bluuebunny/crossref_metadata_2025 huggingface dataset:
Association of Medicaid expansion with timely receipt of treatment and survival among patients with HER2-enriched breast cancer.
Authors: Shi Kewei Sylvia , Ji Xu , Jiang Changchuan , Ruddy Kathryn Jean , Castellino Sharon M. , Yabroff Robin , Han Xuesong
Published: June 2023

6539

Background: HER2-enriched breast cancer (estrogen and progesterone receptors negative and HER2-positive) has no worse prognosis than other breast cancers if it is treated with HER2-targeted therapy. Medicaid expansion under the Affordable Care Act (ACA) has been shown to be associated with improved access to care and outcomes for many cancers, but its impact on care for HER2-enriched breast cancer is unknown. To fill this gap, we examined the association of Medicaid expansion with receipt of guideline-concordant treatment, time to treatment, and survival among newly diagnosed nonelderly women with HER2-enriched breast cancer. Methods: Women aged 18-62 years newly diagnosed with HER2-enriched breast cancer between 2010 and 2018 were identified from the National Cancer Database. Our primary outcomes included receipt of stage-based guideline-concordant treatment, initiation of treatment <60 days, and stage-specific 2-year overall survival. A difference-in-differences (DD) approach compared outcome changes following the expansion in Medicaid expansion vs. non-expansion states. A linear probability model estimated treatment outcome, and a flexible parametric survival model evaluated survival. All models were clustered at the state level and adjusted for age group, race/ethnicity, rurality of residence, zip code-level income, comorbidity, and diagnosis year. Results: A total of 31,354 patients with HER2-enriched breast cancer were included, including 19,255 in expansion states and 12,099 in non-expansion states. Compared to patients in expansion states, patients in non-expansion states were more likely to be racial/ethnic minorities, uninsured, and diagnosed at late-stage. Medicaid expansion was not significantly associated with changes in receipt of surgery for stage I-III disease but was associated with an increase of 4.42 percentage points (ppt, 95% CI: 0.09, 8.74) in receipt of chemotherapy/targeted therapy for stage IV disease, with an increase from 90.4% pre-expansion to 92.8% post-expansion in expansion states and a decrease from 93.7% to 91.9% in non-expansion states. Medicaid expansion was also significantly associated with a 2.41 ppt increase in initiating guideline-concordant treatment within 60 days (95% CI: 0.66, 4.17; 83.5% to 82.5% in expansion states vs. 86.6% to 83.7% in non-expansion states), and a 1.18 ppt increase in two-year survival rate (95% CI: 0.03, 2.33; 94.0% to 94.9% in expansion states vs. 94.3% to 94.1% in non-expansion states). The increase in two-year survival associated with Medicaid expansion was most prominent for stage III patients (DD=3.63 ppt; 95% CI: 0.64, 6.62). Conclusions: Medicaid expansion was associated with increased receipt of timely treatment and improved 2-year survival among nonelderly women newly diagnosed with HER2-enriched breast cancer.
Racial and ethnic disparities in employment of patients and caregivers following breast cancer diagnosis.
Authors: Weiss Marisa C. , Meske Sam , Giaddui Muath , Uscher Jennifer , Manasseh Donna-Marie , Danese Sherry , Ulloa Julie , Thom Bridgette , Chino Fumiko
Published: June 2023

6543

Background: Breast cancer (BC) can negatively impact employment, risking healthcare benefits, financial security and quality of life, especially for underserved minority populations. To better understand the impact of BC diagnosis and treatment on employment, Breastcancer.org conducted an online survey. Methods: Between 6/7-7/12/2022, Breastcancer.org community members were recruited to participate in an anonymous survey in English or Spanish via email, social media, or website ads. Eligible participants were US residents, age ≥18, and diagnosed with BC within the past 10 years. Consented participants answered questions on socio-demographics, financial toxicity, and employment status. Results: Of 2,420 screened, 1,710 met eligibility, and 1,437 participated (84% participation rate). Mean age and time since diagnosis was 46 and 2 years, respectively; 75% were in active treatment for non-metastatic (89%) or metastatic (11%) BC. Patients identified as 60% White (n=868), 26.7% Hispanic (n=384), 8% Black (n=121), or 4% Other (n=64). 94% were women. BC negatively impacted employment for 92% of patients. Full-time employment went from 62% at diagnosis to 40% by the time of the survey. This was more pronounced in metastatic (56% to 25%) vs non-metastatic (63% to 42%) patients (p=0.015). 64% attributed employment changes to their diagnosis, noting reduced hours/income (40%), job change (26%), disability (13%), permanent job loss (13%), and/or early retirement (12%). 36% noted changes in their caregiver’s employment status as well with 30% of caregivers having reduced hours/income, 30% taking time off work, and 27% changing jobs; 9% of caregivers had permanent job loss and 10% retired early. Hispanic patients were younger (p<0.001) and more likely to have young children (p<0.001) and take unpaid leave (p=0.02). (Table). BC diagnosis was also more likely to impact their caregiver’s employment (58%, vs White 25% or Black 41% patients, p<0.001). Conclusions: Breast cancer can cause significant, lasting negative effects on employment status for patients and caregivers that can decrease financial security of the entire family unit. Hispanic patients and individuals with metastatic disease appear to be at highest risk. Legislative protections and financial support may be required to mitigate the significant financial toxicity of a cancer diagnosis, especially for the most vulnerable. [Table: see text]
Racial disparities in cancer mortality in patients with gastrointestinal malignancies following Medicaid expansion.
Authors: Manisundaram Naveen , Snyder Rebecca A , Hu Chung-Yuan , DiBrito Sandra R. , Chang George J.
Published: June 2023

