bluuebunny/crossref_metadata_2025 huggingface dataset:
Real-world (RW) treatment patterns and comparative effectiveness of Bruton tyrosine kinase inhibitors (BTKi) in patients (pts) with mantle cell lymphoma (MCL).
Authors: Shah Bijal D. , Yang Keri , Klink Andrew J. , Liu Tom , Zimmerman Todd M. , Gajra Ajeet , Tang Boxiong
Published: June 2022

e18727

Background: BTKi therapies, approved for relapsed or refractory (R/R) MCL, have not been comprehensively evaluated in RW populations. This study aimed to assess patient characteristics, treatment patterns and associated outcomes in RW BTKi-treated MCL pts. Methods: The retrospective multicenter chart review was conducted in the Cardinal Health Oncology Provider Extended Network. EMR data were extracted for eligible pts diagnosed with MCL who initiated any of the approved BTKi (ibrutinib [ibr], acalabrutinib [acal], zanubrutinib [zanu]) from 2018 to 2021; pts enrolled in trials were excluded. Index date was defined as the use of any of the BTKis. Pts were followed 12-mo pre-index for medical history, and from index to last follow-up or death. Descriptive analyses were conducted to assess demographic/clinical characteristics, MCL baseline features, BTKi treatment patterns, adverse events (AE), and response rates by BTKi. Multivariable logistic regression was performed to assess factors associated with response and AE. Results: The study cohort consisted of 300 MCL pts (59% male; 69% white); most (64%) pts were covered by Medicare, 34% had commercial insurance. BTKis were given mainly as monotherapy (93%) and in R/R setting (86%). Pts in zanu group were significantly older (n = 100, median age = 71, range = 50-91) than pts in ibr (n = 100, median age = 69, range = 39-87) and acal (n = 100, median age = 70, range = 51-86) groups. Significantly fewer pts in the zanu group had baseline Ann Arbor stage I-II (4%) than ibr (10%) or acal (13%), while more zanu pts had presence of B symptoms (67%) than ibr (44%) or acal (57%). Pts in the zanu group also had significantly less with ECOG of 3+ (4%) compared to ibr (8%) or acal (6%). At BTKi initiation, significantly more pts in zanu group (18%) had history of atrial fibrillation than ibr (1%) or acal (5%). Multivariable regression reported a significant association of age, gender, extranodal/splenic involvement, and timing of BTKi initiation with response and AE (Table). Conclusions: This study provides the first RW evidence on comparative effectiveness of ibr, acal, zanu in MCL pts. While pts treated with zanu were older and had more complex MCL baseline features at initiation, multivariable regression suggested a trend favoring zanu over ibr or acal for both response and AE. Frontline initiation of BTKi therapy was also associated with improved tolerability. Future RW studies are needed to discern long-term outcomes.[Table: see text]
Real-world treatment (tx) patterns and economic burden of patients (pts) with marginal zone lymphoma (MZL).
Authors: Yang Keri , Liu Tom , Tang Boxiong , Shah Bijal D.
Published: June 2022

e18730

Background: MZL remains understudied with limited real-world evidence on how current tx conform to clinical guidelines. This study aimed to assess real-world tx patterns, costs, and healthcare resource utilization (HRU) in US MZL pts. Methods: A retrospective, observational study was conducted using the IBM MarketScan® commercial and Medicare supplemental claims dataset (2017-2020). Newly diagnosed adult MZL pts (≥18 yr) continuously enrolled 6 month pre- and 3 month post-index date, defined as the first diagnosis date, were included. Tx regimens were identified by line of therapy and mutually exclusively categorized as rituximab monotherapy (R-mono), bendamustine + rituximab (BR), rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP), ibrutinib (ibr), or other. Descriptive analyses were conducted to assess pt sociodemographic/clinical characteristics and tx utilization patterns (frequency, duration, discontinuation). Costs and HRU assessed included inpatient, outpatient, and pharmacy visits per-patient-per-month (PPPM). Multivariable logistic regression was conducted to examine predictors of costs and HRU. Results: In 2491 MZL pts (median age = 63; 52% male), 59% were commercially insured (median age = 57) and 41% in Medicare (median age = 76). Common comorbidities were hypertension (44%), diabetes (17%), atrial fibrillation (AF; 16%), and gastroesophageal reflux disease (15%). Mean time from diagnosis to tx initiation was 223 days. A total of 1,781 (72%) pts received first-line (1L), 518 (29%) pts received second-line (2L) and 239 (13%) pts received third-line (3L) therapies. R-mono was the most common regimen across both commercial and Medicare pts and all tx lines (Table). R-CHOP and BR were the second most used regimen in 1L with decreased use in 2L+. Ibr was used more in 2L+ setting but had the lowest 1L PPPM cost (median $2958.9) than other regimens. Overall MZL pts had PPPM 4.6 outpatient visits, 0.5 hospitalization, and mean length of stay of 2.6 days. Total PPPM healthcare cost was $19,895.8. Multivariable regression showed that baseline comorbidities (AF, renal disease, neutropenia) and tx discontinuation were significant predictors of higher costs and HRU. Conclusions: This real-world data suggested that US MZL real-world tx pattern across lines of therapy follows the regimen recommendations by the National Comprehensive Cancer Network clinical practice guidelines and that MZL pts incur high economic burden. Future studies are needed to evaluate long-term outcomes and the impact of heterogenous MZL subtypes.[Table: see text]
The longitudinal impact of COVID-19 on the diagnosis and treatment of lung cancer at a Canadian academic center: Interim analysis from a retrospective chart review.
Authors: Rizzolo Angelo , Kasymjanova Goulnar , Pepe Carmela , Friedmann Jennifer Elisabeth , Small David I. , Price-Gallagher Colton , Spicer Jonathan , Sirois Christian , Lecavalier-Barsoum Magali , Sultanem Khalil , Wang Hangjun , Spatz Alan , Cohen Victor , Agulnik Jason S.
Published: June 2022

