The effect of integrating knowledge-based planning with multicriteria optimization in treatment planning for prostate SBRT.

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.

Trastuzumab with trimodality treatment for oesophageal adenocarcinoma with HER2 overexpression (NRG Oncology/RTOG 1010): a multicentre, randomised, phase 3 trial.

BACKGROUND: Trastuzumab is a monoclonal antibody against HER2 (also known as ERBB2). The primary objective of the NRG Oncology/RTOG-1010 trial was to establish whether trastuzumab improves disease-free survival when combined with trimodality treatment (paclitaxel plus carboplatin and radiotherapy, followed by surgery) for patients with untreated HER2-overexpressing oesophageal adenocarcinoma. METHODS: NRG Oncology/RTOG-1010 was an open label, randomised, phase 3 trial for which patients were accrued from 111 NRG-affiliated institutions in the USA. Eligible patients were adults (aged ≥18 years) with newly diagnosed pathologically confirmed oesophageal adenocarcinoma, American Joint Committee on Cancer 7th edition T1N1-2 or T2-3N0-2 stage disease, and a Zubrod performance status of 0-2. Patients were stratified by adenopathy (no vs yes [coeliac absent] vs yes [coeliac present ≤2 cm]) and randomly assigned (1:1) to receive weekly intravenous paclitaxel (50 mg/m2 intravenously over 1 h) and carboplatin (area under the curve 2, intravenously over 30-60 min) for 6 weeks with radiotherapy 50·4 Gy in 28 fractions (chemoradiotherapy) followed by surgery, with or without intravenous trastuzumab (4 mg/kg in week one, 2 mg/kg per week for 5 weeks during chemoradiotherapy, 6 mg/kg once presurgery, and 6 mg/kg every 3 weeks for 13 treatments starting 21-56 days after surgery). The primary endpoint, disease-free survival, was defined as the time from randomisation to death or first of locoregional disease persistence or recurrence, distant metastases, or second primary malignancy. Analyses were done by modified intention to treat. This study is registered with Clinicaltrials.gov, NCT01196390; it is now closed and in follow-up. FINDINGS: 606 patients were entered for HER2 assessment from Dec 30, 2010 to Nov 10, 2015, and 203 eligible patients who were HER2-positive were enrolled and randomly assigned to chemoradiotherapy plus trastuzumab (n=102) or chemoradiotherapy alone (n=101). Median duration of follow-up was 2·8 years (IQR 1·4-5·7). Median disease-free survival was 19·6 months (95% CI 13·5-26·2) with chemoradiotherapy plus trastuzumab compared with 14·2 months (10·5-23·0) for chemoradiotherapy alone (hazard ratio 0·99 [95% CI 0·71-1·39], log-rank p=0·97). Grade 3 treatment-related adverse events occurred in 41 (43%) of 95 patients in the chemoradiotherapy plus trastuzumab group versus 52 (54%) of 96 in the chemoradiotherapy group and grade 4 events occurred in 20 (21%) versus 21 (22%). The most common grade 3 or worse treatment-related adverse events for both groups were haematological (53 [56%] of 95 patients in the chemoradiotherapy plus trastuzumab group vs 55 [57%] of 96 patients in the chemotherapy group) or gastrointestinal disorders (28 [29%] vs 20 [21 %]). 34 (36%) of 95 patients in the chemoradiotherapy plus trastuzumab group and 27 (28%) of 96 patients in the chemoradiotherapy only group had treatment-related serious adverse events. There were eight treatment-related deaths: five (5%) of 95 patients in the chemoradiotherapy plus trastuzumab group (bronchopleural fistula, oesophageal anastomotic leak, lung infection, sudden death, and death not otherwise specified), and three (3%) of 96 in the chemoradiotherapy group (two multiorgan failure and one sepsis). INTERPRETATION: The addition of trastuzumab to neoadjuvant chemoradiotherapy for HER2-overexpressing oesophageal cancer was not effective. Trastuzumab did not lead to increased toxicities, suggesting that future studies combining it with or using other agents targeting HER2 in oesophageal cancer are warranted. FUNDING: National Cancer Institute and Genentech.

