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

Fonteyne, Valérie; Sarrazyn, Camille; Swimberghe, Martijn; Meerleer, Gert De; Rammant, Elke; Vanderstraeten, Barbara; Vanpachtenbeke, Frank; Lumen, Nicolaas; Decaestecker, Karel; Colman, Roos; Villeirs, Geert; Ost, Piet

doi:10.1016/j.ijrobp.2017.12.016

Cited by 8 publications

(6 citation statements)

References 9 publications

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“…Brenner et al26 suggested that BEDs for moderate H-RT should not exceed approximately a BED 1.5 of 183 Gy or a BED 5 of 102 Gy; under this guideline, several fraction patterns may be adopted. However, different fraction patterns may result in events including both disease failure and complication; there is still no consensus about the standard fraction and total dose of moderate hypofractionation 27…”

Section: Discussionmentioning

confidence: 99%

<p>Moderate hypofractionated radiotherapy vs conventional fractionated radiotherapy in localized prostate cancer: a systemic review and meta-analysis from Phase III randomized trials</p>

Yin¹,

You²,

Wang³

et al. 2019

OTT

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Purpose To determine the efficacy and late toxicities of moderate (2.5–4 Gy) hypofractionated radiotherapy (H-RT) in localized prostate cancer, a meta-analysis of published randomized clinical trials comparing moderate H-RT with conventional fractionated RT (C-RT) was performed. Materials and methods Systematic search on published randomized clinical trials in English according to Cochrane review guidelines in databases of Pubmed, Embase, Cochrane, web of science, and Wiley Online Library was carried out. Outcomes of interests were biochemical and clinical disease failure (BCDF), biochemical failure (BF), overall survival (OS), and late toxicities. Results Seven of the 365 studies fulfilled inclusion criteria with 8,156 participants. Compared with C-RT, moderate H-RT showed a lower BF rate (risk ratio [RR] =0.80, 95% CI: 0.68–0.95, P =0.009), while did not improve OS (RR =0.68, 95% CI: 0.78–1.02, P =0.10). There was no significant difference in BCDF rates between H-RT and C-RT (RR =0.92, 95% CI: 0.82–1.02, P =0.12). The H-RT was deeply grouped into dose-escalated H-RT (with a higher biologically effective dose [BED 1.5 ] than C-RT) and no dose-escalated H-RT; dose-escalated H-RT significantly decreased BCDF rate compared with C-RT (RR =0.84, 95% CI: 0.73–0.96, P =0.01). Regarding late toxicities, there is no significant difference in late gastrointestinal (GI; RR =0.97, 95% CI: 0.71–1.33, P =0.85) and genitourinary (GU) toxicities (RR =1.04, 95% CI: 0.87–1.24, P =0.69). When subgrouped into dose-escalated H-RT (with a higher BED 5 compared with C-RT) and no dose-escalated H-RT, dose-escalated H-RT increased GI toxicity (RR =1.62, 95% CI: 1.26–2.09, P =0.0002) and GU toxicity (RR =1.28, 95% CI: 1.05–1.55, P =0.01), while no dose-escalated H-RT significantly lowered GI toxicity (RR =0.81, 95% CI: 0.70–0.94, P =0.005) and placed no influence on GU toxicity (RR =1.02, 95% CI: 0.88–1.20, P =0.77). Conclusion This meta-analysis provides reliable evidence that moderate H-RT decreases BF rate, while does not improve OS. Compared with C-RT, H-RT with an increase in BED 1.5 improved BCDF rates significantly, and accordingly, an increase in BED 5 will result in elevated late GI and GU toxicities.

