidities + Ger.    3 (5.1%)
Syndromes

ADL +/- Others               40 (69.0%)
   MANAGEMENT AND SURVIVAL
   OF FRAIL ELDERLY CANCER
   PATIENTS WITHIN A GERIATRIC
       ONCOLOGY PROGRAM

U. Basso1, L. Vamvakas2, C. Falci1, A. Jirillo1, E. Lamberti1, L.
M. Pasetto1, A. Brunello1, S. Tonti1, S. Lonardi1, S. Vigorelli1, S.
Monfardini1

 From the Department of Medical Oncology, Istituto Oncologico Veneto1,
    Padova, Italy; University General Hospital 2 , Heraklion, Greece.
                           METHODS
•To evaluate management and survival of all consecutive frail
patients  70 years, seen from October 2004 to December 2005
within our Geriatric Oncology Program.
•Frailty was defined by one or more of the following:
    age  85 years
    dependence in one or more ADL
    at least three grade 3 comorbidities, or one of grade 4 (CIRS-G scale)
    one or more geriatric syndromes
                                         [Balducci L, Cancer Control 2001].
           RATIONALE




Management of frail elderly
       patients:

     adapted treatment or only
       supportive care?

Few data on outcome and survival.
          RESULTS: PATIENTS


•   A total of 364 elderly patients
    underwent Multidimensional Geriatric
    Assessment: fit (26.4%), vulnerable
    (49.5%) and frail patients (24.2%)


•   88 eligible frail patients had a median
    age of 79 years (range, 70-93), 43.2%
    males.
         RESULTS: PATIENTS
     Treatment of 88 frail patients


                    No Therapy     Elderly Adapted
                       13%         Chemotherapy
                                         17%



Radiotherapy.
    7%                                          Standard
                                              Chemotherapy
                                                  17%

        Endocrine                Best supportive
         Therapy                      care
          32%                         14%
          RESULTS: CHEMOTHERAPY


• 8 patients gastro-intestinal tumors, 7 lung, 7 hematological
and 8 other sites.
These 30 Patients received
• standard regimens at standard doses (26.6%)
•or with  25% dose reduction (23.3%),
•age-adapted regimens at standard doses (43.3%)
or with reduced doses (6.6%).
       RESULTS:Chemotherapy
• Six patients (20%) derived some clinical benefit but
  only two (6.7%) showed a radiological response.
•    Twenty      patients    interrupted   chemotherapy
    prematurely due to either toxicity/death (23.3%) or
    refusal/drop out (43.3%).
                                 OVERALL SURVIVAL
So far, 30 patients have died (34%), with a projected 1 and
2-year overall survival of 61 and 35%, respectively.

                       1,0


                       0,9


                       0,8


                       0,7


                       0,6


                       0,5


                       0,4


                       0,3


                       0,2
      Cumulative Surviva




                       0,1


                           0,0    182,5    1365,0
                                             year      547,5     2730,0
                                                                   years   912,5

                                          Overall Survival (years)
              DISCUSSION
Frailty was observed in 1/4 of all patients our elderly
but it did not prevent treatment of tumor with either
chemo- or endocrine therapy in 66% of cases.

•Dose reductions or adapted regimens were frequently
applied,
• but almost 30% were still treated with regimens studied
only in younger patients.
                   DISCUSSION

• Chemotherapy: very few radiological responses,
some form of clinical benefit reported by 20% of
patients, high rate of early interruption due to toxicity
or refusal.
•New treatment algorythms are urgently needed in
order to help the oncologist in the pivotal decision of
whether to treat or not these patients.
  Definition of frailty from oncological causes

  • Neoplastic comorbidity grade 4

  • ADL < 6 due to neoplastic disease*
  • Grade 3 neoplastic comorbidity** plus two or
       more grade 3 comorbidities

•* Defined as any advanced tumor amenable with
chemotherapy or hormonotherapy, but not curable
** If ADLand /or tumor related comorbidity grade 4 may
improve after therapy, frailty may be reversible
                                 S.Monfardini and U.Basso
ONCOLOGICAL CAUSES OF FRAILTY
    (COMORBIDITY GRADE 4)


• Liver failure from primary or metastatic
  disease
• Pulmonary insufficiency from primary or
  metastatic disease
• Brain or meningeal extensive primary or
  metastatic disease
ONCOLOGICAL CAUSES OF FRAILTY
EXAMPLES OF INFLUENCE ON ADLS

• Cachexia
• Uncontrolled pain
• Loss of mobility from refractory pathological
  fractures
• Esofageal stenosis
• Intestinal obstruction
• Recurrent peritoneal effusion
ONCOLOGICAL CAUSES OF FRAILTY
 TO BE CONSIDERED IN GERIATRIC
          SYNDROMES


• Neoplastic urinary incontinence (due to
  neoplasia or surgical or RT sequelae)
• Neoplastic rectal incontinence (due to
  neoplasia or surgical or RT sequelae)
  Treatment of elderly cancer patients:we
     probably only know the tip of the
        iceberg,frail are in the base
                   Elderly selected for clinical studies



  ? %                  Elderly selected for empirical
                       treatment



? %                       Elderly not receiving any
                          treatment because of frailty,
                          lack of family support, other
                          age-associated conditions
Clinical trials in the elderly frail
      patients are lacking

• Elderly frail patients excluded from clinical
  trials
• Results from trials conducted with younger
  adults may not2 be applicable to the majority
  of elderly cancer patients
• Different chemotherapy regimens should also
  be tested in elderly frail patients3


                          2Brunello   A et al. Ann Oncol 2005;16:1276–1282
                        3Monfardini   S et al. Ann Oncol 2005;16:1352–1358
Example: A trial designed for frail
        elderly patients
      Barriers to the informed consent to be overcome
       in elderly (frail) cancer patients before trials
                             entry

•     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

				
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