Comparison of two validated instruments to measure financial hardship in cancer survivors: comprehensive score for financial toxicity (COST) versus personal financial wellness (PFW) scale.

PURPOSE: Financial distress and financial toxicity are recognized challenges in cancer survivorship. Financial toxicity includes both objective measures of hardship and subjective distress. We hypothesized that subjective financial distress is correlated to overall holistic financial toxicity. We compared two widely accepted instruments to measure financial distress and financial toxicity. METHODS: Patients in the follow-up phase of care at a single institution were surveyed regarding demographic and economic status. Financial toxicity was measured using the comprehensive score for financial toxicity-functional assessment of chronic illness (COST-FACIT) and financial distress using the personal financial wellness (PFW) scale. Surveys were analyzed for correlation and internal consistency. Patient score distributions were compared. Associations between survey scores and patient factors were assessed using multivariable linear regression models. RESULTS: A total of 116 patients were included. Scores from the COST-FACIT showed a strong correlation with PFW scores (r = 0.90, p < 0.0001). Scale reliability was high for both the COST-FACIT (α = 0.92) and PFW (α = 0.97) surveys. Score distributions exhibited left skew for both surveys, with 9.5% of patient scores falling in the worst quartile of possible scores on each respective survey. The strongest predictors of financial distress and financial toxicity included young age, lower monetary savings, lower household income, and less perceived social support during cancer treatment. CONCLUSIONS: The COST-FACIT measure of financial toxicity correlated strongly with PFW measure of financial distress. Although these instruments were designed to assess different concepts (financial distress vs financial toxicity), they gave strikingly similar results. Either instrument may be used as a meaningful patient-reported outcome for study of financial distress in cancer survivors. However, the COST-FACIT construct of financial toxicity does not appear to add additional information beyond financial distress.

Trade-Off between Treatment of Early Prostate Cancer and Incidence of Advanced Prostate Cancer in the Prostate Screening Era.

PURPOSE: Prostate specific antigen screening has led to the early detection of prostate cancer. However, there has also been concern about the over diagnosis and overtreatment of patients with indolent cancers. We performed a population based analysis to evaluate the trade-off between excess treatment and prevention. MATERIALS AND METHODS: We used the CDC (Centers for Disease Control and Prevention) Behavioral Risk Factor Surveillance System survey from 2001 to 2010 to determine rates of prostate specific antigen screening. We used the SEER database to identify all patients diagnosed with prostate cancer from 1988 (pre-prostate specific antigen screening) to 2010. Demographic, staging and treatment data were collected. Cases were classified as early (low/intermediate risk), high risk, node positive or metastatic disease. RESULTS: Prostate specific antigen screening rates in the last 2 years were 54% for men older than 40 years, including 71% for those older than 60, and did not vary during 2001 to 2010. Comparing 1988 and 2000 to 2010, per 100,000 men the incidence of early prostate cancer increased (61.7 to 113.7), while high risk cancer increased (20.7 to 28.2), node positive cancer decreased (3.7 to 1.8) and metastatic cancer decreased (13.6 to 6.2). The rate of definitive primary treatment (radical prostatectomy or radiation therapy) for men with early cancer increased from 47% to 67% (p <0.001). CONCLUSIONS: Prostate specific antigen screening has led to an additional diagnosis of 5.8 cases of early stage cancer and 3.9 cases receiving treatment for early cancer for every 1 less case of stage IV disease at initial diagnosis. This ratio represents the worst-case scenario for overtreatment and provides a quantitative basis for studying the effect of prostate specific antigen screening.

Contemporary Role of Radiation Therapy in Testicular Cancer.

Testicular cancer is a rare but curable male malignancy. Seminoma represents the majority of germ cell tumors and is considered radiation sensitive. Radiation treatment plays a role in adjuvant therapy after orchiectomy of stage I, IIA, and IIB seminomas. Radiation dose de-escalation has been effective in preventing tumor recurrences while also limiting acute and long-term toxicities. However, long-term risks, including the prevailing concern of secondary malignancy risk, between adjuvant radiation and chemotherapy play a role in recommendations. Ongoing work continues to be performed to reduce radiation field and dose in combination with chemotherapy while still maintaining excellent outcomes.