6546

Background: Racial minorities experience disparities in receipt of cancer treatment and survival. The optional Medicaid expansion provision of the Affordable Care Act provided federal funding to participating states to improve healthcare access for disadvantaged populations by expanding Medicaid eligibility criteria. This study aimed to investigate the effect of Medicaid expansion on racial disparities in mortality among patients with gastrointestinal malignancies. Methods: A cross-sectional cohort study of patients with pancreatic ductal adenocarcinoma (PDAC), colorectal cancer (CRC), and gastric adenocarcinoma (GC) of any stage was conducted using the National Cancer Database (2009-2019). Difference-in-difference analysis (DID) was performed to compare adjusted 2-year mortality separately among Black and White patients residing in Medicaid expansion states (MES) and non-expansion states (non-MES) before (2009-2013) and after (2014-2019) expansion. Differences in receipt of surgery and chemotherapy were also evaluated. Results: A total of 86,052 patients were included for analysis, including 19,188 patients with PDAC, 60,404 with CRC, and 6,460 with GC. Two-year mortality decreased among Black patients with PDAC residing in MES compared to non-MES following expansion (DID -9.4%, p<0.001) (Table). Mortality also decreased among Black and White patients with CRC in MES compared to non-MES following expansion (DID -4.2%, p < 0.001 and -2.9%, p = 0.047). Among patients with GC, Black patients in MES experienced a marked reduction in mortality compared to non-MES (DID -7.7%, p = 0.07). Both Black and White stage 3-4 PDAC patients had an increase in receipt of chemotherapy in MES following expansion (DID 3.7%, p=0.28 and DID 2.7%, p=0.20). Rates of surgery, but not chemotherapy receipt, increased among Black patients with stage 4 CRC in MES following expansion (DID 5.7%, p=0.03 and 1.0%, p=0.66, respectively). A greater increase in receipt of chemotherapy was observed among Black patients with stage 4 GC in MES than in non-MES (DID 11%, p=0.06). Conclusions: Medicaid expansion was associated with a greater reduction in 2-year mortality rates for Black patients residing in MES than for those in non-MES. Existing racial disparities in mortality remained the same or worsened in non-MES but in almost all cases were mitigated in MES following Medicaid expansion. [Table: see text]
Patient-level interventions to increase guideline concordant treatment among Black breast cancer patients: Can they close the racial gap in survival after diagnosis?
Authors: Yanguela Juan , Jackson Bradford E. , Reeder-Hayes Katherine Elizabeth , Kuo Tzy-Mey , LeBlanc Matthew Roger , Baggett Christopher D , Green Laura , Laurie Erin , Wheeler Stephanie B.
Published: June 2023

6549

Background: While we have seen impressive improvements in breast cancer (BC) survival over the last few decades, substantial racial disparities persist. Inequities in the receipt of guideline-concordant treatment contribute to worse survival in Black BC patients. Previous studies have shown that patient-level disparity reduction interventions (e.g., patient navigation) can significantly increase guideline-concordant treatment receipt among Black patients, with positive spillover effects in nonBlack patients. The aim of this study was to estimate the potential impact of disparity reduction interventions on racial inequities in survival after BC diagnosis in North Carolina. Methods: We used data from the Cancer Information and Population Health Resource, which links multipayer claims to North Carolina’s cancer registry for biological women diagnosed with BC in 2004-2017. We calculated Black/nonBlack disparities in the receipt of chemotherapy (CTx) within 4 months of diagnosis for patients ages <70 with hormone-receptor negative stage Ib-III BC (CTx cohort; N=2223) and the receipt of endocrine therapy (ET) within 12 months of diagnosis for stage I-III hormone receptor-positive BC (ET cohort=16220). We then simulated the potential increase in the proportion of patients receiving CTx and ET if proven patient-level disparity-reduction interventions were implemented across the state. Based on the literature, we assumed that the effects of these interventions in increasing treatment receipt would be same in the CTx and ET cohorts. We estimated the effect of this potential increase in CTx and ET receipt on 10-year overall survival using cohort-, race-, and treatment receipt-stratified Markov models. We report confidence bounds representing 95% of simulation results. Results: Over the 2004-2017 period, 72.9% and 70.8% of Black patients in our cohorts received CTx and ET, respectively. This was significantly lower than among nonBlack patients (p<.05). State-wide implementation of disparity reduction interventions could increase CTx and ET receipt among Black patients to 86.7% (80.9-92.5%) and 84.2% (78.5-89.9%), respectively. As a result, the racial 10-year survival gap would decrease from 9.4 to 8.1 (5.7-10.5) percentage points in the CTx cohort, and from 6.2 to 5.4 (4.0-6.7) percentage points in the ET cohort. Conclusions: Patient-level interventions can reduce disparities in guideline-concordant-treatment receipt. However, increases in treatment receipt alone would not be enough to close the racial survival gap, suggesting that, in isolation, patient-level interventions are unable to eliminate disparities. Action on the structural factors that disadvantage Black BC patients is needed. Our team is conducting community-engaged work to share and interpret these findings.
Disparities in clinical trial enrolment at a Canadian comprehensive cancer centre: A 15-year retrospective study.
Authors: Shapiro Gilla , Conti Rena M. , Santiago Anna , Pittman Tyler , Rodin Gary , Jones Jennifer M. , Cole Heather , Zeman Katherine , Sellmann Susanna , Rosenthal Meredith B. , Oza Amit M. , Rodin Danielle
Published: June 2023

