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PURPOSE In an effort to promote cost-conscious, high-quality, and patient-centered care in the palliative radiation of painful bone metastases, the National Quality Forum (NQF) formed measure 1822 in 2012, which recommends the use of one of the four dose-fractionation schemes (30 Gy in 10 fractions, 24 Gy in 6 fractions, 20 Gy in 5 fractions, or 8 Gy in a single fraction). We investigated whether a custom electronic health record (EHR) alert system improved quality measure compliance among 88 physicians at a large academic center and institutional network. METHODS In March 2018, a multiphase alert system was embedded in a custom web-based EHR. Prior to a course of palliative bone radiation, the alert system notified the user of NQF 1822 recommendations and, once prescription was completed, either affirmed compliance or advised a change in treatment schedule. Rates of compliance were evaluated before and after implementation of alert system. RESULTS Of 2,399 treatment courses, 86.5% were compliant with NQF 1822 recommendations. There was no difference in rates of NQF 1822 compliance before or after implementation of the custom EHR alert (86.0% before March 2018 v 86.9% during and after March 2018, P = .551). CONCLUSION There was no change in rates of compliance following implementation of a custom EHR alert system designed to make treatment recommendations based on national quality measure guidelines. To be of most benefit, future palliative bone metastasis decision aids should leverage peer review, target a clear practice deficiency, center upon high-quality practice guidelines, and allow flexibility to reflect the diversity of clinical scenarios.

PURPOSE: Patients with cancer frequently encounter financial hardship, yet systematic strategies to identify at-risk patients are not established in care delivery. We assessed sensitivity of distress-based screening to identify patients with cancer-related financial hardship and associated care delivery outcomes. METHODS: A survey of 225 patients at a large cancer center assessed cancer-related financial hardship (0-10 Likert scale; highest quintile scores ≥ 5 defined severe hardship). Responses were linked to electronic medical records identifying patients’ distress screening scores 6 months presurvey (0-10 scale) and outcomes of missed cancer care visits and bad debt charges (unrecovered patient charges) within 6 months postsurvey. A positive screen for distress was defined as score ≥ 4. We analyzed screening test characteristics for identifying severe financial hardship within 6 months and associations between financial hardship and outcomes using logistic models. RESULTS: Although patients with positive distress screens were more likely to report financial hardship (odds ratio [OR], 1.21; 1.08-1.37; P < .001), a positive distress screen was only 48% sensitive and 70% specific for identifying severe financial hardship. Patients with worse financial hardship scores were more likely to miss oncology care visits within 6 months (for every additional point in financial hardship score from 0 to 10, OR, 1.28; 1.12-1.47; P < .001). Of patients with severe hardship, 72% missed oncology visits versus 35% without severe hardship ( P = .006). Patients with worse hardship were more likely to incur any bad debt charges within 6 months (OR, 1.32; 1.13-1.54; P < .001). CONCLUSION: Systematic financial hardship screening is needed to help mitigate adverse care delivery outcomes. Existing distress-based screening lacks sensitivity.

Background: The incidence and etiology of liver cancer varies widely across geographical regions. Etiological factors involved in hepatocarcinogenesis, which vary according to geographical location seem to play an important role in therapeutic efficacy. According to the International Agency for Research on Cancer 2020 report, the combined percentage of total hepatocellular carcinoma (HCC) and biliary tract carcinoma (BTC) cases in the world was 72.3% from Asia, 9.9% from the Americas, 9.8% from Europe, 7.4% from Africa, and 0.5% from Oceania. We describe the regional accrual of multinational phase III liver cancer clinical trials in the last ten years. Methods: We performed a database search in PubMed, Embase, and Web of Science: Core Collection for multinational phase III clinical trials of HCC or BTC, studying first and second line treatments published in the last 10 years (08/2012 - 08/2022). Trials meeting these criteria were identified and the percentage of regional distribution was calculated. Results: 17 multinational phase III clinical trials studying treatments for HCC and BTC were identified; 16 reported regional patient characteristics. The trials enrolled a total of 10,834 patients, of which 48.6% were from Asia, 17.1% from Europe, 8.5% from the Americas, 0.7% from Oceania, and 0.1% from Africa. The remaining patients were missing regional data. Conclusions: In phase III multinational liver cancer studies seeking FDA approval does not include patients from all geographical regions. Table 1: Regional characteristics of multinational phase III clinical trials of Liver Cancer Trial name, identifier Treatment Total patients Europe Africa South America North America Asia Oceania Other/Multiple BRISK-FLNCT00858871 Brivanib, Sorafenib 1155 269 7 152* 718 9 - BRISK-PSNCT00825955 Brivanib 395 166 - 67* 162 - - NCT00699374 Sunitinib, Sorafenib 1074 - - - - 812 - 262 SEARCHNCT0901901 Sorafenib, Erlotinib 720 369 - 173* 178 - - REACHNCT01140347 Ramucirumab 565 248 - 65* 252 - - NCT01009593 Linifanib, Sorafenib 1035 - - - - 689 - 346 RESORCENCT01774344 Regorafenib 573 - - - - 216 - 357 NCT01761266 Lenvatinib, Sorafenib 954 - - - - 640 - 314 CELESTIALNCT01908426 Cabozantinib 707 339 - - 167 175 26 - REACH-2NCT02435433 Ramucirumab 292 - - - - 141 - 151 ClarIDHyNCT02989857 Ivosidenib 185 49 - - 124 12 - - IMbrave150NCT03434379 Atezolizumab, Bevacizumab, Sorafenib 501 - - - - - - 501 KEYNOTE-240NCT02702401 Pembrolizumab 413 139 - - 37 157 - 80 TOPAZ-1NCT03875235 Durvalumab, Gemcitabine, Cisplatin - - - - 374 - 311 - CheckMate459NCT02576509 Nivolumab, Sorafenib - - - - 295 - 448 - COSMIC-312NCT03755791 Cabozantinib, Atezolizumab, Sorafenib 276 - 77 57 241 44 142 - *Includes both North and South America Citation Format: J. Alberto Maldonado, Katherine A. McGlynn, Tim F. Greten, Cecilia Monge. Disparities in multinational phase III liver cancer clinical trials by regions of the world [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2023; Part 1 (Regular and Invited Abstracts); 2023 Apr 14-19; Orlando, FL. Philadelphia (PA): AACR; Cancer Res 2023;83(7_Suppl):Abstract nr 1943.