e18737

Background: The coronavirus disease 2019 (COVID-19) has significantly impacted clinical activities across many medical specialties. The care of lung cancer (LC) patients is no exception. Our group recently reported that the rate of new lung cancer diagnoses declined by 35% during the first year of COVID-19 pandemic (year 2020). The objective of the present study is to continue to evaluate changes in lung cancer diagnosis and management during 3rd and 4th waves of the pandemic (2021). Methods: This is a retrospective chart review study including patients diagnosed with lung cancer between March 1st 2019 and February 1st 2022 at the Jewish General Hospital, Montreal, QC, Canada. We compared 3 cohorts: Cohort 1: 2019 (pre-COVID). Cohort 2: 2020 (1st year of COVID). Cohort 3: 2021 (2nd year of COVID; reporting for 10 months of 2021). Results: A total of 388 patients were diagnosed with lung cancer throughout the three-year study: 130 in cohort 1, 103 in cohort 2 and 155 in cohort 3. Although there was a 35% decline of new lung cancer (LC) diagnoses observed in the 1st year of COVID, there was a 50% increase in diagnoses during the 2nd year comparing to the first year and a 19.2% increase compared to the pre-COVID year. Stage 4 LC diagnoses increased by 29% in 2021 compared to 2019 (88 cases vs 68 cases) and by 54% compared to 2020 (88 cases vs 57 cases). Early stage curative treatments (which had significantly changed in 2020, as the use of radiation therapy [RT] increased by 125% and surgery decreased by 38%), approached pre-pandemic levels in 2021. In 2021 we observed a decrease in RT and a significant increase in surgical resections. Analyses of wait time for initiation of treatment is still ongoing. Conclusions: The present study represents interim data in our ongoing effort to evaluate the dynamic impacts of the COVID-19 pandemic on diagnosis and delivery of LC care. The pattern of lung cancer treatment modalities for early stage disease appears to be recovering to pre-COVID rates. However, the significant decrease in lung cancer diagnoses during the first year of the pandemic has resulted in an increase in new diagnoses during the 2nd year at unfortunately more advanced stage of disease.[Table: see text]
Trends in treatments and in-hospital outcomes of primary malignant cardiac tumors: A 16-year U.S. nationwide study.
Authors: Datar Yesh , Yin Kanhua , Reardon Michael J. , Dobrilovic Nikola
Published: June 2022

e18756

Background: Primary malignant cardiac tumors are a rare but highly aggressive disease. Recent studies have quantified its long-term survival and the efficiencies of different treatment modalities. However, the trends in treatment patterns and in-hospital outcomes in the United States are still poorly understood. Methods: The National Inpatient Sample (NIS) was queried to identify adult patients (age ≥ 18) who were diagnosed with primary malignant cardiac tumors (ICD-9: 164.1; ICD-10: C38.0). Surgical treatments and chemotherapy were identified using the corresponding procedure and ICD codes. The national estimates were generated based on the weighted values of the hospitalizations. Results: From 2002 to 2017, 6,494 malignant cardiac tumor-related hospitalizations were identified. The mean age was 53.8 ± 17.5 years, 55.9% White, and 47.9% women. There was an increasing trend in the incidence over the study period, from 1.15 per 100,000 NIS admissions in 2002 to 1.49 per 100, 000 NIS admissions in 2017 (P for trend < 0.001). 1708 (26.3%) patients received some forms of surgery: 733 (11.2%) underwent surgical excision of the tumor, 585 (9.0%) received pericardiotomy, and 397 (6.1%) underwent pericardiectomy. A decreasing trend in surgical therapy was observed (22.0% in 2002 to 16.8% in 2017, P for trend < 0.001). 1403 (21.6%) patients received chemotherapy, with a significant decreasing trend over time (25.8% in 2002 to 19.6% in 2017, P for trend < 0.001). The in-hospital mortality of the entire cohort was 11.1%, which remained unchanged over time (P for trend > 0.05). Conclusions: This study demonstrates that although malignant cardiac tumor-related hospitalizations were increasing between 2002 and 2017, the uses of surgical therapy and chemotherapy were decreasing. The in-hospital mortality was high but remained stable over the study period.
The impact of vertical integration of oncologists on cancer outcomes and healthcare costs among metastatic prostate cancer patients.
Authors: Hu Xin , Lipscomb Joseph , Graetz Ilana
Published: June 2022