6550

Background: Disparities in clinical trials limit the generalizability of study findings and perpetuate disparities in treatment access and outcomes, but there is a paucity of data in the Canadian context. The objective of this study was to examine disparities in cancer clinical trial enrollment at a large, comprehensive Canadian cancer center. Methods: We conducted a retrospective cohort study of clinical trial enrollment among all newly diagnosed cancer patients (N=154,880) at the Princess Margaret Cancer Centre in Toronto, Canada (2006-2021). Multivariable Bayesian hierarchical logistic regression with random effect for most responsible physician was used to examine the correlates of clinical trial enrollment, comparing the population of enrolled and non-enrolled patients. Odds ratios were adjusted for patient variables (sex, age at diagnosis, language, geography, primary care provider), and census tract-level marginalization (residential instability, material deprivation, dependency, ethnic concentration), disease variables (cancer site and disease stage at diagnosis), and provider variables (most responsible physician (MRP), and MRP’s sex, language, medical training, and department). Results: Overall, 11.2% of patients enrolled (n=17,400) in a clinical trial, with 5-, 10-, and 15-year cumulative incidences of 12%, 15%, and 18%, respectively. Small, but significant differences were observed between enrollees and the overall patient population. Lower odds of enrollment were observed in patients who were female (adjusted odds ratio [AOR], 0.82; 95% confidence interval [CI], 0.78-0.86; p<.001), ≥65 years (AOR vs <40, 0.61; 95% CI, 0.56-0.65; p<.001), non-English language speakers (AOR vs English, 0.72; 95% CI, 0.67-0.77; p<.001), lived ≥250 km away from the cancer center (AOR vs <15km, 0.71; 95% CI, 0.62-0.80; p<.001), or lived in areas with greater material deprivation (AOR, 0.94; 95% CI, 0.93-0.96; p<.001) or higher ethnic concentration (AOR, 0.96; 95% CI, 0.94-0.98; p<.001). Greater odds of enrollment were found in patients with metastatic disease (AOR, 1.19; 95% CI, 1.13-1.25; p<.001) and in those with a primary care provider (AOR, 1.69; 95% CI, 1.55-1.85; p<.001). Conclusions: Disparities were observed in clinical trial enrollment, despite a publicly funded health care system. While broader prospective data collection efforts are critical to better understand the influence of patient, provider and system factors on clinical trial enrollment, these findings suggest the need for targeted strategies to increase diversity in clinical trial access.
Racial disparity in dose intensity of early-stage breast cancer chemotherapy.
Authors: Rosenzweig Margaret Q. , Mazanec Susan R , Brufsky Adam , Gordon Brittaney-Belle Elizabeth
Published: June 2023

6556

Background: There are persistent, entrenched racial disparities noted in breast cancer outcomes. A basis for these disparities can be racial inequality for stage matched Black vs. White women in receiving early-stage breast cancer (ESBC) chemotherapy dose intensity of, at minimum, 85% or more of chemotherapy (historic gold standard) within prescribed timeframe. Our study measured dose reductions, early terminations, and overall dose intensity of ESBC chemotherapy in urban breast cancer centers and compared by race. Methods: Using a longitudinal, comparative descriptive design, treatment characteristics were measured in women receiving ESBC cancer chemotherapy in seven cancer centers in Western PA and Eastern Ohio. Dosing scheduled was calculated per patient chemotherapy prescription. Actual dose was measured as percentage of chemotherapy received / prescribed in “prescribed time,” meaning exact, ideal time to complete chemotherapy calculated from dose initiated without delay, dose reduction or early stoppage. The second measurement, “in any time,” measured chemotherapy completed over any course of time, incorporating delays and reductions. Results were dichotomized according to 85% of prescribed dose for both outcomes and compared by patient self-reported race (Black or White). Results: This study was conducted from August 2017 through June 2022. N=260 patients, race self-reported as 100 Black (38.5%) and 160 White (61.5%). Overall, n=36 (13.8%) had early termination of therapy. Early termination was more common for Black patients, 21%, vs 10% for White patients (p=.04). N=100 (38.3%) of all patients had some dose reduction, racially divided by 46.4% of Black patients vs. 34.3% of White patients, NS. By projected endpoint, Black patients received 77% (SD 24.1) of prescribed chemotherapy; White patients 86.7% (SD 16.6), p=.001. By “in any time” endpoint, Black patients received 86.5%, (SD 22.8) of prescribed therapy, White patients received 93.5% (SD 13.2), p=.002. By “in any time” measurement, 15% of White patients and 25% of Black patients did not receive the gold standard of 85% of prescribed chemotherapy. N= 7 of delays or terminations were due to disease progression, or poor response, and rarely, (n=4) to patient nonadherence. Largely, delays and early cessation were due to chemotherapy toxicity. Conclusions: Racial disparities in dose intensity and alterations of prescribed ESBC chemotherapy must be eliminated. Further examining the racial differences around dose delays and early chemotherapy termination, including racial barriers to patient- clinician communication around chemotherapy related toxicity, is essential to ensure equitable ESBC care and outcomes.
A quantitative synthesis of disparities in the inclusion of racial/ethnic minorities and older women in breast cancer trials.
Authors: Islam Mahnoor , Naqvi Syed Arsalan Ahmed , Bin Zafar Muhammad Daim , Ayaz Ahsan , Saleem Yusra , Khalid Atiqa , Wazir Muhammad Hisham Khan , Ijaz Hafsah , Giridhar Karthik , Yadav Siddhartha , Ernst Brenda , Riaz Irbaz Bin
Published: June 2023

