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Background: Although the FLASH radiotherapy (FLASH) can improve the sparing of organs‐at‐risk (OAR) via the FLASH effect, it is generally a tradeoff between the physical dose coverage and the biological FLASH coverage, for which the concept of FLASH effective dose (FED) is needed to quantify the net improvement of FLASH, compared to the conventional radiotherapy (CONV). Purpose: This work will develop the first‐of‐its‐kind treatment planning method called simultaneous dose and dose rate optimization via dose modifying factor modeling (SDDRO‐DMF) for proton FLASH that directly optimizes FED. Methods: SDDRO‐DMF models and optimizes FED using FLASH dose modifying factor (DMF) models, which can be classified into two categories: (1) the phenomenological model of the FLASH effect, such as the FLASH effectiveness model (FEM); (2) the mechanistic model of the FLASH radiobiology, such as the radiolytic oxygen depletion (ROD) model. The general framework of SDDRO‐DMF will be developed, with specific DMF models using FEM and ROD, as a demonstration of general applicability of SDDRO‐DMF for proton FLASH via transmission beams (TB) or Bragg peaks (BP) with single‐field or multi‐field irradiation. The FLASH dose rate is modeled as pencil beam scanning dose rate. The solution algorithm for solving the inverse optimization problem of SDDRO‐DMF is based on iterative convex relaxation method. Results: SDDRO‐DMF is validated in comparison with IMPT and a state‐of‐the‐art method called SDDRO, with demonstrated efficacy and improvement for reducing the high dose and the high‐dose volume for OAR in terms of FED. For example, in a SBRT lung case of the dose‐limiting factor that the max dose of brachial plexus should be no more than 26 Gy, only SDDRO‐DMF met this max dose constraint; moreover, SDDRO‐DMF completely eliminated the high‐dose (V70%) volume to zero for CTV10mm (a high‐dose region as a 10 mm ring expansion of CTV). Conclusion: We have proposed a new proton FLASH optimization method called SDDRO‐DMF that directly optimizes FED using phenomenological or mechanistic models of DMF, and have demonstrated the efficacy of SDDO‐DMF in reducing the high‐dose volume or/and the high‐dose value for OAR, compared to IMPT and a state‐of‐the‐art method SDDRO. [ABSTRACT FROM AUTHOR]

PURPOSE: Patients living in rural communities have greater barriers to cancer care and poorer outcomes. We hypothesized that rural patients with prostate cancer have less access and receive different treatments compared with urban patients. METHODS: We used a population-based prospective cohort, the North Carolina Prostate Cancer Comparative Effectiveness and Survivorship Study, to compare differences in prostate cancer diagnosis, access to care, and treatment in patients by geographic residence. The 2013 rural-urban continuum code (RUCC) was used to determine urban (RUCC 1-3) versus rural (RUCC 4-9) location of residence. RESULTS: Patients with rural residence comprised 25% of the cohort (364 of 1,444); they were less likely to be White race and had lower income and educational attainment. Rural patients were more likely to have <12 cores on biopsy (47.1% v 35.7%; P <.001) and less likely (40.8% v 47.6%; P =.04) to receive multidisciplinary consultation. We observed significant differences in treatment between urban and rural patients, including rural patients receiving less active surveillance or observation (22.6% v 28.7%), especially in low-risk cancer (33.2% v 40.7%). On multivariable analysis that adjusted for patient and diagnostic factors, rural residence was associated with less use of active surveillance or observation over radical treatment (ie, surgery or radiation therapy; odds ratio, 0.49 v urban; P <.001) in patients with low-risk cancer. CONCLUSION: Patients with prostate cancer who live in rural versus urban areas experience several differences in care that are likely clinically meaningful, including fewer cores in the diagnostic biopsy, less utilization of multidisciplinary consultation, less use of active surveillance, or observation for low-risk disease. Future studies are needed to assess the efficacy of interventions in mitigating these disparities. We observed meaningful disparities in rural versus urban prostate cancer diagnosis and treatment. [ABSTRACT FROM AUTHOR]

PURPOSE: Our purpose was to describe the prevalence and predictors of symptom and function clusters related to physical, emotional, and social components of general health-related quality of life (HRQOL) in a population-based sample of prostate cancer (PCa) survivors. METHODS: Participants (N = 1,162) completed a baseline survey at a median of 9 months after diagnosis to ascertain the co-occurrence of eight symptom and functional domains that are common across all cancers and not treatment-specific. We used latent profile analysis (LPA) to identify subgroup profiles of survivors with low, moderate, or high HRQOL levels. Multinomial logistic regression models were used to identify clinical and sociodemographic factors associated with survivors' membership in the low versus moderate or high HRQOL profile. RESULTS: The LPA identified 16% of survivors who were categorized in the low HRQOL profile at baseline, indicative of the highest symptom burden and lowest functioning. Factors related to survivors' membership in the low versus higher HRQOL profile groups included less than age 65 years at diagnosis, identifying as non-Hispanic Black race, not working, being a former versus never smoker, systemic therapy, less companionship, more comorbidities, lower health care financial well-being, or less spirituality. Several factors remained associated with remaining in the low versus higher HRQOL profiles on the follow-up survey (n = 699), including younger age, Black race, comorbidity, and lower financial and spiritual well-being. CONCLUSION: About one of six PCa survivors experienced elevated physical and psychosocial symptoms that were independent of local curative therapy, but with younger age, race, comorbidity, and lower financial and spiritual well-being as stable risk factors for poor HRQOL over time. About 16% of prostate cancer survivors experience concurrent physical and mental health symptoms. [ABSTRACT FROM AUTHOR]

Background Clinical studies are often limited by resources available, which results in constraints on sample size. We use simulated data to illustrate study implications when the sample size is too small. Methods and Results Using 2 theoretical populations each with N  = 1000, we randomly sample 10 from each population and conduct a statistical comparison, to help make a conclusion about whether the 2 populations are different. This exercise is repeated for a total of 4 studies: 2 concluded that the 2 populations are statistically significantly different, while 2 showed no statistically significant difference. Conclusions Our simulated examples demonstrate that sample sizes play important roles in clinical research. The results and conclusions, in terms of estimates of means, medians, Pearson correlations, chi-square test, and P values, are unreliable with small samples. [ABSTRACT FROM AUTHOR]

Background: LATTICE radiation therapy delivers 3D heterogenous dose of high peak‐to‐valley dose ratio (PVDR) to the tumor target, with peak dose at lattice vertices inside the target and valley dose for the rest of the target. Although the lattice vertex positions can impact PVDR inside the target and sparing of organs‐at‐risk (OAR), they are fixed as constants and not optimized during treatment planning in current clinical practice. Purpose: This work proposes a new LATTICE plan optimization method that can optimize lattice vertex positions during LATTICE treatment planning, which is the first lattice position optimization study to the best of our knowledge. Methods: The new LATTICE treatment planning method optimizes lattice vertex positions as well as other plan variables (e.g., photon fluences or proton spot weights), with optimization objectives for target PVDR and OAR sparing. To satisfy mathematical differentiability, the lattice vertices are approximated in sigmoid functions. For geometric feasibility, proper geometry constraints are enforced onto lattice vertex positions. The lattice position optimization problem is solved by iterative convex relaxation (ICR) method and alternating direction method of multipliers (ADMM), and lattice vertex positions and photon/proton plan variables are jointly updated via the Quasi‐Newton method. Results: Both photon and proton LATTICE RT were considered, and the optimal lattice vertex positions in terms of plan objectives were found by solving all possible combinations on given discrete positions via exhaustive searching based on standard IMRT/IMPT, which served as the ground truth for validating the new LATTICE method. The results show that the new method indeed provided the optimal lattice vertex positions with the smallest optimization objective, the largest target PVDR, and the best OAR sparing. Conclusions: A new LATTICE treatment planning method is proposed and validated that can optimize lattice vertex positions as well as other photon or proton plan variables for improving target PVDR and OAR sparing. [ABSTRACT FROM AUTHOR]

