Patricia Mae G Santos, Sierra Silverwood, Gita Suneja, Eric Ford, Nikhil G Thaker, Jamie S Ostroff, Bryan J Weiner, Erin F Gillespie
{"title":"Dissemination and Implementation - A Primer for Accelerating \"Time to Translation\" in Radiation Oncology.","authors":"Patricia Mae G Santos, Sierra Silverwood, Gita Suneja, Eric Ford, Nikhil G Thaker, Jamie S Ostroff, Bryan J Weiner, Erin F Gillespie","doi":"10.1016/j.ijrobp.2024.11.101","DOIUrl":"https://doi.org/10.1016/j.ijrobp.2024.11.101","url":null,"abstract":"<p><p>The field of radiation oncology has achieved significant technological and scientific advancements in the 21<sup>st</sup> century. Yet uptake of new evidence-based practices has been heterogeneous, even in the presence of national and international guidelines. Addressing barriers to practice change requires a deliberate focus on developing and testing strategies tailored to improving care delivery and quality, especially for vulnerable patient populations. Implementation science provides a systematic approach to developing and testing strategies, though applications in radiation oncology remain limited. In this critical review, we aim to 1) assess the time from first evidence to widespread adoption, or \"time to translation,\" across multiple evidence-based practices involving radiation therapy, and 2) provide a primer on the application of implementation science to radiation oncology. Specifically, we discuss potential targets for implementation research in radiation oncology, including both evidence-based practices and quality metrics, and highlight examples of studies evaluating implementation strategies. We also define key concepts and frameworks in the field of implementation science, review common study designs including hybrid trials and cluster randomization, and discuss the interaction with related disciplines such as quality improvement and behavioral economics. Ultimately, this review aims to illustrate how a comprehensive understanding of implementation science could be used to promote equity and quality in cancer care through the development of effective, scalable, and sustainable care delivery solutions.</p>","PeriodicalId":14215,"journal":{"name":"International Journal of Radiation Oncology Biology Physics","volume":" ","pages":""},"PeriodicalIF":6.4,"publicationDate":"2024-12-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142800710","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Shaoyan Pan, Chih-Wei Chang, Zhen Tian, Tonghe Wang, Marian Axente, Joseph Shelton, Tian Liu, Justin Roper, Xiaofeng Yang
{"title":"Data-Driven Volumetric Computed Tomography Image Generation From Surface Structures Using a Patient-Specific Deep Leaning Model.","authors":"Shaoyan Pan, Chih-Wei Chang, Zhen Tian, Tonghe Wang, Marian Axente, Joseph Shelton, Tian Liu, Justin Roper, Xiaofeng Yang","doi":"10.1016/j.ijrobp.2024.11.077","DOIUrl":"10.1016/j.ijrobp.2024.11.077","url":null,"abstract":"<p><strong>Purpose: </strong>Optical surface imaging presents radiation-dose-free and noninvasive approaches for image guided radiation therapy, allowing continuous monitoring during treatment delivery. However, it falls short in cases where correlation of motion between body surface and internal tumor is complex, limiting the use of purely surface guided surrogates for tumor tracking. Relying solely on surface guided radiation therapy (SGRT) may not ensure accurate intrafractional monitoring. This work aims to develop a data-driven framework, mitigating the limitations of SGRT in lung cancer radiation therapy by reconstructing volumetric computed tomography (CT) images from surface images.