bluuebunny/crossref_metadata_2025 huggingface dataset:
Tolerability of capecitabine in difference racial/ethnic groups.
Authors: Dower Joshua , Salei Yana , Dumas Brett , Schlam Ilana
Published: June 2023

e18833

Background: Capecitabine (cap) is an oral chemotherapy agent used for treatment of solid malignancies. The recommended dose of cap generally ranges from 1000mg/m2 to 1250mg/m2 twice daily, but many patients require a dose reduction during treatment due to AE. It is unclear whether patients of different race have better tolerability of cap than others. In Asian populations for example, potential differences in tolerance have been attributed to low dietary folate intake. Race is a social construct; however it has been used to identify groups of patients within a population. We aimed to understand the tolerability of cap among patients of different racial/ethnic groups. Methods: In this retrospective chart review, we studied patients treated with cap at Tufts Medicine (three centers in MA, USA) between 2017-2021. Patients treated with cap alone, concurrent with other chemo, or concurrent with radiation for solid tumors were included. Patients were excluded if race/ethnicity data was not available. We collected demographic information, cap dose, AE, and dose reductions during the treatment period. Dose intensity (DI) was calculated (Total administered cap dose during treatment period (mg)/Recommended cap dose (mg/m2) * BSA (m2)). ANOVA was used to determine difference between groups. Results: 202 patients were included: 134 (66.3%) White, 35 (17.3%) Asian, 22 (10.9%) African American/Black, and 11 (5.4%) other race. 10 (5%) identified as Hispanic ethnicity. Most common cancer types treated were 46 (22.8%) breast, 44 (21.8%) colon, and 39 (19.3%) rectal. Average DI by race/ethnicity is outlined in Table 1. There was no statistically significant difference in DI among patients of different racial groups (p = 0.232). AEs leading to dose reduction or cap discontinuation occurred in 93 (46%) of patients, the most common outlined in Table 1. Conclusions: We found no significant difference in cap DI or toxicity among patients of different racial groups. The study is limited by the small sample size and that it is retrospective. The patients presented are racially diverse but live in one geographic area, which could impact environmental factors such as dietary folate intake. Our findings suggest that there is no difference in tolerated DI among all patients. Clinicians should not empirically reduce the dose of cap based on race and should assess tolerance on an individual basis. [Table: see text]
Is aggregate use of published case reports as a viable option for augmenting pharmacovigilance? An applied example of pembrolizumab-related adverse events in patients with non-small cell lung cancer receiving first-line treatment.
Authors: Khabbaha Suad , Dempsey Sarah Carder , Anema Aranka , Singh Sonal , Thorlund Kristian
Published: June 2023

e18840

Background: Pharmacovigilance suffers from considerable underreporting, and causality is rarely confirmed. We aim to examine the validity of the aggregate use of published case reports as a viable option for augmenting pharmacovigilance. We explore the setting of first line pembrolizumab treatment for non-small cell lung cancer as safety signals in this cohort are relatively well documented and because drug-related adverse events are more easily confirmed with no previous drug treatments. Methods: We compared immune-related adverse event rates (Any and Severe) associated with pembrolizumab from three select first non-small lung cancer KEYNOTE clinical trials (024, 042, and 189) to clinician confirmed pembrolizumab-related adverse event rates from a synthetic cohort case report data from a matching population. The latter were retrieved from the OpenCaseTM database and included 126 non-small cell lung cancer patients, of which 110 had received pembrolizumab monotherapy and 16 pembrolizumab in combination with a platinum-based chemotherapy regimen. Baseline characteristics with respect to age, sex, smoking history, non-drug treatment history, PD-L1 tumor proportion score, and key genetic markers (e.g. EGFR, ALK) were acceptably similar (results will be presented in a table). Results: In the synthetic cohort of case reports, Immune-related adverse events, which were clinician confirmed to be related to pembrolizumab, occurred in 86/126 (68.2%). Life threatening and severe treatment-related AEs were 7.4% and 65% respectively. These were substantially higher than reported in clinical trials 8.0%-9.7% experienced severe immune-related events. The majority of the most frequently occurring immune-related AEs in the KEYNOTE trials had similar reported proportions to the case reports. For example, hypothyroidism (any grade) ranged from 6.7% to 9.1% in the KEYNOTE trials compared to 4.9% among the case reports, and pneumonitis (any grade) ranged from 4.4% to 12.0% in the trials compared to 5.5% in the case reports. Other events such as myositis, type 1 diabetes, liver dysfunction, kidney injury, and colitis were frequent in the cohort of case reports (3.1%-7.9%), but rare or unreported in all KEYNOTE trials (0.0%-2.2%). Conclusions: Overall, adverse event rates in the synthetic cohort of case reports were either similar or higher than observed in clinical trials of matching populations. This observation provides rationale for utilizing case reports in pharmacovigilance practice, specifically for rarer events.
Impact of the COVID pandemic on reporting of breast cancer cases and mortality.
Authors: Khorfan Rhami , Namm Jukes P. , Vora Halley P , Solomon Naveenraj Livingstone , Lum Sharon S.
Published: June 2023