Purpose: There is an increasing awareness of the importance of patient engagement in cancer research, but many basic and translational researchers have never been trained to do so. To address this unmet need, a 1-year patient engagement training program for researchers was developed. Methods: Eleven researchers and eleven paired research advocates participated. This program, designed for virtual delivery, included 3 didactic modules focused on (1) Community Outreach and Engagement principles and methods, (2) Communication skills, and (3) Team Science. This was followed by longitudinal projects to be completed by the researcher/advocate pairs, including learning about the research project, and co-authoring abstracts, manuscripts and grant proposals. Monthly group meetings allowed pairs to share their experiences. The program culminated in the pairs creating and presenting oral abstracts for the University of Kansas Cancer Center's Annual Research Symposium. Results: All participants indicated that the modules had a positive impact on their ability to collaborate in research. Both researcher self-evaluations and patient advocate evaluations of their researcher partner showed an improvement in researcher communication competency. Results from the Patient Engagement in Research Scale showed that advocates were highly engaged. Within 1 year after program completion, participating pairs have completed four abstracts and 9 grant proposals. Conclusion: The program will be modified based on participant feedback, and can be adapted for future cohorts if an increased number of sessions per month and shortened program duration are desired. The program's virtual format allows scalability across institutions to potentially benefit large cohorts of researchers. [ABSTRACT FROM AUTHOR]

Cancer research has led to remarkable advances in our understanding of cancer biology and strategies for prevention, screening and early detection, treatment, and survivorship care, resulting in declines in cancer mortality rates ([1]). Google Scholar Crossref Search ADS PubMed WorldCat 65 Richman I, Tessier-Sherman B, Galusha D, Oladele CR, Wang K. Breast cancer screening during the COVID-19 pandemic: moving from disparities to health equity. Google Scholar Crossref Search ADS PubMed WorldCat 32 Haghighat S, Jiang C, El-Rifai W, Zaika A, Goldberg DS, Kumar S. Urgent need to mitigate disparities in federal funding for cancer research. [Extracted from the article]

Background: The management of ultracentral thoracic tumors with ablative dose of radiotherapy remains challenging given proximity to critical central structures. We report patient outcomes, toxicity, and dosimetry for ultracentrally located tumors with hypofractionated stereotactic body radiotherapy (hfSBRT). Methods: Seventy-eight individuals (50 initial radiotherapy, 28 re-irradiation) undergoing 10 fraction hfSBRT for ultracentrally located thoracic tumors treated between 2009 and 2020 at a single institution were retrospectively reviewed. Overall survival (OS), progression free survival (PFS), and local control (LC) were calculated. Incidence and grade of treatment related toxicity were evaluated. Dosimetric analysis of treatment plans and critical adjacent OARs was performed. Results: At a median follow up time of 13 months, 1- and 3-year OS, PFS, and LC were 89%/63%, 37%/18%, and 84%/65%, respectively. Median dose was 65 Gy (BED10 = 107.25 Gy). Median primary bronchial tree maximum dose (Dmax) was 60 Gy (V50 = 0.96 cc). Median esophageal Dmax was 38 Gy (V40 = 0 cc). Median great vessel Dmax was 68 Gy (V50 = 3.53 cc). The most common ≥ grade 2 adverse event was pneumonitis, in 15 individuals (20%). Grade 3 or higher toxicity was observed in 9 individuals (12%): three cases of grade 3 pneumonitis (two re-irradiation, one initial radiotherapy), one grade 3 esophageal stricture following re-irradiation, two grade 3 endobronchial obstructions both following initial radiotherapy, and three grade 5 hemoptysis events (two re-irradiation, one initial radiotherapy). One hemoptysis event was categorized as "possibly" related to treatment, while the remaining two events were categorized as "unlikely" related to treatment in patients with clear evidence of disease progression. Conclusions: hfSBRT to ultracentral lung tumors delivered over 10 fractions is a safe and effective treatment option, with acceptable rates of toxicity and good rates of tumor control. Trial registration: IRB registration number 12573. [ABSTRACT FROM AUTHOR]

Background: Hybrid proton‐photon radiotherapy (RT) can provide better plan quality than proton or photon only RT, in terms of robustness of target coverage and sparing of organs‐at‐risk (OAR). Purpose: This work develops a hybrid treatment planning method that can optimize the number of proton and photon fractions as well as proton and photon plan variables, so that the hybrid plans can be clinically delivered day‐to‐day using either proton or photon machine. Methods: In the new hybrid treatment planning method, the total dose distribution (sum of proton dose and photon dose) is optimized for robust target coverage and optimal OAR sparing, by jointly optimizing proton spots and photon fluences, while the target dose uniformity is also enforced individually on both proton dose and photon dose, so that the hybrid plans can be separately and robustly delivered on proton or photon machine. To ensure the target dose uniformity for proton and photon plans, the number of proton and photon fractions is explicitly modeled and optimized, so that the target dose for proton and photon dose components is constrained to be a constant fraction of the total prescription dose while the plan quality based on total dose is optimized. The feasibility of hybrid planning using the proposed method is validated with representative clinical cases including abdomen, lung, head‐and‐neck (HN), and brain. Results: For all cases, hybrid plans provided better overall plan quality and OAR sparing than proton‐only or photon‐only plans, better target dose uniformity and robustness than proton‐only plans, quantified by treatment planning objectives and dosimetric parameters. Moreover, for HN and brain cases, hybrid plans also had better target coverage than photon‐only plans. Conclusions: We have developed a new hybrid treatment planning method that optimizes number of proton and photon fractions as well as proton spots and photon fluences, for generating hybrid plans that can be separately and robustly delivered on proton or photon machines. Preliminary results have demonstrated that hybrid plans generated by the new method have better plan quality than proton‐only or photon‐only plans. [ABSTRACT FROM AUTHOR]

Background Disparities in treatment selection based on socioeconomic status for prostate cancer exist. However, the association between patient-level income with treatment selection priorities and treatment received has not been studied. Methods A population-based cohort of 1382 individuals with newly diagnosed prostate cancer was enrolled throughout North Carolina prior to treatment. Patients self-reported household income and were asked about the importance of 12 factors contributing to their treatment decision-making process. Diagnosis details and primary treatment received were abstracted from medical records and cancer registry data. Results Patients with lower income were diagnosed with more advanced disease (P  < .01). Cure was deemed to be "very important" by more than 90% of patients at all income levels. However, patients with lower vs higher household income were more likely to rate factors beyond cure as "very important" such as cost (P  < .01), effect on daily activities (P  = .01), duration of treatment (P  < .01), recovery time (P  < .01), and burden on family and friends (P  < .01). On multivariable analysis, high vs low income was associated with increased utilization of radical prostatectomy (odds ratio = 2.01, 95% confidence interval = 1.33 to 3.04; P  < .01) and decreased use of radiotherapy (odds ratio = 0.48, 95% confidence interval = 0.31 to 0.75; P  < .01). Conclusions New insights from this study on the association between income and treatment decision-making priorities provide potential avenues for future interventions to reduce disparities in cancer care. [ABSTRACT FROM AUTHOR]

Knowledge‐based planning (KBP) and multicriteria optimization (MCO) are two powerful tools to assist treatment planners in achieving optimal target coverage and organ‐at‐risk (OAR) sparing. The purpose of this work is to investigate if integrating MCO with conventional KBP can further improve treatment plan quality for prostate cancer stereotactic body radiation therapy (SBRT). A two‐phase study was designed to investigate the impact of MCO and KBP in prostate SBRT treatment planning. The first phase involved the creation of a KBP model based on thirty clinical SBRT plans, generated by manual optimization (KBP_M). A ten‐patient validation cohort was used to compare manual, MCO, and KBP_M optimization techniques. The next phase involved replanning the original model cohort with additional tradeoff optimization via MCO to create a second model, KBP_MCO. Plans were then generated using linear integration (KBP_M+MCO), non‐linear integration (KBP_MCO), and a combination of integration methods (KBP_MCO+MCO). All plans were analyzed for planning target volume (PTV) coverage, OAR constraints, and plan quality metrics. Comparisons were generated to evaluate plan and model quality. Phase 1 highlighted the necessity of KBP and MCO in treatment planning, as both optimization methods improved plan quality metrics (Conformity and Heterogeneity Indices) and reduced mean rectal dose by 2 Gy, as compared to manual planning. Integrating MCO with KBP did not further improve plan quality, as little significance was seen over KBP or MCO alone. Principal component score (PCS) fitting showed KBP_MCO improved bladder and rectum estimated and modeled dose correlation by 5% and 22%, respectively; however, model improvements did not significantly impact plan quality. KBP and MCO have shown to reduce OAR dose while maintaining desired PTV coverage in this study. Further integration of KBP and MCO did not show marked improvements in treatment plan quality while requiring increased time in model generation and optimization time. [ABSTRACT FROM AUTHOR]