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Section: Discussionmentioning

confidence: 99%

<p>Moderate hypofractionated radiotherapy vs conventional fractionated radiotherapy in localized prostate cancer: a systemic review and meta-analysis from Phase III randomized trials</p>

Yin¹,

You²,

Wang³

et al. 2019

OTT

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“…25 In comparison with CHHiP and HYpofractionated irradiation for PROstate cancer trials, we found much higher grade 1 bladder toxicity in the third month after the completion of HFRT. 26 In comparing with Fonteyne et al trial, 12 notwithstanding the similar HFRT regimen of 56 Gy in 16 fractions, we recorded more grade 1 and less grade 2 of both bowel and bladder toxicities in the third month after completion of HFRT. This dissimilarity might be explained by the difference in treatment volumes or the importance of patient characteristics on radiosensitivity, such as patient's age, use of cigarettes, and comorbidities.…”

Section: Discussionmentioning

confidence: 47%

“…In this regard, the study was run based on the one-stage Fleming's design, and the sample size was calculated to rule out an upper limit of 40% of acute RTOG grade ≥2 bowel complications with an expected rate of 25%. 12 A power of 85% (alpha level 0•096 one-sided) is obtained when including 24 patients per group. 20 However, due to slow patient accrual, the study ended with 20 patients in each arm.…”

Section: Follow-up and Outcomesmentioning

confidence: 99%

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

et al. 2021

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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.

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“…MLC rotation angles were 0°, 350°, 350°, 350°, 10°, 10°, and 10°, respectively. A median dose of 56 Gy in 16 fractions to the clinical target volume (CTV) was prescribed for both coplanar treatment plans with dose objectives for OARs as previously described 26 . Both plans were approved by an experienced radiation oncologist, confirming the clinical eligibility.…”

Section: Methodsmentioning

confidence: 99%

Accuracy and reliability of a commercial treatment planning system in nontarget regions in modern prostate radiotherapy

Danckaert

Ost

Wagter

2023

J Applied Clin Med Phys

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Background:The currently available treatment planning systems (TPSs) are neither designed nor intended for accurate dose calculations in nontarget regions. The aim of this work is to quantify the accuracy and reliability of nontarget doses calculated by a commercially available TPS. Methods: Nontarget doses calculated by the collapsed cone (CC) (v5.2) algorithm implemented in the RayStation (v6) TPS were compared to measured values. Different scenarios were investigated, from simple static fields to intensity modulated radiotherapy (IMRT) and volumetric modulated arc therapy (VMAT) treatment plans. Deviations and confidence limits (CLs) were calculated between results of calculations and measurements-applying both local (δ) and global (Δ) normalization-for various points of interest (POIs). Results were based on a single-institution experience for one clinical test case (prostate) and evaluated against internationally accepted criteria. Results: Overall, the TPS underestimated the nontarget dose by an average of −17.7% ± 25.3% for IMRT. Quantitatively similar results were obtained for VMAT (−17.6% ± 21.2%). POIs receiving < 5% of the prescription dose were significantly underestimated by the TPS (p-value < 0.05 for both IMRT and VMAT). Dose calculation accuracy was also determined by the contribution of secondary radiation, with measured doses for out-of -field POIs being significantly different from calculated values (p-value < 0.01 for both IMRT and VMAT). Although the CL δ in nontarget regions failed the proposed tolerance criteria (40%) for both IMRT (68.8%) and VMAT (52.6%), the CL Δ was within the tolerance limit (4%) for both treatment techniques (1.9% for IMRT and 1.3% for VMAT). No action levels (7%) were exceeded. Conclusions: Based on the currently available benchmarks our TPS is considered acceptable for clinical use, although the dose in some POIs was poorly predicted by the CC algorithm. Some areas were pointed out where TPSs and linear accelerator control systems can be improved.

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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

Cited by 8 publications

References 9 publications

<p>Moderate hypofractionated radiotherapy vs conventional fractionated radiotherapy in localized prostate cancer: a systemic review and meta-analysis from Phase III randomized trials</p>

<p>Moderate hypofractionated radiotherapy vs conventional fractionated radiotherapy in localized prostate cancer: a systemic review and meta-analysis from Phase III randomized trials</p>

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

Accuracy and reliability of a commercial treatment planning system in nontarget regions in modern prostate radiotherapy

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