e18786

Background: The share of oncology practices that were vertically integrated with hospitals more than doubled in the past decade. Vertical integration leads to higher spending, but evidence on quality and outcomes remains inconclusive. This study examines how integration between hospitals and oncologists affects patient outcomes and spending among patients with metastatic prostate cancer. Methods: Using the SEER-Medicare linkage with the Medicare Data on Provider Practice and Specialty file, we identified Medicare beneficiaries diagnosed with metastatic, castration-resistant prostate cancer who initiated chemotherapy between 2008-2017 (n = 9,167). We used a claims-based approach to identify treating oncologists and their integration status (as indexed by percent of total services billed to hospital outpatient departments). Outcomes included: 1) time on chemotherapy, 2) survival from chemotherapy initiation, 3) supportive care use (i.e. bone-modifying agents [BMA]), 4) Medicare payment for the first 3 months of chemotherapy initiation and last 3 months before end of life (EOL). The differences-in-differences approach was used to compare patient outcomes before and after oncologists became integrated versus those whose oncologists remained non-integrated or always integrated. Weibull survival and linear models were used for regression analysis, adjusting for sociodemographic, clinical, and market characteristics. Results: The proportion of patients treated by integrated oncologists increased from 28% in 2008 to 55% in 2017. Vertical integration was associated with 13.6 percentage points increase (95% CI = 6.1 to 21.1) in the likelihood of BMA use, but no significant changes for time on chemotherapy and survival. Average Medicare spending in the first 3 months of chemotherapy initiation and last 3 months of EOL was $34,324 and $42,624, respectively. Vertical integration did not have a significant effect on overall spending. Further decomposition showed decreases in professional service costs (-$4,264, 95% CI = -$6,642 to -$1,887) along with an increase in outpatient care costs ($3,941, 95% CI = $159 to $7,723) for the first 3 months of chemotherapy. A similar pattern was found for spending in the last 3 months of EOL. Conclusions: Vertical integration of oncologists was associated with increased use of supportive care, but not time on chemotherapy or survival among metastatic prostate cancer patients. Although oncologists switched service billing from physician offices to hospital outpatient departments, we did not detect significant increases in total Medicare spending after vertical integration. This suggests the potential for quality improvement following vertical integration without substantial increases in healthcare spending. Future studies should extend the investigation to other cancer types and patient outcomes.
Presentation, management, and outcome of COVID-19 among patients with cancer in the Middle East and North Africa (MENA) region.
Authors: Jazieh Abdul-Rahman , Abdel-Razeq Hikmat , Akbulut Hakan , Bounedjar Adda , Tfayli Arafat H. , Tashkandi Emad M , Jastaniah Wasil A , Ansari Jawaher , Alorabi Mohamed Osama , Darwish Amira D , Rabea Ahmed Magdy , Al Olayan Ashwaq , Ibnshamsah Fahad , Errihani Hassan , Alkaiyat Mohammad , Alkattan Khaled , Hussain Fazal , Bruinooge Suanna Steeby , Garrett-Mayer Elizabeth , Tamim Hani
Published: June 2022

e18797

Background: Patients with cancer are vulnerable population that suffered during the COVID-19 pandemic from SARS-CoV-2 infection and from the pandemic’s impact on healthcare systems. We are presenting the findings of MENA Registry for COVID-19 and Cancer (MRCC) regarding the SARS-CoV-2 infection presentation, diagnosis, treatment, complications, and outcomes. Methods: MRCC was adapted from ASCO COVID-19 Registry and included patients with SARS-CoV-2 infection and underlying cancer diagnosis including a newly diagnosed cancer in the work-up phase or patients with active cancer receiving cancer therapy or supportive care, or within first year of adjuvant chemotherapy or after one year of curative therapy and receiving hormonal therapy. Registry included data on patients from 12 centers in eight countries in the MENA region, namely: Saudi Arabia, Jordan, Lebanon, Turkey, Egypt, Algeria, United Arab Emirates, and Morocco. The data included patient and disease characteristics, COVID-19 presentation, management, and outcomes. The follow up is differential as data get captured at different points of disease trajectory for each patient which may not reflect the final outcome. Results: Data on 1345 patients were captured in the study by December 7, 2021. Median age was 57.1 years (18-98), whereas 56.1% were females. The median follow-up was 98.5 days (0-554). The most common COVID-19 symptoms was fever (50.3%) and 26.8% of patients were asymptomatic. Out of the 959 patients with complete data on hospitalization, 554 (57.8%) were hospitalized and 126 of them (22.7%) were admitted to intensive care unit (ICU). The majority of hospitalized patients (60%) had respiratory complications and 13.9% had sepsis and 8.5% suffered acute renal injury. As shown in Table, more than quarter of the patients died with 47% of death from COVID-19 or related complication and 60.6% died at home. More than half of the patients were fully recovered from infection. Conclusions: Although more than half of the patients recovered form COVID-19 and more are expected to recover with a longer follow up, the death toll and complications remain high in this patient population. Future analysis of the impact of vaccination and better disease management as well as the impact of newer variants would provide a useful insight on managing this vulnerable population.[Table: see text]
Treatment patterns and time to next treatment among patients with OC in a real-life setting in Finland: The OCRWE-Finland study.
Authors: Rauhamaa Heini , Herse Fredrik , Isomeri Outi , Idänpään-Heikkilä Juhana , Käkelä Sari , Hietanen Sakari , Loukovaara Mikko , Auranen Annika
Published: June 2022