</p><p><strong>Methods and materials: </strong>We conducted a retrospective analysis involving 50 patients with lung cancer who underwent radiation therapy and had 10-phase 4-dimensional CT (4DCT) scans during their treatment simulation. For each patient, we used 9 phases of 4DCT images for patient-specific model training and validation, reserving 1 phase for testing purposes. Our approach employed a surface-to-volume image synthesis framework, harnessing cycle-consistency generative adversarial networks to transform surface images into volumetric representations. The framework was extensively validated using an additional 6-patient cohort with resimulated 4DCT.</p><p><strong>Results: </strong>The proposed technique has produced accurate volumetric CT images from the patient's body surface. In comparison with the ground truth CT images, those generated synthetically by the proposed method exhibited the gross tumor volume center of mass difference of 1.72 ± 0.87 mm, the overall mean absolute error of 36.2 ± 7.0 HU, structural similarity index measure of 0.94 ± 0.02, and Dice score coefficient of 0.81 ± 0.07. Furthermore, the robustness of the proposed framework was found to be linked to respiratory motion.</p><p><strong>Conclusions: </strong>The proposed approach provides a novel solution to overcome the limitation of SGRT for lung cancer radiation therapy, which can potentially enable real-time volumetric imaging during radiation treatment delivery for accurate tumor tracking without radiation-induced risk. This data-driven framework offers a comprehensive solution to tackle motion management in radiation therapy, without necessitating the rigid application of first principles modeling for organ motion.</p>","PeriodicalId":14215,"journal":{"name":"International Journal of Radiation Oncology Biology Physics","volume":" ","pages":""},"PeriodicalIF":6.4,"publicationDate":"2024-12-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142692922","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Sarah Barrett, Mohammad U Zahid, Heiko Enderling, Laure Marignol
{"title":"Predicting Individual Tumor Response Dynamics in Locally Advanced Non-Small Cell Lung Cancer Radiation Therapy: A Mathematical Modelling Study.","authors":"Sarah Barrett, Mohammad U Zahid, Heiko Enderling, Laure Marignol","doi":"10.1016/j.ijrobp.2024.10.038","DOIUrl":"https://doi.org/10.1016/j.ijrobp.2024.10.038","url":null,"abstract":"<p><strong>Purpose: </strong>To predict individual tumor responses to radiation therapy (RT) in non-small cell lung cancer.</p><p><strong>Materials and methods: </strong>The proliferation saturation index (PSI) model, which models tumor dynamics in response to RT as an instantaneous reduction in tumor volume, was fit to n = 162 patients with 4 distinct dose fractionation schedules (30-32 fractions × 2 Gy, 23-24 fractions × 2.75 Gy, 32-42 fractions × 1.8 Gy, and 30 fractions × 1.5 Gy Bidaily, followed by 5-12 fractions × 2 Gy daily). Following initial training, the predictive power of the model was tested using only the first 3 tumor volume measurements as measured on daily imaging. The remainder of tumor volume regression during RT was simulated using the PSI model. Comparisons of the measured to the simulated volumes were made using scatter plots, coefficient of determination (R<sup>2</sup>), and Pearson correlation coefficient values.</p><p><strong>Results: </strong>The PSI model predicted tumor volume regression during RT with a high degree of accuracy. Comparison of the measured versus predicted volumes resulted in R<sup>2</sup> values of 0.968, 0.954, 0.968, and 0.937, and Pearson correlation coefficient values of 0.984, 0.977, 0.984, and 0.968 in the 2 Gy, 1.8 Gy, 2.75 Gy, and Bidaily groups, respectively.</p><p><strong>Conclusion: </strong>The proliferation saturation model can predict, with a high degree of accuracy, non-small cell lung cancer tumor volume regression in response to RT in 4 distinct dose fractionation schedules.</p>","PeriodicalId":14215,"journal":{"name":"International Journal of Radiation Oncology Biology Physics","volume":" ","pages":""},"PeriodicalIF":6.4,"publicationDate":"2024-12-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142785640","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
