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. 2021 May:158:312-320.
doi: 10.1016/j.radonc.2021.01.019. Epub 2021 Feb 3.

Risk factors and dose-effects for bladder fistula, bleeding and cystitis after radiotherapy with imaged-guided adaptive brachytherapy for cervical cancer: An EMBRACE analysis

Sofia Spampinato  1 , Lars U Fokdal  2 , Richard Pötter  3 , Christine Haie-Meder  4 , Jacob C Lindegaard  2 , Maximilian P Schmid  3 , Alina Sturdza  3 , Ina M Jürgenliemk-Schulz  5 , Umesh Mahantshetty  6 , Barbara Segedin  7 , Kjersti Bruheim  8 , Peter Hoskin  9 , Bhavana Rai  10 , Fleur Huang  11 , Rachel Cooper  12 , Elzbieta van der Steen-Banasik  13 , Erik Van Limbergen  14 , Marit Sundset  15 , Henrike Westerveld  16 , Remi A Nout  17 , Nina B K Jensen  2 , Christian Kirisits  3 , Kathrin Kirchheiner  3 , Kari Tanderup  2 ; EMBRACE Collaborative Group
Affiliations

Risk factors and dose-effects for bladder fistula, bleeding and cystitis after radiotherapy with imaged-guided adaptive brachytherapy for cervical cancer: An EMBRACE analysis

Sofia Spampinato et al. Radiother Oncol. 2021 May.

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: Cervical cancer; Clinical study; Dose-effect relationship; IGABT; Risk factors; Urinary morbidity.

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Conflict of interest statement

Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.

Comment in

  • Response to Yuce Sari et al.
    Spampinato S, Fokdal LU, Pötter R, Haie-Meder C, Lindegaard JC, Schmid MP, Sturdza A, Jürgenliemk-Schulz IM, Mahantshetty U, Segedin B, Bruheim K, Hoskin P, Rai B, Huang F, Cooper R, van der Steen-Banasik E, Van Limbergen E, Sundset M, Westerveld H, Nout RA, Jensen NBK, Kirisits C, Kirchheiner K, Tanderup K; EMBRACE Collaborative Group. Spampinato S, et al. Radiother Oncol. 2021 May;158:323-324. doi: 10.1016/j.radonc.2021.02.022. Epub 2021 Feb 26. Radiother Oncol. 2021. PMID: 33647355 No abstract available.
  • In regard to Spampinato et al.
    Yuce Sari S, Yigit E, Gultekin M, Yildiz F. Yuce Sari S, et al. Radiother Oncol. 2021 May;158:321-322. doi: 10.1016/j.radonc.2021.02.027. Epub 2021 Feb 26. Radiother Oncol. 2021. PMID: 33647358 No abstract available.
  • Improving Radiation Therapy for Cervical Cancer.
    Kidd E, Harkenrider M, Damast S, Fields E, Chopra S, Chino J. Kidd E, et al. Int J Radiat Oncol Biol Phys. 2022 Mar 15;112(4):841-848. doi: 10.1016/j.ijrobp.2021.12.006. Int J Radiat Oncol Biol Phys. 2022. PMID: 35190051 No abstract available.

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