Financial Toxicity in Radiation Oncology: Impact for Our Patients and for Practicing Radiation Oncologists.

With rising costs of diagnosis, treatment, and survivorship, financial burdens on patients with cancer and negative effects from high costs, called financial toxicity (FT), are growing. Research suggests that FT may be experienced by more than half of working-age cancer survivors and a similar proportion may incur debt or avoid recommended prescription medications due to treatment costs. As FT can lead to worse physical, psychological, financial, and survival outcomes, there is a discrete need to identify research gaps around this issue that constrain the development and implementation of effective screening and innovative care delivery interventions. Prior research, including within a radiation oncology-specific context, has sought to identify the scope of FT among patients with cancer, develop assessment tools to evaluate patient risk, quantify financial sacrifices, and qualify care compromises that occur when cancer care is unaffordable. FT is a multifactorial problem and potential solutions should be pursued at all levels of the health care system (patient-provider, institutional, and systemic) with specific regard for patients' individual/local contexts. Solutions may include selecting alternative treatment schedules, discussing financial concerns with patients, providing financial navigation services, low-cost transportation options, and system-wide health policy shifts. This review summarizes existing FT research, describes tools developed to measure FT, and suggests areas for intervention and study to help improve FT and outcomes for radiation oncology patients.

Differences in Rural Versus Urban Patients With Prostate Cancer in Diagnosis and Treatment: An Analysis of a Population-Based Cohort.

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.

Biological optimization for hybrid proton-photon radiotherapy.

Objective.Hybrid proton-photon radiotherapy (RT) is a cancer treatment option to broaden access to proton RT. Additionally, with a refined treatment planning method, hybrid RT has the potential to offer superior plan quality compared to proton-only or photon-only RT, particularly in terms of target coverage and sparing organs-at-risk (OARs), when considering robustness to setup and range uncertainties. However, there is a concern regarding the underestimation of the biological effect of protons on OARs, especially those in close proximity to targets. This study seeks to develop a hybrid treatment planning method with biological dose optimization, suitable for clinical implementation on existing proton and photon machines, with each photon or proton treatment fraction delivering a uniform target dose.Approach.The proposed hybrid biological dose optimization method optimized proton and photon plan variables, along with the number of fractions for each modality, minimizing biological dose to the OARs and surrounding normal tissues. To mitigate underestimation of hot biological dose spots, proton biological dose was minimized within a ring structure surrounding the target. Hybrid plans were designed to be deliverable separately and robustly on existing proton and photon machines, with enforced uniform target dose constraints for the proton and photon fraction doses. A probabilistic formulation was utilized for robust optimization of setup and range uncertainties for protons and photons. The nonconvex optimization problem, arising from minimum monitor unit constraint and dose-volume histogram constraints, was solved using an iterative convex relaxation method.Main results.Hybrid planning with biological dose optimization effectively eliminated hot spots of biological dose, particularly in normal tissues surrounding the target, outperforming proton-only planning. It also provided superior overall plan quality and OAR sparing compared to proton-only or photon-only planning strategies.Significance.This study presents a novel hybrid biological treatment planning method capable of generating plans with reduced biological hot spots, superior plan quality to proton-only or photon-only plans, and clinical deliverability on existing proton and photon machines, separately and robustly.

Prognostic Significance of Immune Cell Infiltration in Muscle-invasive Bladder Cancer Treated with Definitive Chemoradiation: A Secondary Analysis of RTOG 0524 and RTOG 0712.