George E Naoum, Hazim S Ababneh, Andrzej Niemierko, Laura Salama, Myrsini Ioannidou, Amy Colwell, Alphonse G Taghian
{"title":"Impact of Pre-pectoral Implant Placement and Radiation Modalities (Protons/Photons) in Mastectomy Patients undergoing Immediate Direct-to-Implant Breast Reconstruction.","authors":"George E Naoum, Hazim S Ababneh, Andrzej Niemierko, Laura Salama, Myrsini Ioannidou, Amy Colwell, Alphonse G Taghian","doi":"10.1016/j.ijrobp.2024.11.079","DOIUrl":"https://doi.org/10.1016/j.ijrobp.2024.11.079","url":null,"abstract":"<p><strong>Background: </strong>For breast cancer patients receiving mastectomy with direct-to-implant (DTI) immediate breast reconstruction, placing the implant in the pre-pectoral or subpectoral plane remains debatable; especially in settings of postmastectomy radiotherapy (PMRT).</p><p><strong>Materials/methods: </strong>We reviewed 3,039 patients who underwent mastectomy and reconstruction at our institution between 2005 and 2020. Patients receiving DTI with and without PMRT were included. PMRT was delivered either with photon (3D-conformal or VMAT) or proton therapy mainly with pencil beam scanning. All patients received conventional fractionation (50-50.4Gy in 25-28fractions). Primary endpoints were reconstruction complications defined as infection/necrosis requiring debridement; capsular-contracture requiring capsulotomy; absolute-reconstruction-failure entailing permanent removal of the implant without replacement (i.e: no salvage reconstruction) and overall-reconstruction-failure (removal of implant for any complication with and without salvage reconstruction). Different subgroups analyses were done.</p><p><strong>Results: </strong>815 patients met inclusion criteria, with an overall median follow-up of 6.2 years. We found that there is no significant difference between pre-pectoral vs sub-pectoral for infection/necrosis (OR:1.5, p=0.3); capsular-contracture (OR:0.97, p=0.9); absolute-reconstruction-failure (OR:1.9, p=0.12) and overall-reconstruction-failure (OR:1.2, p=0.5). Findings were confirmed using both logistic regression, time-to-event analysis and multivariable analyses for the entire cohort and subgroups with and without PMRT. There was no significant difference between Protons and Photons in terms of infection/necrosis (OR:1.6, p=0.4) and absolute-reconstruction-failure (OR: 1.2, p=0.7), but significantly higher risks for capsular-contracture with protons (OR:4.4, p<0.001) and overall-reconstruction-failure when compared to photon(OR:2.0, p=0.05). We did not find significant correlation pattern between different dosimetry factors (Dmean, Dmax, volume in cc) in either reconstructed-chest-wall target or the skin structure, to reconstruction complications; whether for protons or photons patients.</p><p><strong>Conclusion: </strong>For patients receiving single-stage DTI reconstruction with and without PMRT, pre-pectoral implant placement had similar rates of complications and reconstruction failure compared to subpectoral reconstruction. Protons compared to Photons did not increase the risk of infection/necrosis but significantly increased capsular-contracture risks.</p>","PeriodicalId":14215,"journal":{"name":"International Journal of Radiation Oncology Biology Physics","volume":" ","pages":""},"PeriodicalIF":6.4,"publicationDate":"2024-11-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142768744","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Kathryn R Tringale, Christian Grommes, Burcin Agridag Ucpinar, Anne S Reiner, Joachim Yahalom, Gustav Cederquist, Lauren Schaff, Vaios Hatzoglou, Robert J Young, Mousa Payinkay, Grace Bartlett, Michael Scordo, Brandon S Imber, Javin Schefflein
