Long-term results of intensity-modulated radiotherapy with three dose-fractionation regimens for localized prostate cancer

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Abstract

We evaluated long-term outcomes of three protocols of intensity-modulated radiation therapy (IMRT) for localized prostate cancer. Between 2005 and 2014, 348 patients were treated with 5-field IMRT. The first 74 patients were treated with a daily fraction of 2.0 Gy to 74 Gy (low-risk prostate cancer) or 78 Gy (intermediate- or high-risk prostate cancer); then 101 patients were treated with 2.1-Gy daily fractions to 73.5 or 77.7 Gy. More recently, 173 patients were treated with 2.2-Gy fractions to 72.6 or 74.8 Gy. The median age of all patients was 70 years and the median follow-up period was 82 months. The median follow-up periods were 124 months in the 2.0-Gy group, 98 months in the 2.1-Gy group, and 69 months in the 2.2-Gy group. The overall and prostate-specific antigen (PSA) failure-free survival (PSA-FFS) rates were, respectively, 89 and 68% at 10 years for the 2.0-Gy group, 91 and 84% at 8 years for the 2.1-Gy group, and 93 and 92% at 6 years for the 2.2-Gy group. The PSA-FFS rate for high-risk patients in all groups was 80% at 7 years. The cumulative incidences of Grade ≥2 late genitourinary (GU) and gastrointestinal (GI) toxicity were, respectively, 7.2 and 12.4% at 10 years for the 2.0-Gy group, 7.4 and 14.1% at 8 years for the 2.1-Gy group, and 7.1 and 7.9% at 6 years for the 2.2-Gy group. All three fractionation schedules yielded good tumor control with acceptable toxicities.

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Defining biochemical failure following radiotherapy with or without hormonal therapy in men with clinically localized prostate cancer: recommendations of the RTOG-ASTRO Phoenix Consensus Conference.

Mack Roach, Gerald R. Hanks, Howard Thames … (2006)

In 1996 the American Society for Therapeutic Radiology and Oncology (ASTRO) sponsored a Consensus Conference to establish a definition of biochemical failure after external beam radiotherapy (EBRT). The ASTRO definition defined prostate specific antigen (PSA) failure as occurring after three consecutive PSA rises after a nadir with the date of failure as the point halfway between the nadir date and the first rise or any rise great enough to provoke initiation of therapy. This definition was not linked to clinical progression or survival; it performed poorly in patients undergoing hormonal therapy (HT), and backdating biased the Kaplan-Meier estimates of event-free survival. A second Consensus Conference was sponsored by ASTRO and the Radiation Therapy Oncology Group in Phoenix, Arizona, on January 21, 2005, to revise the ASTRO definition. The panel recommended: (1) a rise by 2 ng/mL or more above the nadir PSA be considered the standard definition for biochemical failure after EBRT with or without HT; (2) the date of failure be determined "at call" (not backdated). They recommended that investigators be allowed to use the ASTRO Consensus Definition after EBRT alone (no hormonal therapy) with strict adherence to guidelines as to "adequate follow-up." To avoid the artifacts resulting from short follow-up, the reported date of control should be listed as 2 years short of the median follow-up. For example, if the median follow-up is 5 years, control rates at 3 years should be cited. Retaining a strict version of the ASTRO definition would allow comparisons with a large existing body of literature.

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Conventional versus hypofractionated high-dose intensity-modulated radiotherapy for prostate cancer: 5-year outcomes of the randomised, non-inferiority, phase 3 CHHiP trial

David Dearnaley, Isabel Syndikus, Helen Mossop … (2016)

Summary Background Prostate cancer might have high radiation-fraction sensitivity that would give a therapeutic advantage to hypofractionated treatment. We present a pre-planned analysis of the efficacy and side-effects of a randomised trial comparing conventional and hypofractionated radiotherapy after 5 years follow-up. Methods CHHiP is a randomised, phase 3, non-inferiority trial that recruited men with localised prostate cancer (pT1b–T3aN0M0). Patients were randomly assigned (1:1:1) to conventional (74 Gy delivered in 37 fractions over 7·4 weeks) or one of two hypofractionated schedules (60 Gy in 20 fractions over 4 weeks or 57 Gy in 19 fractions over 3·8 weeks) all delivered with intensity-modulated techniques. Most patients were given radiotherapy with 3–6 months of neoadjuvant and concurrent androgen suppression. Randomisation was by computer-generated random permuted blocks, stratified by National Comprehensive Cancer Network (NCCN) risk group and radiotherapy treatment centre, and treatment allocation was not masked. The primary endpoint was time to biochemical or clinical failure; the critical hazard ratio (HR) for non-inferiority was 1·208. Analysis was by intention to treat. Long-term follow-up continues. The CHHiP trial is registered as an International Standard Randomised Controlled Trial, number ISRCTN97182923. Findings Between Oct 18, 2002, and June 17, 2011, 3216 men were enrolled from 71 centres and randomly assigned (74 Gy group, 1065 patients; 60 Gy group, 1074 patients; 57 Gy group, 1077 patients). Median follow-up was 62·4 months (IQR 53·9–77·0). The proportion of patients who were biochemical or clinical failure free at 5 years was 88·3% (95% CI 86·0–90·2) in the 74 Gy group, 90·6% (88·5–92·3) in the 60 Gy group, and 85·9% (83·4–88·0) in the 57 Gy group. 60 Gy was non-inferior to 74 Gy (HR 0·84 [90% CI 0·68–1·03], pNI=0·0018) but non-inferiority could not be claimed for 57 Gy compared with 74 Gy (HR 1·20 [0·99–1·46], pNI=0·48). Long-term side-effects were similar in the hypofractionated groups compared with the conventional group. There were no significant differences in either the proportion or cumulative incidence of side-effects 5 years after treatment using three clinician-reported as well as patient-reported outcome measures. The estimated cumulative 5 year incidence of Radiation Therapy Oncology Group (RTOG) grade 2 or worse bowel and bladder adverse events was 13·7% (111 events) and 9·1% (66 events) in the 74 Gy group, 11·9% (105 events) and 11·7% (88 events) in the 60 Gy group, 11·3% (95 events) and 6·6% (57 events) in the 57 Gy group, respectively. No treatment-related deaths were reported. Interpretation Hypofractionated radiotherapy using 60 Gy in 20 fractions is non-inferior to conventional fractionation using 74 Gy in 37 fractions and is recommended as a new standard of care for external-beam radiotherapy of localised prostate cancer. Funding Cancer Research UK, Department of Health, and the National Institute for Health Research Cancer Research Network.