Background: Accurate representation of ethnic/racial population subgroups in clinical trials is fundamental to ensure universal effectiveness of new therapies as well as to decrease disparities in oncology care. In 2020, Hispanic (Hisp) and Non-Hispanic Black (NHB) people constituted 19% and 14% of the U.S. population, respectively. As of 2019, Hisp and NHB proportionally made up 23.2% and 11.1% of hepatocellular carcinoma cases, respectively, and 22.6% and 8.3% of biliary tract cancer cases. We analyzed the enrollment of racial/ethnic groups of liver cancer trials in the U.S in the last twenty years. Methods: A database search was performed in clinicaltrials.gov for interventional liver cancer studies based only in the U.S. with reported results from 09/2002-08/2022. A total of 3492 trials were identified; studies were excluded if non-interventional (N=168), recruited in a foreign site (N= 2422), results were missing (N=713), or were not liver specific (N=63), resulting in a total of 126 studies. We sought to quantify the enrollment of racial/ethnic subgroups. Results: From a total of 126 studies, enrolling 5197 patients, 53.2% reported race/ethnicity; amongst these, 57.1% of patients were Non-Hispanic White, 14.5% were NHB, 9.9% were Hisp, 8.5% Asian, 0.4% American Indian and 0.2% Native Hawaiian/Pacific Islander. NIH-funded studies had higher rates of race/ethnicity reporting without reaching statistical significance (65.1% vs 47.0%, p= 0.053). The rate of race/ethnicity reporting between clinical trial phases (I- IV) was not statistically significant (p= 0.70). Conclusions: 47% of U.S. liver cancer studies in the last twenty years in clinicaltrials.gov did not report race/ethnicity. The relative representation of NHB and Hispanics in these trials is lower than the incidence reported in the U.S. Race/ethnicity reporting in U.S.-based clinical trials may be beneficial. Table 1: Demographics of U.S-only Clinical Trials of Liver Cancer By Funding By Trial Phase All NIH Non-NIH P- value Phase I or II P- value P- value Trials 126 43 83 - 105 - - Participants 5306 1557 3749 - 3325 - - Race and ethnicity reported 53.2% 65.1% 47.0% 0.053 57.1% 0.70 0.70 Race and Ethnicity NHW* 57.1% 57.7% 56.7% 0.86 60.2% NA NA NHB* 14.5% 11.2% 16.8% 0.07 15.1% NA NA Hisp* 9.9% 13.4% 7.4% 0.30 7.1% NA NA Asian 8.5% 9.9% 7.5% 0.57 7.9% NA NA AI* 0.4% 0.2% 0.5% 0.17 0.4% NA NA NH/PI* 0.2% 0.2% 0.2% 0.76 0.2% NA NA *NHW= Non-Hispanic White, NHB= Non-Hispanic Black, Hisp= Hispanic, AI= American Indian, NH/PI= Native Hawaiian/Pacific Islander Citation Format: J. Alberto Maldonado, Barry I. Graubard, Katherine A. McGlynn, Tim F. Greten, Cecilia Monge. Racial and ethnic disparities in U.S. clinical trials in liver cancer in the last nineteen years [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2023; Part 1 (Regular and Invited Abstracts); 2023 Apr 14-19; Orlando, FL. Philadelphia (PA): AACR; Cancer Res 2023;83(7_Suppl):Abstract nr 1944.