e18806

Background: Ovarian cancer (OC) is a disease characterized by a dynamic treatment landscape in the real-life setting. The OCRWE-Finland study aims at describing the real-life burden of patients with OC, including treatment patterns, time to next treatment, disease characteristics and progression, survival, and healthcare resource utilization. This abstract reports on the observed treatment patterns. Methods: OCRWE-Finland is a multicenter, retrospective, noninterventional study collecting hospital medical records from the university hospitals in Helsinki, Turku, and Tampere. Patients with ovarian, fallopian tube, or primary peritoneal cancer who were newly diagnosed as part of routine clinical care and who received all their OC treatments in these university hospitals during the period 2014-2019 were included, covering about 50% of the Finnish OC care patients. Registry data were collected and combined by Findata (authorization holder), which operates under the performance guidance of the Finnish Ministry of Social Affairs and Health. Results: In total, 1711 patients with OC (mean age = 65.9 y, SD = 13.4 y) and 621 patients with high-grade serous OC (HGSOC) (mean age = 68.0 y, SD = 10.1 y) were identified. Initial diagnosis assumed the origin of the disease was the ovaries in 75% of patients and the peritoneum in 19%. Of the patients with HGSOC, 55% had FIGO stage III disease and 20% stage IV at diagnosis; 5% had stage II and 9% stage I. For 11%, no data of the FIGO stage at diagnosis were found in text mining. 59% of the HGSOC patients were treated with primary debulking surgery (PDS), 21% with neoadjuvant chemotherapy (CT) and interval debulking surgery, and 12% with only CT in first-line treatment (TL1). Among patients with stage I-IV HGSOC who underwent PDS, the disease was optimally debulked in 37% of the patients and suboptimally debulked in 44% (Residual < 1 cm in 27%, Residual≥1 cm in 17%). Residual tumor status was unknown for 19%. During the observation period, 57% of patients received a TL2, and 48% of these patients moved to TL3. The probability of undergoing a TL2 was higher among stage III/IV patients and among patients with residual disease. In TL2, the most common treatment was platinum-based CT (32%), and “other CT” was administered in 26% of cases; 33% of patients did not receive any TL2 during the observation period but were still alive, and 9% died before initiating TL2. Conclusions: This study documents real-life treatment patterns across lines of treatment among patients with OC and HGSOC during the first years of disease from the three biggest university hospitals in Finland. These results can provide useful baseline information about the rapidly evolving treatment landscape in OC in recent years.
Cost-related medication rationing and nonadherence among Cancer Survivors in the United States.
Authors: Chido-Amajuoyi Onyema , Osaghae Ikponmwosa , Undavalli Chaitanya
Published: June 2022

e18814

Background: The cost burden associated with cancer care is substantial event. Studies have shown that this burden has continued to increase over time, even for longer term survivors. However, there is a paucity if studies that have described the characteristics of cancer patients who are at greater risk of adopting cost saving behaviors as a means to cope with cancer-related financial burden. Methods: Study data were derived from the 2018 National Health Interview Survey, which is administered annually by the National Center for Health Statistics. Outcomes of interest were reports of medication rationing and nonadherence among cancer survivors who had received a prescription medication from a doctor/health professional in the past 12 months. Survey questions used to assess this were: This was derived via “yes” responses to the survey questions: “DURING THE PAST 12 MONTHS, were any of the following true for you? ...You skipped medication doses to save money” and “DURING THE PAST 12 MONTHS, were any of the following true for you?....you took less medicine to save money”. Survey logistic regressions were used to identify sociodemographic and behavioral factors associated with cost saving behaviors among cancer patients. All analysis were carried using STATA version 14.2'. Results: A total of 2594 cancer survivors were included in our study. Among those who reported skipping medications to save money, 75.5% were females, 29.1% were aged > 65 years, and 50.7% had an annual income < $34,999. Also, 92% had health insurance coverage, 47.5% were never smokers, and 27.3% were current smokers. As income increased, the odds of medication rationing and non-adherence decreased. For example, cancer survivors earning $50,000 - $74,999 were less likely (aOR: 0.49, 95% CI: 0.24-1.00) to skip medications compared to those with income less than $34,999; while those earning $100,000 and over had 83% (aOR: 0.17, 95% CI: 0.07-0.44) lower odds of skipping medications compared to those with income less than $34,999. Compared to cancer survivors with health insurance coverage, those without health insurance coverage were over two folds (aOR: 2.38, 95% CI: 1.07-5.29) more likely to skip medications to save cost. Current smokers were about twice (aOR: 1.98, 95% CI: 1.13-3.48) as likely to skip medications to save money compared to never smokers. Findings with health insurance and cigarette use were constant for medication rationing. Conclusions: From our study, cancer survivors who skip or ration medications are likely to be younger, low-income and have no health insurance coverage. We also found an association between cancer-related cancer saving behaviors and ongoing tobacco use among cancer survivors. These findings align with previous studies and hint at the need for a multipronged approach to minimize the huge cost of treatment incurred by cancer survivors, their families, and the government.
Cost differential of costly cancer therapies by site of care.
Authors: Warde Prem R. , Junk Christopher , Cavers William , Avalos-Reyes Elisea , Johnson Kjel Andrew
Published: June 2022

e18824

Background: In the past decade, oncology site of care (SOC) for drug infusions has shifted from physicians’ offices to hospital outpatient settings. This shift has raised questions regarding the potential impact of SOC on the value of cancer care. The purpose of this study is to explore current potential cost savings among select infused cancer therapies in stable patients transitioning from an outpatient setting to an office setting. Methods: We identified patients with cancer receiving a check-point inhibitor using medical claims data from June 30, 2018, to June 30, 2021, at a large national commercial insurer. We defined a non-stable patient as a patient who had yet to receive treatment for 180 days and/or may not be clinically stable to transition. A stable patient was defined as having received 180 days of treatment and further divided into either the “stable outpatient,” “stable office,” or “ineligible” group. Stable outpatient was defined as having the first, 6 month and last SOC in an outpatient setting. Stable office was defined as having the first, 6 month and last SOC in an office setting. Ineligible patients included those patients moving between the outpatient and office setting during the study period. We compared the stable outpatient and stable office groups using a t-test and simulated the potential savings of moving stable patients from the outpatient setting to the office, adjusting for drug, insurance type and state. Results: This study included 2,727 patients, of which 511 (18.7%) were stable. Of this stable population, the majority were outpatient 311 (60.9%) and 178 (34.8%) were office; 22 (4.3%) were ineligible. We examined the cost differences of select infusion drugs between the stable outpatient and stable office settings and observed significant cost differences across all drugs (p < 0.01). Based on our observations, 83 (27%) stable outpatient patients are expected to transition to stable office patients during the study period. After adjusting for drug, insurance type and state, transitioning these patients would be $71,169 ($55,259 to $81,709) less costly per patient per year. Conclusions: Our results suggest significant cost savings by transitioning stable outpatient patients to the office setting. Encouraging stable patients to transition from the outpatient setting to the office setting may improve the value of cancer care by reducing the unit cost of therapy, which is key to practices as value-based contracting expands.
Financial impact of immunotherapy-related adverse events among inpatient admissions with solid malignancies.
Authors: Pichardo Rayli , Abu Omar Yazan , Wang Ding
Published: June 2022