6557

Background: Trials that inadequately include underrepresented minority (URM) populations widen inequities in cancer care. We assessed reporting patterns, representation, and trends of URM representation in breast cancer (BC) trials. Methods: We analyzed all phase 2/3 trials for age disparity and trials recruiting from the US for racial/ethnic disparity amongst BC RCTs (1990-2021). Enrollment-incidence ratios (EIR), which compare trial proportions (TP) from age subgroups against global estimates of incidence in the corresponding age group (from Global Burden of Disease) and racial/ethnic subgroups against US-population-based incidence in the corresponding racial/ethnic group (from SEER 22), were calculated. Individual-trial EIRs were pooled using random-effects meta-analyses. EIRs of <0.80 indicated meaningful underrepresentation, while EIRs >1.20 indicated meaningful overrepresentation. Meta-regression was used to explore associations between key trial characteristics and EIR, and trends in EIR over the last three decades. Results: Of 842 global trials with 490,657 participants, 232 (27.6%) reported the number of participants in specific age strata and 144 (17.1%) reported outcomes by age. Only 60 trials recruited exclusively from the US. Of these, 41 (68.3%) reported race and 24 (40.0%) reported ethnicity, and 2 (3.3%) analyzed outcomes by race. Older adults aged ≥65 years (TP: 24.3%; EIR: 0.53 [95% CI: 0.47-0.60]) and Hispanic women (TP: 5.3%; 0.54; 0.40-0.75) were underrepresented across global trials and US-only trials respectively. Black women were significantly underrepresented in trials that led to FDA approval (0.38; 0.25-0.58) but not in US-only trials. Stratified analysis by BC subtype (with subtype-specific population incidence) showed underrepresentation of Black women in US-only trials for HER2+ BC (0.66; 0.47-0.93), Hispanic women in ER+ BC (0.42; 0.20-0.90), Asians in triple-negative BC (0.24; 0.11-0.53), and older women in HER2+ BC (0.35; 0.31-0.40) and triple-negative BC (0.36; 0.29-0.45). From 1990-2021, the representation of older women declined significantly (meta-regression coefficient for EIR: -0.4 per 10 years), while Black and Hispanic representation showed no significant change. Black (p = 0.02) and Hispanic representation (p = 0.05) worsened significantly in larger trials. Conclusions: Published reports of BC trials do not consistently report the inclusion of URM. Older and Hispanic women were consistently underrepresented, whereas Black women were underrepresented in large, practice-changing trials. [Table: see text]
Disparities in intensity of care at the end-of-life for patients with gastrointestinal cancer.
Authors: Rodriguez Gladys M. , Kapphahn Kris , Patel Manali I.
Published: June 2023

6558

Background: Racial/ethnic minority patients experience disparities along the cancer continuum. Studies show that racial/ethnic minorities with cancer have higher rates of intensity of care at the end-of-life (EOL) compared to non-Hispanic Whites (NHW). Less is known whether disparities in intensity of care at EOL exist among racial/ethnic minority patients with a gastrointestinal (GI) cancer. Methods: Using the California Cancer Registry linked to hospital discharge data, we conducted a retrospective study of patients ≥18yrs with upper GI, pancreatic, or colorectal cancer who died from 2005-2018. We evaluated if race/ethnicity was associated with EOL intensity of care defined as hospital/ED visit or death, ICU, intubation, CPR & dialysis within 14-days of death. We used logistic regressions to calculate odds ratios adjusting for age, socioeconomic status (SES), insurance, geography, stage, comorbidities, and NCI-designated centers. Results: 189,837 patients with GI cancer died: 41,389 (21.8%) with upper GI, 46,554 (24.5%) with pancreatic & 101,894 (53.7%) with colorectal cancer. 118,995 (62.7%) were NHW, 14,146 (7.5%) Black, 33,802 (17.8%) Hispanic & 22,894 (12.1%) Asian/Pacific Islander (API). Median age was 74.6 yrs, 54.1% male, 85.9% lived in urban areas, 48.9% had Medicare, 16.1% had low SES & 35.7% had Stage 4. Black, Hispanic, and API patients compared to NHW had higher odds of intensity of care at EOL (Table). Conclusions: This study shows disparities in intensity of care at the EOL among racial/ethnic minorities with GI cancers. Solutions are urgently needed to reduce such disparities in care. [Table: see text]
Source of funding and enrollment disparity in cancer clinical trials.
Authors: Riaz Irbaz Bin , Ijaz Hafsah , Naqvi Syed Arsalan Ahmed , Islam Mahnoor , Kumar Gaurav , Mumtaz Aqsa , Khakwani Kaneez Zahra Rubab , Ayaz Ahsan , Tripathi Nikita , Singh Parminder , Kamran Sophia C. , Warner Jeremy Lyle , Bryce Alan Haruo
Published: June 2023