Chemoradiation therapy (CRT) is a treatment for muscle-invasive bladder cancer (MIBC). Using a novel transcriptomic profiling panel, we validated prognostic immune biomarkers to CRT using 70 pretreatment tumor samples from prospective trials of MIBC (NRG/RTOG 0524 and 0712). Disease-free survival (DFS) and overall survival (OS) were estimated via the Kaplan-Meier method and stratified by genes correlated with immune cell activation. Cox proportional-hazards models were used to assess group differences. Clustering of gene expression profiles revealed that the cluster with high immune cell content was associated with longer DFS (hazard ratio [HR] 0.53, 95% confidence interval [CI] 0.26-1.10; p = 0.071) and OS (HR 0.48, 95% CI 0.24-0.97; p = 0.040) than the cluster with low immune cell content. Higher expression of T-cell infiltration genes (CD8A and ICOS) was associated with longer DFS (HR 0.40, 95% CI 0.21-0.75; p = 0.005) and OS (HR 0.49, 95% CI 0.25-0.94; p = 0.033). Higher IDO1 expression (IFNγ signature) was also associated with longer DFS (HR 0.44, 95% CI 0.24-0.88; p = 0.021) and OS (HR 0.49, 95% CI 0.24-0.99; p = 0.048). These findings should be validated in prospective CRT trials that include biomarkers, particularly for trials incorporating immunotherapy for MIBC. PATIENT SUMMARY: We analyzed patient samples from two clinical trials (NRG/RTOG 0524 and 0712) of chemoradiation for muscle-invasive bladder cancer using a novel method to assess immune cells in the tumor microenvironment. Higher expression of genes associated with immune activation and high overall immune-cell content were associated with better disease-free survival and overall survival for patients treated with chemoradiation.

Variations in Medical Necessity Determinations Across Commercial Insurance Carriers for Prostate Cancer Procedures.

PURPOSE: Variation in commercial insurance coverage may lead to disparity in access to quality cancer care. We evaluated commercial insurance coverage determinations to assess the degree of variation across a national sample. METHODS AND MATERIALS: We identified the predominant carrier of commercial insurance in each state based on the 2020 US Government Accounting Office (GAO-21-34) report on insurance. For each state, publicly available medical policies from January 1, 2021 to January 31, 2021 were analyzed for coverage of 3 widely accepted procedures: hydrogel spacer, fluciclovine- positron emission tomography (PET), and intensity modulated radiation in low volume metastatic prostate cancer. RESULTS: We analyzed 83 commercial medical policies across 51 states and District of Columbia. There was widespread variation in coverage policy. Hydrogel spacer was determined medically necessary in 9 states, mixed coverage in 8, not medically necessary in 22, and no available public policy in 12. Use of fluciclovine-PET required a minimum prostate specific antigen level of 2 ng/mL in 9 states, 1 ng/mL in 17, any minimum prostate specific antigen in 7, mixed coverage in 12, and no publicly available policy in 6. Intensity modulated radiation in low volume metastatic prostate cancer was medically necessary in 17 states, not necessary in 7, and not stated in 27. Insurance carriers often used external utilization management companies such as AIM-Healthcare and Evicore Healthcare. These determinations were more restrictive than carriers which did not use utilization management. CONCLUSIONS: Commercial medical policies vary widely in medical necessity determinations for novel prostate cancer treatment procedures that are Food and Drug-approved and covered by Medicare. These data suggest a need for more consistent methodology for medical necessity determination to mitigate the current state where patients have unequal access to cancer procedures due to the location of residence and age.

Income level and treatment selection in prostate cancer: analysis of a North Carolina population-based cohort.

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.

Androgen Deprivation and Sleep Disturbance: A Mixed Methods Pilot Study of Remote Assessment and Intervention.

BACKGROUND: Men receiving androgen deprivation therapy (ADT) for prostate cancer (PC) are at risk for cardiovascular comorbidities and cognitive changes. Interventional research involves in-person assessment of physical fitness/activity and cognitive function, which has been negatively affected by the COVID-19 pandemic. Androgen deprivation therapy-related hot flashes and nocturia increase risk for insomnia. Insomnia is associated with fatigue and may exacerbate ADT-related cognitive changes. OBJECTIVES: The purpose of this mixed-methods pilot was to (1) determine feasibility/acceptability of remotely assessing physical fitness/activity, cognitive function, and sleep; (2) deliver telehealth cognitive behavioral training for insomnia (teleCBT-I) to improve sleep; and (3) garner qualitative feedback to refine remote procedures and teleCBT-I content. METHODS: Fifteen men with PC receiving ADT completed a 4-week teleCBT-I intervention. Videoconferencing was used to complete study assessments and deliver the weekly teleCBT-I intervention. RESULTS: Self-report of sleep quality improved ( P < .001) as did hot flash frequency ( P = .04) and bother ( P = .025). Minimal clinically important differences were detected for changes in insomnia severity and sleep quality. All sleep logs indicated improvement in sleep efficiency. Remote assessment of fitness/cognitive function was demonstrated for 100% of participants. Sufficient actigraph wear time allowed physical activity/sleep assessment for 80%. Sleep actigraphy did not demonstrate significant changes. CONCLUSIONS: Remote monitoring and teleCBT-I are feasible/acceptable to men with PC on ADT. Further research to confirm teleCBT-I efficacy is warranted in this population. IMPLICATIONS FOR PRACTICE: Preliminary efficacy for teleCBT-I interventions was demonstrated. Remote assessments of physical fitness/activity, sleep, and cognitive function may enhance clinical trial access for rural or economically disadvantaged PC survivors.

