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A B S T R A C T S
S43
régional du Cancer Montpellier/Val d’Aurelle Centre Val d’Aurelle -
Paul Lamarque, Montpellier,
10
Centre hospitalier de Vannes, Vannes,
11
Institut Jean Godinot, Reims,
12
Centre Jean Perrin, Clermont
Ferrand, France,
13
Cliniques universitaires Saint-Luc, Louvain,
Belgium,
14
CHU de Limoges, Limoges,
15
CHI de Créteil, Créteil,
16
Centre Eugène Marquis, Rennes,
17
Grand Hopital de Charleroi
(GHdC), Charleroi,
18
Institut Universitaire du Cancer Toulouse -
Oncopole, Toulouse,
19
Hôpital René Huguenin/Institut Curie, Saint-
Cloud,
20
HalioDx, Marseilles,
21
UNICANCER, Paris,
22
Institut Curie,
Saint-Cloud,
23
CHU Besançon, Besançon, France
Introduction:
The benefit of adjuvant chemotherapy (CT)
added to hormonal therapy (HT) compared with HT alone
remains debated for women
70 with ER+ HER2- breast cancer
(BC). Selection of valid indications might be improved by the
use of better prognosticator.
Objectives:
This trial compares the impact of both strategies
on overall survival (OS) according to genomic grade (GG).
Methods:
Following complete surgery, ~2,000 ER+ HER2-
BC patients were to have a GG centrally performed on FFPE
specimens by RT-PCR. Cases classified “high-risk” (high and
equivocal GG combined) were to be randomized to HT alone
vs
CT+HT, while those classified “low-risk” (low GG) were to be
followed as an observational cohort with HT only. Eligibility
criteria were deliberately not stringent, allowing inclusion
of patients with local relapse, bilateral or multifocal BC, or
previous history of other malignancies, in order to capture the
high level of heterogeneity of ageing.
OS (all deaths) is theprimaryendpoint.Secondaryobjectives
include competing events, cost-effectiveness and Q-TWiST
analysis, geriatric dimension, willingness and health-related
quality of life including specific ELD15. Translational research
will focus on prognostic biomarkers and pharmacogenetics.
Following an IDMC meeting held in September 2014,
the statistical plan was amended to take into account non
adherence to treatment allocated by randomization, mostly
in patients assigned to CT vs those assigned HT only (20% vs
5%, global rate of non adherence 13%): sample size based on
4-year OS benefit favouring CT (87.5
vs
80%; HR 0.60); bilateral
test
=0.05, power increased from 80 to 90% (
decreased from
0.20 to 0.10), number of patients to be randomized in 4 years
increased from 700 to 1,080, with 171 events expected.
Results:
From 04/12 to 05/16, 71 French and Belgium centres
have included 1,989 patients aged 70-92.
GG evaluation was not performed in 60 cases: 22 tumour
blocks not available, 20 consent withdrawals, 10 tumour
status issues, 8 treatment choice issues.
Of 1,929 cases with GG report, 752 (39%), 411 (21.3%) and
753(39%) were low, equivocal and high GG respectively; 13
tests (0.7%) failed for technical reasons. The proportion of
high-risk tumours (high & equivocal GG combined, 60%) was
similar to the one observed in the general BC population (40-
60%). In the high-risk group, 75 cases were not randomized: 48
patient’s or medical team’s choice, 21 inclusion criteria issues,
6 central pathology review discordances.
Conclusion:
With 100% of target recruitment reached in
4 years as planned,we confirmthe feasibilityof such innovative
multicentre program in a usually underserved population.
While interim and primary analysis will be available only in
2018 and 2020, detailed description of the population enrolled
will be presented. Prospective GG assessment might help in
the future to better select adjuvant strategy in the elderly BC
population and to avoid jeopardizing any benefit if stymied by
uncontrolled side effects.
Disclosure of interest:
None declared
Keywords:
Adjuvant, genomic tool, clinical trial,
chemotherapy
P013
FUNCTIONAL AND COGNITIVE IMPAIRMENT, SOCIAL
ENVIRONMENT, FRAILTY AND ADVERSE HEALTH
OUTCOMES IN OLDER PATIENTS WITH HEAD AND NECK
CANCER, A SYSTEMATIC REVIEW
F. J. A. Van Deudekom
1,
*, A. S. Schimberg
2
, M. H. Kallenberg
1,3
,
M. Slingerland
4
, L.-A. van der Velden
2,5
, S. P. Mooijaart
1,6
1
Gerontology and Geriatrics,
2
Department of Otorhinolaryngology
and Head and Neck Surgery,
3
Department of Nephrology,
4
Department of Medical Oncology, Leiden University Medical
Centre, Leiden,
5
Department of Head and Neck Surgery and
Oncology, Netherlands Cancer Institute, Amsterdam,
6
Institute for
Evidence-based Medicine in Old Age, Leiden, Netherlands
Introduction:
With the population ageing there will be an
increasing number of older adults with cancer. This trend can
also be observed in the patient population presenting with
head and neck cancer. Older patients are very heterogenic with
respect to frailty, mobility, functional capacity, and cognitive
function and therefore it remains challenging to identify older
patients who are at highest risk for poor clinical outcome.
Objectives:
The aim of this present systematic review is to
study the association of functional or cognitive impairment,
social environment and frailty with adverse health outcomes
in patients with head and neck cancer.
Methods:
On April 28
th
2016, we searched Pubmed, Embase,
Web of Science and the Cochrane Library for original studies
reporting on an association of functional or cognitive
impairment, social environment and frailty with adverse
outcomes after follow-up in head and neck cancer patients.
Results:
Of 4158 identified citations, we included 31 articles
which reported on 45 associations. The mean age was over
60 years in twelve studies (39%). Geriatric conditions were
prevalent: between 40-50% of the included participants
were functional impaired, around 50% had depressive
symptoms, and around 40% did not have a partner. Functional
impairment was assessed in 18 studies, two studies reported
on a cognitive test, eight studies examined mood and social
status was depicted by 14 studies. None of the included studies
addressed frailty or objectively measured physical capacity
such as hand grip strength, gait speed or balance tests. In
64% of the reported associations, a decline in functional or
cognitive impairment, mood or social environment was
associated with adverse outcomes.
Conclusion:
Functional and cognitive impairment,
depression and social isolation are highly prevalent and
associate with increased risk of adverse health outcomes in