6559

Background: Recent findings that Black and Hispanic patients were significantly underrepresented in industry-sponsored prostate cancer trials warrant a detailed investigation across cancer types to assess the association between funding source and enrollment disparities. Methods: Phase II/III clinical trials in prostate, breast, colorectal, and lung cancers reporting age, gender, race/ethnicity, and reporting NIH or industry as the funding source were considered eligible for inclusion. For age, and gender analysis, all trials were considered eligible. For race/ethnicity analysis, trials recruiting from the United States (US) were considered eligible. Enrollment-incidence ratios (EIR) comparing trial proportion from age/gender or racial/ethnic subgroups against global cancer incidence in the corresponding group (from Global Burden of Disease) or US-population-based incidence in the corresponding racial/ethnic subgroup (from SEER 22), were computed. Trial-level EIRs were pooled using a random-effects model and subsequently stratified by funding source. A univariate meta-regression was conducted to assess the temporal changes in EIR by each funding category. Results: Of 42,390 studies initially identified, 2234 trials (1989-2021) met the eligibility criteria. Regarding age, 361 (16%) trials reported age categories by 65 years threshold. Of 698 trials recruiting from the US, 498 (71%) reported race, and 198 (28%) reported ethnicity. Regarding representation, older adults were under-represented (EIR: 0.66; 95% CI: 0.62-0.70) in the industry but not in NIH-sponsored clinical trials (0.79; 0.62-1.00). Regarding gender, no significant disparity was observed regarding the enrollment of men and women in colorectal and lung cancer clinical trials. In terms of race, there was a greater under-representation of Black patients in industry sponsored trials (0.29; 0.26-0.32) as compared to NIH-sponsored clinical trials (0.65; 0.57-0.74) [Pint <0.01]. Asian patients were significantly overrepresented in industry sponsored trials (3.17; 2.69-3.74) but not in NIH sponsored clinical trials (1.43; 0.85-2.41) [Pint <0.01]. Hispanic patients were significantly under-represented in both, industry (0.27; 0.22-0.34) and NIH-sponsored clinical trials (0.35; 0.22-0.55) [Pint 0.32]. Secondary analyses including trials recruiting exclusively from the US, and analyses by specific cancer types showed consistent results. Recruitment of older adults, men, and Black patients is decreasing over time. Conclusions: There is a consistent under-representation of older adults in industry-sponsored, and of Black and Hispanic patients in both industry-sponsored and NIH-sponsored clinical trials. The under-representation of Black patients is likely to be greater in industry-sponsored trials, which has worsened over the last three decades.
Survival analysis of patients treated at oncology practices with more aggressive end-of-life practice patterns.
Authors: Canavan Maureen , Wang Xiaoliang , Ascha Mustafa , Miksad Rebecca A. , Showalter Timothy N , Calip Gregory Sampang , Gross Cary Philip , Adelson Kerin B.
Published: June 2023

6562

Background: Despite national focus on measuring and reducing end-of-life (EOL) systemic treatment among cancer patients, recent studies show a consistently high use of systemic anticancer therapy (SACT) at the EOL, as well as a shift to more targeted therapies. A criticism of measures that focus on deceased populations is that they do not account for patients who received treatment at the same time in their disease trajectory and had a positive response to therapy. We sought to explore whether being treated at an oncologically aggressive (OA) practice (defined as higher practice-level EOL SACT treatment rates), was associated with a survival benefit among patients in six common cancer types. Methods: This survival analysis used the nationwide Flatiron Health electronic health record (EHR)-derived de-identified database. We included all adult patients with a confirmed diagnosis of metastatic disease in breast (mBC), colorectal (mCRC), renal cell carcinoma (mRCC) or pancreatic cancer (mPanc), or advanced disease in non-small cell lung (aNSCLC), or bladder cancer (aUC), between 2015 and 2019. The primary exposures were the practice-level risk-standardized 30-day EOL SACT rates calculated among decedents. The primary outcome was real-world overall survival (rwOS) among all patients. Adjusted hazard ratios (aHR) for each quintile of increasing OA EOL SACT rates (Q2-Q5) were estimated using disease-specific Cox proportional hazard models (reference: Q1), adjusting for patient and practice-level factors. Bonferroni correction was applied to account for multiple comparisons. Results: A total of 78,446 patients from 144 practices were included in the analysis with most patients seen at less OA practices (Q1-Q2). Patients seen at most OA practices (Q5) were less likely to be <65 (32.5% vs 38.9% in Q1), Black (6.3% vs 12.2%), have Medicare (5.9% vs 10.7%) or Medicaid (1.5% vs 4.1%). After adjusting for covariates, there was no statistically significant difference in rwOS between patients treated at the most (Q5) and the least OA practices (Q1; table). However, there was variation among the moderately OA practices. Patients with mPanc seen at moderately OA (Q2-Q4) had 12% to 19% lower hazards of deaths (aHR range 0.81-0.88), compared to those at the least OA practices (Q1), but these associations were not statistically significant (Bonferroni corrected p-values >0.05). Conclusions: When using rates of SACT at EOL to define OA practices, patients treated at these practices do not have improved survival. [Table: see text]
Use of direct oral anticoagulants (DOACs) in oncology: A phase IV study on impact of edoxaban treatment in Italian patients with cancer with venous thromboembolism during antineoplastic therapy (EDOI trial, GOIRC 05-2018).
Authors: Giovanardi Filippo , Di Maio Massimo , Gervasi Erika , Romagnani Alessandra , Damato Angela , Tiseo Marcello , Tamberi Stefano , Montesarchio Vincenzo , Grisanti Salvatore , Platania Marco , Catino Annamaria , Passalacqua Rodolfo , Bonetti Andrea Vincent , Vicario Giovanni , Finotto Silvia , Gelsomino Fabio , Pinto Carmine
Published: June 2023