{"title":"Consolidation Regimen and Cerebral Atrophy in Patients with Primary Central Nervous System Lymphoma.","authors":"Kathryn R Tringale, Christian Grommes, Burcin Agridag Ucpinar, Anne S Reiner, Joachim Yahalom, Gustav Cederquist, Lauren Schaff, Vaios Hatzoglou, Robert J Young, Mousa Payinkay, Grace Bartlett, Michael Scordo, Brandon S Imber, Javin Schefflein","doi":"10.1016/j.ijrobp.2024.11.088","DOIUrl":"https://doi.org/10.1016/j.ijrobp.2024.11.088","url":null,"abstract":"<p><strong>Background: </strong>In primary central nervous system lymphoma (PCNSL), the extent to which post-methotrexate consolidation contributes to neurotoxicity is unclear. Concerns for neurotoxicity from standard-dose whole-brain radiotherapy (WBRT) have led to declining use. Cerebral atrophy is an established surrogate for neurotoxicity; however, the relative extent to which modern consolidation (i.e., reduced-dose [RD-]WBRT £24Gy, autologous hematopoietic cell transplant [AHCT]) contributes to cerebral atrophy is unclear.</p><p><strong>Methods: </strong>Patients with PCNSL from 2000-2020 who achieved complete response to consolidation following MTX-based induction were included. Inclusion criteria were pre-consolidation MRI (baseline) and ≥1 MRI showing sustained remission at 1, 3, 5, or 10 years. An expert neuroradiologist longitudinally measured parenchymal volume loss via ventricular volumetric change. Linear mixed effects models were performed to estimate absolute and annual volumetric change rates.</p><p><strong>Findings: </strong>Of 139 patients (median follow-up 4.5 years), most were XXXX Center Recursive Partitioning Analysis (RPA) class 2 (age ≥50, Karnofsky performance score [KPS] ≥70). Consolidation therapies included non-myeloablative chemotherapy (n=57; 41%), high-dose myeloablative chemotherapy with AHCT (n=50; 36%), and RD-WBRT (n=28; 20%). Higher RPA class was associated with greater baseline ventricular volume (p<0.001). Overall adjusted annual ventricular volume change rates were greater than those published in healthy controls (4.3% vs. 1.8%) and generally increased by age/decade at diagnosis: 40-49-year-olds 1.8% (95%CI: -1.4%, 5.0%), 50-59-year-olds 3.1% (95%CI: 0.7%, 5.5%), 60-69-year-olds 4.8% (95%CI: 2.4%, 7.3%), 70-79-year-olds 7.2% (95%CI: 4.3%, 10.2%), and 80-89-year-olds 4.2% (95%CI: -1.1%, 9.6%). There were no significant associations between consolidation strategy and ventricular volume change rates accounting for age, KPS, gender, baseline ventricular volume, or interaction between age and consolidation.</p><p><strong>Interpretation: </strong>These findings demonstrate accelerated cerebral atrophy in PCNSL after consolidation compared to healthy adults. However, atrophy did not differ by consolidation strategy. These long-term results suggest acceptable neurotoxicity following RD-WBRT.</p>","PeriodicalId":14215,"journal":{"name":"International Journal of Radiation Oncology Biology Physics","volume":" ","pages":""},"PeriodicalIF":6.4,"publicationDate":"2024-11-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142768737","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Alexander Baikalov, Daline Tho, Kevin Liu, Stefan Bartzsch, Sam Beddar, Emil Schüler
{"title":"Characterization of a Time-Resolved, Real-Time Scintillation Dosimetry System for Ultra-High Dose-Rate Radiation Therapy Applications.","authors":"Alexander Baikalov, Daline Tho, Kevin Liu, Stefan Bartzsch, Sam Beddar, Emil Schüler","doi":"10.1016/j.ijrobp.2024.11.092","DOIUrl":"10.1016/j.ijrobp.2024.11.092","url":null,"abstract":"<p><strong>Purpose: </strong>Scintillation dosimetry has promising qualities for ultra-high-dose-rate (UHDR) radiation therapy (RT), but no system has shown compatibility with mean dose rates (DR¯) above 100 Gy/s and doses per pulse (D<sub>p</sub>) exceeding 1.5 Gy typical of UHDR (FLASH)-RT. The aim of this study was to characterize a novel scintillation dosimetry system with the potential of accommodating UHDRs.