Objective. The optimization of energy layer distributions is crucial to proton arc therapy: on one hand, a sufficient number of energy layers is needed to ensure the plan quality; on the other hand, an excess number of energy jumps (NEJ) can substantially slow down the treatment delivery. This work will develop a new treatment plan optimization method with direct minimization of (NEJ), which will be shown to outperform state-of-the-art methods in both plan quality and delivery efficiency. Approach. The proposed method jointly optimizes the plan quality and minimizes the NEJ. To minimize NEJ, (1) the proton spots x is summed per energy layer to form the energy vector y ; (2) y is binarized via sigmoid transform into y 1 ; (3) y 1 is multiplied with a predefined energy order vector via dot product into y 2; (4) y 2 is filtered through the finite-differencing kernel into y 3 in order to identify NEJ; (5) only the NEJ of y 3 is penalized, while x is optimized for plan quality. The solution algorithm to this new method is based on iterative convex relaxation. Main results. The new method is validated in comparison with state-of-the-art methods called energy sequencing (ES) method and energy matrix (EM) method. In terms of delivery efficiency, the new method had fewer NEJ, less energy switching time, and generally less total delivery time. In terms of plan quality, the new method had smaller optimization objective values, lower normal tissue dose, and generally better target coverage. Significance. We have developed a new treatment plan optimization method with direct minimization of NEJ, and demonstrated that this new method outperformed state-of-the-art methods (ES and EM) in both plan quality and delivery efficiency. [ABSTRACT FROM AUTHOR]

Purpose: This study aimed to examine the effects of participant role (patient vs. partner), race (white vs. non‐white), and place (less vs. more neighborhood deprivation) on health outcomes (quality of life [QOL] and symptoms) and stress‐coping‐related psychosocial factors (appraisals of illness and coping resources). Methods: This descriptive study included 273 patients and their partners (dyads) who transitioned from PCa treatment to self‐management. We used established, psychometrically sound measures to assess health outcomes and psychosocial factors and conducted multilevel modeling analyses. Results: Compared to partners, patients reported worse physical QOL; less frequent anxiety; less pain and fatigue; less bothersome hormonal problems; more bothersome urinary and sexual problems; greater self‐efficacy; and more instrumental support. Compared to their white counterparts, non‐white dyads reported better overall, emotional, and functional QOL; less depression; more positive appraisals, and greater self‐efficacy. Compared to dyads in low ADI neighborhoods, dyads in high ADI (more deprived) neighborhoods reported worse social QOL; more bothersome urinary, sexual, and hormonal symptoms; and less interpersonal support. White patients reported the highest emotional support among all groups, while white partners reported the lowest emotional support. Conclusion: Our findings underscore the need to consider social determinants of health at multiple levels when investigating PCa disparities. Considering neighborhood‐level socioeconomic factors, in addition to race and role, improves our understanding of the PCa disparities in QOL, symptoms, and psychosocial factors among patients and partners. Targeted multilevel supportive care interventions should tailor to the needs of racially diverse PCa patients and partners residing in deprived neighborhoods are needed. [ABSTRACT FROM AUTHOR]

PURPOSE Despite the growing calls for early and ubiquitous completion of advance directives (ADs), studies exploring links between AD completion and their impact on outcomes of patients with cancer have mixed conclusions. We used the ASCO Quality Oncology Practice Initiative (QOPI) registry to compare end-of-life (EOL) quality measures and the effect of QOPI certification among patients with and without early AD completion, defined as completion within the first three oncology visits after cancer diagnosis. METHODS Deidentified patient-level data were analyzed from the QOPI database from 2015 through 2017. Associations were assessed using Chi-square tests between early AD completion and patient enrollment in hospice, 7 days before death, chemotherapy receipt in the last 14 days of life, or with emergency room visits or intensive care unit admissions in the last 30 days of life. RESULTS Data from 31,558 patients eligible for the AD question were analyzed. Patients treated at QOPI-certified practices had higher rates of early AD completion than patients at non-certified practices. Early AD completion was not associated with differences in hospice enrollment for, 7 days before death, chemotherapy receipt in the last 14 days of life, or emergency room visits or intensive care unit encounters in the last 30 days of life. CONCLUSION The study found that QOPI certification is associated with higher rates of early AD completion. However, early AD completion was not associated with recognized EOL quality measures. Future research should focus on the timing, frequency, and content of AD conversations to demonstrate the impact on care at the EOL. [ABSTRACT FROM AUTHOR]

Purpose: Cardiovascular disease (CVD) is a common cause of mortality among men with prostate cancer. However, receipt of preventive care and management of pre-existent CVD has not been well studied in prostate cancer survivors. Methods: This study examined a prospective cohort of men newly diagnosed with localized prostate cancer between 2011 and 2013 throughout North Carolina linked to Medicare and private insurance claims and clinical data from the Veterans Affairs (VA). In patients without pre-existent CVD, the primary outcome was a composite measure of annual preventive care (blood glucose screening, cholesterol level testing, and ≥ 1 primary care provider visit). In patients with pre-existent CVD, the primary outcome was annual cardiologist visit; blood glucose, cholesterol level testing, and primary care visits were also assessed. Results: Our sample comprised 492 patients successfully linked to insurance claims and/or VA data, among whom 103 (20.9%) had pre-existent CVD. Receipt of preventive care declined from 52.7% (95% confidence interval [CI], 47.7 to 57.6%) during the first year after prostate cancer diagnosis to 40.8% (95% CI: 33.7 to 48.4%) during the third year. Among patients with pre-existent CVD, only 23.4% (95% CI: 13.6 to 37.2%) visited a cardiologist in all 3 years. Black men were more likely than White men to visit a cardiologist the first year (risk ratio [RR] = 1.72, 95% CI: 1.10 to 2.71). Conclusion: In a population-based cohort of prostate cancer survivors, receipt of CVD preventive care declined over time, and frequency of cardiologist-led management of pre-existent CVD was low. Implications for Cancer Survivors: There is a need to improve clinical strategies for reducing cardiovascular risk and managing pre-existent CVD in prostate cancer survivors. [ABSTRACT FROM AUTHOR]

Purpose: There is currently no curative treatment for patients diagnosed with triple-negative breast cancer brain metastases (TNBC-BM). CAR T cells hold potential for curative treatment given they retain the cytolytic activity of a T cell combined with the specificity of an antibody. In this proposal we evaluated the potential of EGFR re-directed CAR T cells as a therapeutic treatment against TNBC cells in vitro and in vivo. Methods: We leveraged a TNBC-BM tissue microarray and a large panel of TNBC cell lines and identified elevated epidermal growth factor receptor (EGFR) expression. Next, we designed a second-generation anti-EGFR CAR T construct incorporating a clinically relevant mAb806 tumor specific single-chain variable fragment (scFv) and intracellular 4-1BB costimulatory domain and CD3 ζ using a lentivirus system and evaluated in vitro and in vivo anti-tumor activity. Results: We demonstrate EGFR is enriched in TNBC-BM patient tissue after neurosurgical resection, with six of 13 brain metastases demonstrating both membranous and cytoplasmic EGFR. Eleven of 13 TNBC cell lines have EGFR surface expression ≥ 85% by flow cytometry. EGFR806 CAR T treated mice effectively eradicated TNBC-BM and enhanced mouse survival (log rank p < 0.004). Conclusion: Our results demonstrates anti-tumor activity of EGFR806 CAR T cells against TNBC cells in vitro and in vivo. Given EGFR806 CAR T cells are currently undergoing clinical trials in primary brain tumor patients without obvious toxicity, our results are immediately actionable against the TNBC-BM patient population. [ABSTRACT FROM AUTHOR]