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Randomized Trial of a Hypofractionated Radiation Regimen for the Treatment of Localized Prostate Cancer.

Charles N Catton, Himu Lukka, Chu-Shu Gu … (2017)

Purpose Men with localized prostate cancer often are treated with external radiotherapy (RT) over 8 to 9 weeks. Hypofractionated RT is given over a shorter time with larger doses per treatment than standard RT. We hypothesized that hypofractionation versus conventional fractionation is similar in efficacy without increased toxicity. Patients and Methods We conducted a multicenter randomized noninferiority trial in intermediate-risk prostate cancer (T1 to 2a, Gleason score ≤ 6, and prostate-specific antigen [PSA] 10.1 to 20 ng/mL; T2b to 2c, Gleason ≤ 6, and PSA ≤ 20 ng/mL; or T1 to 2, Gleason = 7, and PSA ≤ 20 ng/mL). Patients were allocated to conventional RT of 78 Gy in 39 fractions over 8 weeks or to hypofractionated RT of 60 Gy in 20 fractions over 4 weeks. Androgen deprivation was not permitted with therapy. The primary outcome was biochemical-clinical failure (BCF) defined by any of the following: PSA failure (nadir + 2), hormonal intervention, clinical local or distant failure, or death as a result of prostate cancer. The noninferiority margin was 7.5% (hazard ratio, < 1.32). Results Median follow-up was 6.0 years. One hundred nine of 608 patients in the hypofractionated arm versus 117 of 598 in the standard arm experienced BCF. Most of the events were PSA failures. The 5-year BCF disease-free survival was 85% in both arms (hazard ratio [short v standard], 0.96; 90% CI, 0.77 to 1.2). Ten deaths as a result of prostate cancer occurred in the short arm and 12 in the standard arm. No significant differences were detected between arms for grade ≥ 3 late genitourinary and GI toxicity. Conclusion The hypofractionated RT regimen used in this trial was not inferior to conventional RT and was not associated with increased late toxicity. Hypofractionated RT is more convenient for patients and should be considered for intermediate-risk prostate cancer.

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Journal

Journal ID (nlm-ta): J Radiat Res

Journal ID (iso-abbrev): J. Radiat. Res

Journal ID (publisher-id): jrr

Title: Journal of Radiation Research

Publisher: Oxford University Press

ISSN (Print): 0449-3060

ISSN (Electronic): 1349-9157

Publication date (Print): March 2019

Publication date (Electronic): 19 December 2018

Publication date PMC-release: 19 December 2018

Volume: 60

Issue: 2

Pages: 221-227

Affiliations

[1 ]Department of Radiology, Nagoya City University Graduate School of Medical Sciences, 1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, Aichi, Japan

[2 ]Department of Radiology, Fujieda Heisei Memorial Hospital, 123-1 Mizukami, Fujieda, Shizuoka, Japan

[3 ]Department of Radiation Oncology, Nanbu Tokushukai Hospital, 171-1 Hokama, Yaese-cho, Shimajiri-gun, Okinawa, Japan

[4 ]Department of Radiology, Narita Memorial Hospital, 134 Haneihonmachi, Toyohashi, Aichi, Japan

[5 ]Department of Radiation Oncology, Nagoya Proton Therapy Center, Nagoya City West Medical Center, 1–1-1 Hirate-cho, Kita-ku, Nagoya, Aichi, Japan

Author notes

Corresponding author. Department of Radiology, Nagoya City University Graduate School of Medical Sciences, 1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, Aichi, 467–8601, Japan. Tel: +81-52-853-8274; Fax: +81-52-852-5244; Email: gmst124i@ 123456gmail.com

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Publisher ID: rry089

DOI: 10.1093/jrr/rry089

PMC ID: 6430249

PubMed ID: 30566649

SO-VID: 2f048ba0-1ae3-40a8-97cc-94752cd17978

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This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( http://creativecommons.org/licenses/by/4.0/), which permits unrestricted reuse, distribution, and reproduction in any medium, provided the original work is properly cited.

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Date received : 04 May 2018

Date revision received : 18 July 2018

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Long-term results of intensity-modulated radiotherapy with three dose-fractionation regimens for localized prostate cancer

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Most cited references 34

Defining biochemical failure following radiotherapy with or without hormonal therapy in men with clinically localized prostate cancer: recommendations of the RTOG-ASTRO Phoenix Consensus Conference.

Conventional versus hypofractionated high-dose intensity-modulated radiotherapy for prostate cancer: 5-year outcomes of the randomised, non-inferiority, phase 3 CHHiP trial

Randomized Trial of a Hypofractionated Radiation Regimen for the Treatment of Localized Prostate Cancer.

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