Abstract
Background and purpose
The EMBRACE study is a prospective multi-institutional study on MRI guided adaptive
brachytherapy (IGABT) in locally advanced cervix cancer (LACC). This analysis describes
early to late urinary morbidity assessed by physicians and patients (PRO).
Material and methods
A total of 1176 patients were analysed. Median follow up (FU) was 27 (1–83) months.
Morbidity (CTCAE v.3) and PRO (EORTC QLQ-C30&CX24) was prospectively assessed at baseline
(BL), and during FU.
Results
The most frequent symptoms were frequency/urgency, incontinence, and cystitis with
grade 2–4 prevalence rates of 4.3%, 5.0% and 1.7% and grade 1–4 prevalence rates of
24.5%, 16.1% and 5.8% at 3-years. The most frequent PRO endpoints were “urinary frequency”
and “leaking of urine”. Prevalence of “Quite a bit” or “very much” bother fluctuated
from 14.0% to 21.5% for “frequency”, while “leaking of urine” increased from 4.6%
at BL to 9.3% at 3-years.
Actuarial 3-year incidence of grade 3–4 urinary morbidity was 5.3% with most events
being urinary frequency, incontinence and ureteral strictures. Grade 3–4 fistula,
bleeding, spasm and cystitis were all <1.0% at 3/5-years. No grade 5 toxicity occurred.
Conclusion
Urinary grade 3–4 morbidity with IGABT was limited. Urinary morbidity grade 2–4 comprises
mainly frequency/urgency, incontinence and cystitis and has considerable prevalence
in PRO. Various urinary morbidity endpoints have different patterns of manifestation
and time course.
Keywords
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Article info
Publication history
Published online: May 18, 2018
Accepted:
May 1,
2018
Received in revised form:
April 30,
2018
Received:
July 30,
2017
Identification
Copyright
© 2018 Elsevier B.V. All rights reserved.
