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A B S T R A C T S
S33
personnALisation de la prise en charge en OncoGériatrie)
has been launched in 2014, combining the cooperative group
GERICO/Unicancer dedicated to clinical research in geriatric
oncology and the large network of the Unités de Coordination
en Oncogériatrie (UCOG). It brings together expert forces
(clinicians and epidemiologists) to address issues related to
design of trials in elderly cancer patients.
Objectives:
Our objective was to conduct an overview of
criteria used as primary endpoints in RCTs for elderly cancer
patients.
Methods:
French trials conducted between 1998 and 2015
were identified based on trials’ registries, scientific societies and
cooperative groups: Institut National du Cancer (INCa), Société
Francophone d’Onco-Gériatrie (SoFOG), GERICO/Unicancer,
Association de Recherche sur les CAncers dont Gynécologiques
(ARCAGY-GINECO), Groupe Français de Pneumo-Cancérologie
(GFPC), Fédération Francophone de Cancérologie Digestive
(FFCD), GERCOR/Groupe Coopérateur Multidisciplinaire en
Oncologie. Information collected included: phase of the trial (1,
2, 3), nature and target of primary and secondary endpoints.
The nature of the primary endpoint was described as single
or combined, including composite endpoints (e.g. PFS), co-
primary endpoints (e.g. tumor response and tolerance), or co-
primary and composite endpoints [e.g. OS and quality of life
(QoL)]. In addition, target of the endpoint was classified as
“cancer-related”(e.g. OS, tumor progression, toxicity),“geriatric”
(e.g. QoL, autonomy), or “other” (e.g. feasibility of treatment,
patients’ adherence to treatment).
Results:
Of 102 trials listed, most were phase II (n=46) or
phase III (n=31). Sixty-four (62.7%), 27 (26.5%) and 20 (19.6%)
trials used cancer-related, geriatric or other target criteria for
primary endpoint respectively. Composite and co-primary
endpoints were frequently used in 54 (59.3%) and 10 (11%)
trials respectively.
Conclusion:
This work illustrates the important
heterogeneity of primary endpoints in RCT for elderly
cancer patients, both in terms of dimension/target (tumor-
centered versus patient centered) and nature (single primary
endpoint, co-primary, composite). Standardization and
guidelines on relevant endpoints to be used in RCT for elderly
cancer- patients are needed to improve and to allow better
comparative analysis across trials and to shape the design
of future programs addressing innovative strategies. The
ongoing international DATECAN-Elderly project is aimed at
developing these recommendations.
Disclosure of interest:
None declared
Keywords:
Clinical trial, endpoint, geriatric
O17
FRAILTY AND SYSTEMIC INFLAMMATION-BASED
GLASGOW PROGNOSTIC SCORE
M. Harneshaug
1,
*, L. Kirkhus
1
, J. Šaltyte-Benth
1,2,3
,
B. H. Grønberg
4,5
, S. Bergh
1
, J. E. Whist
6
, S. Rostoft
7
,
M. S. Jordhøy
3,8
1
Research Centre for Old Age Psychiatry, Innlandet Hospital TRUST,
Hamar,
2
HØKH, Research Center, Akershus University Hospital,
3
Institute of Clinical Medicine, Faculty of Medicine,, University
of Oslo, Oslo,
4
The Cancer Clininc, St. Olavs Hospital, Trondheim
University hospital,
5
Department of Cancer Research and Molecular
Medicine, NTNU, Norwegian University of Science and Technology,
Trondheim,
6
Department of Medical Biochemistry, Innlandet
Hospital TRUST, Lillehammer,
7
Department of Geriatric Medicine,
Faculty of Medicine, University of 0slo, Oslo,
8
The Cancer Unit,
Innlandet Hospital TRUST, Hamar, Norway
Introduction:
Ageing is associated with a chronic, low-
grade inflammatory state, which also is a feature in many
age-related diseases such as sarcopenia, dementia, metabolic
syndrome and depression. The systemic inflammation-based
Glasgow prognostic score (GPS) combines C-reactive protein
(CRP) and Albumin, and has been thoroughly validated as an
independent prognostic factor in a variety of cancer cohorts.
However, few have investigated the relationship between GPS
and frailty.
Objectives:
To investigate the relationship between frailty
identified by using a modified Geriatric assessment (mGA)
and the GPS.
Methods:
Prospective observational, multicenter study.
Eligible patients were
70 years with a newly diagnosed,
histologically confirmed cancer, or first relapse after previous
curative treatment. CRP, albumin and mGA were assessed at
inclusion. The mGA evaluated 8 different aspects: nutritional-
and emotional status, physical performance, cognitive
function, comorbidities, polypharmacy, falls and activities of
daily living. For each aspect a cut-off value for impairment was
defined, and patients with impairment in one or more aspect
were categorized as frail. The GPS is scored in the following
way: 0 (CRP<10mg/L, Alb
35g/L), 1 (CRP
10mg/L or Alb<35g/L)
or 2 (CRP
10mg/L and Alb< 35g/L).The relationship between
frailty and GPS was assessed by multivariate logistic regression,
adjusted for diagnosis, stage, the use of anti-inflammatory
medications (NSAIDs and steroids) and Body Mass Index
.
Results:
From January -13 till April -15, 255 eligible patients
were included. According to the mGa, 50% of the patients
were frail.The most common cancer types were colorectal (n=
69, 27%), lung (n= 55, 22%) and prostate (n=47, 18%). A total of
56% (n=143) had distant metastasis, 19% (n= 48) had locally
advanced disease and 25% (n= 64) localized disease, 17% used
anti-inflammatory medication.
GPS 0, indicative of low risk of systemic inflammation,
was seen in 64% (n=162), among whom 43% were frail. Of the
29% (n= 74) who presented with GPS 1(intermediate risk), 53%
were frail. GPS 2 was only seen in 8%, however 95% of them
were frail. In multivariate logistic regression analysis patients
with GPS 2 had an OR of 18.45 (95% CI 2.30; 148.23) of being
frail compared with the reference group GPS 0. GPS 2 predicts
frailty with a specificity of 99%, but a sensitivity of only 14%.