Improving prognosis of glioblastoma in the 21st century: who has benefited most?

BACKGROUND: Glioblastoma multiforme (GBM) is the most frequent primary brain tumor in adults. Temozolomide was rapidly incorporated into first-line treatment following the publication of the pivotal European Organization for Research and Treatment of Cancer-National Cancer Institute of Canada phase 3 trial in 2005. However, in the trial, enrollment was limited to younger patients with good performance status. Therefore, this study performed a population-based survival analysis of patients with newly diagnosed GBM covering the period before and after the introduction of temozolomide. METHODS: Survival statistics and clinical and demographic variables were extracted from the Survival, Epidemiology and End Results Database for patients diagnosed with GBM from 2001 to 2007. Mean regional income for each patient was also collected. Survival was analyzed using the Kaplan-Meier method and proportional hazard models. RESULTS: A total of 13,003 adult patients diagnosed with a GBM were identified. Prognostic variables included age <70 years, use of radiation, gross total resection, and residence in a high-income district (P < .001). Between 2001 and 2007, the median survival time increased from 7 to 9 months for the entire population. The 1-year survival increased from 29% to 39%. Prognosis of patients aged 70 or more years did not improve over this time. Over the study period, the absolute disparity in 1-year survival between low- and high-income districts increased from 6.6% to 10.1%. CONCLUSIONS: There has been a stepwise improvement in the overall survival of patients with GBM between 2001 and 2007. This improvement has been confined to patients <70 years of age and has been most prominent among patients living in high-income districts.

Characterization and outcomes of optic nerve gliomas: a population-based analysis.

Optic nerve gliomas (ONG) are rare astrocytic neoplasms. A paucity of literature exists on the epidemiology and outcomes of ONG. Here, we present a series of 445 cases of ONG obtained from the Surveillance, epidemiology and end results (SEER) database. Data on patient and tumor characteristics as well as initial treatment with surgery or radiation were extracted from the SEER Database. Survival rates were calculated using the Kaplan-Meier method. A multivariate analysis was performed to determine independent prognostic factors predicting mortality hazard ratios (HRs) using Cox proportional hazards modeling. The median age range at diagnosis was 5-9 years. Twenty percent of patients were over the age of 20 years. Amongst patients with information available on tumor grade (n = 131), 83% had a low-grade tumors and 17% had a high-grade tumors. Sixteen percent of patients received radiation therapy and 18.4% of patient underwent a sub- or gross total resection. The 5 year overall survival was 96% and 20% for patients with low- and high-grade tumors, respectively. In a multivariate analysis, grade was the only significant predictor of overall survival (HR 29.3, CI: 4.3, 205.4, P < 0.001). Age at diagnosis, receipt of radiation therapy, and extent of surgical resection were not significantly correlated with overall survival. In conclusion, ONG are rare tumors seen predominantly in children. The overall prognosis of high-grade tumors remains poor in all age groups despite multi-modality treatment.

Comparative effectiveness research for prostate cancer radiation therapy: current status and future directions.

Comparative effectiveness research aims to help clinicians, patients and policymakers make informed treatment decisions under real-world conditions. Prostate cancer patients have multiple treatment options, including active surveillance, androgen deprivation therapy, surgery and multiple modalities of radiation therapy. Technological innovations in radiation therapy for prostate cancer have been rapidly adopted into clinical practice despite relatively limited evidence for effectiveness showing the benefit for one modality over another. Comparative effectiveness research has become an essential component of prostate cancer research to help define the benefits, risks and effectiveness of the different radiation therapy modalities currently in use for prostate cancer treatment.

