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S31
underwent major (intra-thoracic or intra-abdominal) surgery.
Baseline measures for TUG, HGS and GFI were 8.7 sec,
31.7 kg and 2.3 (scale 0-15) respectively; all measures are
within the normal range indicating that this was a non-frail
population. Nearly fifty-three percent of patients encountered
a complication. Most complications were Clavien Dindo grade
1 or 2 (78.7%), five patients deceased as a result of a grade 5
complication (1.6%). Mortality after 30 days was 1.6%. Three
month mortality was 2.0% and 1 year mortality was 13.8%.
Univariate logistic regression showed a significant association
between 1 year mortality and GFI score preoperative (p value
0.010, OR 1.28) and GFI score after 3 months (p value 0.027,
OR 1.19). In multivariate logistic regression this association
was not significant anymore. GFI score at discharge was not
significantly associated with 1 year mortality. There weren’t
any significant associations between any of the frailty
indicators and short-term mortality. GFI both at discharge
and at 3 months postoperatively were significantly associated
with 30-day morbidity (p value 0.002, OR 1.19 respectively
p value 0.011, OR 1.17) in univariate regression analysis. In
multivariate regression, GFI at discharge remained significant
(p value 0.048, OR 1.162).
Conclusion:
We found a significant relationship between
1-year mortality and GFI score both at admission and 3months
postoperatively. Interestingly, the GFI score at discharge
was not associated with mortality although it did show a
significant relationship with 30-day morbidity. Therefore,
the Groningen frailty indicator can be used as a predictor of
both morbidity and long-term mortality and surgeons should
consider this factor in the surgical decision process.
Disclosure of interest:
None declared
Keywords:
Frailty indicators, long term mortality, surgery
O14
INCLUSION OF ELDERLY PATIENTS IN ONCOLOGY CLINICAL
TRIALS
O. Le Saux
1,
*, C. Falandry
2
, H. K. Gan
3
, B. You
4
, G. Freyer
5
,
J. Péron
5
1
Geriatric oncology,
2
Centre Hospitalier Lyon Sud, Pierre-Bénite,
France,
3
Medical oncology, Austin Health, Heidelberg, Australia,
4
Medical oncology,
5
Institut de Cancérologie des Hospices Civils de
Lyon, Pierre-Bénite, France
Introduction:
The creation of International Society of
Geriatric Oncology (SIOG) in 2000 was an important landmark
in the field of geriatric oncology as onemain goal of this society
is to increase the relevance of clinical trials for older patients
and improve research in the field of geriatric oncology.
Objectives:
We undertook a review of changes in inclusion
and reporting on elderly patients between the time of its
creation and ten years after.
Methods:
Two researchers (OLS and JP) defined a search
strategy on MEDLINE via PubMed
(http://www.pubmed.gov) to
identify all reports of clinical trials (phase I, phase II, and phase
III trials) assessing therapies for hematological or solid tumors
and dedicated to the elderly (at least using a chronological
landmark to define the elderly). Another research was
performed to identify all phase III clinical trials assessing
therapies for hematological or solid tumors among adults in
order to identify subgroup analyses of elderly patients. One
researcher (OLS) performed the literature search. In case of
uncertainty, another researcher (JP) reviewed the study and
appropriateness for inclusion in this study was achieved by
consensus. Reports were included if they were published in
English between January 1
st
2001 and December 31
st
2004 or
between January 1
st
2011 and December 31
st
2014.
Data extraction was completed by the same authors who
carried out the initial article selection (OLS and JP). The work
was split up between them and each author double checked
the other’s data.
Results:
A total of 1084 trials were included: 366 and
718 from the first and second time period respectively. We
identified 264 clinical trials including only elderly patients (or
elderly patients along with unfit patients -impaired functional
status or comorbidities-), over the two time periods: 27 phase I
clinical trials, 193 phase II trials and 43 phase III clinical trials.
The number of clinical trials reporting specifically on
elderly patients increased from 128 to 415 between the two
time periods. This increase in absolute number (more than
three times) was mostly related to an increased number of
dedicated phase I trials and subgroup analyses of phase III
RCTs.
A large proportion of phase III trials published between
2011 and 2014 reported at least one analysis dedicated to
elderly patients (46.7%) versus 19.3% during the first time
period. The use of subgroup analyses of elderly patients in
phase III trials was the most frequent source of information.
Subgroup analyses were more frequent among trials with
industrial funding, trials published in high impact factor
journal, intercontinental trials, and trials with large sample
size. The age threshold defining the elderly subgroup
increased over time.
Conclusion:
Elderly patients have become a topic of
interest during the past decade. However, data available is
mostly extracted from subgroup analyses, which can only be
regarded as preliminary evidence.
Disclosure of interest:
None declared
Keywords:
Clinical trials, geriatric oncology, neoplasms
O15
LARGE OUTCOME DISPARITIES BY OLDER AGE AND 21-
GENE RECURRENCE SCORE (RS) RESULT IN HORMONE
RECEPTOR POSITIVE (HR+) BREAST CANCER (BC)
S. Shak
1,
*, V. I. Petkov
2
, D. P. Miller
1
, N. Howlader
2
, L. Penberthy
2
1
Genomic Health, Redwood City,
2
National Cancer Institute,
Bethesda, United States
Introduction:
BC diagnoses in older patients (pts) are rising
as population demographics change and life expectancy
increases. There is a growing global awareness of under-
treatment of BC in the elderly in general, and the TEAM study
(N=9,766) reported worse outcomes for older pts with HR+ BC.