Patients with prostate cancer presenting with advanced T stage, mainly T4, might have a unique pattern of nodal failure and disease involvement that is not typically covered when local therapy is offered. We attempted to identify common sites of nodal disease presentation and failure for patients presenting with cT4 prostate cancer.All patients with treatment-naïve cT4 prostate cancer were retrospectively identified. All patients were required to have a confirmed diagnosis reviewed by our genitourinary pathologist and completed baseline staging. Lymph node (LN) involvement and location at diagnosis were reviewed by a genitourinary radiologist. All patients' follow-up scans were also reviewed; based on LN size, imaging characteristics, and progression/regression characteristics on systemic therapy, the locations of sites of LN failure were recorded. For patients who underwent surgery, any pathologically involved LNs and their anatomic locations were recorded. A total of 103 patients met these criteria, with a median follow-up of 8 years (range, 0.5-14 years).Rectal involvement by the primary disease was associated with a higher risk of perirectal and mesorectal LN involvement (45%) relative to no rectal involvement (26%) (P.05). These echelons are typically not covered with conventional pelvic external beam radiation therapy and are not routinely part of pelvic LN dissection in patients treated surgically. Conversely, bladder or pelvic side wall invasion did not correlate with increased frequency of involvement of perirectal/mesorectal LNs (P.05).When offering local therapy, target modification to include the perirectal and mesorectal LNs should be considered for patients presenting with T4 prostate cancer with rectal involvement.

BACKGROUND: Inferior vena cava tumor thrombus (IVC-TT) is a rare yet deadly sequel of renal cell carcinoma (RCC) with limited treatment options. The standard treatment is extirpative surgery, which has high rates of morbidity and mortality. As a result, many patients are unfit or unwilling to undergo surgery and face poor prognosis. This stresses the need for alternative options for local disease control. Our study aims to assess the feasibility and oncological outcomes of stereotactic ablative radiation (SAbR) for IVC-TT. METHODS: A retrospective study reviewing six leading international institutions’ experience in treating RCC with IVC-TT with SAbR. Primary end point was overall survival using Kaplan-Meier. RESULTS: Fifteen patients were included in the cohort. Over 50% of patients had high level IVC-TT (level III or IV), 66.7% had metastatic disease. Most eschewed surgery due to high surgical risk (7/15) or recurrent thrombus (3/15). All patients received SAbR to the IVC-TT with a median biologically equivalent dose (BED(10)) of 72 Gy (range: 37.5–100.8) delivered in a median of 5 fractions (range 1–5). Median overall survival was 34 months. Radiographic response was observed in 58% of patients. Symptom palliation was recorded in all patients receiving SAbR for this indication. Only grade 1–2 adverse events were noted. CONCLUSIONS: SAbR for IVC-TT appears feasible and safe. In patients who are not candidates for surgery, SAbR may palliate symptoms and improve outcomes. SAbR may be considered as part of a multimodal treatment approach for patients with RCC IVC-TT.

Background:. “Time burden” (time required during treatment) is relevant when choosing a local therapy option for early-stage breast cancer but has not been rigorously studied. We compared the time burden for three common local therapies for breast cancer: (1) lumpectomy plus whole-breast irradiation (Lump+WBI), (2) mastectomy without radiation or reconstruction (Mast alone), and (3) mastectomy without radiation but with reconstruction (Mast+Recon). Methods:. Using the MarketScan database, we identified 35,406 breast cancer patients treated from 2000 to 2011 with these local therapies. We quantified the total time burden as the sum of inpatient days (inpatient-days), outpatient days excluding radiation fractions (outpatient-days), and radiation fractions (radiation-days) in the first two years postdiagnosis. Multivariable regression evaluated the effect of local therapy on inpatient-days and outpatient-days adjusted for patient and treatment covariates. Results:. Adjusted mean number of inpatient-days was 1.0 for Lump+WBI, 2.0 for Mast alone, and 3.1 for Mast+Recon (P < 0.001). Adjusted mean number of outpatient-days was 42.9 for Lump+WBI, 42.2 for Mast alone, and 45.8 for Mast+Recon (P < 0.001). The mean number of radiation-days for Lump+WBI was 32.4. Compared with Mast+Recon (48.9 days), total adjusted time burden was 4.7 days shorter for Mast alone (44.2 days) and 27.4 days longer for Lump+WBI (76.3 days). However, use of a 15 fraction WBI regimen would reduce the time burden differential between Lump+WBI and Mast+Recon to just 10.0 days. Conclusions:. Although Mast+Recon confers the highest inpatient and outpatient time burden, Lump+WBI carries the highest total time burden. Increased use of hypofractionation will reduce the total time burden for Lump+WBI.

Clinical Decision Support Systems (CDSS) help to improve health care and reduce costs. However, the lack of knowledge management and modelling hampers their maintenance and reuse. Current EHR standards and terminologies can allow the semantic representation of the data and knowledge of CDSS systems boosting their interoperability, reuse and maintenance. This paper presents the modelling process of respiratory conditions' symptoms and signs by a multidisciplinary team of clinicians and information architects with the help of openEHR, SNOMED and clinical information modelling tools for a CDSS. The information model of the CDSS was defined by means of an archetype and the knowledge model was implemented by means of an SNOMED-CT based ontology.