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A B S T R A C T S
interactions in the daily medications, but also between daily
medications and chemotherapy drugs.
Objectives:
To identify Potential Drugs Interactions (PDI)
in the daily medications, PDI between daily medications and
chemotherapy, Potential Clinical Outcomes (PCO) related to
major PDI.
Methods:
From2007 to 2014, all consecutive cancer patients
aged 70 years or older, referred for geriatric assessment were
included in the prospective ELCAPA cohort survey. For the
present study patients receiving chemotherapywere analyzed.
PDI were analyzed using Lexicomp Online
®
(Lexi-Comp, Inc.,
Hudson, USA) software and completed with the Theriaque
®
website for French medications. Collected PCO were those
relevant in geriatrics. PDI and PCO were classified according
to importance (A: no interactions known, B: no action needed;
C: monitor therapy; D: consider therapy modification; X: avoid
combination). Factors associated with PDI of grades C, D or X
were analyzed using ordered multivariate logistic regression
dependent variable being the PDI in three categories, PDI of
grade A or B (reference), versus C, versus D or X.
Results:
The study included 442 patients (median age: 77
years; Q1: 74.5 - Q3: 81; 48.7% of women). Most frequently
tumor site were colorectal (20.9%), followed by urological
tracts (19%), breast (12.4%)
;
22.9% had metastasis. The median
number of drugs per patients per day was 6 [3-8], the median
comorbidities index CIRS-G was 12 [9-16]. At least 1 PDI per
patient was identified in the daily medications in 70.6% of
patients (median 4 [2-7]), and between daily medications
and chemotherapy drugs in 33.9% (median 2 [1-3]). Overall,
171 patients had PDI of grade C (38.7%) and 166 of grade
D or X (37.6%); 1918 grade C, D or X PDI were identified
(83.8% of C and 16.2% of D or X), 1578 (71.5%) in the daily
medications and 340 (28.5%) between daily medications
and chemotherapy. Considering drug-interactions in daily
medications, main PCO were hypotensive risk (31.7% of all
PDI), psychotropic effects (16.4%), glycemic disorders (11%),
hemostasis deregulation (7.9%), fluid disorders (7.4%), and QT
prolongation (3.6%)
.
Considering drug-interactions between
daily medications and chemotherapy, main PCO were risk of
renal, cardiovascular, hemostasis deregulation, or neurogenic
impairment (17.6%), over-exposition to chemotherapy (11.7%)
or under-exposition (8%). After adjustment for age, tumor
site and metastasis, factors independently associated with
PDI were increase number of daily medications (adjusted
OR (ORa)
1-medication increase
=1.74; CI95%[1.43-2.11] for grade C;
ORa=1.95; 95% CI [1.56-2.43] for grade D-X), hypertension
(ORa=4.10; 95% CI [1.84-9.17] for grade C) and overweight/
obesity (ORa=2.55; 95% CI [1.12-5.82] for grade C).
Conclusion:
PDI were frequent in older cancer patients.
This highlights the need of monitoring the iatrogenic risk,
especially for hypotension risk, psychotropic side-effects,
glycemic and hemostatis regulation mainly in patients with
polypharmacy, hypertension, and overweight, with integrated
team involving geriatricians, pharmacists, and oncologists.
Disclosure of interest:
None declared
Keywords:
Cancer, chemotherapy, drug interaction, older
patients, polypharmacy
P063
APPLICATION OF ADEPT (A PROCESS FOR DECISION-
MAKING AFTER PILOT AND FEASIBILITY TRIALS) TO A PILOT
GERIATRIC ONCOLOGY PROGRAMME IN RADIATIONTHERAPY
A. O’Donovan
1,
*, C. Gillham
2
, C. Cunningham
3
, P. Thirion
2
,
M. Cunningham
2
, N. ElBeltagi
2
, M. Leech
1
1
Radiation Therapy, Trinity College Dublin,
2
Saint Luke’s Radiation
Oncology Network,
3
Saint James’s Hospital, Dublin, Ireland
Introduction:
Under-representation of older patients in
clinical trials is a known problem in oncology. The reasons for
such under-representation are largely unknown. Older patients
present with more complex issues than younger patients, and
this may affect clinical trial participation/adherence. These
issues need to be taken into consideration in trial design.
Medical Research Council (MRC) guidelines on complex
intervention evaluation advise a phased approach to the
implementation of complex interventions in medicine [1].
This includes feasibility studies and pilot trials,with the
aim of optimising aspects of study design for consideration
during a larger scale implementation of in the future. This
is may succeed in more effectively “geriatricizing” trial
design.
Objectives:
The aims of this feasibility study and two-arm,
randomized pilot trial (n=30) were:
1) To determine the feasibility of conducting an RCT of
the effectiveness of incorporating geriatric assessment (GA)
in older patients undergoing radiotherapy The assessments
used have been previously reported [2].
2) To develop and test methods for a main trial (including
eligibility, recruitment, consent, randomization, adherence to
the intervention and participant retention), using the ADePT
framework as guidance [4].
We also reflect upon the implications of our findings for
the development of a more definitive trial.
Methods:
We used the systematic approach on how to
categorize feasibility and pilot studies as outlined by Shanyinde
et al [3], whose list of methodological issues were used to
evaluate the extent to which each issue was addressed in the
current study.
Subsequently, the ADePT guidelines developed by Bugge
et al [4] to support recommendations for clinical practice in
moving from feasibility study to full trial were applied.
Pilot trial data and patient characteristics were analysed
using simple descriptive statistics.
Results:
The results of applying the methodological issues
identified by Shanyinde et al. (5), as an analytic framework to
the current study findings will be presented under each of the
14 items summarised in the accompanying Figure 1.
Conclusion:
This pilot study of GA in radiation therapy has
had little impact on patient treatment decisions. However,
a number of functional, cognitive and other issues were
identified that were previously unknown. A number of issues
with recruitment and retention were identified, which will
help refine future trials. Adapting this framework will help
researchers in making best use of the findings from their
feasibility and pilot work to inform subsequent decisions
regarding a follow-on trial, with incorporation of more age-
appropriate design features and endpoints.