bluuebunny/crossref_metadata_2025 huggingface dataset:
Robotic CT guided biopsy to aid histological confirmation of recurrent lymphoma in cases where tissue sample is challenging to obtain through conventional percutaneous methods.
Authors: Bamania Prashant , Elwood Elliot , Millard Thomas , Smith Sam , Khan Nasir , Fotiadis Nicos , Cunningham David , Johnston Ed , Sharma Bhupinder
Published: June 2023

e18796

Background: Histological confirmation of recurrent lymphoma, suspected on clinical history or imaging, enables the determination of an optimal treatment regimen. Conventional percutaneous biopsy methods often involve computed tomography to plan ‘freehand’ needle paths that will often require multiple in procedure adjustments which increases the risk of collateral damage. In cases where suspected recurrent disease is challenging to access using conventional methods, such as lesions close to major structures or located within the retroperitoneum, histological diagnosis can be delayed. Robotic CT guided biopsy allows precise lesion targeting, minimizing the risk of collateral injury, enabling minimally invasive tissue diagnosis in difficult to access lymphoproliferative disease. The aims of this analysis were to assess the safety of robot assisted biopsy by analyzing the related complications and the effectiveness of robotic CT guided biopsy via the sufficiency of histological specimens obtained. Methods: Retrospective consecutive analysis of 11 patients who underwent robotic CT guided biopsy between the months of January and October 2022 in the context of suspected recurrent lymphoproliferative disease. The decision for robotic guided biopsy was based on a multidisciplinary team assessment of the radiology and proposed target sites. Tissue sample adequacy and histological diagnosis were recorded from local histopathology reports. Biopsy related complications were recorded within a 4-month follow-up period from clinical documentation. Results: 11 patients underwent robotic CT guided biopsy. Sufficient samples consisting of at least 2 cores were obtained in all patients. 9 patients were identified with a recurrent form of lymphoma. 1 patient was negative for recurrence. In 1 case an insufficient sample was obtained. No biopsy related immediate or late complications were recorded. Conclusions: We find that, with careful case selection, robotic CT guided biopsy is allowing us to safely obtain a histological diagnosis in suspected recurrent lymphoma where conventional methods are deemed challenging. In the single case where an insufficient sample was obtained significant patient agitation was documented, highlighting that a static target remains of importance with robotic CT guided biopsy. The targeting accuracy the technique provides is allowing optimal treatment planning in a higher proportion of cases.
Under-screened: COVID-19 lockout measures and the reduction of early-stage cancer patients’ consultations in Argentina.
Authors: Gil Deza Ernesto , Martin Reinas Gaston , Gonzalez Liliana D. , Gil Deza Isaias , Montiel Monica , Garcia Gerardi Carlos , Abal Mariana , Acuna Claudia Lorena , Smolje Leonel , Rojas Francisca , Pollola Juan , Muino Marcelo , Morgenfeld Eduardo L. , Rivarola Edgardo G. J. , Gercovich Daniela
Published: June 2023

e18801

Background: The COVID-19 pandemic caused a disruption in health services, specifically in cancer prevention, during quarantine. Argentina had one of the most extensive social isolation policies, which began on March 20, 2020. We analyzed the pandemic’s impact on the number of new patients and tumor stage distribution for those seen between March 20, 2020 and March 18, 2021 (Group B = Pandemic) and compared it with: i) those seen in the previous five years (Group A = Pre-pandemic); and ii) those seen between March 20, 2021 and December 31, 2022 (Group C = Post-pandemic). Methods: Our database comprised all new patients admitted to Henry Moore Cancer Institute (IOHM) in Buenos Aires, Argentina between March 20, 2015 and December 31, 2022. It included population characteristics at the time of first consultation, diagnosis and tumor stage according to TNM AJCC (8th Edition). The comparisons were made through Statistical t-Test and Chi-square homogeneity test. Results: Between March 20, 2020 and December 31, 2022, 17833 new patients were admitted to IOHM. The distribution of diagnoses was similar for all three groups: Breast (23%), Colorectal (11%), Prostate (10%), Gynecological (9%), Lung (7%), Renal (5%), Lymphomas (5%), Cervix (4%), Head and neck (3%), Pancreas (2%), Melanoma (2%), Sarcomas (2%), others (17%). Table 1 summarizes our main findings. The incidence of in situ tumors (stage 0) showed a significant reduction during the first year of COVID-19 in five tumors, despite strong evidence for screening benefits in all of them: Breast, Colorectal, Prostate, Melanoma and Cervix. The decrease in stage I new patients was observed in virtually all tumors, as well as the relative increase in stage IV (most notable in lung cancer, colorectal cancer and melanoma). Conclusions: A) During the first year of the COVID-19 pandemic, there was an expected quantitative decrease in new patients compared to the previous five years. B) However, we have also found qualitative changes in the characteristics of patients seeking a first consultation: younger patients, with worse ECOG, less early stages (0 and I) and more advanced stages (III and IV) in practically all tumors. C) These figures have improved in the 22 months following the lockdowns, but have not yet recovered to the values of pre-pandemic years. D) Given the strong evidence available for screening benefits in all of the five tumors that have seen a reduction in early stages consultation, preventative actions and campaigns must be reinforced. [Table: see text]
Correlation between step count and clinical outcomes for patients with cancer during treatment: A feasibility study.
Authors: Oakley-Girvan Ingrid , Yunis Reem , Lyden Kate , Davis Sharon W , Zhai Yaya , Blakenship Jen , Kubo Ai , Liu Raymond , Neeman Elad
Published: June 2023

