Highlights
- •Urinary morbidity after treatment of locally advanced cervical cancer is prevalent.
- •Bladder dose constraints based on a high level clinical evidence are not available.
- •EMBRACE I provides prospective morbidity data for analysis in a large cohort.
- •Individual physician and patient reported urinary endpoints were analysed in EMBRACE I.
- •Bladder fistula, bleeding and cystitis showed dose–effect with bladder D2cm3.
Abstract
Purpose
To identify patient- and treatment-related risk factors for fistula, bleeding, cystitis,
pain and difficulty in voiding in locally advanced cervical cancer patients treated
with radio(chemo)therapy and image-guided adaptive brachytherapy (IGABT).
Material and methods
Morbidity within the EMBRACE-I study was prospectively reported for physician-assessed
(CTCAE) fistula, bleeding and cystitis and patient-reported (EORTC) pain and difficulty
in voiding. Analysis of risk factors was performed in patients without bladder infiltration.
Risk factors were tested with Cox regression for grade (G) ≥ 3 cystitis, for G ≥ 2
fistula, bleeding and cystitis, and for EORTC “very much” and “quite a bit” or worse.
Results
Of 1416 patients enrolled, 1153 and 884 patients without bladder infiltration were
evaluable for the analysis of CTCAE and EORTC items, respectively. Median follow-up
was 48[3–120] months. Crude incidence rates for G ≥ 2 fistula, bleeding and cystitis
were 0.7%, 2.7% and 8.8%, respectively, and 16% and 14% for ”quite a bit” or worse
pain and difficulty in voiding, respectively. Baseline urinary morbidity and overweight/obesity
were significant risk factors for most endpoints. Bladder D2cm3 correlated with G ≥ 2 fistula, bleeding and cystitis, while ICRU bladder point dose
correlated with EORTC pain “quite a bit” or worse. An increase from 75 Gy to 80 Gy
in bladder D2cm3 resulted in an increase from 8% to 13% for 4-year actuarial estimate of G ≥ 2 cystitis.
Conclusion
Clinical and treatment-related risk factors for bladder fistula, bleeding and cystitis
were identified within a prospective and multi-institutional setting. A dose–effect
was established with bladder D2cm3, reinforcing the importance of continued optimization during individualized IGABT
planning.
Keywords
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Article info
Publication history
Published online: February 02, 2021
Accepted:
January 12,
2021
Received in revised form:
January 11,
2021
Received:
July 23,
2020
Identification
Copyright
© 2021 Elsevier B.V. All rights reserved.
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- In regard to Spampinato et alRadiotherapy and OncologyVol. 158
- PreviewWe read the article by Spampinato et al. [1] focusing on the importance of ICRU bladder point (BP) dose on the incidence and persistence of urinary frequency and incontinence with great interest. The authors aimed to determine the patient- and treatment-related risk factors that may be associated with urinary frequency and incontinence by analyzing the patients with locally advanced cervical cancer (LACC) in the EMBRACE-I trial who underwent intracavitary brachytherapy (ICB) following chemoradiotherapy (CRT).
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