ACR-ARS Practice Parameter for Communication: Radiation Oncology.

BACKGROUND: This practice parameter was revised collaboratively by the American College of Radiology (ACR), and the American Radium Society (ARS). Timely, accurate, and effective communications are critical to quality and safety in contemporary medical practices. Radiation oncology incorporates the science and technology of complex, integrated treatment delivery and the art of providing care to individual patients. Through written physical and/or electronic reports and direct communication, radiation oncologists convey their knowledge and evaluation regarding patient care, clinical workup, and treatment provided to others in the management of the patient. Applicable practice parameters need to be revised periodically regarding medical record documentation for professional and technical components of services delivered. METHODS: This practice parameter was developed and revised according to the process described under the heading "The Process for Developing ACR Practice Parameters and Technical Standards" on the ACR website ( https://www.acr.org/Clinical-Resources/Practice-Parameters-and-Technical-Standards ) by the Committee on Practice Parameters-Radiation Oncology of the ACR Commission on Radiation Oncology in collaboration with the ARS. Both societies have reviewed and approved the document. RESULTS: This practice parameter addresses radiation oncology communications in general, including (a) medical record, (b) electronic, and (c) doctor-patient communications, as well as specific documentation for radiation oncology reports such as (a) consultation, (b) clinical treatment management notes (including inpatient communication), (c) treatment (completion) summary, and (d) follow-up visits. CONCLUSIONS: The radiation oncologist's participation in the multidisciplinary management of patients is reflected in timely, medically appropriate, and informative communication with patients, caregivers, referring physician, and other members of the health care team. The ACR-ARS Practice Parameter for Communication: Radiation Oncology is an educational tool designed to assist practitioners in providing appropriate communication regarding radiation oncology care for patients.

Vidutolimod in Combination With Atezolizumab With and Without Radiation Therapy in Patients With Programmed Cell Death Protein 1 or Programmed Death-Ligand 1 Blockade-Resistant Advanced NSCLC.

Introduction: Vidutolimod, a CpG-A TLR9 agonist, was investigated in a phase 1b study (CMP-001-003; ClinicalTrials.gov, NCT03438318) in combination with atezolizumab with and without radiation therapy (RT) in patients with advanced NSCLC. Methods: Patients with progressive disease after anti-programmed cell death protein 1 or programmed death-ligand 1 therapy received either vidutolimod and atezolizumab (part A) or vidutolimod, atezolizumab, and RT (part B). The primary objective was to evaluate the safety of vidutolimod and atezolizumab with and without RT. Key secondary end point was best objective response rate per Response Evaluation Criteria in Solid Tumors, version 1.1. Results: Between March 28, 2018, and July 25, 2019, a total of 29 patients were enrolled and received at least one dose of vidutolimod (part A, n = 13; part B, n = 16). Intratumoral injections of vidutolimod were administered successfully, including injection of visceral lesions. The most common treatment-related adverse events (≥30%) were flu-like symptoms and hypotension. No objective responses were observed; 23.1% and 50.0% of the patients in parts A and B, respectively, had stable disease as best response. In parts A and B, 15.4% and 25.0% of the patients, respectively, had tumor shrinkage (<30% decrease in tumor size, nonirradiated). Enrollment was stopped owing to lack of objective responses. In the two patients with initial tumor shrinkage in part A, a strong serum induction of C-X-C motif chemokine ligand 10 was observed. Conclusions: Vidutolimod and atezolizumab with and without RT had a manageable safety profile, with minimal clinical activity in heavily pretreated patients with programmed cell death protein 1 or programmed death-ligand 1 blockade-resistant NSCLC.

Factors Associated With Image-Guided Radiation Therapy Image Rejection in a Multisite Institution.