</p><p><strong>Methods and materials: </strong>We undertook a thorough dosimetric characterization of the system on an UHDR electron beamline. The system's response as a function of dose, DR¯, D<sub>p</sub>, and the pulse dose-rate (DR<sub>p</sub>) was investigated, as was the system's dose sensitivity (signal per unit dose) as a function of dose history. The capabilities of the system for time-resolved dosimetric readout were also evaluated.</p><p><strong>Results: </strong>Within a tolerance of ±3%, the system exhibited dose linearity and was independent of DR¯ and D<sub>p</sub> within the tested ranges of 1.8 to 1341 Gy/s and 0.005 to 7.68 Gy, respectively. A 6% reduction in the signal per unit dose was observed as DR<sub>p</sub> was increased from 8.9e4 to 1.8e6 Gy/s. The dose delivered per integration window of the continuously sampling photodetector had to remain between 0.028 and 11.56 Gy to preserve a stable signal response per unit dose. The system accurately measured D<sub>p</sub> of individual pulses delivered at up to 120 Hz. The day-to-day variation of the signal per unit dose in a reference setup varied by up to ±13% but remained consistent (<±2%) within each treatment day and showed no signal loss as a function of dose history.</p><p><strong>Conclusions: </strong>With daily calibrations and DR<sub>p</sub>-specific correction factors, the system reliably provides real-time, millisecond-resolved dosimetric measurements of pulsed conventional and UHDR beams from typical electron linacs, marking an important advancement in UHDR dosimetry and offering diverse applications to FLASH-RT and related fields.</p>","PeriodicalId":14215,"journal":{"name":"International Journal of Radiation Oncology Biology Physics","volume":" ","pages":""},"PeriodicalIF":6.4,"publicationDate":"2024-11-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142768733","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Toxicity and Efficacy of Different Target Volume Delineations of Radiation Therapy Based on the Updated Radiation Therapy Oncology Group/National Research Group and European Organization for Research and Treatment of Cancer Guidelines in Patients With Grade 3-4 Glioma: A Randomized Controlled Clinical Trial.","authors":"Yanfang Qiu, Yanxian Li, Cuihong Jiang, Xiangwei Wu, Wen Liu, Changgen Fan, Xu Ye, Lili He, Shuai Xiao, Qi Zhao, Wenqiong Wu, Kailin Chen, Chao Tan, Yuyi Li, Hui Wang, Feng Liu","doi":"10.1016/j.ijrobp.2024.11.094","DOIUrl":"10.1016/j.ijrobp.2024.11.094","url":null,"abstract":"<p><strong>Purpose: </strong>Our study aimed to evaluate the safety and efficacy of radiation therapy (RT) in the treatment of grade 3-4 glioma by comparing the updated Radiation Therapy Oncology Group (RTOG)/National Research Group (NRG) with European Organization for Research and Treatment of Cancer (EORTC) guidelines for target volume delineation.</p><p><strong>Methods and materials: </strong>A total of 245 patients with newly diagnosed World Health Organization grade 3-4 glioma were enrolled and randomly assigned (1:1 ratio) to undergo postoperative RT with concurrent and maintenance temozolomide. The radiation target volume delineation was determined by using either the updated RTOG/NRG (n = 122) or EORTC guidelines (n = 123). The primary endpoint was the toxicity associated with treatment. Progression-free survival (PFS) and overall survival (OS) were considered secondary endpoints.