Comparison of proton therapy and intensity modulated photon radiotherapy for locally advanced non-small cell lung cancer: considerations for optimal trial design

Cushman, Taylor R.; Verma, Vivek; Rwigema, Jean‐Claude M.

doi:10.21037/jtd.2018.04.59

Cited by 6 publications

(8 citation statements)

References 26 publications

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“…Combined rates of local failure and radiation pneumonitis in the PBT group were 31% in the first half of patients recruited versus 13.1% in the latter half (P = 0.027). 58 Both PBT and IMRT plan quality improved as the trial progressed, supporting the downstream benefits of a concurrent PT service and a focus on quality assurance. 59 The implications of a learning curve with experience, or other improvements in planning and delivery techniques occurring through the trial duration, mean extra caution needs to be taken in implementation, quality assurance and verification of the latest technology in radiation oncology, and expertise needs to be acquired before its use can be compared to existing interventions.…”

Section: Discussionmentioning

confidence: 78%

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Particle therapy toxicity outcomes: A systematic review

Hwang

Gorayski

et al. 2020

J Med Imag Rad Onc

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Owing to its physical properties, particle therapy (PT), including proton beam therapy (PBT) and carbon ion therapy (CIT), can enhance the therapeutic ratio in radiation therapy. The major factor driving PT implementation is the reduction in exit and integral dose compared to photon plans, which is expected to translate to reduced toxicity and improved quality of life. This study extends the findings from a recent systematic review by the current authors which concentrated on tumour outcomes for PT, to now examine toxicity as a separate focus. Together, these reviews provide a comprehensive collation of the evidence relating to PT outcomes in clinical practice. 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 seventy-nine studies were included. Most demonstrated acceptable and favourable toxicity results. Comparative evidence reported reduced morbidities and improvement in quality of life in head and neck, paediatrics, sarcomas, adult central nervous system, gastrointestinal, ocular and prostate cancers compared to photon radiotherapy. This suggestion for reduced morbidity must be counterbalanced by the overall low quality of evidence. A concerted effort in the design of appropriate comparative clinical trials is needed which takes into account integration of PT's pace of technological advancements, including evolving delivery techniques, image guidance availability and sophistication of planning algorithms.

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Section: Discussionmentioning

confidence: 78%

“…52,53 These issues must be addressed in the design of future PT studies. 58 More recently, initiated PT RCTs, which are based on IMPT, use reduced margins. 52 Finally, this study highlights that learning curves exist with the implementation of any new technology.…”

Section: Discussionmentioning

confidence: 99%

Particle therapy toxicity outcomes: A systematic review

Hwang

Gorayski

et al. 2020

J Med Imag Rad Onc

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“…There was no benefit in RP and local failure after proton therapy [60,61]. Some criticism has been raised for inadequate planning of proton therapy due to the learning curve, the use of passive scattering techniques, non-standard RT doses of 66 to 74 Gy (RBE), and selection bias due to insurance coverage issues [62]. Nevertheless, this study concluded that there was no clear benefit of proton therapy in locally advanced NSCLC.…”

Section: Non-small Cell Lung Cancermentioning

confidence: 94%

Proton therapy: the current status of the clinical evidences

2019

Precis Future Med

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Proton therapy has the potential advantages of better conformal planning and higher biological effect than photon therapy (X-ray) for targeting tumor tissues. While the energy of a photon passes through the target, the energy of a proton is deposited at a certain depth, which in turn is negligible beyond this stopping point (i.e., the "Bragg peak"). In addition, the proton beam has a 10% higher biological effect in the same dose than the photon beam. Recent technological advances have led to wide use of proton therapy in clinical practice. To date, more than 170,000 patients have received proton therapy. Although clinical experience with proton therapy is increasing now, only approximately 1% of all radiation therapy recipients receive proton therapy and prospective randomized studies involving large sample populations remain very limited yet. The aim of this review is to describe the physical and biological properties of proton therapy and discusses the clinical evidence supporting proton therapy in various disease sites.

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“…However, this may be challenging when data are sparse, especially for novel technologies (e.g., protons). Bayesian adaptive trial design is exploring this uncertain domain, which can allocate more patients with updated information to the more beneficial treatment arm if a difference is observed during a trial as recently used when evaluating protons in lung cancer [25] , [26] . However, it is not being used in four ongoing Phase III proton trials in HNC (NCT04607694, NCT01893307, NCT02923570, TORPEdO trial-ISRCTN16424014).…”

Section: Methodsmentioning

confidence: 99%

Statistical fundamentals on cancer research for clinicians: Working with your statisticians

Huang

et al. 2021

Clinical and Translational Radiation Oncology

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To facilitate understanding statistical principles and methods for clinicians involved in cancer research. Methods: An overview of study design is provided on cancer research for both observational and clinical trials addressing study objectives and endpoints, superiority tests, non-inferiority and equivalence design, and sample size calculation. The principles of statistical models and tests including contemporary standard methods of analysis and evaluation are discussed. Finally, some statistical pitfalls frequently evident in clinical and translational studies in cancer are discussed. Results: We emphasize the practical aspects of study design (superiority vs non-inferiority vs equivalence study) and assumptions underpinning power calculations and sample size estimation. The differences between relative risk, odds ratio, and hazard ratio, understanding outcome endpoints, purposes of interim analysis, and statistical modeling to minimize confounding effects and bias are also discussed. Conclusion: Proper design and correctly constructed statistical models are critical for the success of cancer research studies. Most statistical inaccuracies can be minimized by following essential statistical principles and guidelines to improve quality in research studies.

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Comparison of proton therapy and intensity modulated photon radiotherapy for locally advanced non-small cell lung cancer: considerations for optimal trial design

Cited by 6 publications

References 26 publications

Particle therapy toxicity outcomes: A systematic review

Particle therapy toxicity outcomes: A systematic review

Proton therapy: the current status of the clinical evidences

Statistical fundamentals on cancer research for clinicians: Working with your statisticians

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