S23
ESTRO 36 2017
_______________________________________________________________________________________________
THIS ABSTRACT FORMS PART OF THE MEDIA PROGRAMME
AND WILL BE AVAILABLE ON THE DAY OF ITS PRESENTATION
TO THE CONFERENCE
OC-0052 Physician assessed and patient reported
bladder morbidity after RCHT and IGABT for cervical
cancer
L.U. Fokdal
1
, K. Kirchheiner
2
, N. Kibsgaard Jensen
1
, J.C.
Lindegaard
1
, K. Kirisits
2
, C. Chagari
3
, U. Mahantshetty
4
,
I.M. Jürgenliemk-Schulz
5
, B. Segedin
6
, P. Hoskin
7
, R.
Pötter
2
, K. Tanderup
1
1
Aarhus University Hospital, Department of Oncology,
Aarhus C, Denmark
2
Medical University of Vienna, Department of Radiation
Oncology, Vienna, Austria
3
Gustave-Roussy, Department of Radiotherapy, Paris,
France
4
Tata Memorial Hospital, Department of Radiotherapy,
Mumbai, India
5
Utrecht University, Department of radiotherapy,
Utrecht, The Netherlands
6
Institute of Oncology Ljubljana, Department of
Oncology, Ljubljana, Slovenia
7
Mount Vernon Cancer Centre, Department of
Radiotherapy, Northwood, United Kingdom
Purpose or Objective
Bladder morbidity is a well known side effect to
radiochemotherapy of locally advanced cervical cancer
(LACC). The EMBRACE study is a prospective multi-
institutional study with focus on MR image guided adaptive
brachytherapy (IGABT) in LACC. The study includes
registration of physician assessed morbidity and patient
reported outcome (PRO). This analysis evaluates bladder
morbidity with both assessment methods
Material and Methods
Out of 1419 patients recruited for the EMBRACE study,
1176 patients with assessment of bladder morbidity were
analysed. Treatment included external beam radiotherapy
with prescribed dose 45-50 Gy in 25-30 fx with
concomitant cisplatin in 95% of the patients. IGABT was
delivered with HDR BT (57%) or PDR BT (43%). Total mean
D
2cm3
to the bladder was 76.6 Gy. Median follow up (FU)
was 27M (months). Morbidity and PRO was assessed
according to the CTCAE v.3 and EORTC QLQ-CX24 at
baseline (BL), every 3M (year 1), every 6M (year 2-3) and
annually thereafter. Patients reporting ”quite a bit” or
”very much” bladder symptoms in EORTC were considered
as clinically relevant endpoint analogue to CTCAE G2 and
G3. Morbidity and PRO were analysed with crude
incidence, prevalence rates, and actuarial estimates
Results
Prevalence of urinary frequency CTCAE G≥2 ranges
between 4-5%, irrespectively of FU time, PRO ”frequent
urination” ranges between 14-23%. Urinary incontinence
CTCAE G≥2 increases gradually from 3% (BL) to 5% at 60M,
PRO 'leaking of urine” increases from 5% (BL) to 11% at
60M. Prevalence of bladder bleeding CTCAE G≥1 is
reported in 1% (BL) and progresses to a maximum of 5% at
36M, followed by a reduction to 2% at 60M. This
manifestation pattern is also seen for bladder cystitis
CTCAE G≥2 which increases from 1% (BL) to a maximum of
3% at 30M, and decreases slightly thereafter. PRO such as
'difficulty emptying the bladder” is slightly increasing
during FU, while disturbance from a 'burning sensation
during
urination”
is
slightly
reduced.
Actuarial estimates at 5-year of CTCAE G≥2 was 16.4%,
16.2% and 11.0% for incontinence, frequency, and cystitis,
respectively. Severe bladder morbidity (ureter stenosis
analysed separately) CTCAE G≥3 was recorded in 39
patients (54 events), corresponding to an actuarial
estimate of 4.7% risk at 5-years. G≥3 morbidity was 2.1%,
1.9%, 1.5%, and 0.7% at 5-years, for incontinence,
frequency, cystitis and bladder fistula, respectively.