Purpose: To estimate the clinical impact of differences between delivered and planned dose using dose metrics and normal tissue complication probability (NTCP) modeling. Methods: Forty‐six consecutive patients with prostate adenocarcinoma between 2010 and 2015 treated with intensity‐modulated radiation therapy (IMRT) and who had undergone computed tomography on rails imaging were included. Delivered doses to bladder and rectum were estimated using a contour‐based deformable image registration method. The bladder and rectum NTCP were calculated using dose–response parameters applied to planned and delivered dose distributions. Seven urinary and gastrointestinal symptoms were prospectively collected using the validated prostate cancer symptom indices patient reported outcome (PRO) at pre‐treatment, weekly treatment, and post‐treatment follow‐up visits. Correlations between planned and delivered doses against PRO were evaluated in this study. Results: Planned mean doses to bladder and rectum were 44.9 ± 13.6 Gy and 42.8 ± 7.3 Gy, while delivered doses were 46.1 ± 13.4 Gy and 41.3 ± 8.7 Gy, respectively. D10cc for rectum was 64.1 ± 7.6 Gy for planned and 60.1 ± 9.3 Gy for delivered doses. NTCP values of treatment plan were 22.3% ± 8.4% and 12.6% ± 5.9%, while those for delivered doses were 23.2% ± 8.4% and 9.9% ± 8.3% for bladder and rectum, respectively. Seven of 25 patients with follow‐up data showed urinary complications (28%) and three had rectal complications (12%). Correlations of NTCP values of planned and delivered doses with PRO follow‐up data were random for bladder and moderate for rectum (0.68 and 0.67, respectively). Conclusion: Sensitivity of bladder to clinical variations of dose accumulation indicates that an automated solution based on a DIR that considers inter‐fractional organ deformation could recommend intervention. This is intended to achieve additional rectum sparing in cases that indicate higher than expected dose accumulation early during patient treatment in order to prevent acute severity of bowel symptoms. [ABSTRACT FROM AUTHOR]

Randomized clinical trials are critical for evaluating the safety and efficacy of interventions in oncology and informing regulatory decisions, practice guidelines, and health policy. Patient-reported outcomes (PROs) are increasingly used in randomized trials to reflect the impact of receiving cancer therapies from the patient perspective and can inform evaluations of interventions by providing evidence that cannot be obtained or deduced from clinicians' reports or from other biomedical measures. This commentary focuses on how PROs add value to clinical trials by representing the patient voice. We employed 2 previously published descriptive frameworks (addressing how PROs are used in clinical trials and how PROs have an impact, respectively) and selected 9 clinical trial publications that illustrate the value of PROs according to the framework categories. These include 3 trials where PROs were a primary trial endpoint, 3 trials where PROs as secondary endpoints supported the primary endpoint, and 3 trials where PROs as secondary endpoints contrast the primary endpoint findings in clinically important ways. The 9 examples illustrate that PROs add valuable data to the care and treatment context by informing future patients about how they may feel and function on different treatments and by providing clinicians with evidence to support changes to clinical practice and shared decision making. Beyond the patient and clinician, PROs can enable administrators to consider the cost-effectiveness of implementing new interventions and contribute vital information to policy makers, health technology assessors, and regulators. These examples provide a strong case for the wider implementation of PROs in cancer trials. [ABSTRACT FROM AUTHOR]

Purpose: Spot‐scanning arc therapy (SPArc) is an emerging proton modality that can potentially offer a combination of advantages in plan quality and delivery efficiency, compared with traditional IMPT of a few beam angles. Unlike IMPT, frequent low‐to‐high energy layer switching (so called switch‐up (SU)) can degrade delivery efficiency for SPArc. However, it is a tradeoff between the minimization of SU times and the optimization of plan quality. This work will consider the energy layer optimization (ELO) problem for SPArc and develop a new ELO method via energy matrix (EM) regularization to improve plan quality and delivery efficiency. Methods: The major innovation of EM method for ELO is to design an EM that encourages desirable energy‐layer map with minimal SU during SPArc, and then incorporate this EM into the SPArc treatment planning to simultaneously minimize the number of SU and optimize plan quality. The EM method is solved by the fast iterative shrinkage‐thresholding algorithm and validated in comparison with a state‐of‐the‐art method, so‐called energy sequencing (ES). Results: EM is validated and compared with ES using representative clinical cases. In terms of delivery efficiency, EM had fewer SU than ES with an average of 35% reduction of SU. In terms of plan quality, compared with ES, EM had smaller optimization objective values and better target dose conformality, and generally lower dose to organs‐at‐risk and lower integral dose to body. In terms of computational efficiency, EM was substantially more efficient than ES by at least 10‐fold. Conclusion: We have developed a new ELO method for SPArc using EM regularization and shown that this new method EM can improve both delivery efficiency and plan quality, with substantially reduced computational time, compared with ES. [ABSTRACT FROM AUTHOR]

PURPOSE Medical oncologists have a variety of options for demonstrating proficiency in providing high-quality patient care. Perhaps, the best-known opportunity for demonstrating individual expertise and lifelong learning is the American Board of Internal Medicine (ABIM) maintenance of certification (MOC) program. At the practice level, ASCO has offered the Quality Oncology Practice Initiative (QOPI) as a means of optimizing cancer care delivery. In this study, we assess the association between active involvement in MOC on an individual basis and whether that individual's practice is involved with the QOPI program. METHODS We evaluated 13,600 US medical oncologists initially certified by the ABIM and divided them into those initially certified before 1990 (the year in which ABIM started to require periodic recertification), those from 1990 to 2007, and those from 2008 to 2016. It was then determined which of these had let their certificates expire by 2020. These data were then compared with practices that participated in QOPI from 2017 to 2019, resulting in the matching of 97% of physicians RESULTS Of individuals initially certified before 1990 (and technically with lifelong certification), 22% were in QOPI practices. Among those who did not have lifelong certification, there was an association between QOPI participation and maintenance of ABIM certification. For those initially certified between 1990 and 2007, 35% of oncologists with up-to-date ABIM certification were in QOPI practices, whereas only 11% with expired ABIM certification were QOPI participants (P<.0001). For those in the 2008-2016 category, the numbers were 36% v 16%, respectively (P < .0001). CONCLUSION Our analysis identifies a relationship between participation in these ABIM and ASCO proficiency programs. The reasons for this are likely complex and based on a variety of institutional, professional, monetary, and personal factors. [ABSTRACT FROM AUTHOR]

PURPOSE For patients with nonmetastatic rectal cancer, the National Comprehensive Cancer Network guidelines recommend initial staging using pelvic magnetic resonance imaging or endorectal ultrasound to determine the stage of the disease before initial therapy or surgery. This imaging workup helps determine the T and N staging, which is essential to determine optimal treatment for a patient. The current study examined practice concordance with this guideline using a quality measure in ASCO's Quality Oncology Practice Initiative (QOPI) that specifically addressed staging workup for patients with rectal cancer. METHODS From Fall 2016 through Fall 2019, 103 QOPI-participating practices reported performance on QOPI measure Colorectal 78, which addresses staging workup for patients with rectal cancer. The percentage and 95% CI of patients who received guideline-concordant imaging were calculated for each of the seven assessment time points. Difference of concordance rates between subsequent time points and the initial time point was assessed using logistic regression with random-effects models. In addition, 69 practices that submitted data in 2016 and 2017 were surveyed to gain insight on potential reasons for nonconcordance and the results were described. RESULTS At each time point, a total of 20-33 practices reported data across 1,158 unique patients. Adherence appeared to increase over time, with 38% of patients receiving guideline-recommended staging in Fall 2016, to 56% in Fall 2019. The practice survey revealed that nonconcordance was mostly because of lack of care coordination between oncology and surgery disciplines (n516 practices of 28, 57.1%) and a lack of awareness of appropriate staging scans (n 5 8 practices, 28.6%). CONCLUSION As one half to one third of patients still do not receive appropriate imaging, our findings highlight the need for concerted quality improvement efforts that involve the multidisciplinary team to close this gap. [ABSTRACT FROM AUTHOR]