PURPOSE: Nonclinical factors and cognitive biases have been shown to significantly affect clinical decision making. In this study, we aimed to identify clinical and environmental factors that might influence the decision to approve or reject image-guided radiation therapy (IGRT) images in a large multisite institution. METHODS: We identified all IGRT image approval and rejection decisions recorded within an electronic imaging system from July 1, 2016, to June 30, 2018. For each decision, we tabulated the following parameters: the attending physician of the patient, the physician reviewing the image, total images reviewed by the physician that day, time of day, day of week, treatment site, and imaging modality (kilovoltage or cone beam computed tomography [CBCT]). We created a binary multivariable logistic regression model to identify factors associated with IGRT image rejection. RESULTS: Overall, of 51,797 total image records evaluated, 881 (1.70%) were rejected and 50,916 (98.30%) were approved. Univariable analysis revealed that images reviewed by physicians with high rejection rates (odds ratio [OR], 3.16; P < .001) and by physicians reviewing fewer IGRT images (OR, 0.99; P = .024), images from various anatomic sites (particularly skin, breast, and head and neck), and CBCT imaging compared with kilovoltage imaging (OR, 1.49; P < .001) were associated with the increased rate of rejection. On multivariable analysis, images reviewed by physicians with high rejection rates (OR, 3.28; P < .001), images from specific anatomic sites including breast (P < .001), and CBCT imaging (P < .001) persisted as independent predictors of image rejection. CONCLUSION: These data provide important insight into the clinical, cognitive, and environmental factors that might influence the routine clinical decision of IGRT image approval. Recognition of these factors may not only improve the quality of individual decisions but also identify opportunities for systems-based quality improvement in IGRT.

The economic impact of circulating tumor-tissue modified HPV DNA for the post-treatment surveillance of HPV-driven oropharyngeal cancer: A simulation.

PURPOSE: Following treatment of HPV-driven oropharynx cancer, surveillance nasopharyngoscopy and imaging are often performed but are expensive and frequently ineffective. A novel plasma circulating tumor-tissue modified viral HPV DNA (TTMV-HPV-DNA) assay accurately detects recurrences. We modeled the cost of the new assay. METHODS: We designed and validated a partitioned survival model which replicated the results of the RTOG 1016 study and calculated cumulative surveillance costs from the payer's perspective. Two strategies were considered: a standard of routine endoscopy with imaging as needed and an alternative strategy which omitted scopes and imaging but obtained serial TTMV-HPV-DNA samples. No difference in effectiveness (QALY or LY) was assumed in the base case. A 5-year horizon was used, costs were reported in 2020 U.S. dollars discounted by 3%. Seven scenarios tested model assumptions and practice variation. Deterministic and probabilistic sensitivity analyses assessed parameter uncertainty. RESULTS: In the base case, at the list TTMV-HPV-DNA price, the cumulative cost of surveillance was $11,674 for the standard strategy and $20,756 for the TTMV-HPV-DNA strategy (+$9082 over 5 years). Probabilistic sensitivity analysis demonstrated the cost difference ranged from $4917-$12,047. The TTMV-HPV-DNA strategy was most likely to be either cost saving or cost-effective if future data demonstrate small improvements in quality or quantity of life (approximately 33 quality-adjusted life-days), if the assay reduces utilization of imaging, and if the periodicity of TTMV-HPV-DNA draws could be reduced from that on clinical trials. CONCLUSIONS: This data informs providers seeking to design more accurate, accessible, and economical post-treatment surveillance strategies.

PSA: Declining utilization of prostate brachytherapy.

