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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