e18842

Background: The National Cancer Database (NCDB) introduced COVID-specific variables in 2020 to assess the impact of the pandemic on cancer care. Variables include (1) any SARS-CoV-2 test and (2) SARS-CoV-2 test result. We evaluated patterns of breast cancer reporting and mortality compared to pre-pandemic. Methods: From the 2020 NCDB breast cancer participant user file, we separately examined reporting and mortality in the years 2017-2020. Pre-pandemic years (2017-2019) were used as a baseline to evaluate secular trends not related to the pandemic. For patients diagnosed in the study period, patient/hospital factors associated with complete reporting (CR) or no reporting (NR) of COVID variables were compared. For patients who died during the study period, yearly mortality rate and overall survival (OS) were examined overall and by stage. Patient/hospital factors were examined for associations with year of death. Results: Fewer breast cancer cases were reported in 2020 (232,023) compared to 2019 (268,210) and 2018 (260,259). In 2020, there were 97,810 (42%) with NR and 116,455 (50%) with CR of COVID variables. On multivariable analysis, patients with NR were more likely to be > 70 years old, of Asian race, with Medicare coverage, lower education quartile, and treated at community hospitals and those in the Middle Atlantic region. There were 60,933 deaths in 2020, 64,502 in 2019, 63,865 in 2018, and 61,930 in 2017. There were significantly fewer stage 4 deaths in 2020 compared to prior (Table). Although there was a steady trend of increasing OS across the 4-year period, the incremental increase from 2019 to 2020 was higher than expected based on previous years. This finding was particularly true for stage 4 patients (median OS: 31.4 months in 2020, 20.2 months in 2019). On multivariable analysis, 2020 mortalities were less likely in patients > 80 years old (OR 0.88, p < .01) or with stage 3 (0.81, p < .01) or stage 4 (0.64, p < .01) disease, and more likely at academic centers (1.05, p < .01) than in 2017-2019. Conclusions: Non-reporting of COVID data is not at random, and is more common in populations at risk. In addition, fewer breast cancer mortalities were reported in 2020, with higher than expected OS. These findings suggest that OS was artificially increased in 2020 due to underreporting of patients who may be at higher risk of mortality. Accurate and complete data is crucial for evaluating the pandemic's impact on patient care. Underreporting of patients who may be most vulnerable limits our ability to comment on the true impact of the pandemic. These limitations must be considered to avoid blind spots in evaluation of pandemic data and risk deepening disparities. [Table: see text]
Clinical characterization of patients with recurrent glioblastoma in trials involving CED and non-CED treatment.
Authors: Ensign Lisa G. , Boisvert Denis , LaFrance Norman David , Hendershot Jacob , Michalek Joel , Brenner Andrew J. , Davi Ruthanna
Published: June 2023

e18845

Background: Glioblastoma (GBM) is the most common and aggressive of the primary malignant brain tumors in adults. Bevacizumab (beva) remains the only currently approved therapeutic for recurrent GBM (rGBM) patients who progress on prior therapy. Despite advances in care, rGBM has a median expected progression-free survival (PFS) of < 4 months and overall survival (OS) of ~8 months. NCCN guidelines [Version 2.2022], and other oncology medical societies unanimously recommend patients seek treatment by entering a clinical trial. Since the late 1990’s a number of studies have explored the use of convection-enhanced delivery (CED) of drugs, a well-accepted and widely published delivery option for the treatment of rGBM. This analysis compares the demographics, medical history and survival outcome of patients enrolled into recently completed clinical trials with beva monotherapy to those entered into CED studies. Methods: Data for this analysis was sourced from the Medidata Enterprise Data Store (MEDS), comprised of over 28,000 historical clinical trials for de-identified aggregate patient-level analyses and from the study and patient-level data in the CED studies referenced in D’Amico [J Neurooncol 2021]. Aggregate summary statistics comparing beva and CED patients were based on combined study- and patient-level data using weighted (by sample size) means, incidence and overall survival (OS) rates and median of medians. Results: 163 rGBM beva patients were identified from MEDS. The CED cohort included 636 patients from MEDS and studies referenced in D’Amico. Cohort comparisons (beva vs CED) found median age: 56 vs 55 years; Caucasian race: 91% vs 93%; male sex: 68% vs 65%; not Hispanic or Latino ethnicity: 90% vs 94%; median OS: 7.9 vs 8.4 months. Over the last 2 decades there was a 23% increase in patients with ECOG Performance Status = 0 and 25% decrease in tumor area size at study enrollment, whereas there was no clear temporal OS trend. Conclusions: Patient demographics and most tumor attribute variables were similarly distributed between the beva and CED cohorts. While there is some indication that recent CED studies have enrolled healthier patients with smaller tumors; as expected, this does not appear to have translated to a consistent survival benefit.
Association of cannabis use with real-world time to treatment discontinuation (rwTTD) in patients with advanced cancer initiating immune checkpoint inhibition (ICI).
Authors: Zylla Dylan M. , Knowlton Greg , Gilmore Grace , Pawloski Pamala A. , Salz Talya , Kulkarni Amit , Cowger Jordan , Kuranz Seth
Published: June 2023