PURPOSE: To analyze rates of brachytherapy use for prostate cancer over time and evaluate patient characteristics, demographics and factors predictive for its utilization. METHODS: Data was retrospectively analyzed from the National Cancer Database (NCDB) for patients with localized prostate cancer treated between 2010 and 2015. Patients were included if they had biopsy confirmed localized adenocarcinoma of the prostate, were treated with radiation as definitive local therapy, and were at least 18 years old. Utilization rates of external beam radiation (EBRT), brachytherapy (BT) and combination (EBRT + BT) were evaluated over time. Univariable (UVA) and backwards elimination multivariable (MVA) analysis were performed to determine characteristics predictive for brachytherapy use. RESULTS: We analyzed 178,837 patients with localized adenocarcinoma of the prostate treated between 2010 and 2015 with radiation therapy. During this period, the use of EBRT increased from 67% to 78%, BT (both monotherapy and combination with EBRT) decreased from 33% to 22%, BT monotherapy decreased from 25% to 16% and EBRT + BT decreased from 8% to 6%. Age >70, government funded insurance or lack of insurance, intermediate or high-risk disease and treatment at an academic center were associated with significantly lower utilization of brachytherapy (all p <0.001), while higher median zip code income was associated with increased use (p = 0.02). On multivariable analysis patients who were younger, had private insurance, were lower NCCN risk category and treated in non-academic cancer centers, had a higher rate of brachytherapy utilization. Notably, on both UVA and MVA brachytherapy practice decreased with increasing year of diagnosis (OR 0.881, 95% CI 0.853-0.910, p <0.001). CONCLUSION: Rates of brachytherapy utilization for the treatment of prostate cancer continue to decrease over time. Treatment at an academic center was associated with reduced likelihood of brachytherapy use. This has significant implications for the training of future radiation oncology residents/fellows and direct consequences for both our patients and healthcare expenditure.

Racial and Ethnic Disparities Among Participants in US-Based Phase 3 Randomized Cancer Clinical Trials.

Although improving representation of racial and ethnic groups in United States clinical trials has been a focus of federal initiatives for nearly 3 decades, the status of racial and ethnic minority enrollment on cancer trials is largely unknown. We used a broad collection of phase 3 cancer trials derived from ClinicalTrials.gov to evaluate racial and ethnic enrollment among US cancer trials. The difference in incidence by race and ethnicity was the median absolute difference between trial and corresponding Surveillance, Epidemiology, and End Results data. All statistical tests were 2-sided. Using a cohort of 168 eligible trials, median difference in incidence by race and ethnicity was +6.8% for Whites (interquartile range [IQR] = +1.8% to +10.1%; P < .001 by Wilcoxon signed-rank test comparing median difference in incidence by race and ethnicity to a value of 0), -2.6% for Blacks (IQR = -5.1% to +1.2%; P = .004), -4.7% for Hispanics (IQR = -7.5% to -0.3%; P < .001), and -4.7% for Asians (IQR = -5.7% to -3.3%; P < .001). These data demonstrate overrepresentation of Whites, with continued underrepresentation of racial and ethnic minority subgroups.

An in-silico quality assurance study of contouring target volumes in thoracic tumors within a cooperative group setting.

INTRODUCTION: Target delineation variability is a significant technical impediment in multi-institutional trials which employ intensity modulated radiotherapy (IMRT), as there is a real potential for clinically meaningful variances that can impact the outcomes in clinical trials. The goal of this study is to determine the variability of target delineation among participants from different institutions as part of Southwest Oncology Group (SWOG) Radiotherapy Committee's multi-institutional in-silico quality assurance study in patients with Pancoast tumors as a "dry run" for trial implementation. METHODS: CT simulation scans were acquired from four patients with Pancoast tumor. Two patients had simulation 4D-CT and FDG-FDG PET-CT while two patients had 3D-CT and FDG-FDG PET-CT. Seventeen SWOG-affiliated physicians independently delineated target volumes defined as gross primary and nodal tumor volumes (GTV_P & GTV_N), clinical target volume (CTV), and planning target volume (PTV).Six board-certified thoracic radiation oncologists were designated as the 'Experts' for this study. Their delineations were used to create a simultaneous truth and performance level estimation (STAPLE) contours using ADMIRE software (Elekta AB, Sweden 2017). Individual participants' contours were then compared with Experts' STAPLE contours. RESULTS: When compared to the Experts' STAPLE, GTV_P had the best agreement among all participants, while GTV_N showed the lowest agreement among all participants. There were no statistically significant differences in all studied parameters for all TVs for cases with 4D-CT versus cases with 3D-CT simulation scans. CONCLUSIONS: High degree of inter-observer variation was noted for all target volume except for GTV_P, unveiling potentials for protocol modification for subsequent clinically meaningful improvement in target definition. Various similarity indices exist that can be used to guide multi-institutional radiotherapy delineation QA credentialing.