Testis cancer care requires fastidious adherence to clinical guidelines, especially for those pursuing active surveillance. However, quality remains largely unknown. Using linked NC Cancer Registry-insurance claims data, we assessed whether patients received recommended evaluation and monitoring. Among 487 men diagnosed between 2003 and 2013, 18.9% had a complete evaluation and even fewer of those on active surveillance received the recommended monitoring. Introduction: Contemporary testis cancer management requires fastidious adherence to clinical guidelines and care principles, especially for those pursuing active surveillance (AS). However, real-world testis cancer care remains largely undescribed. Accordingly, we sought to assess the rigor of evaluation and monitoring among men with testis cancer. Patients and Methods: Using North Carolina Central Cancer Registry data linked to insurance claims, we selected adult males diagnosed with primary testis cancer from 2003 to 2013. After identifying demographics, care setting, histology, stage, and index management, we evaluated the receipt of tumor markers, imaging, and clinic visits during initial evaluation and subsequent monitoring with respect to contemporaneous clinical guidelines. Care patterns were compared using chi-squared testing and multivariable logistic regression. Results: Of 2526 men with primary testis cancer, we assembled a cohort of 487 with seminoma (59.3%) or nonseminoma (40.7%), losing most to a lack of insurance or continuous coverage. The cohort was predominantly white (92.4%) and had stage I disease (87.9%). Overall, 18.9% had complete tumor markers, staging imaging, and visits with 2 relevant specialists as recommended during their initial evaluation. For subsequent monitoring, 17.5% of patients with seminoma on active surveillance met minimal thresholds for recommended testing and follow-up during the first year vs. 21.9% and 34.9% of patients with seminoma treated with adjuvant radiation and chemotherapy, respectively. For nonseminoma, 10.1% of men on active surveillance met the minimal thresholds for recommended monitoring compared with 60.4% and 62.0% of those treated with surgery and chemotherapy, respectively. Recommended monitoring also differed by academic vs. community setting and receipt of recommended evaluation (P < .05). Conclusions: From real-world data, the evaluation and monitoring of patients with testis cancer appears substandard. Ongoing data and quality gaps highlight potential challenges with generating real-world evidence and ensuring adequate surveillance in this population. [ABSTRACT FROM AUTHOR]

Purpose/objectives: Although ample intermediate-term prostate stereotactic body radiotherapy (SBRT) outcomes have been reported, 10-year results remain relatively sparse. Materials/methods: Eighteen institutions enrolled 259 low- and intermediate-risk patients. Median follow-up is 5.5 years, with 66 patients followed = 10 years. This SBRT regimen specifically emulated an existing HDR brachytherapy dose schedule and isodose morphology, prescribed to 38 Gy/4 fractions, delivered daily by robotic SBRT, mandating > 150% dose escalation in the peripheral zone. Androgen deprivation therapy was not allowed, and a hydrogel spacer was not available at that time. Results: Median pre-SBRT PSA 5.12 ng/mL decreased to 0.1 ng/mL by 3.5 years, with further decrease to a nadir of < 0.1 ng/mL by 7 years, maintained through 10 years. Ten-year freedom from biochemical recurrence measured 100% for low-risk, 84.3% for favorable intermediate risk (FIR), and 68.4% for unfavorable intermediate (UIR) cases. Multivariable analysis revealed that the UIR group bifurcated into two distinct prognostic subgroups. Those so classified by having Gleason score 4 + 3 and/or clinical stage T2 (versus T1b/T1c) had a significantly poorer 10 year freedom from biochemical recurrence rate, 54.8% if either or both factors were present, while UIR patients without these specific factors had a 94.4% 10-year freedom from biochemical recurrence rate. The cumulative incidence of grade 2 GU toxicity modestly increased over time - 16.3% at 5 years increased to 19.2% at 10 years--while the incidence of grade 3+ GU and GI toxicity remained low and stable to 10 years - 2.6% and 0%, respectively. The grade 2 GI toxicity incidence also remained low and stable to 10 years - 4.1% with no further events after year 5. Conclusion: This HDR-like SBRT regimen prescribing 38 Gy/4 fractions but delivering much higher intraprostatic doses on a daily basis is safe and effective. This treatment achieves a median PSA nadir of <0.1 ng/mL and provides high long-term disease control rates without ADT except for a subgroup of unfavorable intermediate-risk patients. [ABSTRACT FROM AUTHOR]

PURPOSE In the first decade of this millennium, ASCO pioneered a quality measurement tool, the Quality Oncology Practice Initiative (QOPI). Despite an Accreditation Council for Graduate Medical Education (ACGME) requirement since 2012 for oncology fellows to participate in quality improvement (QI) projects, the uptake of QOPI remains modest. METHODS This study examined reasons for low QOPI participation by surveying participating and nonparticipating HemOnc Fellowship Programs. The survey elicited views toward QI and QOPI as well as ideas about making the program more helpful. RESULTS Among 69 fellowship programs, only 39% (n 5 27) participated in QOPI. Other findings were that (1) the majority of programs considered their fellows' QI projects beneficial but were not fulfilling the ACGME standard for all fellows' QI participation; (2) nonparticipating programs were unfamiliar with but interested in QOPI; (3) participating programs tended to view QI as easier to conduct and more beneficial than nonparticipating programs; and (4) programs that withdrew from QOPI and participating programs alike were dissatisfied with the educational benefit and data abstraction burden for fellows. CONCLUSION Academic oncology programs generally valued QI but many have not fully engaged in it. Fellows in programs participating in QOPI may have had less difficulty conducting QI and their projects may have been more beneficial than that of nonparticipating programs. However, perceived lack of educational benefits for fellows and the burden of manual data abstraction from the electronic medical record are impediments to satisfaction with the program. Higher faculty involvement and longitudinal reports for each fellow may significantly increase participation. [ABSTRACT FROM AUTHOR]

PURPOSE People with cancer are at increased risk for severe acute respiratory syndrome coronavirus 2 (SARSCoV-2) infection. ASCO's COVID-19 registry promotes systematic data collection across US oncology practices. METHODS Participating practices enter data on patients with SARS-CoV-2 infection in cancer treatment. In this analysis, we focus on all patients with hematologic or regional or metastatic solid tumor malignancies. Primary outcomes are 30- and 90-day mortality rates and change over time. RESULTS Thirty-eight practices provided data for 453 patients from April to October 2020. Sixty-two percent had regional or metastatic solid tumors. Median age was 64 years. Forty-three percent were current or previous cigarette users. Patients with B-cell malignancies age 61-70 years had twice mortality risk (hazard ratio 5 2.1 [95% CI, 1.3 to 3.3]) and those age. 70 years had 4.5 times mortality risk (95% CI, 1.8 to 11.1) compared with patients age#60 years. Association between survival and age was not significant in patients with metastatic solid tumors (P5 .12). Tobacco users had 30-day mortality estimate of 21% compared with 11% for never users (logrank P 5 .005). Patients diagnosed with SARS-CoV-2 before June 2020 had 30-day mortality rate of 20% (95% CI, 14% to 25%) compared with 13% (8% to 18%) for those diagnosed in or after June 2020 (P 5 .08). The 90-day mortality rate for pre-June patients was 28% (21% to 34%) compared with 21% (13% to 28%; P 5 .20). CONCLUSION Older patients with B-cell malignancies were at increased risk for death (unlike older patients with metastatic solid tumors), as were all patients with cancer who smoke tobacco. Diagnosis of SARS-CoV-2 later in 2020 was associated with more favorable 30- and 90-day mortality, likely related to more asymptomatic cases and improved clinical management. [ABSTRACT FROM AUTHOR]

Purpose: Compared to CONV‐RT (with conventional dose rate), FLASH‐RT (with ultra‐high dose rate) can provide biological dose sparing for organs‐at‐risk (OARs) via the so‐called FLASH effect, in addition to physical dose sparing. However, the FLASH effect only occurs, when both dose and dose rate meet certain minimum thresholds. This work will develop a simultaneous dose and dose rate optimization (SDDRO) method accounting for both FLASH dose and dose rate constraints during treatment planning for pencil‐beam‐scanning proton therapy. Methods: SDDRO optimizes the FLASH effect (specific to FLASH‐RT) as well as the dose distribution (similar to CONV‐RT). The nonlinear dose rate constraint is linearized, and the reformulated optimization problem is efficiently solved via iterative convex relaxation powered by alternating direction method of multipliers. To resolve and quantify the generic tradeoff of FLASH‐RT between FLASH and dose optimization, we propose the use of FLASH effective dose based on dose modifying factor (DMF) owing to the FLASH effect. Results: FLASH‐RT via transmission beams (TB) (IMPT‐TB or SDDRO) and CONV‐RT via Bragg peaks (BP) (IMPT‐BP) were evaluated for clinical prostate, lung, head‐and‐neck (HN), and brain cases. Despite the use of TB, which is generally suboptimal to BP for normal tissue sparing, FLASH‐RT via SDDRO considerably reduced FLASH effective dose for high‐dose OAR adjacent to the target. For example, in the lung SBRT case, the max esophageal dose constraint 27 Gy was only met by SDDRO (24.8 Gy), compared to IMPT‐BP (35.3 Gy) or IMPT‐TB (36.6 Gy); in the brain SRS case, the brain constraint V12Gy≤15cc was also only met by SDDRO (13.7cc), compared to IMPT‐BP (43.9cc) or IMPT‐TB (18.4cc). In addition, SDDRO substantially improved the FLASH coverage from IMPT‐TB, e.g., an increase from 37.2% to 67.1% for lung, from 39.1% to 58.3% for prostate, from 65.4% to 82.1% for HN, from 50.8% to 73.3% for the brain. Conclusions: Both FLASH dose and dose rate constraints are incorporated into SDDRO for FLASH‐RT that jointly optimizes the FLASH effect and physical dose distribution. FLASH effective dose via FLASH DMF is introduced to reconcile the tradeoff between physical dose sparing and FLASH sparing, and quantify the net effective gain from CONV‐RT to FLASH‐RT. [ABSTRACT FROM AUTHOR]