e18846

Background: Studies suggest that the immunomodulatory effect of cannabis may impair responsiveness to ICI in cancer patients. These studies were limited by small sample size in a heterogeneous group. Determining the impact of cannabis on cancer control in patients receiving ICI is critical to informing patients and clinicians. We assessed the relationship of cannabis with cancer treatment outcomes using a large national healthcare claims database linked to retail cannabis purchase data. Methods: Using the Forian Inc database from 2017-2022, we identified adults (age > 18 years) with advanced cancer who had ≥ 90 days of continuous health plan enrollment and received ≥ 1 ICI treatment. Point-of-sale purchase records from 18 state cannabis programs defined cannabis consumers (CC; any purchase prior to first ICI to last known follow-up) and cannabis non-consumers (CNC; no known cannabis purchases). We abstracted data on patient demographics, cancer history, cannabis utilization (dates of purchases, routes, strains), and all cancer-directed therapy claims. rwTTD was calculated from time of first ICI to a defining discontinuation event (change in therapy, gap of > 120 days, or end of enrollment in health plan). Results: From a database of nearly 68 million patients, 20,675 patients met the inclusion criteria (374 CC and 20,301 CNC). Baseline characteristics were similar between the two groups (e.g., age, diagnosis type, time to first ICI) (Table 1). Lung, melanoma and renal cancers account for nearly half of all identified diagnoses. By day 30 after ICI initiation, 45% of CC had made at least one cannabis purchase. Median time from advanced cancer diagnosis to first ICI and median follow up time were also similar (Table 1). The difference in median rwTTD between CC and CNC groups was small relative to the overall variation of this outcome (Table 1) and remained similar (88 days) when restricting analysis to CC with first purchase within 30 days of ICI. Conclusions: Cannabis use does not appear to be associated with rwTTD in advanced cancer patients initiating ICI. Formal statistical testing using inverse probability treatment propensity weighting and adjustment for confounding factors (opioids/glucocorticoids) to assess rwTTD and real-world overall survival is ongoing. Well designed, prospective cohort studies of CC and CNC are needed to minimize selection bias in studies of cannabis use. [Table: see text]
Safety of same day administration of pegfilgrastim in breast cancer patients.
Authors: Reynolds Kathryn , Katz Julia , Nabell Lisle , Grant Stefan C.
Published: June 2023

e18850

Background: Myelosuppressive therapy plays a crucial role in the treatment plan of patients with cancer; one common toxicity associated with myelosuppressive regimens is neutropenic fever. Pegfilgrastim is approved for use no sooner than 24 hours after receiving cytotoxic therapy, based on the initial FDA indication, requiring a return to clinic or the use of a patented on-body injector placed at the time of treatment. However, alternative schedules assessing earlier administration were never examined in the FDA registration studies. Small studies have suggested that same-day administration of pegfilgrastim can be carried out safely, including a prior safety study at UAB. The present analysis sought to test the non-inferiority of same day pegfilgrastim compared to administration 24-72 hours after cytotoxic chemotherapy. Methods: We undertook a retrospective analysis of 241 breast cancer patients receiving cytotoxic therapy from May 2016 through October 2018. The patient population was predominately Caucasian women with 28% African American or Asian women, and a median age of 55 (33-81). I2B2 codes identified patients with breast cancer receiving adjuvant or neoadjuvant therapy patients receiving same day versus next day pegfilgrastim were compared. Blood counts, delays in therapy, and neutropenic hospitalizations were analyzed for same day versus 24-hour delayed pegfilgrastim at two separate institutions. Dose reduced metastatic regimens were excluded from this review. Results: We comparedthe rate of neutropenia resulting in dose-delay for breast cancer patients receiving standard chemotherapy with administration of pegfilgrastim on both schedules. Overall, neutropenia with fever resulting in delay of subsequent chemotherapy was similar in both groups with same day administration being non-inferior to the standard administration schedule. Other treatment delays due to non-neutropenic conditions included mucositis, port malfunction, COPD, fatigue, and transportation delays. Conclusions: Policies requiring 24-hour delays following chemotherapy for pegfilgrastrim administration, reduce utilization of biosimilars and make the on-body injector, Onpro, a more convenient, albeit expensive option, for patients and the health system. These data suggest that same day administration of pegfilgastrim are non-inferior to delayed administration and may provide both substantial cost savings and quality of life benefits to patients and health care systems by increasing utilization of biosimilars and removing the need for a return visit after chemotherapy. In addition, same day administration also reduces the risk of complications associated with on body injector use, where failure rates of up to 10% are reported.
Evaluating patient adherence and persistence to first-line tyrosine-kinase inhibitors for metastatic renal cell carcinoma.
Authors: Arter Zhaohui , Benjamin David Joseph , Cao Yen , Forsyth Michael , Thirumaran Ranjit , Farias Jorge , Rezazadeh Arash
Published: June 2023