e18825

Background: Immune checkpoint inhibitors (ICPis) have shifted the landscape of cancer treatment from conventional cytotoxic regimens. The mechanism of action involves suppression of immunologic checkpoints that often results on a unique spectrum of side effects associated with immune-mediated inflammations. The Aim of this study is to evaluate the financial impact from immune-related adverse events (IrAEs) reflected in hospitalized patients undergoing anti-neoplastic immunotherapy using the data from a nation-wide database. Methods: We performed retrospective analysis with the National Inpatient Sample (NIS) using ICD10-CM and PCS codes to identify patients with solid tumors hospitalized for immunotherapy between October 2015 and 2018. Inpatient data from patients with or without having developed IrAEs during the hospitalizations were compared in this study. IRAEs included systemic symptoms, diarrhea/colitis, hepatic and endocrine adverse events. Baseline characteristics and inpatient complication variables were collected and analyzed between these two groups. Results: From 5,795 admissions of ICPi-treated cancer patients, 1,160 patients or 20 % of these hospitalizations presented with IrAEs, females represented (37.5%) with an age of 57 years though not statistically different from admissions without IrAE. On the other hand, length of stay was statistically longer (7 vs 5 days, p < 0.05) with higher admission expenses ($184,255 vs $ 133,305, p < 0.05) from IRAE-associated admissions. Higher IrAEs were observed among patients who were ICPi-treated for genitourinary (GU) cancers (22% vs 15%, p < 0.05). IRAE as an independent risk factor was associated with higher costs even when adjusted for other risk factors, significantly contributed to a higher admission expenses by a coefficient at $46,624 (SE +/- $13,943). Conclusions: Although ICPi-therapies have offered various clinical benefits among cancer patients. They have also contributed to both direct and indirect costs of cancer management. Our analysis showed a higher IrAE incidence associated with ICPi-treated GU cancer patients, patients who developed IRAEs had a longer hospital stay and higher in-hospital mortality, resulting in higher care expenses as one of the indirect financial burdens of ICPi therapies, no differences were observed between gender, race, or income.[Table: see text]
Communication about cost of cancer care: Attitudes and practices of oncologists.
Authors: Khalid Ahmed Bilal , Urrutia Samuel , Hanna Nasser H.
Published: June 2022

e18826

Background: With the cost of cancer care rising, it is becoming ever so important for physicians to be mindful of financial toxicity to their patients. Patient-provider cost discussions are associated with lower out of pocket costs (Hong el al, Value in Health 2020), yet few patients report having this discussion with their physician. There are few reports on oncologist’s preparedness, current practice, and barriers in discussing costs with their patients. Methods: An online survey was administered to hematology/oncology faculty physicians and fellows at the IU Simon Comprehensive Cancer Center. The objectives were to assess attitudes on communication about cost of cancer care and awareness around financial toxicity of cancer therapy. The questions included physician perception on patient’s attitudes towards cost discussion in clinics, current state of cost discussion in their clinic and their preparedness on having this discussion in the future. Results: 27/48 (56%) fellows and faculty members completed the survey. All respondents believed cost communication is associated with improved patient outcomes and 82% believed cost communication is desired by most patients. 22/27 (81%) indicated cost of care were discussed in less than half of patient encounters. 22/27 (81%) believed clear communication about cost should be a part of the patient’s clinic visit. When asked to rate their preparedness level on a scale of 0-100 on discussing cost of cancer care in their clinics, the median preparedness level was 20. Median awareness level about patient’s insurance plan was 20 and median awareness level about patient out of pocket cost was 21. 26/27 (96%) believed knowing cost of therapy and out of pocket cost would change the way they practice. 20/27 (74%) reported that not knowing the cost of cancer care themselves was the greatest barrier behind not discussing costs. Conclusions: Despite believing cost of cancer care should be discussed in the clinic, most hematologists/oncologists surveyed did not do so. Physician education on cost of cancer care and patient out-of-pocket costs is greatly needed.
Changes in oncology pharmacy benefit drug spend and trend in the United States.
Authors: Junk Christopher , Warde Prem R. , Hoversten Shanna , Sapkota Ujwal , Cavers William , Avalos-Reyes Elisea , Johnson Kjel Andrew
Published: June 2022