Ureter stenosis G≥3 (19 patients) was found in 3.4% at 5-
year (patients with BL ureter stenosis excluded). There
was no G5 bladder morbidity
Conclusion
Bladder morbidity shows different manifestation patterns.
Urinary frequency fluctuates during FU, while
incontinence progresses. Bladder bleeding, cystitis and
patient reported 'burning sensation” progress to reach a
maximum prevalence followed a tendency to resolve at
later FU. Further studies have to explore these findings
and relate them to patient and treatment parameters in
order to find strategies to reduce bladder morbidity in
future radiotherapy.
OC-0053 Physician assessed and patient reported limb
edema after RCHT + IGABT for cervical cancer
(EMBRACE)
D. Najjari Jamal
1
, S. Smet
1
, N. BK Jensen
2
, L. Fokdal
2
,
J.C. Lindegaard
2
, C. Kirisits
1
, C. Chargari
3
, U.
Mahantshetty
4
, I.M. Jügenliemk-Schulz
5
, B. Segedin
6
, P.
Hoskin
7
, K. Tanderup
2
, R. Pötter
1
, K. Kirchheiner
1
1
Medical University of Vienna / General Hospital of
Vienna, Department of Radiation Oncology-
Comprehensive Cancer Center, Vienna, Austria
2
Aarhus University Hospital, Department of Oncology,
Aarhus, Denmark
3
Gustave-Roussy, Department of Radiotherapy, Villejuif,
France
4
Tata Memorial Hospital, Department of Radiation
Oncology, Mumbai, India
5
University Medical Centre Utrecht, Department of
Radiation Oncology, Utrecht, The Netherlands
6
Institute of Oncology, Department of Radiotherapy,
Ljubljana, Slovenia
7
Mount Vernon Hospital, Cancer Centre, London, United
Kingdom
Purpose or Objective
Treatment-related limb edema of the lower extremities
after definitive radiochemotherapy for locally advanced
cervical cancer has been reported to have a substantial
impact on patients’ well-being and body image. The aim
of this report is to evaluate the manifestation pattern of
limb edema during the first years of follow-up within the
prospective, observational, multi-center EMBRACE study
(www.embracestudy.dk).
Material and Methods
The analysis was based on 1419 locally advanced cervical
cancer patients enrolled from 2008-2015 who underwent
combined external beam radiotherapy (either with 3D
conformal technique or IMRT to 45-50Gy) ± concurrent
chemotherapy and MRI-guided brachytherapy following
the GEC-ESTRO guidelines. In case of pathological lymph
nodes, a boost to 55-65Gy was applied. Limb edema was
prospectively assessed with physician assessed common
toxicity criteria for adverse events (CTCAE v.3) and
patient reported EORTC quality of life questionnaire
(module CX24, Q38) at baseline before treatment, every 3
months (1
st
year), and every 6 months (2
nd
and 3
rd
year)
and yearly thereafter. Crude incidence rates, prevalence
rates and actuarial estimates using the Kaplan-Meier
method were analyzed.
Results
Information on limb edema at baseline and follow-up was
available for analysis in 1176 patients regarding CTCAE
(943 patients regarding EORTC) from 22 centers with a
median follow-up of 27 months (range 1-85 months).
Crude incidence rates of limb edema were 18% for CTCAE
G1, 4% for G2 and <1% for G3 (n=4 patients); no G4 or G5
morbidity occurred. The progressive manifestation
pattern of limb edema is reflected in the gradually
increasing prevalence rates as shown in in figure 1a for
CTCAE and 1b for EORTC outcome. Actuarial analyses
revealed a 3-year/5-year probability of 0.5%/0.5% for G≥3,
6.1%/6.6% for G≥2 and 26.5%/30.7% for G≥1. Laparoscopic
lymph node staging increased the risk for the development