Palliation or Prolongation? The Impact of a Peer-Review Intervention on Shortening Radiotherapy Schedules for Bone Metastases.

PURPOSE: Shorter fractionation radiation regimens for palliation of bone metastases result in lower financial and social costs for patients and their caregivers and have similar efficacy as longer fractionation schedules, although practice patterns in the United States show poor adoption. We investigated whether prospective peer review can increase use of shorter fractionation schedules. METHODS: In June 2016, our practice mandated peer review of total dose and fractionation for all patients receiving palliative treatment during our weekly chart rounds. We used descriptive statistics and Fisher's exact test to compare lengths of treatment of uncomplicated bone metastases before and after implementation of the peer review process. RESULTS: Between July 2015 and December 2016, a total of 242 palliative treatment courses were delivered, including 105 courses before the peer review intervention and 137 after the intervention. We observed greater adoption of shorter fractionation regimens after the intervention. The use of 8 Gy in one fraction increased from 2.8% to 13.9% of cases postadoption. Likewise, the use of 20 Gy in five fractions increased from 25.7% to 32.8%. The use of 30 Gy in 10 fractions decreased from 55.2% to 47.4% ( P = .002), and the use of ≥ 11 fractions decreased from 16.2% before the intervention to 5.8% after ( P = .006). CONCLUSION: Prospective peer review of palliative regimens for bone metastases can lead to greater adoption of shorter palliative fractionation schedules in daily practice, in accordance with national guidelines. This simple intervention may therefore benefit patients and their caregivers as well as provide value to the health care system.

Provider variability in intensity modulated radiation therapy utilization among Medicare beneficiaries in the United States.

BACKGROUND: In this study, we sought to examine the variation in intensity modulated radiation therapy (IMRT) use among radiation oncology providers. METHODS AND MATERIALS: The Medicare Physician and Other Supplier Public Use File was queried for radiation oncologists practicing during 2014. Healthcare Common Procedural Coding System code 77301 was designated as IMRT planning with metrics including number of total IMRT plans, rate of IMRT utilization, and number of IMRT plans per distinct beneficiary. RESULTS: Of 2759 radiation oncologists, the median number of total IMRT plans was 26 (mean, 33.4; standard deviation, 26.2; range, 11-321) with a median IMRT utilization rate of 36% (mean, 43%; standard deviation, 25%; range, 4% to 100%) and a median number of IMRT plans per beneficiary of 1.02 (mean, 1.07; range, 1.00-3.73). On multivariable analysis, increased IMRT utilization was associated with male sex, academic practice, technical fee billing, freestanding practice, practice in a county with 21 or more radiation oncologists, and practice in the southern United States (P < .05). The top 1% of users (28 providers) billed a mean 181 IMRT plans with an IMRT utilization rate of 66% and 1.52 IMRT plans per beneficiary. Of these 28 providers, 24 had billed technical fees, 25 practiced in freestanding clinics, and 20 practiced in the South. CONCLUSIONS: Technical fee billing, freestanding practice, male sex, and location in the South were associated with increased IMRT use. A small group of outliers shared several common demographic and practice-based characteristics.

Insurance Status and Racial Disparities in Cancer-Specific Mortality in the United States: A Population-Based Analysis.