e18856

Background: Tyrosine kinase inhibitors (TKIs) have been approved in treating advanced renal cell carcinoma (RCC) since 2005. More recently, combination therapy with an immune checkpoint inhibitor (ICI) and a kinase inhibitor (TKI) is considered standard of care in the first-line setting of metastatic RCC. While oral neoplastic therapies such as TKIs promote patient autonomy, these therapies pose unique challenges including ensuring patients take medications as indicated (i.e., adherence) and for the recommended duration (i.e., persistence). Persistence and adherence data from prescription dispensing and refill patterns are important to health care providers, systems, and payers in order to assess and/or optimize the therapeutic goal(s) of anticancer treatment. Therefore, we sought to explore adherence and persistence of first-line TKIs when used in combination with ICIs for treating metastatic RCC. Methods: Adults with metastatic RCC who received at least two prescriptions for FDA-approved TKIs used in combination with ICIs between April 29, 2019 and August 29,2022 were identified at University of California Irvine Medical Center. Adherence was determined by calculating the Medication Possession Ratio (MPR) and the Proportion of Days Covered (PDC). TKI persistence was evaluated using the Kaplan-Meier method. Also evaluated was the average length of therapy. We examined additional dispensing and refill pattern indicators, including the monthly total number of prescriptions filled. Results: A total of 66 individuals and 849 prescriptions were discovered. The mean duration of treatment for all patients was 237 days, and the median duration was 201 days (Table 1). The mean persistence was 303 days, whereas the median persistence was 233 days. Over 180 days, the median MPR was 83%, whereas the median PDC was 72%. The median variable PDC was 86%, while the median variable MPR was 105%. September was historically the month with the lowest prescription counts (16 +/- 2). Conclusions: We observed a significantly longer median duration of oral TKIs therapy (201 days) in an academic medical center than the national average ( < 100 days). This analysis of real-world data reveals that lengthier treatment durations for TKI+ICI combinations are feasible. Further research is warranted to identify possible factors such as clinical monitoring or adverse effect management that may prolong adherence and persistence. [Table: see text]
Correlation of survival in colorectal cancer with tumor mutational burden and mutations identified by next-generation sequencing.
Authors: Taflin Nicholas , Sandow Lyndsey , Thawani Rajat , Kardosh Adel , Corless Christopher L. , Chen Emerson Yu-sheng
Published: June 2023

e18861

Background: Next-generation sequencing (NGS) can identify specific mutations and molecular abnormalities such as high tumor mutational burden (TMB), defined as 10 or more mutations per megabase. Immune checkpoint inhibitors (ICI) have been approved for all solid tumors with high TMB, including colorectal cancer (CRC), though studies have been inconclusive regarding prognosis of high TMB as well as the efficacy of ICI’s in treating CRC specifically. We aimed to use data collected from next-generation sequencing (NGS) of CRC at our institution to correlate survival to TMB, correlate survival to presence of mutations of interest, and to investigate efficacy of ICI in this patient population. Methods: This was a retrospective cohort analysis of patients at a single institution, analyzing NGS of patients who were identified as TMB-high and microsatellite stable (MSS) (n = 161) from January 20218 to December 2020.Demographics, clinical-pathological factors, and NGS results were extracted along with clinical outcomes. We conducted a survival analysis looking at TMB status and selected mutations of interest. A descriptive subset analysis of the patients who underwent treatment with immunotherapy was performed. Results: Patients with high TMB MSS CRC trended to have worse survival with a HR of 1.45, though this was not significant (p = 0.22). Median survival for high TMB patients was 28.1 months and was 77.5 months for non-high TMB. Analysis of NGS revealed 112 unique mutations, with TP53 (82.0%), APC (80.1%), and KRAS (43.5%) occurring the most frequently. Patients were found to have statistically significant worse overall survival with KRAS (HR = 1.81, p = 0.023), CDKN2A (HR = 4.81, p = 0.0002), RB1 (HR = 2.83, p = 0.047), and SMAD4 (HR = 1.858, p = 0.039) mutations. Twelve patients underwent treatment with ICI with nine patients having between 0.7 to 4.1 months of progression-free survival (PFS) and three patients with long PFS of 13.2, 24.7, and 26.3 months. The two patients with the longest PFS were not high TMB. Conclusions: Presence of high TMB in MSS CRC did not show a statistically significant difference in outcome. Presence of KRAS, CDKN2A, RB1, and SMAD4 correlated with significantly worse prognosis. Treatment with ICI’s was effective in some CRC patients though survival did not correlate with high TMB. There is a need to identify a marker beyond TMB which better indicates which patients with MSS CRC will have good response to ICI therapy.
Association of weight loss with risk of myelodysplastic syndromes (MDS) in adults with obesity: Insights from the SPLENDID cohort.
Authors: Mishra Rahul , Wilson Rickesha , Tu Chao , Milinovich Alex , Carraway Hetty E , Abraham Jame , Aminian Ali , Singh Abhay
Published: June 2023