Background Active surveillance (AS) is underutilized for low-risk prostate cancer. This study examines decision-making factors associated with AS vs aggressive treatment in a population-based cohort of low-risk patients. Methods Newly diagnosed patients (n = 599) were enrolled through the North Carolina Central Cancer Registry from 2011 to 2013 and surveyed regarding 5 factors that may impact treatment decision making: perceived cancer aggressiveness, aggressiveness of treatment intent, most important goal (eg, cure, quality of life), primary information source, and primary decision maker. We examined the association between treatment decision-making factors with patient choice for AS vs aggressive treatment using multivariable logistic regression analysis. Results This is a sociodemographically diverse cohort reflective of the population-based design, with 37.6% overall (47.6% among very low-risk patients) choosing AS. Aggressive treatment intent (odds ratio [OR] = 7.09, 95% confidence interval [CI] = 4.57 to 11.01), perceived cancer aggressiveness (OR = 4.93, 95% CI = 2.71 to 8.97), most important goal (cure vs other, OR = 1.72, 95% CI = 1.12 to 2.63), and primary information source (personal and family vs physician, OR = 1.76, 95% CI = 1.10 to 2.82) were associated with aggressive treatment. Overall, 88.4% of patients (92.2% among very low-risk) who indicated an intent to treat the cancer "not very aggressively" chose AS. Conclusions These data from the patient's perspective shed new light on potentially modifiable factors that can help further increase AS uptake among low-risk patients. Helping more low-risk patients feel comfortable with a "not very aggressive" treatment approach may be especially important, which can be facilitated through patient education interventions to improve the understanding of the cancer diagnosis and AS having a curative intent. [ABSTRACT FROM AUTHOR]

Objective. Deliverable proton spots are subject to the minimum monitor-unit (MMU) constraint. The MMU optimization problem with relatively large MMU threshold remains mathematically challenging due to its strong nonconvexity. However, the MMU optimization is fundamental to proton radiotherapy (RT), including efficient IMPT and proton arc delivery (ARC). This work aims to develop a new optimization algorithm that is effective in solving the MMU problem. Approach. Our new algorithm is primarily based on stochastic coordinate decent (SCD) method. It involves three major steps: first to decouple the determination of active sets for dose-volume-histogram (DVH) planning constraints from the MMU problem via iterative convex relaxation method; second to handle the nonconvexity of the MMU constraint via SCD to localize the index set of nonzero spots; third to solve convex subproblems projected to this convex set of nonzero spots via projected gradient descent method. Main results. Our new method SCD is validated and compared with alternating direction method of multipliers (ADMM) for IMPT and ARC. The results suggest SCD had better plan quality than ADMM, e.g. the improvement of conformal index (CI) from 0.56 to 0.69 during IMPT, and from 0.28 to 0.80 during ARC for the lung case. Moreover, SCD successfully handled the nonconvexity from large MMU threshold that ADMM failed to handle, in the sense that (1) the plan quality from ARC was worse than IMPT (e.g. CI was 0.28 with IMPT and 0.56 with ARC for the lung case), when ADMM was used; (2) in contrast, with SCD, ARC achieved better plan quality than IMPT (e.g. CI was 0.69 with IMPT and 0.80 with ARC for the lung case), which is compatible with more optimization degrees of freedom from ARC compared to IMPT. Significance. To the best of our knowledge, our new MMU optimization method via SCD can effectively handle the nonconvexity from large MMU threshold that none of the current methods can solve. Therefore, we have developed a unique MMU optimization algorithm via SCD that can be used for efficient IMPT, proton ARC, and other particle RT applications where large MMU threshold is desirable (e.g. for the delivery of high dose rates or/and a large number of spots). [ABSTRACT FROM AUTHOR]

Background: Men with localized prostate cancer often experience urinary, sexual, bowel, and hormonal symptoms; general distress; pain; fatigue; and sleep disturbance. For men in an intimate relationship, these symptoms disrupt couples' relationships and intimacy. The symptoms also reduce quality of life for both men and their partners, who are often their primary caregivers. Management of the negative effects of cancer and its treatment is a significantly under-addressed supportive care need for these men and their intimate partners. To address these unmet supportive care needs, our interdisciplinary team developed and pilot tested the usability and feasibility of an evidence-based, couple-focused, tailored eHealth intervention, "Prostate Cancer Education & Resources for Couples" (PERC). Based on the adapted stress and coping theoretical framework and developed with stakeholder involvement, PERC aims to improve quality of life for both men and their partners by enhancing their positive appraisals, self-efficacy, social support, and healthy behaviors for symptom management.Methods: We will test the efficacy of PERC using a population-based, geographically and demographically diverse cohort in a randomized controlled trial. Primary aim: Assess if patients and partners receiving PERC will report greater improvement in their cancer-related quality of life scores than those in the control group (usual care plus the National Cancer Institute prostate cancer website) at 4, 8, and 12 months post-baseline. Secondary aim: Test if patients and partners in PERC will report significantly more positive appraisals and higher levels of coping resources at follow-ups than those in the control group. Exploratory aim: Determine if patient race and ethnicity, education, type of treatment, or couples' relationship quality moderate the effects of PERC on patient and partner QOL at follow-ups.Discussion: This study will provide a novel model for self-managing chronic illness symptoms that impact couples' relationships, intimacy, and quality of life. It addresses the National Institute of Nursing Research's goal to develop and test new strategies for symptom self-management to help patients and caregivers better manage their illness and improve quality of life. It also responds to calls for programs from the Institute of Medicine and American Cancer Society to address treatment-related effects and improve survivors' QOL.Trial Registration: CT.gov NCT03489057. [ABSTRACT FROM AUTHOR]

Purpose: Electronic patient-reported outcomes (ePROs) are increasingly being used for symptom monitoring during routine cancer care, but have rarely been evaluated in diverse patient populations. We assessed ePRO user experiences and perceived value among Black and White cancer patients.Methods: We recruited 30 Black and 49 White bladder and prostate cancer patients from a single institution. Participants reported symptoms using either a web-based or automated telephone interface over 3 months and completed satisfaction surveys and qualitative interviews focused on user experiences and value. Using a narrative mixed methods approach, we evaluated overall and race-specific differences in ePRO user experiences and perceived value.Results: Most participants selected the web-based system, but Blacks were more likely to use the automated telephone-based system than Whites. In satisfaction surveys, Whites more commonly reported ease in understanding and reporting symptoms compared with Blacks. Blacks more often reported that the ePRO system was helpful in facilitating symptom-related discussions with clinicians. During interviews, Blacks described how the ePRO helped them recognize symptoms, while Whites found value in better understanding and tracking symptoms longitudinally. Blacks also expressed preferences for paper-based ePRO options due to perceived ease in better understanding of symptom items.Conclusion: Electronic patient-reported outcomes are perceived as valuable for variable reasons by Black and White cancer populations, with greater perceived value for communicating with clinicians reported among Blacks. To optimize equitable uptake of ePROs, oncology practices should offer several ePRO options (e.g., web-based, phone-based), as well as paper-based options, and consider the e-health literacy needs of patients during implementation. [ABSTRACT FROM AUTHOR]

