8LBA 5 year outcomes of a phase III randomised trial of conventional or hypofractionated high dose intensity modulated radiotherapy for prostate cancer (CRUK/06/016): report from the CHHiP Trial Investigators Group

Dearnaley, David P.; Syndikus, Isabel; Mossop, Helen; Birtle, Alison; Bloomfield, D.; Cruickshank, Clare; Graham, J.; Hassan, Shama; Khoo, V.; Logue, John P; Mayles, Helen; Money-Kyrle, Julian; Naismith, O.; Panades, Miguel; Patterson, Helen; Scrase, Christopher; Staffurth, J.; Tremlett, Jean; Griffin, Clare; Hall, Emma

doi:10.1016/s0959-8049(16)31932-3

Cited by 12 publications

(7 citation statements)

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“…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: 83%

“…Noninferiority trials are currently ongoing to resolve the scientific debate. The clinical evidence seems to show that a shortened course of radiotherapy is as safe and effective as a long course of conventionally fractionated radiotherapy [29][30][31] , supporting current practice changing trends. Muchneeded robust evidence of the efficacy of hypo fractionation is currently being accrued in clini cal trials, but these studies run for long time periods and their results might have a limited effect on clinical practice by the time they are published.…”

Section: Future Perspectivesmentioning

confidence: 88%

“…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: 92%

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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: 83%

Section: Future Perspectivesmentioning

confidence: 88%

Section: Fiducial Markersmentioning

confidence: 92%

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

Arcangeli

Greco

2016

Nat Rev Urol

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“…Two of the trials were carried out before dose-escalation was known and therefore delivered insufficient dose ( 15 , 16 ). Three of the trials showed no significant difference reported in BFFR, OS, or toxicity compared with conventional fractionation for prostate cancer with median follow-up from 51 to 90 months ( 17 – 19 ). The recent 5-year data published from the non-inferiority HYPRO trial of intermediate- and high-risk patients concluded that dose-escalated moderate hypofractionation was not superior with comparable relapse-free survival but higher toxicity profiles compared with standard fractionation ( 20 , 21 ).…”

Section: Discussionmentioning

confidence: 98%

Propensity Score Matched Comparison of Intensity Modulated Radiation Therapy vs Stereotactic Body Radiation Therapy for Localized Prostate Cancer: A Survival Analysis from the National Cancer Database

2017

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PurposeNo direct comparisons between extreme hypofractionation and conventional fractionation have been reported in randomized trials for the treatment of localized prostate cancer. The goal of this study is to use a propensity score matched (PSM) analysis with the National Cancer Database (NCDB) for the comparison of stereotactic body radiation therapy (SBRT) and intensity modulated radiation therapy (IMRT) for organ confined prostate cancer.MethodsMen with localized prostate cancer treated with radiation dose ≥72 Gy for IMRT and ≥35 Gy for SBRT to the prostate only were abstracted from the NCDB. Men treated with previous surgery, brachytherapy, or proton therapy were excluded. Matching was performed to eliminate confounding variables via PSM. Simple 1–1 nearest neighbor matching resulted in a matched sample of 5,430 (2,715 in each group). Subset analyses of men with prostate-specific antigen (PSA) > 10, GS = 7, and GS > 7 yielded matched samples of 1,020, 2,194, and 247, respectively.ResultsNo difference in survival was noted between IMRT and SBRT at 8 years (p = 0.65). Subset analyses of higher risk men with PSA > 10 or GS = 7 histology or GS > 7 histology revealed no difference in survival between IMRT and SBRT (p = 0.58, p = 0.68, and p = 0.62, respectively). Variables significant for survival for the matched group included: age (p < 0.0001), primary payor (p = 0.0001), Charlson/Deyo Score (p = 0.0002), PSA (p = 0.0013), Gleason score (p < 0.0001), and use of hormone therapy (p = 0.02).ConclusionUtilizing the NCDB, there is no difference in survival at 8 years comparing IMRT to SBRT in the treatment of localized prostate cancer. Subset analysis confirmed no difference in survival even for intermediate- and high-risk patients based on Gleason Score and PSA.

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“…Radiotherapy clinical trials play a vital role in assessing new treatment fractionations, dose escalation regimes, chemo-radiation techniques, quality of life, toxicity and long-term survival 22 . Recent landmark prostate trials by Dearnaley et al led to a national change in radiotherapy delivery for low/intermediate prostate cancer patients 23 . The trial randomised more than 3,200 patients between 74 Gray in 37 fractions (control arm), 60 Gray in 20 fractions and 57 Gray in 19 fractions in combination with hormone therapy.…”

Section: Crr Role Developmentmentioning

confidence: 99%

Evaluating the effectiveness of the clinical research radiographer undertaking the on-treatment review of clinical trial patients receiving radiotherapy for prostate cancer

Murray

Gilleece²,

Flood³

2018

J Radiother Pract

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BackgroundRadiotherapy clinical trials are at the forefront of modern-day prostate cancer patient management. Patients are reviewed during treatment by clinical oncologists or competent on-treatment review radiographers to minimise treatment toxicities. Clinical Research Radiographers (CRRs) routinely monitor and gather research data from patients participating in clinical trials.PurposeThe aim of this article is to evaluate the effectiveness of the CRR undertaking the on-treatment review of clinical trial patients.MethodAn experienced CRR within the Northern Ireland Cancer Trials Network was supervised by a clinical oncologist to undertake the role of the on-treatment review of patients receiving radiotherapy for prostate cancer. The CRR explored published literature and compiled this written evaluation as part of their advanced practice learning.ResultsThe supervising clinical oncologist verified, following the planned period of supervised practice and academic study, that the CRR was competent to fulfil the role. Evidence of the beneficial synergistic impact of co-joining the roles was experienced at first hand during the undertaking of supervised practice.ConclusionCo-joining the roles and responsibilities of the CRR and the on-treatment review radiographer enhanced the quality of care offered to the patients participating in clinical trials.

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8LBA 5 year outcomes of a phase III randomised trial of conventional or hypofractionated high dose intensity modulated radiotherapy for prostate cancer (CRUK/06/016): report from the CHHiP Trial Investigators Group

Cited by 12 publications

References 0 publications

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

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

Propensity Score Matched Comparison of Intensity Modulated Radiation Therapy vs Stereotactic Body Radiation Therapy for Localized Prostate Cancer: A Survival Analysis from the National Cancer Database

Evaluating the effectiveness of the clinical research radiographer undertaking the on-treatment review of clinical trial patients receiving radiotherapy for prostate cancer

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