e18865

Background: MDS arises from pre-existing somatic mutations or clonal hematopoiesis (CH). A normal body mass index (BMI) is strongly associated with a lower prevalence of CH. We hypothesized that intentional weight loss (IWL) might be associated with lower incidence of MDS and studied this in the context of bariatric surgery (BSx) among adults with obesity. Methods: In the SPLENDID (Surgical Procedures and Long-term Effectiveness in Neoplastic Disease Incidence and Death) matched cohort study, adults with BMI ≥35Kg/m2 who had BSx (ages 18-80) during 2004-2017 were included. Each patient (pt) who underwent BSx was matched with propensity score by the nearest-neighbor method to five pts who did not undergo BSx for their obesity, resulting in a total of 30318 pts. MDS diagnosis was made using contemporary WHO criteria and myeloid sequencing mutation data were analyzed. Multivariable cox regression analysis estimated time to MDS as the primary endpoint. Results: 5053 adults with obesity had BSx while 25265 adults underwent nonsurgical (NS) care. Median age and BMI were 46 years (y) and 45kg/m2. The majority were females (77%); and had white (73%) race. Follow-up was over 17y period with median (IQR) of 6.1 (3.8-8.9)y for the entire cohort. BSx-group had 19.2% greater WL at 10-y [mean between-group difference: 24.8 (95% CI, 24.6-25.1) kg]. One patient (male) in the BSx-group vs twenty-four patients (twelve females) in the NS-group developed MDS (incidence rate: 0.03 vs 0.14, per 1000 person-years). A fully adjusted hazard ratio was 0.14 (95%CI 0.02-1.14), which did not reach conventional level of statistical significance (p = 0.066) due to small number of events. A third of MDS pts had high-risk disease per IPSS-R prognostic score (7/20 evaluable pts). 10 (of 11 NS MDS pts with available NGS data) pts had ≥1 nonsynonymous mutations and most pts (6/11) harbored multiple [Median (IQR): 2 (1-3)] high-risk mutations despite a younger median age of the cohort. Conclusions: In this large cohort of adults with obesity, we observed a lower incidence of MDS after IWL achieved with BSx. Higher prevalence of high-risk-MDS mutations in a relatively young NS-cohort with obesity warrants further investigation of effects of IWL on clonal evolution, its clinical relevance, and role of screening in halting progression of CH to MDS via early detection and targeted intervention. [Table: see text]
The impact of COVID-19 on national trends of hospitalization and outcomes for acute leukemias.
Authors: Bhardwaj Prarthna V. , Nagesh Rao Sneha , Pasupula Deepak , Mehta Kathan , Siddappa Malleshappa Sudeep Kumar
Published: June 2023

e18869

Background: Acute leukemias are traditionally managed in a hospital setting. During the initial phase of the COVID-19 pandemic, there was a gross shortage of hospital resources and rationing of care. We aimed to study the differences in national trends of hospitalizations and outcomes for acute leukemias in 2019 (pre-pandemic) and 2020 across the United States. Methods: We performed a retrospective study utilizing the National Inpatient Sample (NIS) of adults hospitalized for management of acute leukemias as the primary diagnosis using ICD-10-CM codes. We excluded all patients with a prior or current hospitalization for stem cell transplantation. We compared the outcomes between patients presenting in 2019 (pre-pandemic) and 2020. Outcomes included mortality, length of stay (LOS) and cost of hospitalization. We compared mortality among patients with and without COVID in 2020 using chi-square analysis. Results: Of 166795 admissions for acute leukemia, 71.8% were acute myeloid leukemia (AML), 25.2% were acute lymphoblastic leukemia (ALL) and 3.1% were acute promyelocytic leukemia (APML). Overall, patients were predominantly male (55%), White (68%) presenting to large hospitals (67%) specifically urban teaching hospitals (88%). When compared between 2019 and 2020, there was no difference in the proportion not receiving chemotherapy for their leukemia (77.7% vs 78.6% in 2019 and 2020 respectively). There were no differences between mortality (8.6% vs 8.7%) or median LOS (6 days vs 5 days). The total cost of hospitalization was higher in 2020 ($155,961) compared to 2019 ($151,372). When stratified by COVID-19 infection in 2020, mortality was higher among COVID infected patients in AML (27.5% vs 10.08%, p=0.000), in ALL (16.87% vs 3.30%, p=0.000) as well as APML (26.32% vs 11.5%, p=0.139). Conclusions: Overall, there were no differences in the hospitalizations, rates of chemotherapy administration, mortality or LOS for acute leukemia pre and post COVID-19. However, in 2020, patients with AML and ALL with a concurrent COVID-19 diagnosis had a higher mortality. [Table: see text]
Real world challenges in defining oligometastatic disease in clinical practice.
Authors: Navarro-Domenech Inmaculada , Barry Aisling S. , Tsai Jane , Ma Grace , García-Pardo Miguel , Hirsch Ian , Wong Philip
Published: June 2023

e18873

Background: There is little data understanding the multi-disciplinary application of oligo-metastatic disease (OMD) treatment and decision-making. Through an anonymous survey, we sought to understand the knowledge gaps and challenges faced by physicians caring for cancer patients in deciphering and delivering treatments for patients with OMD. Methods: This was an IRB approved single institution quality improvement study conducted via an anonymous electronic survey. Three clinical cases of OMD that ranged from de-novo OMD to oligo-progressive disease, were presented to check participants’ comprehension of OMD. Descriptive statistics were used to summarize quantifiable information obtained from the survey. A qualitative approach was taken for the open-ended questions, in which the answers were reviewed by 2 independent readers and grouped together into common themes, and analyzed using sector and bar diagram, decision-tree method and sorted by prevalence. Results: The survey was answered by 70 clinicians (39 (56%) medical oncologists, 17 (24%) radiation oncologists, 5 (7%) surgeons, 9 (13%) from anatomical pathology/radiology/palliative care). The three clinical cases were correctly answered in 63%, 94% and 76%, respectively; of these, 76% to 84% would offer local treatment for each OMD scenario. Most (79%) perceived differences between local therapies (surgery, SBRT and RFA). Surgery was preferred to improve local control and overall survival, while SBRT was considered as being less invasive and more beneficial to patient quality of life. The definition of OMD was perceived by 94% as patients harboring 1-5 metastases. The main perceived challenges consist of lack of evidence in clinical and prospective trial data. Referrals are hindered as the goals and approach of OMD care are unclear. The most important determinant in deciding whether patients may benefit from OMD treatment is tumor histology and molecular profile. Conclusions: SBRT as a treatment of OMD emerged during an era of rapid expansion in systemic treatments and improvements in imaging techniques. Positive and negative trials in various histologies of cancer further added uncertainty on who would best benefit from OMD SBRT. As more radiation centres offer SBRT, the discordance in the outcome expectations from referring physicians, radiation oncologists and patients will need to be addressed to ensure that patients’ goals of care are met.
Assessing gender disparities in young patients with lung cancer among a diverse urban population.
Authors: Edwards Kyle , Manoharan Aysswarya , Noriega Esquives Blanca , Ramos Leana , El-Abbar Nora , Parikh Nitin , Kareff Samuel A. , Lopes Gilberto , Rodriguez Estelamari , Olazagasti Coral
Published: June 2023