Background: Cancer-specific mortality (CSM) is known to be higher among blacks and lower among Hispanics compared with whites. Private insurance confers CSM benefit, but few studies have examined the relationship between insurance status and racial disparities. We sought to determine differences in CSM between races within insurance subgroups.Methods: A population-based cohort of 577,716 patients age 18 to 64 years diagnosed with one of the 10 solid malignancies causing the greatest mortality over 2007 to 2012 were obtained from Surveillance, Epidemiology, and End Results. A Cox proportional hazards model for CSM was constructed to adjust for known prognostic factors, and interaction analysis between race and insurance was performed to generate stratum-specific HRs.Results: Blacks had similar CSM to whites among the uninsured [HR = 1.01; 95% confidence interval (CI), 0.96-1.05], but higher CSM among the Medicaid (HR = 1.04; 95% CI, 0.01-1.07) and non-Medicaid (HR = 1.14; 95% CI, 1.12-1.16) strata. Hispanics had lower CSM compared with whites among uninsured (HR = 0.80; 95% CI, 0.76-0.85) and Medicaid (HR = 0.88; 95% CI, 0.85-0.91) patients, but there was no difference among non-Medicaid patients (HR = 0.99; 95% CI, 0.97-1.01). Asians had lower CSM compared with whites among all insurance types: uninsured (HR = 0.80; 95% CI, 0.76-0.85), Medicaid (HR = 0.81; 95% CI, 0.77-0.85), and non-Medicaid (HR = 0.85; 95% CI, 0.83-0.87).Conclusions: The disparity between blacks and whites was largest, and the advantage of Hispanic race was absent within the non-Medicaid subgroup.Impact: These findings suggest that whites derive greater benefit from private insurance than blacks and Hispanics. Further research is necessary to determine why this differential exists and how disparities can be improved. Cancer Epidemiol Biomarkers Prev; 26(6); 869-75. ©2017 AACR.

Synchronous primary adenocarcinoma of the lung and pancreas: a case series and review of the literature.

AIM: The frequency of pancreatic cancer in association with cancer of other organs ranges from 1 to 20%, with the most common ones being gastric, colon, thyroid and genitourinary. The presence of synchronous lung and pancreatic cancers is extremely rare. CASE SERIES: Two patients with extensive smoking history and variable presentations were found to have simultaneous lung and pancreatic masses both lesions being different histologically and on immunohistochemical staining. After individualized treatment plans, the first patient remains free of disease and the second patient is being treated with a palliative intent. CONCLUSION: The early recognition and treatment is important as there exists a significant survival difference in patients who have synchronous primaries as opposed to those with metastatic pancreatic adenocarcinoma.

A brighter future? The impact of insurance and socioeconomic status on cancer outcomes in the USA: a review.

Uninsured and Medicaid-insured cancer patients have been shown to present with more advanced disease, less often receive cancer-directed therapy and suffer higher rates of mortality than those with private insurance. The Patient Protection and Affordable Care Act was signed into law in March of 2010 and seeks to increase rates of public and private health insurance. Although several provisions will in particular benefit those with chronic and high-cost medical conditions such as cancer, the extent to which disparities in cancer care will be eliminated is uncertain. Further legislative changes may be needed to ensure equal and adequate cancer care for all patients regardless of insurance or socioeconomic status.

Impact of Insurance Status on Radiation Treatment Modality Selection Among Potential Candidates for Prostate, Breast, or Gynecologic Brachytherapy.

PURPOSE: The Patient Protection and Affordable Care Act looks to expand both private and Medicaid insurance. To evaluate how these changes may affect the field of radiation oncology, we evaluated the association of insurance status with the use of brachytherapy in cancers for which this treatment technique is used. METHODS AND MATERIALS: A total of 190,467 patients met the inclusion criteria, of whom 95,292 (50.0%) had breast cancer, 61,096 (32.1%) had prostate cancer, 28,194 (14.8%) had endometrial cancer, and 5885 (3.1%) had cervical cancer. A multivariate logistic regression model was used to determine the association between insurance status and receipt of brachytherapy among patients treated definitively for prostate and cervical cancer or postoperatively for breast and endometrial cancer. RESULTS: The rates of non-Medicaid insurance were 49.9% (cervical), 85.3% (endometrial), 87.4% (breast), and 90.9% (prostate) (P<.001). In a logistic regression, patients who received radiation therapy were less likely to receive brachytherapy if they had Medicaid coverage (odds ratio [OR] 0.57, 95% confidence interval [CI] 0.53-0.61, P<.001) or did not have insurance coverage (OR 0.50, 95% CI 0.45-0.56, P<.001) compared with those with non-Medicaid insurance. On subset analysis, patients with Medicaid coverage or without insurance coverage were significantly less likely to receive brachytherapy than were those with non-Medicaid insurance for all 4 sites, except for patients with endometrial cancer. CONCLUSIONS: Despite being a cost-effective treatment modality, brachytherapy is less often used in the definitive or postoperative management of cancer in patients with Medicaid coverage or without insurance. Upcoming health policy changes resulting in the expansion of private insurance and Medicaid will likely increase access to and demand for brachytherapy.

