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Acute toxicity of 4-week versus 5-week hypofractionated radiotherapy in localised prostate cancer

Published online by Cambridge University Press:  14 April 2021

Mohammad Houshyari
Affiliation:
Department of Radiation Oncology, Shohada-e Tajrish Educational Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran
Bahram Mofid
Affiliation:
Department of Radiation Oncology, Shohada-e Tajrish Educational Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran
Maryam Alavi Tabatabaee*
Affiliation:
Department of Radiation Oncology, Shohada-e Tajrish Educational Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran
Mohsen Bakhshandeh
Affiliation:
Department of Radiology Technology, School of Allied Medical Sciences, Shahid Beheshti University of Medical Sciences, Tehran, Iran
Farzad Taghizadeh-Hesary*
Affiliation:
Department of Radiation Oncology, Shohada-e Tajrish Educational Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran
*
Author for correspondence: Dr Maryam Alavi Tabatabaee, Department of Radiation-Oncology, Shohada-e Tajrish Hospital, Tehran, 19839-63113, Iran. Tel: +98 913 9110313. E-mail: maryam.alavi.taba@gmail.com; Dr Farzad Taghizadeh-Hesary, Department of Radiation-Oncology, Shohada-e Tajrish Hospital, Tehran, 19839-63113, Iran. Tel: +98 912 6086713. E-mail: f_taghizadeh@sbmu.ac.ir
Author for correspondence: Dr Maryam Alavi Tabatabaee, Department of Radiation-Oncology, Shohada-e Tajrish Hospital, Tehran, 19839-63113, Iran. Tel: +98 913 9110313. E-mail: maryam.alavi.taba@gmail.com; Dr Farzad Taghizadeh-Hesary, Department of Radiation-Oncology, Shohada-e Tajrish Hospital, Tehran, 19839-63113, Iran. Tel: +98 912 6086713. E-mail: f_taghizadeh@sbmu.ac.ir

Abstract

Aim:

To compare the acute radiation-induced bowel and bladder toxicities of two hypofractionated radiotherapy (HFRT) regimens in localised prostate cancer (PCa).

Materials and methods:

This trial consists of patients with histologically confirmed stage T1-T3aN0M0 PCa, a prostate-specific antigen concentration of 40 ng/mL or lower, and Eastern Cooperative Oncology Group performance status of 0–2. Participants were randomly assigned (1:1) to 56 Gy in 16 fractions over 4 weeks (arm A) or 70·2 Gy in 26 fractions over 5 weeks (arm B). Acute bowel and bladder toxicities were assessed using Radiation Therapy Oncology Group criteria.

Results:

Between June 2018 and December 2019, 40 patients were randomly assigned to treatment with 4-week (n = 20) and 5-week HFRT (n = 20). In the third month after completion of radiotherapy, the cumulative incidence of acute bowel and bladder toxicities of arms A and B was 20 versus 5% and 70 versus 85%, respectively. The cumulative incidence of grade 2 or worse bowel and bladder toxicities of the 5-week regimen was non-inferior to 4-week HFRT [bowel toxicity: 5% (arm A) versus 5% (arm B), bladder toxicity: 50% (arm A) versus 60% (arm B), p = 0·52).

Findings:

The 5-week regimen of HFRT is non-inferior to 4-week HFRT in terms of acute bowel and bladder toxicities.

Type
Original Article
Copyright
© The Author(s), 2021. Published by Cambridge University Press