Purpose: To create a crosswalk that predicts Short Form 6D (SF-6D) utilities from Memorial Anxiety Scale for Prostate Cancer (MAX-PC) scores. Methods: The data come from prostate cancer patients enrolled in the North Carolina Prostate Cancer Comparative Effectiveness & Survivorship Study (NC ProCESS, N = 1016). Cross-sectional data from 12- to 24-month follow-up were used as estimation and validation datasets, respectively. Participants' SF-12 scores were used to generate SF-6D utilities in both datasets. Beta regression mixture models were used to evaluate SF-6D utilities as a function of MAX-PC scores, race, education, marital status, income, employment status, having health insurance, year of cancer diagnosis and clinically significant prostate cancer-related anxiety (PCRA) status in the estimation dataset. Models' predictive accuracies (using mean absolute error [MAE], root mean squared error [RMSE], Akaike information criterion [AIC] and Bayesian information criterion [BIC]) were examined in both datasets. The model with the highest prediction accuracy and the lowest prediction errors was selected as the crosswalk. Results: The crosswalk had modest prediction accuracy (MAE = 0.092, RMSE = 0.114, AIC = − 2708 and BIC = − 2595.6), which are comparable to prediction accuracies of other SF-6D crosswalks in the literature. About 24% and 52% of predictions fell within ± 5% and ± 10% of observed SF-6D, respectively. The observed mean disutility associated with acquiring clinically significant PCRA is 0.168 (standard deviation = 0.179). Conclusion: This study provides a crosswalk that converts MAX-PC scores to SF-6D utilities for economic evaluation of clinically significant PCRA treatment options for prostate cancer survivors. [ABSTRACT FROM AUTHOR]

Purpose: To examine the feasibility of an enhanced survivorship care plan (ESCP) that integrated the web-based program Patient Education Resources for Couples (PERC) into a standardized survivorship care plan (SCP) and estimated the outcomes of ESCPs versus SCPs. Methods: In this randomized pilot trial, localized prostate cancer (PC) patients and partners (i.e., couple) were randomly assigned to ESCP that contained a link to PERC or to SCP that contained a link to general PC information on the National Cancer Institute website. Couples completed assessments measuring quality of life (QOL), appraisal of symptoms, and coping resources at baseline (T1) and 4–6 months later (T2). We examined feasibility (e.g., recruitment and retention) using descriptive statistics. Linear mixed models examined changes in couples' outcomes over time and Poisson regression examined differences in patient healthcare utilization. Results: Sixty-two couples completed T1 surveys (recruitment rate 41.6%) and were randomly assigned to receive ESCP (n = 31) or SCP (n = 31). Twenty-eight (ESCP) and 25 (SCP) couples completed T2 surveys (retention rates = 90.3% vs. 80.7%). ESCP participants (70%) reviewed webpages consistent with patients' symptoms. ESCP patients reported greater program satisfaction (p = 0.02) and better urinary symptom scores (p < 0.01) than SCP patients. Conclusions: Delivering ESCPs that embed a web-link to a couple-focused, tailored program is feasible and can potentially improve patient outcomes. The promising results need to be validated in a larger definitive trial using a diverse sample. Implications for Cancer Survivors: SCPs, enhanced using a web-based intervention (e.g., PERC), may help PC cancer survivors better manage their urinary symptoms. Trial registration: ClinicalTrials.gov identifier: NCT04350788 [ABSTRACT FROM AUTHOR]

Purpose: NRG Oncology, part of the National Cancer Institute's National Clinical Trials Network, took efforts to increase patient-reported outcome measures (PROMs) completion and institutional data submission rates within clinical trials. Lack of completion diminishes power to draw conclusions and can be a waste of resources. It is hypothesized that trials with automatic email reminders and past due notifications will have PROM forms submitted more timely with higher patient completion. Methods: Automatic emails sent to the research associate were added to selected NRG Oncology trials. Comparisons between trials with and without automatic emails were analyzed using Chi-square tests with respect to patient completion and timeliness of form submission rates. Multivariable analyses were conducted using repeated measures generalized estimating equations. If PROMs were not completed, a form providing the reason why was submitted and counted towards form submission. Results: For both disease sites, form submission was significantly higher within 1 month of the form's due date for the studies with automatic emails vs. those without (prostate: 79.7% vs. 75.7%, p < 0.001; breast: 59.2% vs. 31.3%, p < 0.001). No significant differences in patient completion were observed between the breast trials. The prostate trial with automatic emails had significantly higher patient completion but this result was not confirmed in the multivariable analysis. Conclusions: Although patient completion rates were higher on trials with automatic emails, there may be confounding factors requiring future study. The automatic emails appeared to have increased the timeliness of form submission, thus supporting their continued use on NRG Oncology trials. [ABSTRACT FROM AUTHOR]

Background: Cabozantinib Versus Sunitinib as Initial Targeted Therapy for Patients With Metastatic Renal Cell Carcinoma of Poor or Intermediate Risk: The Alliance A031203 CABOSUN Trial (CABOSUN) was a randomized, open-label, phase 2 trial evaluating first-line cabozantinib versus sunitinib in patients with advanced renal cell carcinoma (aRCC). This post hoc analysis evaluated quality-adjusted survival using Quality-adjusted Time Without Symptoms of disease or Toxicity of treatment (Q-TWiST).Methods: Survival plots for cabozantinib and sunitinib (650-day follow-up) were partitioned into 3 health states: time spent before disease progression without toxicity (TWiST; toxicity based on National Cancer Institute Common Terminology Criteria for Adverse Events [version 4.0] grade 3/4 adverse events), time spent before disease progression with toxicity (TOX; durations of adverse events based on published literature), and time after disease recurrence (relapse) or progression to death (REL). Q-TWiST was the sum of the mean time spent in each state, with each state weighted to reflect patient preferences (from 0 [worst] to 1 [best]) using utility scores. TWiST was always weighted as 1. Overall survival and time to disease progression were based on all randomized patients (157 patients); TOX was based on all randomized and treated patients (150 patients).Results: Across all utility combinations tested, Q-TWiST was found to be longer with cabozantinib versus sunitinib (range of differences, +24 days to +137 days). Q-TWiST differences that were found to be statistically significant (+92 days [95% confidence interval, 5-178 days] to +137 days [95% confidence interval, 60-214 days]) were of a clinically meaningful effect size (≥80 days), and were based on utility values that included those considered relevant for patients with aRCC (REL utility weight of 0.355, TOX utility weight of 0-1, and TWiST utility weight of 1).Conclusions: In patients with aRCC, first-line cabozantinib was found to provide longer quality-adjusted survival compared with sunitinib. These findings may help to inform clinical decision making.Lay Summary: Cabozantinib and sunitinib are drugs that are used to treat patients with advanced kidney cancer. Clinical trials have shown that cabozantinib offers benefits over sunitinib, giving patients more time before their cancer progresses. It is important that this additional time before disease progression does not come at the expense of patients' quality of life, which can be affected by treatment side effects and/or ongoing cancer symptoms. Both quantity and quality of life are central to optimal treatment. In the current analysis of patients with advanced kidney cancer who were initiating treatment for the first time, cabozantinib provided more quality time before cancer progression compared with sunitinib. [ABSTRACT FROM AUTHOR]

Background: Ultrahypofractionation using stereotactic body radiotherapy (SBRT) is an increasingly utilized technique for men with prostate cancer (PC). The comparative efficacy of SBRT plus androgen deprivation therapy (ADT) compared to fractionated radiotherapy (EBRT) plus ADT in higher-risk prostate cancer is unknown.Methods: Men > 40 years old with localized PC treated with external beam radiation and concomitant ADT for curative intent between 2004 and 2016 were analyzed from the National Cancer Database. Patients who lacked ADT or risk stratification data were excluded. 558 men treated with SBRT versus 40,797 men treated with conventional or moderately hypofractionated EBRT were included. Patients were stratified by unfavorable intermediate (UIR) and high (HR) risk using NCCN criteria. Kaplan Meier and Cox proportional hazards were used to compare overall survival (OS) between RT modality, adjusting for age, race, and comorbidity index.Results: With a median follow up of 74 months, there was no difference in estimated 6-year OS between men treated with SBRT versus EBRT regardless of risk group. On multivariable analysis, there was no difference in risk of death for men treated with SBRT compared to EBRT (UIR: adjusted HR 1.09, 95% CI 0.68-1.74, p = .72; HR: adjusted HR 0.93, 95% CI 0.76-1.14, p = .51). On sensitivity analyses, when confining the cohort to men treated with NCCN-preferred dose fractionations, with no comorbidities, or < 65 years old, there remained no survival difference between treatment groups for both UIR and HR.Conclusion: Within study limitations, we found no difference in survival between SBRT+ADT and standard of care EBRT+ADT for UIR or HR PC. These results support recent NCCN guideline updates, which include SBRT as a non-preferred option for higher risk men. Prospective validation would further strengthen the evidence basis behind these recommendations. [ABSTRACT FROM AUTHOR]

