Risk factors and dose-effects for bladder fistula, bleeding and cystitis after radiotherapy with imaged-guided adaptive brachytherapy for cervical cancer: An EMBRACE analysis
Spampinato, Sofia; Fokdal, Lars U.; Pötter, Richard; Haie-Meder, Christine; Lindegaard, Jacob C.; Schmid, Maximilian P.; Sturdza, Alina; Jürgenliemk-Schulz, Ina M.; Mahantshetty, Umesh; Segedin, Barbara; Bruheim, Kjersti; Hoskin, Peter; Rai, Bhavana; Huang, Fleur; Cooper, Rachel; van der Steen-Banasik, Elzbieta; Van Limbergen, Erik; Sundset, Marit; Westerveld, Henrike; Nout, Remi A.; Jensen, Nina B.K.; Kirisits, Christian; Kirchheiner, Kathrin; Tanderup, Kari
(2021) Radiotherapy and Oncology, volume 158, pp. 312 - 320
(Article)
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
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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.
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Keywords: Cervical cancer, Clinical study, Dose-effect relationship, IGABT, Risk factors, Urinary morbidity, Radiotherapy Dosage, Prospective Studies, Humans, Risk Factors, Radiotherapy, Image-Guided, Chemoradiotherapy, Brachytherapy/adverse effects, Uterine Cervical Neoplasms/drug therapy, Female, Cystitis/epidemiology, Hematology, Oncology, Radiology Nuclear Medicine and imaging, Research Support, Non-U.S. Gov't, Journal Article
ISSN: 0167-8140
Publisher: Elsevier Ireland Ltd
Note: Funding Information: The EMBRACE study was supported by Elekta AB and Varian Medical System through unrestricted research grants and study sponsoring through the Medical University of Vienna. The work of this manuscript was supported via grants from the Danish Cancer Society ( R101-A685414-S31 , R150-A10177-001 , R146-A9459-16-S2 ). Publisher Copyright: © 2021 Elsevier B.V. Copyright © 2021 Elsevier B.V. All rights reserved.
(Peer reviewed)