6564

Background: The EDOI Study (EUDRACT 2018-003833-14) was designed to evaluate venous thromboembolism (VTE), a common complication of cancer and cancer therapy. VTE contributes to mortality and morbidity, and may interfere with therapy. When drafting the protocol, the standard treatment for VTE consisted of low-molecular weight heparin followed by vitamin K antagonists. DOACs are as effective as vitamin K antagonists in the treatment of VTE. Edoxaban has been confirmed to be effective and safe in the treatment of VTE. Adverse events (AEs) associated with DOACs can delay or interfere with chemotherapy; to date, data regarding the impact of Edoxaban treatment on cancer treatment AEs are scanty. Methods: In this multicentric, phase IV study, patients receiving an antineoplastic treatment (and candidates for at least 3 additional months of treatment) and diagnosed with VTE, received Edoxaban as per clinical practice. Patients received between 6 and 12 months of Edoxaban and were evaluated at baseline and after 1, 3 and 6 months. Primary endpoint was the impact of Edoxaban-related AEs on antineoplastic therapy, defined as delays/interruptions/reductions due to adverse drug reactions (ADR) related to Edoxaban (bleeding, hepatobiliary toxicity, renal toxicity, anemia, hypersensitivity reactions). As secondary endpoint, we assessed patient-reported outcomes (PROs) during treatment with Edoxaban (health-related quality of life: FACT-G, expectations and satisfaction with anticoagulant treatment: PACT-Q2 and ACTS). For each tool, mean scores at each time point were calculated. Results: One hundred and fifty patients were enrolled, 147 patients were evaluable. The Incidence density rate of antineoplastic therapy delay/interruption/reduction due to ADR related to Edoxaban was 0,8% per person-month (90% CI: [0,4; 1,5%] and 95% CI: [0,4; 1,6%]). For all the patient-reported outcomes, mean scores were maintained at different time points. Conclusions: The results of the study clearly show that the edoxaban treatment is well tolerated and has no relevant impact on the delivery of cancer treatments. Results in terms of quality of life and patients’ satisfaction with anticoagulant treatment are reassuring. Clinical trial information: EUDRACT 2018-003833-14 . [Table: see text]
The IMPACT of an interdisciplinary goals-of-care program on readmission rates at a comprehensive care center.
Authors: Leung Cerena , Andersen Clark R. , Wilson Kaycee , Nortje Nico , George Marina C. , Flowers Christopher , Bruera Eduardo , Hui David
Published: June 2023

6565

Background: Unplanned readmissions are associated with substantial distress for patients and their families. We hypothesized that goals-of-care (GOC) discussions, by improving goal-concordant care, may reduce unplanned readmissions. However, only a handful of studies have specifically examined this question. We assessed the implementation of a system-wide multicomponent interdisciplinary GOC (myGOC) program on the 30-day unplanned readmission rate and other hospital outcomes for medical patients at our comprehensive cancer center. Methods: In this retrospective cohort study, we compared the 30-day unplanned readmission rates in consecutive medical patients during the pre-implementation period from May 1, 2019 to December 31, 2019 and the post-implementation period from May 1, 2020 to December 31, 2020. The primary outcome was the 30-day unplanned readmission rate as defined by Vizient. Secondary outcomes included 7-day unplanned readmission rates, inpatient do-not-resuscitate (DNR) orders and supportive care consults. A multi-variate analysis model was used to examine the association between 30-day unplanned readmission rates and the implementation of the myGOC program adjusting for age, sex, race, index hospitalization type, and Sequential Organ Failure Assessment (SOFA) score. Results: This study included 7028 and 5982 unique medical patients during the pre- and post-implementation period, respectively. The 30-day unplanned readmission rates decreased from 13.7% before to 12.0% after implementation of the myGOC program. After adjusting for covariates, the myGOC implementation remained significantly associated with a reduction in 30-day unplanned readmission rates (OR [95% CI] 0.85 [0.77, 0.95], p=0.003). Other factors significantly associated with a decreased likelihood of a 30-day unplanned readmission were hematologic malignancies (vs. solid: 0.71 [0.64, 0.79]), White race (vs. Hispanic: 0.86 [0.75, 0.98]), an inpatient DNR order (0.30 [0.25, 0.37], an ICU admission (0.58 [0.48, 0.71], and an emergent admission (vs. elective: 0.86 [0.76, 0.99]). We also observed a significant decrease in 7-day unplanned readmission rates (0.75 [0.64, 0.89], p=0.0009), an increase in inpatient DNR orders (1.48 [1.35, 1.63], p<0.0001) and an increase in supportive care consults (1.22 [1.13, 1.31], p<0.0001) post-implementation. Conclusions: Implementation of a system-wide multicomponent GOC intervention was associated with a significant reduction in 30-day unplanned readmission rates after accounting for other key clinical factors.
Trends of using immune checkpoint inhibitors near end of life in limited resources setting: Experience of single cancer center in the MENA region.
Authors: Al-Rabi Kamal Hosni , Maakoseh Mohammad , Jaddoua Saad , Salah Samer , Alta'ani Omar , Yasin Abeer , Alrawshdeh Dalia , almasri Yosra , Shamiah Omar , Al-Ibraheem Akram , Abdel-Razeq Hikmat
Published: June 2023