e18832

Background: The American Cancer Society projects the total cost of cancer care to increase to approximately $246 billion by 2030, an increase of roughly 34% from 2015. Estimating the nature and extent of health care spending on cancer care is vital to understanding the scope of cancer costs. Additionally, this information will help inform the development of policies and programs to optimize the value of cancer care. The purpose of this study is to evaluate changes in oncology-pharmacy benefit (PB) spend and highlight areas that may be targets for value improvement. Methods: We identified patients with cancer using medical claims data from January 1, 2019, to December 31, 2020 at a large national Medicaid, Medicare, and commercial insurer. We defined total oncology spend (TOS) as the sum of allowed costs paid for medical and pharmacy claims per year, including chemotherapy, supportive therapy, radiology, radiation, emergency room, inpatient admission and evaluation and management. We compared the total oncology spend, by type of service, for each year by cancer for patients receiving therapies paid under the PB. Results: This study included 72,923 patients in 2019 and 52,486 patients in 2020. During this time, the top 3 disease states with the highest percent of oncology spend attributed to PB were chronic myeloid leukemia (CML), multiple myeloma (MM) and chronic lymphocytic leukemia (CLL). Approximately 87% and 77% of total oncology spend were attributed to PB chemotherapy among CML and MM patients, respectively. CLL costs varied by type of insurance with 80%, 26% and 19% of the total oncology spend attributed to PB chemotherapy in Medicare, fully insured and self-insured patients, respectively. When examining year-over-year changes in PB spend from 2019 to 2020, we observed an increase in total oncology spend in gynecologic cancers regardless of the type of insurance. Additionally, we observed increases in rectal, gastric, head and neck cancers and hepatobiliary cancers primarily driven by Medicare patients. Conclusions: The economic burden of cancer is substantial and expected to significantly increase in the future. In this study, we observed differences in total oncology spend by cancer type and insurance, a proxy for age. Identifying trends in cancer spending allows the development of programs designed to better optimize value for certain tumor types.[Table: see text]
The risks of thrombotic and bleeding events in patients receiving PEGylated asparaginase for treatment of acute lymphoblastic leukemia.
Authors: Mautner Ben , Pierce Eric , Mort Joseph , DiBenedetto Samantha , Wells Leah , Ghamsari Farid , Morse Emily , Morris Amy , Keng Michael Kenneth , El Chaer Firas
Published: June 2022

e19015

Background: The prognosis of adult patients with acute lymphoblastic leukemia (ALL) has improved with the adoption of pediatric-inspired chemotherapy regimens. PEGylated asparaginase (PEG-Asp) is essential to these regimens. Although PEG-Asp is associated with an increased risk of coagulopathy, venous thromboembolism, and depletion of antithrombin III (AT3), there is limited data evaluating the risk of thrombosis and bleeding and optimal antithrombotic interventions in these patients are unknown. Methods: We performed a single-center retrospective study of patients ≥ 18 years-old who received PEG-Asp for B- or T-ALL at the University of Virginia between 2015 and 2020. The primary outcomes were the incidence of thrombosis and bleeding events. All patients received prophylactic AT3 repletion for activity level <60% & cryoprecipitate for fibrinogen <100mg/dL. None received prophylactic anticoagulation. All received prednisone during induction at a median daily dose of 1 mg/kg. Results: We identified 57 patients who received PEG-Asp for ALL. Median age was 32 years (range 18-63). Five patients (8.8%) had a thrombotic event during induction versus five (16%) during post-induction. Four patients (7%) had a bleeding event during induction versus five (10%) during post-induction. The most common type of thrombosis was deep venous thrombosis, with the majority being catheter-associated. Pulmonary embolism and CNS thrombosis were less common. During induction, the median time to thrombotic event was 18 days after last PEG-Asp administration. 60% and 80% of patients received AT3 and cryoprecipitate, respectively. During post-induction, the median time to thrombotic event was 58 days after last PEG-Asp administration. 38% and 63% of the patients received AT3 and cryoprecipitate, respectively. There was one episode of major bleeding during induction and six during post-induction. Conclusions: Though the increase in thrombotic risk in adult patients receiving PEG-Asp is well-characterized, rates of reported thromboses vary widely. Studies examining bleeding risk associated with PEG-Asp regimens are even scarcer and with variable outcomes. There was a significant occurrence of both thrombotic and bleeding events associated with administration of PEG-Asp. More investigation into the relative thrombotic and bleeding risks associated with PEG-Asp is needed to determine optimal antithrombotic interventions in adult patients with ALL.[Table: see text]
Inpatient outcomes of blinatumomab use: A national inpatient sample analysis.
Authors: Bakalov Veli , Tang Amy , Helfand Alexander M , Kancharla Pragnan , White Richard , Khattab Ahmed , Alhousani Mohammad , Samhouri Yazan
Published: June 2022

