Pragmatic randomised clinical trial of proton versus photon therapy for patients with non-metastatic breast cancer: the Radiotherapy Comparative Effectiveness (RadComp) Consortium trial protocol

Bekelman, Justin E.; Lu, Hien L.; Pugh, Stephanie L.; Baker, Kaitlyn; Berg, Christine D.; González, Amy Berrington de; Braunstein, Lior Z.; Bosch, Walter; Chauhan, Cynthia; Ellenberg, Susan S.; Fang, Liwei; Freedman, Gary M.; Hahn, Elizabeth A.; Haffty, Bruce G.; Khan, Atif J.; Jimenez, Rachel; Kesslering, Christy; Ky, Bonnie; Lee, Choonsik; Lu, Hsiao Ming; Mishra, Mark V.; Mullins, C. Daniel; Mutter, Robert W.; Nagda, S.; Pankuch, Mark; Powell, Simon N.; Prior, Fred; Schupak, Karen D.; Taghian, Alphonse G.; Wilkinson, J. Ben; MacDonald, Shannon M.; Cahlon, Oren

doi:10.1136/bmjopen-2018-025556

Cited by 79 publications

(44 citation statements)

References 55 publications

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“…Darby et al found that the rate of the incidence of ischemic heart disease increased linearly with the mean heart dose by 7.4% per Gy [13]. In addition, the RADCOMP (Radiotherapy Comparative Effectiveness) trial has also pointed out that the mean heart dose as a critical indicator for cardiotoxicity [45,49]. The mean heart dose of the delivered vIMPT plans in our study was 6.38cGy, which is higher than SPArc 4.5cGy (p=0.04).…”

Section: Discussionmentioning

confidence: 40%

Feasibility study: Spot-scanning Proton Arc therapy (SPArc) for left-sided whole breast radiotherapy

Chang

Liu

Zhao

et al. 2020

Preprint

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Background : This study investigated the feasibility and potential clinical benefit of utilizing a new proton treatment technique: Spot-scanning Proton Arc (SPArc) therapy for left-sided whole breast radiotherapy (WBRT) to further reduce radiation dose to healthy tissue and mitigate the probability of normal tissue complications compared to conventional Intensity Modulated Proton Therapy (IMPT). Methods : Eight patients diagnosed with left-sided breast cancer and treated with breast-preserving surgery followed by whole breast irradiation without regional nodal irradiation were included in this retrospective planning. Two proton treatment plans were generated for each patient: vertical intensity-modulated proton therapy used for clinical treatment (vIMPT, gantry angle 10°-30°) and SPArc for comparison purpose. Both SPArc and vIMPT plans were optimized using the robust optimization of ±3.5% range and 5mm setup uncertainties. Root-mean-square deviation dose (RMSD) volume histogram s were used for plan robustness evaluation. All dosimetric results were evaluated based on dose-volume histograms (DVH), and the interplay effect was evaluated based on the accumulation of single-fraction 4D dynamic dose on CT50. The treatment beam delivery time was simulated based on a gantry rotation with energy-layer-switching-time (ELST) from 0.2 to 5s. Results: The average D1 to the heart and LAD were reduced to 53.63cGy and 82.25cGy compared with vIMPT 110.38cGy (p = 0.001) and 170.38cGy (p = 0.001), respectively. The average V5Gy and V20Gy of ipsilateral lung was reduced to 16.77% and 3.07% compared to vIMPT 25.56% (p = 0.001) and 4.68% (p = 0.003). Skin3mm mean and maximum dose were reduced to 3999.38cGy and 4395.63cGy compared to vIMPT 4104.25cGy (p=0.039) and 4411.63cGy (p=0.043), respectively. A significant relative risk reduction (RNTCP = NTCP SPArc / NTCP vIMPT ) for organs at risk (OARs) was obtained with SPArc ranging from 0.61 to 0.86 depending on the clinical endpoint. The RMSD Volume Histogram (RVH) analysis shows SPArc provided better plan robustness in OARs sparing, including the heart, LAD, ipsilateral lung, and skin. The average estimated treatment beam delivery times were comparable to vIMPT plans when the ELST is about 0.5s. Conclusion: SPArc technique can further reduce dose delivered to OARs and the probability of normal tissue complications in patient treated for left-sided WBRT.

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Section: Discussionmentioning

confidence: 40%

Feasibility study: Spot-scanning Proton Arc therapy (SPArc) for left-sided whole breast radiotherapy

Chang

Liu

Zhao

et al. 2020

Preprint

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“…[33][34][35][36][37][38][39][40][41] For breast cancer specifically, small series have described significantly reduced cardiac and pulmonary exposures when RT is delivered with photons compared with protons, with particular emphasis on cardiac structures. [20][21][22]42 However, clinicians and national clinical trial protocols 43 continue to base RT planning goals (and, by extrapolation, plan quality) on historical photon constraints. Although it is widely accepted that PBT plans should meet, if not significantly improve, on classical photon dose constraints, new target ranges have not been established.…”

Section: Discussionmentioning

confidence: 99%

Assessing the Need for Adjusted Organ-at-Risk Planning Goals for Patients Undergoing Adjuvant Radiation Therapy for Locally Advanced Breast Cancer with Proton Radiation