e18874

Background: Lung cancer is the leading cause of cancer mortality in the United States and has a higher mortality rate in men. While most patients are typically elderly adults, research shows that rates of lung cancer among younger patients have been increasing. Furthermore, younger patients with lung cancer have unique clinicopathologic characteristics. Methods: A total of 139 lung cancer patients (59 Male and 80 Female) who were under the age of 45 and treated at the University of Miami between 2012-2021were included. Demographics and clinicopathologic characteristics were analyzed. Results: The median age at diagnosis for female and male patients was 39.6yrs vs 38.4yrs. (Table 1) Among females, 28% were White non- Hispanic (NH), 47% were White Hispanic, 8% were Black NH, 2% were Black Hispanic and 11% were of other race. Among males, 38% were White non- Hispanic (NH), 44% were White Hispanic, 8% were Black NH, 5% were Black Hispanic and 3% were of other race. While 67% of male patients smoked tobacco, only 43% of female patients endorsed a history of smoking tobacco (p = 0.005). Male patients underwent surgery after an average of 22 days from diagnosis compared to 17 days for female patients. Moreover, 40% of females had surgical resection compared to 29% of males. The average number of days between a positive biopsy and initiation of chemotherapy for male vs female patients was 39 days vs 36 days, respectively. Female patients had higher trends of adenocarcinoma (68%) and actionable mutations (62%) than their male counterparts (44% and 42%). Lastly, they had lower trends of metastatic disease at diagnosis (58%) than male subjects (62%). Conclusions: Lung cancer trends in older adults appear to remain consistent in younger patients. Young male patients smoke cigarettes significantly more than young female patients. While no other statistically significant differences were found, our study noted a few trends. Overall, females presented with localized disease at a higher rate and had a higher percentage of actionable mutations. Male patients appeared to be more likely to present with systemic disease, which reduced the opportunity for surgical resection. Further prospective studies will be of paramount importance to explore these trends in large cohorts. [Table: see text]
Impact of COVID-19 pandemic on breast cancer screening rates.
Authors: Rutter Cliff , Avalos-Reyes Elisea , Brito Rogelio A. , Craig Kelly , Verbrugge Dorothea J. , Liu Chen , Kipping Emily , Johnson Kjel Andrew
Published: June 2023

e18875

Background: The COVID-19 pandemic disrupted healthcare utilization in the US, with cancer screening being severely impacted. Little is known about the impact COVID-19 had nationally on breast cancer screening. The objective of this study was to examine the potential impact of the COVID-19 pandemic on breast cancer screening rates. Methods: Commercial Fully Insured and Medicare members of large national health plan meeting the Healthcare Effectiveness Data and Information Set (HEDIS) inclusion and exclusion criteria for the measurement years 2019, 2020 and 2021 were included in the study. Member demographic data were linked to race, zip code, socioeconomic status and region information. The pre-COVID period was defined as measurement year 2019, peak-COVID was defined as measurement year 2020 and post-peak-COVID-19 was defined as measurement year 2021. Screening incidence rate differences (IRD) and ratios (IRR) were calculated between the three time periods. Logistic regression was conducted to control for socio-demographic confounders. All analyses were conducted in Python; a p-value less than 0.05 was significant. Results: This study included 324,707, 400,740 and 532,879 members in pre-COVID, peak-COVID and post-peak-COVID periods, respectively. The screening IRD between pre-COVID and peak-COVID periods was -3.1% (95% confidence interval [CI] -3.5% to -2.7%; p < 0.001) and the IRR was 0.961 (95% CI 0.956 – 0.966; p < 0.001). Between the peak-COVID and post-peak-COVID periods, the IRD was -0.33% (95% CI -0.68% to 0.02%; p = 0.0675) and the IRR was 0.996 (95% CI 0.991-1.000; p = 0.0667). Comparing the pre-COVID to the post-peak-COVID period revealed a significant IRD (-3.4% [95% CI -3.8% to -3.0%]; p < 0.0001) and IRR (0.956 [95%CI 0.952-0.961]; p < 0.0001). Controlling for other confounders, the pre-COVID period was associated with significantly higher odds of receiving a screening mammogram compared to the peak-COVID period (odds ratio [OR]: 1.19 [95% CI 1.17-1.2], p < 0.0001). Additionally, the post-peak-COVID period was associated with lower odds compared to the peak-COVID period (OR: 0.98 [95% CI 0.97-0.99], p < 0.0001). Additional results are shown in Table 1. Conclusions: The COVID-19 pandemic resulted in significantly lower screening mammogram rates when compared to the pre-COVID period. Additionally, this decrease appeared to be durable into the post-peak-COVID period after controlling for other confounders for screening. Further follow up studies are warranted to characterize the potential rebound of screenings. [Table: see text]
Utilization and barriers to genomic profiling in breast cancer treatment among oncologists.
Authors: Miller Taavy A. , Brown-Bickerstaff Cherrishe , Brown Madison , Dulka Brooke , Jeune-Smith Yolaine , Feinberg Bruce A.
Published: June 2023

