Randomized Trials of Proton Therapy: Why They Are at Risk, Proposed Solutions, and Implications for Evaluating Advanced Technologies to Diagnose and Treat Cancer

Bekelman, Justin E.; Denicoff, Andrea; Buchsbaum, Jeffrey C.

doi:10.1200/jco.2018.77.7078

Cited by 44 publications

(50 citation statements)

References 23 publications

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“…The debate between the advocates in favour of level I evidence in all circumstances, and those who consider this to be unfeasible or even unethical in some cases, continues. [65][66][67][68][69][70][71][72] Tumours set to benefit most from PT are paediatric and other rare tumours. Paediatric solid tumours are regarded as a special category by many jurisdictions.…”

Section: What Evidence Is Needed?mentioning

confidence: 99%

“…65,77,78 Countries offering PT are conducting or planning clinical trials. 15,72 However, a waning of clinical trial initiation was noted by Odei et al 79 in 2016 with funding barriers one cited cause. There is however currently increasing support from insurers in the USA to fund PBT treatment in clinical trials.…”

Section: What Evidence Is Needed?mentioning

confidence: 99%

“…There is however currently increasing support from insurers in the USA to fund PBT treatment in clinical trials. 69,72 This, along with the recent operation of PBT facilities in nationally funded healthcare systems such as Denmark, the United Kingdom and the Netherlands with prospective patient databases and defined groups of patients for funded PBT, is likely to lead to a new generation of evidence becoming available. It is not too late for Australia to contribute patients to international efforts in generating further evidence through registries, and prospective databases for both PBT and CIT, helping to shape and expand indications for PT over time.…”

Section: What Evidence Is Needed?mentioning

confidence: 99%

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Particle therapy tumour outcomes: An updated systematic review

Hwang

Gorayski

et al. 2020

J Med Imag Rad Onc

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Particle therapy (PT) offers the potential for reduced normal tissue damage as well as escalation of target dose, thereby enhancing the therapeutic ratio in radiation therapy. Reflecting the building momentum of PT use worldwide, construction has recently commenced for The Australian Bragg Centre for Proton Therapy and Research in Adelaidethe first PT centre in Australia. This systematic review aims to update the clinical evidence base for PT, both proton beam and carbon ion therapy. The purpose is to inform clinical decision-making for referral of patients to PT centres in Australia as they become operational and overseas in the interim. Three major databases were searched by two independent researchers, and evidence quality was classified according to the National Health and Medical Research Council evidence hierarchy. One hundred and thirty-six studies were included, two-thirds related to proton beam therapy alone. PT at the very least provides equivalent tumour outcomes compared to photon controls with the possibility of improved control in the case of carbon ion therapy. There is suggestion of reduced morbidities in a range of tumour sites, supporting the predictions from dosimetric modelling and the wide international acceptance of PT for specific indications based on this. Though promising, this needs to be counterbalanced by the overall low quality of evidence found, with 90% of studies of level IV (case series) evidence. Prospective comparative clinical trials, supplemented by database-derived outcome information, preferably conducted within international and national networks, are strongly recommended as PT is introduced into Australasia.

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Section: What Evidence Is Needed?mentioning

confidence: 99%

Section: What Evidence Is Needed?mentioning

confidence: 99%

Section: What Evidence Is Needed?mentioning

confidence: 99%

See 1 more Smart Citation

Particle therapy tumour outcomes: An updated systematic review

Hwang

Gorayski

et al. 2020

J Med Imag Rad Onc

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“…It must also be acknowledged that the CBS was developed based on the expert opinion and scientific literature was available at the time [4][5]8]. Although the state of knowledge has evolved since, there continues to be a lack of high-level evidence comparing PBT and photon therapy [17]. However, a number of trials are ongoing to address this issue in several disease sites [18][19][20][21][22][23].…”

Section: Discussionmentioning

confidence: 99%

Patient Prioritization for Proton Beam Therapy in a Cost-neutral Payer Environment: Use of the Clinical Benefit Score for Resource Allocation

Sharma¹,

Khairnar²,

Kowalski³

et al. 2019

Cureus

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“…Yet enrollment in these trials has been slowed by denials of insurance coverage for care and preferences by clinicians and patients for one treatment or the other. 6 Evaluating the effectiveness of proton therapy most critically depends on 2 primary opportunities: (1) improved patient access to proton therapy and to these trials through insurance coverage for proton therapy when patients are on study and (2) community equipoise among clinicians and patients. We propose 4 potential strategies going forward.…”

mentioning

confidence: 99%