DeCesaris

Pollock

Zhang

et al. 2021

Practical Radiation Oncology

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Locally advanced breast cancer requires surgical management via lumpectomy or mastectomy with or without systemic therapy followed by chest wall or breast (CW) and comprehensive nodal irradiation (CNI). Radiation (RT) dose constraints for the heart and ipsilateral lung have been developed based on photon RT. Proton therapy (PBT) can deliver significantly lower doses of RT to these organs-at-risk (OARs) and may warrant adjustments to OAR planning goals. Methods and Materials: The RT plans of consecutive patients undergoing adjuvant CW-CNI RT with PBT within a single center were reviewed. A inital treatment volume, comprised of CW/intact breast þ CNI (CTV_init) structure, including the CW and CNI but excluding any boost plans was analyzed. Frequency distributions were generated based on doses received by the heart, lungs, and esophagus for validated dosimetric parameters. Frequency distributions were generated and then stratified by laterality and compared using the Kruskal-Wallis H test. The 75th, 85th, and 95th percentiles for each dosimetric parameter were calculated, overall and by laterality. The 75th percentile (Q3), was used as a suggested primary goal, and the 95th percentile was used as a suggested secondary goal. Results: One hundred and seventy-two plans were analyzed. Forty-nine plans were right-sided, 107 were left-sided, and 16 were bilateral. The overall Q3 of the mean and V25 of the heart were 1.5 Gy and 1.7%, respectively. The mean and V25 to the heart differed significantly by laterality. Pulmonary values were similar to current recommendations. For all lateralites, the median volume of the esophagus receiving 70% prescription dose was 1 cm 3. Conclusions: We present the first dosimetric study providing complete OAR dose-volume histograms data for patients undergoing adjuvant pencil-beam scanning-PBT for locally advanced breast cancer, with detailed information on central tendencies, ranges and distributions of data. We have provided suggested planning goals and metrics for the lungs, heart, and esophagus; the latter 2 differing Sources of support: No outside funding was used in the development of this manuscript.

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“…This was chosen as a relatively comprehensive protocol, intended for patients requiring RNI due to high risk of LRR, but has been found to be complex to follow in practice. The second was the atlas for ClinicalTrials.gov Identifier: NCT02603341 – a Pragmatic Phase III Randomized Trial of Proton vs. Photon Therapy for Patients with Non‐Metastatic Breast Cancer: A Radiotherapy Comparative Effectiveness (RADCOMP) Consortium Trial …”

Section: Methodsmentioning

confidence: 99%

“…Two recent trial guidelines are also worthy of comparison. Following concerns about LRR at the edge or just outside these guidelines, a consortium developed a trial version of RTOG guidelines, here called ‘RADCOMP’, for a Phase III clinical trial comparing the use of photons and protons to treat breast cancer where RNI is required . The Trans‐Tasman Radiation Oncology Group (TROG) Trial 12.02: PET Scans for Locally Advanced Breast Cancer and Diagnostic MRI to Determine the Extent of Operation and Radiotherapy (PET‐LABRABOR) examines the use of PET Scans and MRI to determine extent of operation and RT for locally advanced breast cancer.…”

Section: Introductionmentioning

confidence: 99%

Contouring consensus guidelines in breast cancer radiotherapy: Comparison and systematic review of patterns of failure

et al. 2018

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Summary Adequate coverage of sites harbouring potential microscopic disease is paramount, where the clinical decision has been made to include regional lymph node radiotherapy for patients with breast cancer. This must be achieved in balance with minimising dose to normal tissues. Several international consensus guidelines detailing clinical target volumes (CTVs) are available, but there is currently no agreement as to which is most appropriate for a given clinical situation. Contouring guidelines are beneficial for routine practice and essential for clinical trial quality assurance. The aims of this study were as follows: to provide a single point of comparison of four commonly used contouring guidelines, including one used in a current Trans‐Tasman Radiation Oncology Group trial; and to undertake a systematic review of existing studies which map sites of breast cancer recurrence against contouring guidelines. Two international consensus guidelines (European Society for Radiotherapy and Oncology, and Radiation Therapy Oncology Group) were compared with two clinical trial guidelines (TROG 12.02 PET LABRADOR and the Proton/Photon trial NCT02603341 RADCOMP). Comprehensive literature search for patterns of failure studies was undertaken using Embase and Pubmed. We detail the small but significant differences between the breast consensus guidelines, particularly the supraclavicular (SCF) and internal mammary chain CTVs. Seven series were found mapping recurrence patterns. These results are discussed in the context of the contouring guidelines. Several studies found the SCF CTV is the area at greatest risk of geographical ‘miss’. This review will facilitate further discussion about guideline selection and modification, particularly for future clinical trials in Australia and New Zealand.

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Pragmatic randomised clinical trial of proton versus photon therapy for patients with non-metastatic breast cancer: the Radiotherapy Comparative Effectiveness (RadComp) Consortium trial protocol

Cited by 79 publications

References 55 publications

Feasibility study: Spot-scanning Proton Arc therapy (SPArc) for left-sided whole breast radiotherapy

Feasibility study: Spot-scanning Proton Arc therapy (SPArc) for left-sided whole breast radiotherapy

Assessing the Need for Adjusted Organ-at-Risk Planning Goals for Patients Undergoing Adjuvant Radiation Therapy for Locally Advanced Breast Cancer with Proton Radiation

Contouring consensus guidelines in breast cancer radiotherapy: Comparison and systematic review of patterns of failure

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