Variation in insurance status by patient demographics and tumor site among nonelderly adult patients with cancer.

BACKGROUND: In the United States, an estimated 48 million individuals live without health insurance. The purpose of the current study was to explore the Variation in insurance status by patient demographics and tumor site among nonelderly adult patients with cancer. METHODS: A total of 688,794 patients aged 18 to 64 years who were diagnosed with one of the top 25 incident cancers (representing 95% of all cancer diagnoses) between 2007 and 2010 in the Surveillance, Epidemiology, and End Results (SEER) database were analyzed. Patient characteristics included age, race, sex, marital status, and rural or urban residence. County-level demographics included percent poverty level. Insurance status was defined as having non-Medicaid insurance, Medicaid coverage, or no insurance. RESULTS: On multivariate logistic regression analyses, younger age, male sex, nonwhite race, being unmarried, residence in counties with higher levels of poverty, and rural residence were associated with being uninsured versus having non-Medicaid insurance (all P <.001). The highest rates of non-Medicaid insurance were noted among patients with prostate cancer (92.3%), melanoma of the skin (92.5%), and thyroid cancer (89.5%), whereas the lowest rates of non-Medicaid insurance were observed among patients with cervical cancer (64.2%), liver cancer (67.9%), and stomach cancer (70.9%) (P <.001). Among uninsured individuals, the most prevalent cancers were lung cancer (14.9%), colorectal cancer (12.1%), and breast cancer (10.2%) (P <.001). Lung cancer caused the majority of cancer mortality in all insurance groups. CONCLUSIONS: Rates of insurance coverage vary greatly by demographics and by cancer type. The expansion of health insurance coverage would be expected to disproportionally benefit certain demographic populations and cancer types.

Factors associated with radiation therapy incidents in a large academic institution.

BACKGROUND: This study evaluated factors associated with radiation therapy (RT) planning and delivery incidents at a large academic institution. METHODS AND MATERIALS: The RT incidents (including near-misses) were recorded using an electronic incident reporting system from April 1, 2011 to April 30, 2013. Each incident's origin was categorized according to the step in the treatment process (simulation, physician prescription, treatment planning, scheduling, treatment delivery, and other) in which it occurred. The incident database was linked to the RT delivery (record and verify) database to evaluate the effect of various factors on the rate of RT incidents. RESULTS: There were 189 reported RT incidents (including near-misses) among 326,448 fractions, of which there were 70 (37%) treatment planning incidents and 56 (30%) treatment delivery incidents. The rates of total incidents, planning incidents, and delivery incidents were 136.0, 50.4, and 40.3 per 10,000 patients, respectively. Logistic multivariate analysis showed that fewer work days from plan approval to treatment start, fewer fractions, higher number of prescription items, and longer beam duration were significantly associated with radiation planning incidents. Multivariate analysis also showed that first day of treatment, fewer fractions, higher number of prescription items, and longer beam duration were significantly associated with treatment delivery incidents; intensity modulated radiation therapy was associated with a lower rate of treatment delivery incidents. CONCLUSIONS: More complicated radiation plans, fewer fractions, first day of treatment, and rushed processes were associated with higher risk of RT incidents. We hope that a national incident reporting database will lead to greater understanding of factors influencing the rate of RT incidents.