</p><p><strong>Results: </strong>No differences in low- or high-grade toxicities between the 2 groups, and neither group exhibited grade 5 toxicities. No significant differences in neurologic toxicities were observed between the RTOG/NRG and EORTC groups. The median PFS in the RTOG/NRG group and the EORTC group was 11.0 months (95% confidence interval [CI], 7.1-14.9 months) and 10.0 months (95% CI, 3.8-16.2 months), respectively (P = .73). The median OS in the RTOG/NRG group and the EORTC group was 19.5 months (95% CI, 14.2-24.8 months) and 18.5 months (95% CI, 12.8-24.2 months), respectively (P = .80). In patients with isocitrate dehydrogenase wild-type glioblastoma, there were no significant differences between the RTOG/NRG group and the EORTC group in median PFS (8.0 months [95% CI, 6.8-9.2 months] vs. 8.0 months [95% CI, 7.0-9.0 months], P = .38) and median OS (12.0 months [95% CI, 7.2-16.8 months] vs. 11.0 months [95% CI, 9.7-12.3 months], P = .10).</p><p><strong>Conclusions: </strong>Compared with EORTC principles, postoperative RT according to RTOG/NRG principles did not increase treatment-related toxicities and was equally effective for patients with grade 3-4 glioma, including the subgroup of patients with isocitrate dehydrogenase wild-type glioblastoma.</p>","PeriodicalId":14215,"journal":{"name":"International Journal of Radiation Oncology Biology Physics","volume":" ","pages":""},"PeriodicalIF":6.4,"publicationDate":"2024-11-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142768746","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Juliette Thariat, Mathieu Bosset, Antoine Falcoz, Dewi Vernerey, Yoann Pointreau, Severine Racadot, Jean-Christophe Faivre, Joel Castelli, Sebastien Guihard, Florence Huguet, Sophie Chapet, Yungan Tao, Christian Borel, Jerome Fayette, Audrey Rambeau, François-Régis Ferrand, Adeline Pechery, Jean Bourhis, Xu-Shan Sun
{"title":"Survival without Quality of Life Deterioration in the GORTEC 2014-04 \"OMET\" Randomised Phase 2 Trial in Head and Neck Cancer Patients with Oligometastases using Stereotactic Ablative Radiotherapy (SABR)-alone or chemotherapy SABR.","authors":"Juliette Thariat, Mathieu Bosset, Antoine Falcoz, Dewi Vernerey, Yoann Pointreau, Severine Racadot, Jean-Christophe Faivre, Joel Castelli, Sebastien Guihard, Florence Huguet, Sophie Chapet, Yungan Tao, Christian Borel, Jerome Fayette, Audrey Rambeau, François-Régis Ferrand, Adeline Pechery, Jean Bourhis, Xu-Shan Sun","doi":"10.1016/j.ijrobp.2024.11.084","DOIUrl":"https://doi.org/10.1016/j.ijrobp.2024.11.084","url":null,"abstract":"<p><strong>Purpose: </strong>Patients with oligometastasis may have prolonged survival with multisite stereotactic ablative radiotherapy (SABR). Evidence to support this paradigm is scarce in squamous cell carcinomas of the head and neck cancers (HNSCC). The multicentre open-label randomised, GORTEC 2014-04 (NCT03070366) phase II study assesses survival without definitive quality of life (QoL) deterioration of omitting upfront chemotherapy in oligometastatic HNSCC patients by using SABR-alone.</p><p><strong>Methods and materials: </strong>Eligible participants (≥18 years-old with 1-3 oligometastases, ECOG score 0-2), were randomly assigned (1:1) to receive chemo-SABR or SABR-alone. Salvage treatments were left to physician's appreciation. The standard therapy was considered to be systemic therapy and SABR (chemo-SABR; EXTREME regimen). The primary endpoint was one-year (± 3 months) OS rate without definitive deterioration (i.e. without subsequent better QoL score) of the global QLCQ-C30 QoL score.</p><p><strong>Results: </strong>Between Sept, 2015 & Oct, 2022, 69 participants were assigned to receive chemo-SABR (N=35) or SABR-alone (N=34); 57 had lung-only metastases (82.6%), 40 had isolated metastasis (58.0%). Median baseline QoL score was 66.7 (IQR[50.0-83.3]). Median follow-up was 55.3months (95%CI:45.0-69.7). Of participants (N=59) evaluable for the primary endpoint, 16/29 (55.2%, 90%CI:0.38-0.71), and 16/30 (53.3%, 90%CI:0.37-0.69) were alive and free of QoL deterioration at one year in the SABR-alone and chemo-SABR arms. However, QoL deterioration was deeper with chemo-SABR (50.0;IQR[41.7-66.7] than SABR-alone (16.7;IQR[16.7-41.7]). In intent-to-treat analysis (N=69), median survival was 42.3 months (95%CI:26.5-not reached) with chemo-SABR and 41.1months (95%CI:32.1-66.9) with SABR-alone; median PFS were 12.9 (95%CI:7.5-17.3) and 7.4months (95%CI:4.2-15.6) in the chemo-SABR and SABR-alone arms, respectively. Rates of severe treatment-related toxicities were 21/35 (60.0%) with chemo-SABR and 3/34 (8.8%, no grade 5) with SABR-alone.