Estimation of Patient Out-of-Pocket Cost for Radiation Therapy by Insurance Type and Treatment Modality.

PURPOSE: Financial toxicity is increasingly identified as an important issue in cancer care. Limited data are available on direct out of pocket (OOP) costs for radiation therapy, which are important for providers and patients. METHODS AND MATERIALS: Retrospective analysis of 247 consecutive patients with nonmetastatic breast and prostate cancer treated with curative intent. Data were collected on demographics, treatments received and insurance plan specifications, including annual OOP maximum, deductibles, co-insurance rates, OOP already paid prior to starting radiation therapy, and actual estimated OOP for radiation therapy. Multivariable logistic regression was used to examine associations between insurance factors, radiation technique, concurrent systemic therapy, and month of treatment with a patient reaching OOP maximum with radiation treatment. RESULTS: In the study, 137 and 110 patients with breast and prostate cancer were evaluated. Mean plan specified annual OOP maximum for commercial and Medicare Advantage plans were $4064 and $4661, respectively; 100% of commercially insured patients and 54.7% Medicare Advantage patients reached their OOP maximum with radiation therapy. Annual OOP maximum for Medicare plus supplement, Medicaid, and Tricare were minimal. On multivariable analysis, concurrent systemic therapy (odds ratio 6.20, P = .03) was associated with patient reaching OOP maximum, but radiation technique was not. CONCLUSIONS: Out of pocket cost for radiation therapy services may be reasonably estimated based on insurance type and structure. Medicare plus supplement and Medicaid plans have negligible OOP, while all patients with commercial plans reached annual OOP maximums. This study provides practical information to help providers to better counsel patients.

Patient Decision-Making Factors in Aggressive Treatment of Low-Risk Prostate Cancer.

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.

Postprostatectomy radiation therapy: an evidence-based review.

While the majority of men with localized prostate cancer who undergo a radical prostatectomy will remain disease free, men with certain clinical and pathological features are known to be at an increased risk for developing a biochemical recurrence and, ultimately, distant metastatic disease. The optimal management of these patients continues to be a source of controversy. To date, three randomized Phase III trials have demonstrated that adjuvant radiation therapy (ART) for patients with certain adverse pathological features results in an improvement in several clinically-relevant end points, including biochemical recurrence-free survival and overall survival. Despite the evidence from these trials showing a benefit for ART, many believe that ART results in overtreatment and unwarranted treatment morbidity for a significant number of patients. Many physicians, therefore, instead advocate for close observation followed by early salvage radiation therapy (SRT) at the time of a biochemical recurrence. The purpose of this review is to evaluate the evidence for and to distinguish between ART and early SRT. We will also highlight current and future areas of research for this patient population, including radiation treatment dose escalation, hypofractionation and androgen deprivation therapy. We will also discuss the cost-effectiveness of ART and early SRT.

Narrative review of management strategies and outcomes in node-positive prostate cancer.

Pelvic nodal involvement is present in 13% of new prostate cancer diagnoses each year and is associated with a poor prognosis compared to localized disease. Grouped as stage IV along with distant metastatic disease, node-positive nonmetastatic patients historically received systemic therapy alone as primary treatment. This treatment paradigm has shifted as data have demonstrated that these patients may benefit from aggressive locoregional therapy and are potentially curable. There is currently a lack of randomized evidence to define the optimal management for node-positive patients. While a few trials have included node-positive patients, the majority of data are derived from large multi-institutional series or population-based series. This narrative review summarizes the current literature supporting curative-intent management strategies for patients diagnosed with nonmetastatic clinically node-positive prostate cancer (cN1M0), as well as patients found to have pathologic nodal disease at the time of surgery (pN1M0). Treatment of both scenarios requires multimodality considerations including surgery, radiation therapy (RT) and systemic therapy to minimize the risks of both locoregional and distant recurrence. Future considerations include developments in enhanced imaging and systemic therapy. Inclusion of node-positive patients on prospective, randomized trials such as NRG GU 008 is needed to enhance our understanding of optimal management strategies.