6566

Background: Immune checkpoint inhibitors (ICIs) are standard of care nowadays in the treatment of many solid tumors as single agent or in combination. Recent literature suggested increased use of ICI near end of life; our aim was to find the characteristics of the patients who received ICI 30 days or less before their death. Methods: Data of patients with advanced solid tumors who have (ICI) therapy and died with disease were retrospectively retrieved. Patients were categorized into those dying within 30 days of the last dose of ICI and those receiving the last dose of ICI more than 30 days before death. Variables of potential interest were compared between the two groups by the Chi-square and independent sample t-tests as appropriate. Results: A total of 411 patients were included in this analysis; 135 (33%) received the last dose of ICI within 30 days of death and 276 (67%) received their last dose more than 30 days before death. Major cancer types included: lung (n=214; 52%), kidney (n=61; 15%), melanoma (n=44; 11%), head and neck (n=41; 10%), and others (n=14; 3%). Patients’ characteristics: median age = 58, majority were males (310; 75%), 105 (26%) had ECOG PS ≥3, and 147 (36%) had brain metastasis. Patients who received the last dose of ICI within 30 days of death had more frequent ICU admissions (50 (37%) vs. 60 (22%), p=0.001, and were less likely to die under the care of the hospice care service (22 patients (16%) vs. 84 (31%), p=0.001. In addition, patients who received the last dose of ICI within 30 days of death were more likely to have a full code status (89 (66%) vs. 147 (53%), p=0.015, and have received a lower number of doses of ICI treatments (mean number of doses: 4.2 vs. 6.5 doses, p=0.001). We did not observe any significant difference between the two groups regarding type of cancer, age, gender, ECOG PS, presence of brain metastasis, number of hospital admissions, dying inside hospital, and number of emergency room visits. Conclusions: Immune checkpoint inhibitors may be overused near end of life which leads to minimal clinical benefits, less likelihood of dying under hospice care, and utilization of ICU resources.
The effects of social determinants of health on colorectal cancer screening.
Authors: Franklin Isabelle , Gambatese Rebecca , Levin Theodore R. , Ngo-Metzger Quyen , Coronado Gloria D
Published: June 2023

6568

Background: Colorectal cancer is the 3rd leading cause of cancer death in the United States yet has consistently lagged in screening rates compared to other cancers. While patient-reported barriers have been previously described, few studies have analyzed how patients’ social needs affect screening rates. Methods: This cross-sectional study includes 3974 Kaiser Permanente (KP) patients ages 50-75 years who completed the 2020 KP National Social Needs Survey. Survey respondents were from the seven KP regions of Southern California, Northern California, Colorado, Washington, Northwest, Georgia, and Hawaii. Five Social Needs categories were assessed: Financial Strain, Housing Instability, Transportation Issues, Social Isolation, and Food Insecurity. Being up to date on CRC screening was determined from patients’ KP electronic health records, defined as meeting HEDIS criteria for screening. Multivariate analyses compared the level of social need to the respondents’ completion of colorectal screening between the years of 2019-2021, adjusting for age, sex, race/ethnicity, diagnostic category group (DxCG), neighborhood deprivation index (NDI), and insurance type. Results: Among the 3974 survey respondents, 92.2% were up to date on their colorectal cancer screening. Not being up to date on CRC screening was significantly associated with having any social need and having severe needs in four of the five social need domains adjusted for sociodemographic and health status (Table). Patients were less likely to be screened if they had severe financial strain (OR 0.54, 95% CI 0.40-0.73), severe social isolation (OR 0.52, 95%CI 0.38-0.71), severe transportation issues (OR 0.33, 95% CI 0.18-0.61), and severe food insecurity (OR 0.41, 95% CI 0.27-0.62). No significant association between screening status and the domain of severe housing instability were found (OR 0.74, 95% CI 0.52-1.06). Conclusions: Respondents with financial strain, social isolation, food insecurity, and transportation issues had lower odds of being up to date with colorectal cancer screening. Future efforts aimed to improve colorectal cancer screening rates should assess patients’ social needs and target ways to address these potential barriers to screening. [Table: see text]
Use of germline testing in patients with prostate, pancreatic, or ovarian cancer in Washington (WA) state.
Authors: Sun Qin , Shankaran Veena , Fedorenko Catherine R. , Kreizenbeck Karma L. , Ramsey Scott David
Published: June 2023

6572

Background: Germline genetic mutations are seen in approximately 10-15% of patients with prostate, pancreatic, and ovarian cancer. While universal germline testing is recommended for patients with these cancers to inform both familial risk and therapeutic approach, underutilization of germline testing has been reported. We investigated the rates of and factors associated with germline testing in a population-based sample of patients with prostate, pancreatic, and ovarian cancer in WA state. Methods: We linked Washington state cancer registry records from 2017-2019 with claims records for two large commercial insurers, Medicare, and Medicaid. Patients with prostate (metastatic, regional node-positive, or high-risk localized), pancreatic, and ovarian (including fallopian tube and peritoneum) cancer who were diagnosed in 2017-2019 were identified. Using claims from this database, we identified patients who received germline testing in the first two years of diagnosis. We excluded those who were not continuously enrolled in a health plan during the testing period of interest or died within 3 months of diagnosis. We used a multivariate logistic regression model to investigate factors associated with germline testing. Results: Among 2,077 patients, 429 (20.7%) received germline testing. Testing rates were 6.3% (53 of 842 patients) in prostate cancer, 15.4% (118 of 765 patients) in pancreas cancer, and to 54.9% (258 of 470 patients) in ovarian cancer; median time to testing for prostate, pancreas, and ovarian cancer was 162, 133, and 64 days respectively. Testing rates were higher in later years, in patients with more advanced stage cancers and lower in Asian patients and patients with more comorbid conditions. Conclusions: Despite guideline recommendations, germline testing rates are low among cancer patients in WA state, with the lowest rates in prostate cancer patients and in Asian and higher comorbidity populations. Underutilization of germline testing may not only adversely affect treatment, but also represents a missed opportunity for testing of high-risk families. Further studies should identify and address barriers to germline testing in high-risk populations. [Table: see text]
Reporting of patient reported outcomes in randomized clinical trials (RCTs) in non-small cell lung cancer (NSCLC) patients (pts).
Authors: Palmeri Laura , Derkach Sergii , Mazur-Janik Ewelina , Soman Arundhati , Ribeiro Alves Catarina , Shah Radhika , Vidal-Fisher Liat , Shahmarvand Nahid
Published: June 2023