e18882

Background: Genomic profiling (GP) may help identify novel, targeted breast cancer (BC) treatments. Increased utilization and technology of GP, including options such as next-generation sequencing (NGS) to identify mutations (e.g., PI3K, PTEN, and AKT) among patients with BC, has allowed for improved care and outcomes. Yet, there are limited standard guidelines for the application of GP, and little is known about current use and challenges in the United States (US). The objective of this study was to describe the utilization of and barriers to GP among US-based community oncologists. Methods: Three live meetings held between July and September 2022 convened oncologists to discuss trends in health care. Participants responded to survey questions online and onsite; not all participants answered every question. Results were aggregated and analyzed using descriptive statistics. Results: A total of 171 physicians participated (primary specialty: 56% hematology/oncology, 42% medical oncology, 2% other). The cohort is geographically diverse (Northeast 23%, Midwest 16%, South 43% and West 18%) and have a median of 18 years of experience. Most participants (92%) are using an NGS-based panel to test their patients with ER+ breast cancer for biomarkers (e.g., PI3K, AKT, and PTEN) and the most common panels utilized are indicated in the table. When treating BC, physicians indicated they most often order NGS-based tests prior to any treatment (33%) or prior to first-line treatment in the relapsed/metastatic setting (47%) (Table). Overall, the top two resources participants felt would increase their use of GP when treating patients with BC are: financial aid and reimbursement support (51%) and more clinical evidence on its utility for improving patient outcomes (48%) (Table). Education on the use of GP and decision support tools were also reported as resources that will increase utilization (34% each). Conclusions: Most oncologists are using GP when managing patients with BC, but the extent of utilization may be limited by barriers. Specifically, a lack of financial aid and/or reimbursement support and evidence on the utility to improve patient outcomes are reported as barriers. Despite high utilization of GP for patients with BC, there remains opportunity to increase uptake, such as more education and access to decision tools, which may increase the utilization and application in oncology settings. [Table: see text]
Return to work in breast cancer patients with and without pre-diagnosis psychological distress.
Authors: Pai Tanmayi , Klassen Christine , Pruthi Sandhya , Cornell Lauren
Published: June 2023

e18883

Background: Women comprise more than 40% of the American workforce, with many women working at the time of a breast cancer diagnosis. Pre-diagnosis psychological distress is a rarely studied factor that may affect cancer survivors’ workforce participation and mental health status post treatment. In this 2-site prospective cohort study, we evaluated return to work (RTW) in breast cancer patients (pts) with and without reported pre-diagnosis stress. Methods: We enrolled 198 female pts at Mayo Clinic in Minnesota and Florida with newly diagnosed stage 0-III breast cancer who worked 35-plus hours/week at time of diagnosis. Pts were screened for eligibility at the intake visit. Eligible pts were emailed a baseline survey at the time of diagnosis, then a follow-up survey at 3 months. Surveys assessed demographics, work factors, treatment, and psychological distress per the validated Kessler Psychological Distress Scale (K6). Primary aims were to assess 1) the impact of pre-diagnosis psychological distress on RTW in pts with a breast cancer diagnosis and 2) the incidence of severe psychological distress (K6 ≥13) in those with and without delay in RTW. Wilcoxon rank sum tests were used to compare pts with and without pre-diagnosis stress at baseline and 3 months. Results: 189 and 142 pts took part in the baseline and 3-month surveys, respectively. Here, 40.7% of enrolled pts reported experiencing one or more major life stressors in the 18 months before diagnosis. At 3 months, 6 of the 75 pts who responded (8.0%) endorsed a delay in RTW after breast cancer diagnosis. Half of these pts (3/75) had reported a pre-diagnosis stressor, revealing no significant difference in time to RTW between the stressed and not-stressed groups. Median K6 at diagnosis in those with delay in RTW was 14 (range, 10-17), significantly higher than the median K6 of 9 in those without delay in RTW (range, 6-23; p = 0.026). 5/6 pts who reported delay in RTW had baseline or 3-month K6 ≥13. There was no significant difference in the number of pts with K6 ≥13 at baseline vs. 3 months (31.2% vs. 21.8%, p = 0.85). Overall, the pt population was well educated and well salaried. Conclusions: Pre-diagnosis psychological distress is prevalent, but it does not seem to be associated with delayed RTW in breast cancer pts; indeed, few pts reported a delay in RTW. Pts with delayed RTW after a breast cancer diagnosis had significantly higher median K6, generally ≥13. Thus, delay in RTW in breast cancer pts may be a surrogate marker of more serious psychological illness. Additional study in a socioeconomically diverse pt population is needed.
Incidence of skin cancer among patients with Waldenström macroglobulinemia: Analysis of the SEER database (2000-2019).
Authors: Taneja Alankrita , Mishra Rahul , Arun Kumar Sumukh , Hillengass Jens
Published: June 2023