Background: There are uncertainties about prostate cancer‐related anxiety's (PCRA) associations with health‐related quality of life (HRQOL) and major depression, and these could affect the quality of mental healthcare provided to prostate cancer patients. Addressing these uncertainties will provide more insight into PCRA and inform further research on the value of PCRA prevention. The goals of this study were to measure associations between PCRA and HRQOL at domain and subdomain levels, and to evaluate the association between PCRA and probable (ie, predicted major) depression. Method: We analyzed secondary cross‐sectional data from the North Carolina Prostate Cancer Comparative Effectiveness & Survivorship Study (NC ProCESS—a population‐based cohort of prostate cancer patients enrolled shortly after diagnosis [between January 2011 and June 2013] and followed prospectively). Patient‐reported measures of PCRA and HRQOL from 1,016 enrollees who participated in NC ProCESS's 1‐year follow‐up survey were assessed. Outcomes of interests were a) linear correlations between contemporaneous memorial anxiety scale for prostate cancer (MAX‐PC) and Short Form 12 (SF‐12) scores, and b) measures of association between indicators of clinically significant PCRA (ie, MAX‐PC > 27) and probable depression during survey contact (ie, SF‐12 mental component score ≤43). Results: PCRA measures had notable associations with SF‐12's mental health subscale (assesses low mood/nervousness [rho = −0.42]) and emotional role functioning subscale (assesses subjective productivity loss [rho = −0.46]). Additionally, the risk of probable depression was significantly higher in participants with clinically significant PCRA compared with those without it (weighed risk ratio = 5.3, 95% confidence interval 3.6‐7.8; P <.001). Conclusion: Prostate cancer patients with clinically significant PCRA should be assessed for major depression and productivity loss. [ABSTRACT FROM AUTHOR]

Purpose: To assess the performance and limitations of contour propagation with three commercial deformable image registration (DIR) algorithms using fractional scans of CT‐on‐rails (CTOR) and Cone Beam CT (CBCT) in image guided prostate therapy patients treated with IMRT/VMAT. Methods: Twenty prostate cancer patients treated with IMRT/VMAT were selected for analysis. A total of 453 fractions across those patients were analyzed. Image data were imported into MIM (MIM Software, Inc., Cleveland, OH) and three DIR algorithms (DIR Profile, normalized intensity‐based (NIB) and shadowed NIB DIR algorithms) were applied to deformably register each fraction with the planning CT. Manually drawn contours of bladder and rectum were utilized for comparison against the DIR propagated contours in each fraction. Four metrics were utilized in the evaluation of contour similarity, the Hausdorff Distance (HD), Mean Distance to Agreement (MDA), Dice Similarity Coefficient (DSC), and Jaccard indices. A subfactor analysis was performed per modality (CTOR vs. CBCT) and time (fraction). Point estimates and 95% confidence intervals were assessed via a Linear Mixed Effect model for the contour similarity metrics. Results: No statistically significant differences were observed between the DIR Profile and NIB algorithms. However, statistically significant differences were observed between the shadowed NIB and NIB algorithms for some of the DIR evaluation metrics. The Hausdorff Distance calculation showed the NIB propagated contours vs. shadowed NIB propagated contours against the manual contours were 14.82 mm vs. 8.34 mm for bladder and 15.87 mm vs. 11 mm for rectum, respectively. Similarly, the Mean Distance to Agreement calculation comparing the NIB propagated contours vs. shadowed NIB propagated contours against the manual contours were 2.43 mm vs. 0.98 mm for bladder and 2.57 mm vs. 1.00 mm for rectum, respectively. The Dice Similarity Coefficients comparing the NIB propagated contours and shadowed NIB propagated contours against the manual contours were 0.844 against 0.936 for bladder and 0.772 against 0.907 for rectum, respectively. The Jaccard indices comparing the NIB propagated contours and shadowed NIB propagated contours against the manual contours were 0.749 against 0.884 for bladder and 0.637 against 0.831 for rectum, respectively. The shadowed NIB DIR, which showed the closest agreement with the manual contours performed significantly better than the DIR Profile in all the comparisons. The OAR with the greatest agreement varied substantially across patients and image guided radiation therapy (IGRT) modality. Intra‐patient variability of contour metric evaluation was insignificant across all the DIR algorithms. Statistical significance at α = 0.05 was observed for manual vs. deformably propagated contours for bladder for all the metrics except Hausdorff Distance (P = 0.01 for MDA, P = 0.02 for DSC, P = 0.01 for Jaccard), whereas the corresponding values for rectum were: P = 0.03 for HD, P = 0.01 for MDA, P < 0.01 for DSC, P < 0.01 for Jaccard. The performance of the different metrics varied slightly across the fractions of each patient, which indicates that weekly contour propagation models provide a reasonable approximation of the daily contour propagation models. Conclusion: The high variance of Hausdorff Distance across all automated methods for bladder indicates widely variable agreement across fractions for all patients. Lower variance across all modalities, methods, and metrics were observed for rectum. The shadowed NIB propagated contours were substantially more similar to the manual contours than the DIR Profile or NIB contours for both the CTOR and CBCT imaging modalities. The relationship of each algorithm to similarity with manual contours is consistent across all observed metrics and organs. Screening of image guidance for substantial differences in bladder and rectal filling compared with the planning CT reference could aid in identifying fractions for which automated DIR would prove insufficient. [ABSTRACT FROM AUTHOR]

An increasingly diversified demographic landscape in rural and urban America warrants the attention of The University of Kansas Cancer Center (KU Cancer Center) researchers, clinicians, outreach staff and administrators as the institution assesses ways to reach its expansive, bi-state catchment area. Within the counties of the KU Cancer Center catchment area, patient level and public health data are available and categorized by varying geographic regional boundaries. Multiple data sources and different data collection processes complicate summarizing catchment area data. A curated data warehouse that retrieves and structures the data, with a common denominator, can support meaningful use of the data in a standard and consistent format. The KU Cancer Center built a data warehouse to Organize and Prioritize Trends to Inform KU Cancer Center (OPTIK), which functions to streamline the process of synthesizing data regarding Kansas and Missouri demographics, cancer risk factors and incidence and mortality rates. OPTIK standardizes these diverse data sources to enable analyses of the cancer burden at local, regional and national levels while upholding a strict standard of patient privacy. The OPTIK database enables researchers to use available data and create heat maps and other visualizations to aid in funding proposals, presentations and research activities. Furthermore, using knowledge provided by OPTIK, the KU Cancer Center is able to prioritize action items for research and outreach and more effectively communicate the impact of those efforts. [ABSTRACT FROM AUTHOR]

Background: Although patients with prostate cancer face many treatment options, to the authors' knowledge the comparative effects of different surgical and radiotherapy (RT) options on sexual function are unclear.Methods: In the current study, a population-based cohort of 835 men with newly diagnosed prostate cancer from 2011 through 2013 was recruited throughout North Carolina in collaboration with the Rapid Case Ascertainment system of the North Carolina Central Cancer Registry. All men were enrolled prior to treatment and followed prospectively using the validated Prostate Cancer Symptom Indices (PCSI) instrument. This analysis compares the sexual dysfunction scores of the PCSI among patients who received external-beam RT (EBRT), EBRT with androgen deprivation therapy (ADT), brachytherapy, nerve-sparing radical prostatectomy (RP), and non-nerve-sparing RP. Propensity scores were used to balance patient characteristics across groups, and multiple imputation was used for missing data.Results: EBRT and brachytherapy resulted in similar PCSI scores through 24 months. Compared with those receiving EBRT, patients treated with EBRT with ADT and RP with or without nerve sparing were found to have worse PCSI scores at all posttreatment time points. Preservation of useful sexual function at 24 months was associated with treatment type, baseline score, and age. Predicted preservation rates were 14.1% to 70.7% for EBRT, 8.4% to 52.3% for EBRT with ADT, 4.7% to 45.3% for nerve-sparing RP, and 4.8% to 34.5% for non-nerve-sparing RP.Conclusions: The findings of the current study indicate that RT alone results in the best preservation of sexual function, and brachytherapy provides similar outcomes. RT with ADT and nerve-sparing RP yielded similar outcomes, whereas patients treated with non-nerve-sparing RP experienced the worst sexual function. These results help patients to make decisions among the specific types of surgery and RT they face based on each individual's diagnosis. [ABSTRACT FROM AUTHOR]