6573

Background: A patient-centric approach to clinical trials has become necessary, with regulators emphasizing the importance of pts' experience. PRO is of utmost relevance for pts with cancers such as NSCLC, that are likely to be highly symptomatic and/or with an unfavorable prognosis. Methods: To evaluate the rate at which PRO included in clinical trials are made publicly available when trial results are published, we searched Citeline Trialtrove, a registry of clinical trials, for NSCLC phase 3 RCTs, recruiting during 2017-2022, with PRO listed - regardless of publication type. We excluded supportive care, radiotherapy, and unpublished trials. We identified publications associated with the trial, and extracted various parameters, including if PRO outcome was published. Results: Of 122 NSCLC RCTs identified, 66 listed at least 1 PRO. Trials were reported as full-text (43), abstract (9), 1 only in a trials registry; 13 not published. Fifty-three trials were included, all had PRO as a secondary endpoint. The sponsor was industry in the majority of the trials. Most included stage III/IV NSCLC pts, and 1st/2nd line or maintenance. 24 PRO tools were used, mainly EORTC QLQ LC13 (35 trials), EORTC QLQ C30 (34), EQ-5D-5L (14), LCSS (8), EQ-5D-3L (6). Seven trials listed 1 tool, 26 listed 2, 18 listed >3. PRO was reported in 36 (68%) of the published trials. In the subgroup of trials with disease control (DC) benefit and no overall survival (OS) benefit, PRO was reported in 15/21 (71%) trials. PRO benefit was shown in 9 of them. Of 43/53 trials published as full-text, 31 (72%) had PRO reported. A benefit in at least 1 PRO tool was reported in 21 studies, 9 did not show a PRO benefit; in 5 trials, only descriptive and no comparative analysis of PRO was reported. Of the 21 trials with PRO benefit, 19 had a DC benefit and 10 had also OS benefit. PRO was reported together with the first reporting of other outcomes in 18 (50%) trials, and after 7-32 months after the initial one in 18 trials. Conclusions: Of 122 RCTs only 66 had at least 1 planned PRO, and only 35 had it published. Even where full-text was available or no OS benefit shown, about 1/3 of the trials did not report PRO. Characteristics as disease stage, therapy line, sponsor, and primary endpoint did not differ between all included trials and those reporting PRO. The reporting rate increased compared to our previous report yet it is not satisfactory. The importance of quality of life and pts centric outcomes, and the great efforts needed from pts and operators to collect the data, should translate into routine, timely and appropriate reporting of PRO to allow a thorough assessment of treatment effect. [Table: see text]
Machine learning and postoperative complications: Determining risk before surgery in patients with cancer.
Authors: Hernandez Matthew C , Chen Chen , Carlin Cameron S , Seth Naini S. , Yuh Bertram , Eftekhari Zahra , Nguyen Andrew , Lai Lily L.
Published: June 2023

6575

Background: In patients with advanced cancer who need unplanned surgery, shared decision making is complex. Surgical risk assessment with high accuracy and in real time may help improve prediction of postoperative outcomes. We previously trained and tested an explainable machine learning model (MLM) to estimate postoperative Clavien-Dindo grade 3 or higher (CD 3+) complication risk in cancer inpatients undergoing unplanned surgery. In this prospective validation study, we report the performance of the MLM Surgical Risk Score (SRS) in the prediction of postoperative outcomes as well as determine association of the risk score with hospital length of stay and mortality. Methods: A MLM SRS for cancer inpatients requiring an unplanned, same-hospitalization major surgery was generated using real-time patient specific EHR data. The SRS was integrated into surgeon preoperative workflow. Postoperative outcomes including complications, length of hospital stay, and 30-day mortality were reported. The SRS was dichotomized as high or low based on prior validation threshold for postoperative CD3+ complication development. Model performance was assessed with area under receiver operating characteristic (AUROC) and area under precision-recall curves (AUPRC). Differences in outcomes between high and low-risk SRS groups were studied using Mann-Whitney U test and Fisher's exact test. Results: During the study period, 135 cancer inpatients were assessed by surgeons for 166 major unplanned operations. Of the 166 operations, 126 were completed and 40 were cancelled. The SRS was high in 81 (49%) and low in 85 (51%). The most common cancer diagnosis was colorectal (n=39, 28.8%). Operations performed with the highest frequencies were for enteral access (e.g.gastrostomy) followed by exploratory laparotomy and enterectomy. CD 3+ complications were identified in 31% of the completed operations (n=39/126) and included death (n = 10); abscess (n=4); postoperative hemorrhage (n=3); and anastomotic leak (n=2). The SRS predicted CD 3+ complications with a precision of47% and recall of 73%, resulting in an AUROC of 0.75 and AUPRC of 0.58. When comparing patients with high-risk to low-risk SRS, median overall LOS was 10 vs 7 days (p=0.013), median LOS after operation was 9 vs 6 days (p=0.003), 30-day mortality was 19.0% vs 5.3% (p=0.015), and 30-day postoperative mortality was 13.2% vs 3.3% (p=0.04). Conclusions: In this prospective study, preoperative SRS generated from a trained MLM on real-time EHR data demonstrated an excellent ability to predict individual risk of postoperative complications. In addition, patients with high SRS have longer postoperative LOS and increased mortality. By improving discrimination of risk of postoperative complications and informing on treatment outcomes, integration of the MLM SRS into the consenting process may enable better informed decision making in cancer inpatients.