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References

Beckmann, K, Garmo, H, Nilsson, P, Franck Lissbrant, I, Widmark, A, Stattin, P. Radical radiotherapy for prostate cancer: patterns of care in Sweden 1998–2016. Acta Oncol 2020; 59 (5): 549557.CrossRefGoogle ScholarPubMed
Rakhsha, A, Mofid, B, Yousefi Kashi, AS, Taghizadeh-Hesary, F, Sajjadi rad, M. Comparison of survival between hypofractionated and conventional radiotherapy in clinically localized prostate cancer: a single-center retrospective cohort. Int J Cancer Manag 2020; 13 (7): e105762.CrossRefGoogle Scholar
Abdollahi, H, Tanha, K, Mofid, B et al. MRI radiomic analysis of IMRT-induced bladder wall changes in prostate cancer patients: a relationship with radiation dose and toxicity. J Med Imaging Radiat Sci 2019; 50 (2): 252260.CrossRefGoogle ScholarPubMed
Collins, C, Lloyd-Davies, R, Swan, A. Radical external beam radiotherapy for localised carcinoma of the prostate using a hypofractionation technique. Clin Oncol 1991; 3 (3): 127132.CrossRefGoogle ScholarPubMed
Incrocci, L, Wortel, RC, Alemayehu, WG et al. Hypofractionated versus conventionally fractionated radiotherapy for patients with localised prostate cancer (HYPRO): final efficacy results from a randomised, multicentre, open-label, phase 3 trial. Lancet Oncol 2016; 17 (8): 10611069.CrossRefGoogle ScholarPubMed
Arcangeli, G, Saracino, B, Arcangeli, S et al. Moderate hypofractionation in high-risk, organ-confined prostate cancer: final results of a phase III randomized trial. J Clin Oncol 2017; 35 (17): 18911897.CrossRefGoogle ScholarPubMed
Pollack, A, Walker, G, Horwitz, EM et al. Randomized trial of hypofractionated external-beam radiotherapy for prostate cancer. J Clin Oncol 2013; 31 (31): 3860.CrossRefGoogle ScholarPubMed
Catton, CN, Lukka, H, Gu, C-S et al. Randomized trial of a hypofractionated radiation regimen for the treatment of localized prostate cancer. J Clin Oncol 2017; 35 (17): 18841890.CrossRefGoogle ScholarPubMed
Lee, WR, Dignam, JJ, Amin, MB et al. Randomized phase III noninferiority study comparing two radiotherapy fractionation schedules in patients with low-risk prostate cancer. J Clin Oncol 2016; 34 (20): 2325.CrossRefGoogle ScholarPubMed
Rancati, T, Palorini, F, Cozzarini, C, Fiorino, C, Valdagni, R. Understanding urinary toxicity after radiotherapy for prostate cancer: first steps forward. Tumori J 2017; 103 (5): 395404.CrossRefGoogle ScholarPubMed
Di Franco, R, Borzillo, V, Ravo, V et al. Rectal/urinary toxicity after hypofractionated vs conventional radiotherapy in low/intermediate risk localized prostate cancer: systematic review and meta analysis. Oncotarget 2017; 8 (10): 17383.CrossRefGoogle ScholarPubMed
Fonteyne, V, Sarrazyn, C, Swimberghe, M et al. 4 Weeks versus 5 Weeks of Hypofractionated High-dose Radiation Therapy as Primary Therapy for Prostate Cancer: Interim Safety Analysis of a Randomized Phase 3 Trial. Int J Radiat Oncol Biol Phys 2018; 100 (4): 866870.CrossRefGoogle ScholarPubMed
Oken, MM, Creech, RH, Tormey, DC et al. Toxicity and response criteria of the Eastern Cooperative Oncology Group. Am J Clin Oncol 1982; 5 (6): 649656.CrossRefGoogle ScholarPubMed
Bian, SX, Kuban, DA, Levy, LB et al. Addition of short-term androgen deprivation therapy to dose-escalated radiation therapy improves failure-free survival for select men with intermediate-risk prostate cancer. Ann Oncol 2012; 23 (9): 23462352.CrossRefGoogle ScholarPubMed
Muralidhar, V, Chen, M-H, Reznor, G et al. Definition and validation of “favorable high-risk prostate cancer”: implications for personalizing treatment of radiation-managed patients. Int J Radiat Oncol Biol Phys 2015; 93 (4): 828835.CrossRefGoogle ScholarPubMed
Roach, M. RTOG 0924: Androgen deprivation therapy and high dose radiotherapy with or without whole-pelvic radiotherapy in unfavorable intermediate or favorable high risk prostate cancer: A phase III randomized trial, 2011. http://www.rtog.org/ClinicalTrials/ProtocolTable/StudyDetails.aspx?studyZ0924.Google Scholar
Gay, HA, Barthold, HJ, O’Meara, E et al. Pelvic normal tissue contouring guidelines for radiation therapy: a Radiation Therapy Oncology Group consensus panel atlas. Int J Radiat Oncol Biol Phys 2012; 83 (3): e353e362.CrossRefGoogle ScholarPubMed
Zaorsky, NG, Showalter, TN, Ezzell, GA et al. ACR Appropriateness Criteria for external beam radiation therapy treatment planning for clinically localized prostate cancer, part II of II. Adv Radiat Oncol 2017; 2 (3): 437454.CrossRefGoogle ScholarPubMed
Cox, JD, Stetz, J, Pajak, TF. Toxicity criteria of the Radiation Therapy Oncology Group (RTOG) and the European Organization for Research and Treatment of Cancer (EORTC). Int J Radiat Oncol Biol Phys 1995; 31 (5): 13411346.CrossRefGoogle Scholar
Kim, S, Wong, WK. Phase II two-stage single-arm clinical trials for testing toxicity levels. Commun Stat Appl Methods 2019; 26 (2): 163.Google ScholarPubMed
McBride, WH, Schaue, D. Radiation-induced tissue damage and response. J Pathol 2020; 250 (5): 647655.CrossRefGoogle ScholarPubMed
Thames, HD Jr, Withers, HR, Peters, LJ, Fletcher, GH. Changes in early and late radiation responses with altered dose fractionation: implications for dose-survival relationships. Int J Radiat Oncol Biol Phys 1982; 8 (2): 219226.CrossRefGoogle ScholarPubMed
Withers, HR. The four R’s of Radiotherapy. Advances in Radiation Biology. 5: Houston: Elsevier; University Texas, 1975: 241271.Google Scholar
Denekamp, J. Cell kinetics and radiation biology. Int J Radiat Biol Relat Stud Phys Chem Med 1986; 49 (2): 357380.CrossRefGoogle ScholarPubMed
Dearnaley, D, Syndikus, I, Sumo, G et al. Conventional versus hypofractionated high-dose intensity-modulated radiotherapy for prostate cancer: preliminary safety results from the CHHiP randomised controlled trial. Lancet Oncol 2012; 13 (1): 4354.CrossRefGoogle ScholarPubMed
Aluwini, S, Pos, F, Schimmel, E et al. Hypofractionated versus conventionally fractionated radiotherapy for patients with prostate cancer (HYPRO): acute toxicity results from a randomised non-inferiority phase 3 trial. Lancet Oncol 2015; 16 (3): 274283.CrossRefGoogle ScholarPubMed
Barnett, GC, West, CM, Dunning, AM et al. Normal tissue reactions to radiotherapy: towards tailoring treatment dose by genotype. Nat Rev Cancer 2009; 9 (2): 134142.CrossRefGoogle Scholar
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