e19021

Background: Blinatumomab, a bispecific (CD3/CD19) T-cell engager, is indicated for the treatment of acute lymphoblastic leukemia (ALL). The initial portion of each cycle is administered in the inpatient setting for close monitoring for cytokine release syndrome and neurotoxicity. Real world data are lacking on the cost of hospitalization, length of stay (LOS), and mortality in inpatients treated with blinatumomab. The goal of this study was to analyze the clinical outcomes of inpatient blinatumomab administration utilizing a national database. Methods: The ICD-10 diagnosis and procedure codes were used to identify Blinatumomab admissions and related complications from the 2018 version of the Nationwide Inpatient Sample (NIS) database from the Healthcare Cost and Utilization Project (HCUP). Weighted analysis was used to calculate national estimates. Logistic regression analyses were used to examine predictors of hospital outcomes (in-hospital mortality, length of stay, and cost), with p < 0.05 considered statistically significant. Data were analyzed using SAS v9.4 (SAS Institute, Cary, NC). Results: A total of 228 patients received inpatient blinatumomab in this cohort. Median age was 46 years old (IQR 26.8, 63.0) and 59.2% were males, 50.4% were white, and 47.4% had private insurance. The majority of patients received care at an urban teaching (96.1%) or large hospital (76.3%). The most relevant inpatient complications during hospitalization included hypotension (7.5%), pneumonia (6.1%), sepsis (9.2%), seizure (2.2%), neutropenia (6.1%), thrombocytopenia (14.0), tumor lysis syndrome (3.9%), and acute kidney injury (9.6%). Median LOS was 9.0 days (IQR 3.0-16.2) and median hospitalization charge was $114,936 USD (IQR 51,984.2-240,557.5). On multivariate regression analysis, dialysis (OR 1.67, 95% CI 1.05-2.65), blood product transfusion (OR 1.5, 95% CI 1.14-1.97), sepsis (OR 2.63, 95% CI 1.86-3.73), neutropenia (OR 1.86, 95% CI 1.23-2.81), and pancreatitis (OR 1.46, 95% CI 1.11-1.91) were all associated with longer LOS. Dialysis (OR 1.83, 95% CI 1.29-2.6), transfusions (OR 1.52, 95% CI 1.01-2.28), sepsis (OR 1.87, 95% CI 1.20-2.91) and neutropenia (OR 1.84, 95% 1.04-3.24) significantly increased the cost of hospitalization. Conclusions: In this cross-sectional study of a large national cohort of patients receiving inpatient blinatumomab, multiple blinatumomab associated toxicities led to increased LOS and cost of hospitalization.
Association of genetic variants and survival in patients with acute myeloid leukemia in rural Appalachia.
Authors: Gates Christopher , Shultz Carl , Petros William Phillip , Wen Sijin , Primerano Don , Hazlehurst Lori , Denvir Jim , Sdrimas Konstantinos
Published: June 2022

e19022

Background: Many previous population health studies examining adults with acute myeloid leukemia (AML) are derived from national databases within large urban centers. To address the concern of under-representation of rural Appalachian population in cancer genomic databases, we performed exploratory whole exome sequencing in patients with newly diagnosed AML. As the only stem cell transplantation center in the state, WVU is uniquely situated to capture most of these patients from the state and surrounding area. Due to its unique industry and environmental exposures, we hypothesized that WV may have both different rates of mutations and differing outcomes than the nation as a whole. Methods: We performed whole exome sequencing on 26 patients with newly diagnosed AML from paired bone marrow and buccal samples that were obtained from 2015 to 2017. Whole exome sequencing libraries were prepared using Agilent SureSelect Human Whole Exome technology. The libraries were sequenced on an Illumina HiSeq1500 sequencer using paired end runs. Correlations between genetic variants and clinical outcome variables were examined via retrospective chart review. Variables measured included association between biomarker data and progression-free survival (PFS) and overall survival (OS). Results: Median patient age was 68 years and women represented 10 of the patients (37%). Twenty-one patients had de novo AML (84%), 3 patients had preceding MDS (12%), and 1 patient had therapy-related AML (4%). As per ELN criteria, 8 patients were favorable (32%), 12 were intermediate (48%), and 5 were adverse risk (20%). Eight patients proceeded to transplant with the following donors: 4 MUD (50%), DUCB (37.5%), and 1 haploidentical (12.5%). The median PFS and OS were 16.5 months and 26.6 months, respectively. Tobacco use was the largest known exposure with 7 patients. We noted a similar mutational trend compared to national TCGA data, except for an increased tumor mutation burden and higher frequency of the following mutations as seen in Table. Neither MUC3A or MUC5AC were identified in the TCGA database. Of our five patients with BCOR mutations, two had a co-existing FLT3-ITD mutation, one of which also had a NPM1 mutation. Two patients had secondary AML, while the other 3 had de novo disease. The median OS was 63 days. While not statistically significant, BCOR mutation was trending toward a poor prognostic indicator.Conclusions: Despite our small patient cohort, the findings provide further assessment of predisposing detrimental mutations in AML in the Appalachian region and associated survival outcomes.[Table: see text]
MUC family influence on acute lymphoblastic leukemia in Native American populations from Brazilian Amazon.
Authors: Alcântara Angélica Leite de , Pastana Lucas Favacho , Gellen Laura Patrícia Albarello , Vieira Giovana Miranda , Dobbin Elizabeth Ayres Fragoso , Silva Thays Amâncio , Pereira Esdras Edgar Batista , Barra Williams Fernandes , Rodrigues Juliana Carla Gomes , Fernades Marianne Rodrigues , Assumpção Paulo Pimentel , Guerreiro João Farias , Santos Sidney Emanuel Batista dos , Santos Ney Pereira Carneiro dos
Published: June 2022