e18893

Background: The association between non-Hodgkin lymphoma, including chronic lymphocytic leukemia, and aggressive skin cancers is well established. We studied the incidence of melanoma and non-melanoma skin cancers (NM) skin malignancies (SM) among patients with Waldenstrom macroglobulinemia (WM). Methods: We used the SEER 17 registry to identify adult [Age > 20] patients(pts) with an index diagnosis (dx) of WM between 2000- 2019. We included ICD-O-3 codes 9671/3 (Lymphoplasmacytic lymphoma) and 9761/ (Waldenstrom macroglobulinemia) to identify index dx. Only first of the two codes was used if both were mentioned for same pt. We excluded patients with diagnosis made from death certificate or autopsy. We used ICD-O-3/WHO 2008 codes assigned to melanoma of skin and other NM SM to identify subsequent diagnosis ( > 2months after index diagnosis) of SM excluding basal cell and squamous cell cancers. SM were categorized using ICD-O-3 codes for histology. Follow up period was till December 2019. Data variables and standardized incidence ratio [SIR] for SM were obtained with multiple primary SIR analyses using SEER Stat v 8.4.0.1 software. Kaplan Meier method was used to estimate overall survival (OS) using R 4.2.2. Results: We identified 8099 patients with WM of which 68 patients (0.84%) had a subsequent dx of SM. WM and SM were diagnosed at median (IQR) ages of 69 (60-77) and 74 (67-81), with a median gap of 52 (30-95) months. Majority of WM survivors with SM were males (51 or 75%), white (100%) and older than 60 years of age (72%) at WM diagnosis. Almost half of the patients who developed SM underwent chemotherapy for WM (n = 35, 45%). The overall risk of developing SM was significantly higher in WM patients as compared to the general population [SIR (95%CI) = 1.34 (1.01-1.74) (p < 0.05) for melanoma and 2.85 (1.52-4.87) (p < 0.05) for NM]. Eleven different types of histology for SM were noted, with malignant melanoma, NOS (n = 30, 44%) and Merkel cell carcinoma (n = 7, 10%) being the most common melanoma and NM subtype (Table). The median survival after SM dx was 68 (55-NA) months. Conclusions: Patient with WM had higher risk of SM (melanoma and NM skin cancers, excluding basal cell and squamous cell cancers) compared to the general population. This study highlights the need for screening and counseling for skin cancers in WM patients in routine clinical practice. [Table: see text]
Real-world duration of hospitalization for CAR-T treatment: U.S. patient experience in multiple hematologic malignancies.
Authors: Kish Jonathan , Liu Rachael , Pfeffer Daniel , Vennam Srinivasa , Lussier Courtney , Nayak Pratibha
Published: June 2023

e18896

Background: Since 2017, 6 CAR-t therapies have been approved to treat pediatric and adult hematologic malignancies (HM). Due to the complexity of administration and severe toxicity including cytokine release syndrome (CRS), CAR-t is usually administered in an inpatient setting. We sought to provide the first pan-cancer, U.S. based analysis of duration of hospitalization during CAR-t overall and for patients who experience CRS. Methods: Patients were identified from a large, US based EMR database including more >40M patients, >500 hospitals and 30 healthcare systems including both community/academic health systems. Patients with ≥1 procedure code for general administration of CAR-t therapy (e.g.: XW033C3, introduction of engineered autologous chimeric antigen receptor t-cell immunotherapy into peripheral vein) or a specific approved CAR-T (XW033K7, introduction of idecabtagene vicleucel immunotherapy into peripheral vein) between 2017 and 2022 and a diagnosis of a HM were selected. CRS was identified as the presence of any ICD-10 diagnosis code of D89.83X post-administration. Time from the date of CAR-t administration to hospital discharge was calculated overall, by cancer type, and for patients with and without a confirmed diagnosis of CRS. Results: A total of 212 patients (multiple myeloma [MM] = 64, b-cell lymphoma = 77, follicular lymphoma = 47, mantle cell lymphoma [MCL] = 13, acute lymphoblastic leukemia = 11) meeting selection criteria were identified. Cohort characteristics are shown in Table 1. Median duration of hospitalization was 12 days (range 1-56); shortest at 10 days for MM and longest at 15 days for MCL. Mean duration of hospitalization decreased slightly from 12.3 days (sd = 11) for patients treated in 2019 or earlier to 11.9 days (sd = 4.2) for patients treated in 2022 Median duration of hospitalization for patients with a CRS diagnosis (n = 100) was 12 (range 1-30) versus 11 days (range 1-56) for those without CRS (n = 112). Conclusions: CAR-t poses a unique set of administrative, logistical and clinical challenges. This study provides the first contemporaneous estimates of the length of hospital stays during CAR-t infusion which was found to be 12 days. Differences in length of hospitalizations did not decline significantly over time or were significantly different between those with and without CRS however further research to examine health system factors and patient factors (i.e., severity of CRS) are needed. [Table: see text]