</p><p><strong>Conclusion: </strong>Using SABR-alone, omission of upfront EXTREME-based chemotherapy and maintenance cetuximab in oligometastatic HNSCC patients resulted in similar survival but much less severe QoL deterioration and fewer toxicity rates. SABR alone could be a reasonable alternative in oligometastatic HNSCC patients.</p>","PeriodicalId":14215,"journal":{"name":"International Journal of Radiation Oncology Biology Physics","volume":" ","pages":""},"PeriodicalIF":6.4,"publicationDate":"2024-11-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142754989","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"StrataXRT and Mepitel Film for preventing post-mastectomy acute radiation dermatitis in breast cancer: an intra-patient non-inferiority randomized clinical trial.","authors":"Shing Fung Lee, Pui Lam Yip, Sandra Spencer, Huong Ho, Brindha Subramanian, Wei Ding, Carminia Lapuz, Farshad Foroudi, Cynleen Kai, Michael Chao","doi":"10.1016/j.ijrobp.2024.11.076","DOIUrl":"https://doi.org/10.1016/j.ijrobp.2024.11.076","url":null,"abstract":"<p><strong>Purpose: </strong>Acute radiation dermatitis (ARD) is a notable challenge for patients with breast cancer undergoing post-mastectomy radiation therapy (RT). This study evaluates the efficacy, safety, and user experience of StrataXRT versus Mepitel Film for ARD prevention.</p><p><strong>Methods: </strong>This multicenter, non-inferiority trial involved intra-patient randomization of 44 histologically confirmed breast carcinoma patients undergoing post-mastectomy RT across four Australian hospitals from January 1 to December 31, 2017. Patients were randomized to receive Mepitel Film and StrataXRT on alternate halves of the irradiated chest wall. Mepitel Film was applied by nurses and replaced every one to two weeks or as necessary, ensuring continuous coverage throughout RT. Conversely, patients self-applied StrataXRT daily to the opposite half, with adherence details recorded in patient diaries. The primary outcome was the mean difference in the time-weighted average (TWA) grade of ARD within designated rectangles in each half over 10 weeks from the commencement of RT.</p><p><strong>Results: </strong>Forty patients were analyzed per-protocol. Measurements using thermoluminescent dosimeters showed no significant dose differences between medial and lateral rectangles. StrataXRT was inferior to Mepitel Film in the primary outcome, with a mean difference in TWA grade of 0.19 (95%confidence interval: 0.12-0.26; P<0.001). Secondary outcomes-mean difference in TWA grade in chest wall halves, worst ARD grade, and incidence of moist desquamation-showed non-inferiority between treatments. Patient preferences were closely matched, with 37.5% favoring StrataXRT and 40% Mepitel Film. StrataXRT caused itching in one patient and Mepitel Film in three, leading to one removal.</p><p><strong>Conclusion: </strong>Although StrataXRT did not meet the non-inferiority threshold in the primary outcome and is considered inferior, its ease of application and patient acceptance suggest that it may still be offered for ARD prevention in post-mastectomy RT when Mepitel Film is not a practical option. Open discussion with patients and caregivers is recommended to determine the most appropriate skin protection agent, considering both efficacy and practicality.</p>","PeriodicalId":14215,"journal":{"name":"International Journal of Radiation Oncology Biology Physics","volume":" ","pages":""},"PeriodicalIF":6.4,"publicationDate":"2024-11-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142750851","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}