Randomized Phase III Noninferiority Study Comparing Two Radiotherapy Fractionation Schedules in Patients With Low-Risk Prostate Cancer

Lee, William R.; Dignam, James J.; Amin, Mahul B.; Bruner, Deborah Watkins; Low, Daniel A.; Swanson, Gregory P.; Shah, Amit; D’Souza, David; Michalski, Jeff M.; Dayes, Ian S.; Seaward, Samantha A.; Hall, William A.; Nguyen, Paul L.; Pisansky, Thomas M.; Faria, Sergio; Chen, Yuhchyau; Koontz, Bridget F.; Paulus, Rebecca; Sandler, Howard M.

doi:10.1200/jco.2016.67.0448

Cited by 542 publications

(482 citation statements)

References 28 publications

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“…With the exception of the HYPRO trial 28 , which found an estimated hazard ratio for cumulative inci dence of grade ≥2 late gastrointestinal and genitourinary toxicity of 1.19 (90% CI 0.93-1.52) and 1.16 (90% CI 0.98-1.38), respectively, in the hypofractionation arm at a median followup duration of 60 months, available clinical evidence supports the notion that the short term safety and efficacy of these experimental regimens is comparable to that of standard fractionation [29][30][31] . Regardless of the radiation schedule employed, the data show comparable diseasefree survival (DFS) and similar toxicity rates at the available time points, thus confirming the noninferiority of hypofractionation over conventional regimens -at least at relatively early time points [29][30][31] .…”

Section: Fiducial Markersmentioning

confidence: 59%

“…Regardless of the radiation schedule employed, the data show comparable diseasefree survival (DFS) and similar toxicity rates at the available time points, thus confirming the noninferiority of hypofractionation over conventional regimens -at least at relatively early time points [29][30][31] . Mature results from complementary non inferiority trials are pending and will help to clarify the role of moderately hypofractionated radiotherapy for organconfined prostate cancer.…”

Section: Fiducial Markersmentioning

confidence: 78%

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Hypofractionated radiotherapy for organ-confined prostate cancer: is less more?

Arcangeli

Greco

2016

Nat Rev Urol

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Moderate hypofractionation of radiotherapy is widely considered a viable alternative to conventional fractionation for the treatment of patients with organ-confined prostate cancer, but stereotactic body radiotherapy (SBRT) is rapidly emerging as a novel treatment modality for this disease. Advances in treatment planning, image guidance, target position reproducibility and on-line tracking, coupled with a compelling radiobiological rationale, have promoted SBRT as a safe and effective treatment. Dose escalation to the tumour tissue through a decreased number of radiation fractions improves patient comfort and convenience, as well as treatment cost-effectiveness, compared with conventional radiotherapy regimens. Several clinical trials have investigated moderate and extreme hypofractionation of radiotherapy in patients with prostate cancer. Evidence is accumulating which suggests that the use of moderately hypofractionated radiotherapy can be recommended regardless of cancer risk group. Regimens of extremely hypofractionated radiotherapy have shown very good short-term efficacy and safety outcomes, but appropriately designed trials with extended follow-up monitoring are required to confirm long-term outcomes.

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Section: Fiducial Markersmentioning

confidence: 59%

Section: Fiducial Markersmentioning

confidence: 78%

Hypofractionated radiotherapy for organ-confined prostate cancer: is less more?

Arcangeli

Greco

2016

Nat Rev Urol

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“…Thirdly, evolution in therapeutic techniques over the past decade may have had an impact on the relative cost and value of care delivered in the present day, which was not adequately captured in this dataset. Of particular interest is emerging data on hypofractionated radiotherapy whereby a course of radiation is delivered over 2-4 weeks instead of the conventional 8-9 weeks (38,39). While there are certainly limitations to this type of analysis, the volume and detail of data available within an IDFS create advantages not available in other cost models, and we anticipate this analysis will serve as a model for future work.…”

Section: Discussionmentioning

confidence: 99%

Challenges in the Analysis of Outcomes for Surgical Compared to Radiotherapy Treatment of Prostate Cancer

Glaser

Kalash

Bongiorni

et al. 2018

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“…Hypofractionated radiotherapy schedules have been explored in a series of recent randomised controlled trials 2, 3, 4, 5. These have shown that 20–28 days fractionation schedules result in approximately equivalent biochemical control and rectal toxicities compared with 37–39 days conventional fractionation regimens.…”

Section: Introductionmentioning

confidence: 99%

Rectal protection in prostate stereotactic radiotherapy: a retrospective exploratory analysis of two rectal displacement devices

Wilton

Richardson

Keats³

et al. 2017

J of Medical Radiation Sci

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IntroductionHigh rectal doses are associated with increased toxicity. A rectal displacement device (RDD) reduces rectal dose in prostate stereotactic body radiation therapy (SBRT). This study investigates any dosimetric difference between two methods of rectal displacement (Rectafix and SpaceOAR) for prostate SBRT.MethodsRectal dosimetry of 45 men who received SBRT within the PROMETHEUS trial was retrospectively examined, across two radiation therapy centres using the two RDD's. Men received a total dose (TD) of 19 or 20 Gy in two fractions followed by 46 Gy in 23 fractions. Centre 1 contributed 16 Rectafix and 10 SpaceOAR patients. Centre 2 contributed 19 Rectafix patients. Rectal dose volume histogram (DVH) data were recorded as a TD percentage at the following volume intervals; V1%, V2%, V5%, V10% and then 10% increments to V80%. As only one centre employed both RDD's, three sequential rectal dosimetry comparisons were performed; (1) centre 1 Rectafix versus centre 1 SpaceOAR; (2) centre 1 Rectafix versus centre 2 Rectafix and (3) centre 1+ centre 2 Rectafix versus centre 1 SpaceOAR.ResultsIn comparison (1) Rectafix demonstrated lower mean doses at 9 out of 11 measured intervals (P = 0.0012). Comparison (2) demonstrated a moderate difference with centre 2 plans producing slightly lower rectal doses (P = 0.013). Comparison (3) further demonstrated that Rectafix returned lower mean doses than SpaceOAR (P < 0.001). Although all dose levels were in favour of Rectafix, in absolute terms differences were small (2.6–9.0%).ConclusionsIn well‐selected prostate SBRT patients, Rectafix and SpaceOAR RDD's provide approximately equivalent rectal sparing.

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Randomized Phase III Noninferiority Study Comparing Two Radiotherapy Fractionation Schedules in Patients With Low-Risk Prostate Cancer

Abstract: In men with low-risk prostate cancer, the efficacy of 70 Gy in 28 fractions over 5.6 weeks is not inferior to 73.8 Gy in 41 fractions over 8.2 weeks, although an increase in late GI/genitourinary adverse events was observed in patients treated with H-RT.

Cited by 542 publications

References 28 publications

Hypofractionated radiotherapy for organ-confined prostate cancer: is less more?

Hypofractionated radiotherapy for organ-confined prostate cancer: is less more?

Challenges in the Analysis of Outcomes for Surgical Compared to Radiotherapy Treatment of Prostate Cancer

Rectal protection in prostate stereotactic radiotherapy: a retrospective exploratory analysis of two rectal displacement devices

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