e19025

Background: The MUC family includes several genes previously associated with carcinogenesis and it is associated with solid neoplasms such as those of the gastrointestinal tract. As far as we are aware, there are no studies relating MUC genes to acute lymphoblastic leukemia (ALL), and this type of cancer is more frequent in the Amerindian population, which has been understudied. Therefore, the present work aimed to investigate the MUC family exome in Amerindian individuals from Brazilian Amazon, in a sample containing healthy Native Americans (NAM) and indigenous with ALL, comparing the frequency of polymorphisms between these two groups. Methods: The population was formed by 64 Amerindians from the Brazilian Amazon from 12 different ethnic groups, 5 of whom were diagnosed with ALL. We analyzed 16 genes from the MUC family (MUC1, MUC2, MUC3A, MUC4, MUC5AC, MUC5B, MUC6, MUC7, MUC12, MUC13, MUC15, MUC16, MUC17, MUC19, MUC20, MUC21) and found a total of 1858 variants. Results: After the quality filter, only 743 variants remained. Among them, we compared the frequency of each polymorphism in the LLA vs NAM group, which led to 77 variants with a significant difference, and, among these, we excluded those with LOW impact, resulting in 63. The 63 polymorphisms were distributed in 9 genes, concentrated especially in MUC 19 (n = 30) and MUC 3A (n = 18). Finally, 11 new variants were found in the NAM population. Conclusions: This is the first work with a sample of native americans with cancer, a population which is susceptible to ALL, but remains understudied. The MUC family seems to have an influence on the development of ALL in the Amerindian population, and especially MUC19 and MUC3A are shown as possible hotspots. In addition, the 11 new variants found point to the need to have their clinical impact analyzed. Keywords: MUC family; ALL; Susceptibility; Native American Populations; Brazil.
Efficacy and safety of high-intensity versus reduced-intensity induction in Philadelphia chromosome-positive all ineligible for HSCT.
Authors: Tran Valerie , Bouligny Ian Michael , Zacholski Kyle , Venn Chad Michael , Alnimer Yanal Mufeed , Ho Thuy , Maher Keri Renee
Published: June 2022

e19031

Background: Treatment options for Philadelphia chromosome-positive (Ph+) ALL are increasing. When combined with TKIs, it is unclear if high-intensity regimens lead to a survival benefit compared to reduced-intensity regimens in patients that are not candidates for allogenic hematopoietic stem cell transplant (HSCT). In this study, we sought to examine outcomes of high-intensity and reduced-intensity induction regimens and concurrent TKI administration with respect to toxicity, response, and survival in non-transplant candidates. Methods: We retrospectively analyzed 31 patients with Ph+ B-ALL treated at our institution during January 2015 to January 2021 that were not candidates for HSCT. Baseline patient demographics were obtained, including age, performance status at diagnosis, cytogenetic and molecular profiling through NGS, doses of induction, toxicity, response, MRD analysis, and survival. The event for calculating the overall survival (OS) was the date of death and patients were otherwise censored at the date of last contact. Results: We divided the cohort of 31 patients into two sub-cohorts: a high-intensity cohort of 22 patients treated with TKIs and hyperCVAD, CALGB 10403, or ECOG 1910 and a low-intensity cohort of 9 patients treated with TKI + steroids + vincristine, TKI + steroids, or TKI alone. There was expectedly a significant difference in age between the two groups (p = .002) with more advanced age in the reduced-intensity cohort, though no difference in sex (p≥.999), ECOG score at diagnosis (p = .886), or Charlson Comorbidity Index score (p = .180). Grade 3 or higher toxicity was approaching statistical significance with more toxicity in the higher-intensity group (p = .075). With fewer deaths during induction, achievement of CR or CRi was higher in the reduced-intensity cohort (100% versus 73.7%), though was not significantly different between the groups (p = .288) and the median OS was not reached in either cohort (p = .935) after a median follow-up time of 3.29 years. Conclusions: Acknowledging the limits of a small sample size and retrospective nature of the study, there was no observed difference in survival between high-intensity and reduced-intensity induction with TKIs for patients ineligible for HSCT. Reduced-intensity inductions were associated with a trend toward less severe toxicity. These findings are suggestive that reduced-intensity induction with TKIs in Ph+ ALL may represent a reasonable option for those ineligible for HSCT. Prospective randomized controlled trials in this population are warranted.
Clostridioides difficile infection in hospitalized patients with leukemia: A nationwide analysis of incidence and outcomes.
Authors: Mansour Mahmoud , Abu-Farsakh Yomna , Darweesh Mohammad , Mahfouz Ratib , Obeidat Adham E. , Ghous Ghulam , Daglilar Ebubekir
Published: June 2022

e19042

Background: Clostridioides difficile infection (CDI) is the most common cause of nosocomial diarrhea. The incidence and severity of CDI have increased in adults. However, CDI has not been well studied in leukemia patients in the recent years. This study aims to evaluate incidence, mortality, and health care burden in patients with acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), chronic myeloid leukemia (CML) and chronic lymphocytic leukemia (CLL). Methods: The United States Nationwide Inpatient Sample was used to extract hospitalization data of patients admitted between Jan 1st, 2016, to Dec 31st, 2019. Using International Classification of Diseases 10th revision codes, we identified adults with a discharge diagnosis of CDI and a concomitant leukemia diagnosis. The control group included non-leukemia patients with CDI. Primary outcome was in-hospital mortality. Secondary outcomes were length of stay (LOS) and hospital charges. Multivariate logistic regression was used to adjust for relevant variables. Results: An estimated 1,235,465 patients were admitted with CDI during the study period. CDI incidence per 100 discharges was higher among leukemia patients, particularly in AML and ALL patients (4.1 and 3.6, respectively) vs. 1 in general population. After adjusting for comorbidities and demographic variables, AML and ALL were independently associated with increased odds of mortality (adjusted odds ratio [AOR] 2.19 and 1.90 respectively: P <0.01). Additionally, both AML and CML had significant mean increase in length of stay (7.2 and 3.1 days respectively; P <0.01) and hospital charges (115,245$ and 87,198$ respectively; P <0.01) compared to non-leukemia patients. Conclusions: Among leukemia patients admitted with CDI, those with AML and ALL have significantly higher adjusted odds of mortality, length of stay, and hospital charges. AML and ALL patients also had the highest incidence of CDI. Applying antibiotic stewardship and appropriately diagnosing and treating CDI is pertinent in these high-risk patients.[Table: see text]