e18804

Background: Step count, as measured by a wearable accelerometer, has been shown to have a relationship to premature death, cardiovascular events, functional decline, longer stay, and higher rehospitalization rates. However, few cancer studies or trials have incorporated accelerometers to measure response to active treatment. We developed the DigiBioMarC™ smartphone application for cancer patients to enable participation in decentralized clinical trials and remote cancer care by collecting informed consent, ePROs and accelerometer data using an Apple Watch. This analysis assessed whether daily step data were associated with participants clinical events. Methods: We tested the feasibility of the DigiBioMarC application along with the Apple Watch for approximately 4 weeks with 50 cancer patients undergoing IV chemotherapy or immunotherapy recruited in a fully decentralized study through Kaiser Permanente Northern California. Participants used the app for at least 28 days and were provided with an Apple Watch if they did not already have one. Data pre-processing was performed to identify periods of missing data and non-wear time. Step count was calculated for each calendar day and days that included at least ten hours of wear time while awake were considered sufficient and included in the analysis. Specific clinical events were collected from the patients’ electronic health records (EHR) up to six months following the study. Results: Thirteen participants experienced at least one clinical event, and there were 5 deaths. Using Cox regression, patients with more sufficient days were less likely to die during follow up (p = 0.122) than patients with fewer sufficient days. On sufficient days, median daily steps < = 2,510 were associated with one or more adverse clinical events, while daily steps > 2,510 were associated with no clinical events and had a longer time to adverse clinical event (p = 0.068) compared to those with less than or equal to 2,510 median daily steps on sufficient days. Daily median step count on sufficient days predicted clinical event occurrence with an accuracy of 0.833. Conclusions: Findings from this feasibility study support the hypothesis that daily stepping behavior is a valid real-world digital measure to predict clinical events in patients undergoing cancer treatment. Although the predictive models did not reach statistical significance (p < 0.05), this is likely due to the low frequency of clinical events in the dataset. These findings indicate that future investigations with larger sample sizes are warranted as this may be a beneficial tool for decentralized trials or care when patients have longer periods of time between clinical visits. In patients undergoing cancer treatment, real-world based step data extracted from wearables can provide early indication of poor or declining health.
Retrospective analysis of the effect of COVID-19 in hospitalized cancer patients.
Authors: Shah Senin , Sherif Akil Adrian , Hsu Andrew
Published: June 2023

e18822

Background: Immunocompromised states such as cancer have been established as predictors of worse outcomes in COVID-19. The pandemic affected delivery of healthcare to this subset of the population, resulting in delays in diagnosis and increasing the overall mortality of cancer patients. We examined outcomes of cancer patients who were hospitalized with COVID-19 across the United States during the COVID-19 pandemic. Methods: We conducted a retrospective analysis of the discharge data from National Inpatient Sample (NIS), from 2020. A search was performed using ICD-10 codes for cancer (solid, hematologic and metastatic) and COVID-19. Patients with a primary diagnosis of COVID-19 and secondary diagnosis of cancer were identified. Baseline characteristics were analyzed. Outcomes of in-hospital mortality, length of stay (LOS) and health care costs were compared between patients with cancer and COVID-19, and those with cancer without COVID-19. Multivariate regression analysis was used to adjust for confounders. Results: We identified a total of 1,759,235 hospitalizations related to cancer out of which 45,660(2.6%) also had COVID-19. Cancer patients with COVID-19 were more likely to be older (69.8 vs 65.6 years, P < 0.001), African-American (18.2 vs 13.33 %, P < 0.001), Hispanic (14.3 vs 8.8 %, p = 0.002), and had a median household income in the 1st quartile (30.6 vs 26.2%, p < 0.001). Cancer patients with COVID-19 were also more likely to have diabetes, hypertension, obesity, CKD, chronic pulmonary disease, and heart failure (p-values < 0.001). Multivariate logistic regression analysis of the two groups showed that cancer patients with COVID-19 had higher odds of dying in the hospital (19.2% vs 6.6%) with adjusted odds ratio (aOR) 3.13 (P < 0.001, CI: 2.95-3.31). Cancer patients with COVID-19 also had statistically significant higher LOS (8.6 vs 6.1 days; aOR 2.49; P < 0.001 and CI: 2.12-2.56) and higher rates of mechanical ventilation (10.8 vs 4.4%; aOR 2.49; P < 0.001; CI:2.33-2.66). Mean hospitalization charges were higher in cancer patients with COVD-19 ($101,538 vs $85,756; P < 0.001). Conclusions: In patients hospitalized with cancer, those with COVID-19 had higher odds of in hospital mortality as compared to those without COVID-19. Patients with cancer and COVID-19 were more likely to be older, African American and had a higher comorbidity burden. This data is consistent with previous studies that have established that COVID-19 disproportionally affected people of lower socio-economic status, African Americans and Hispanics. It is noteworthy that these differences persist in the cancer population, even though they are presumably more active participants in healthcare, highlighting the racial and socio-economic disparities in our healthcare system. This study re-enforces the importance of preventative public health measures and investigating the social determinants of health in this high-risk population.
Real-world effectiveness of prophylactic tixagevimab-cilgavimab monoclonal antibodies on incidence and severity of COVID-19 infection in patients with cancer.
Authors: Naser Maryam , Bhardwaj Prarthna V , Warriach Fatima Zahid , Jadoon Yamna , Gupta Kush , Rastegar Vida , Loke Chandravathi , Siddappa Malleshappa Sudeep Kumar
Published: June 2023

e18843

Background: Mortality rate secondary to COVID-19 in patients with cancer is estimated to be > 10% after vaccination, with an increased risk of infection and hospitalization The FDA granted emergency use approval for pre-exposure prophylaxis with tixagevimab-cilgavimab (Evusheld)based on preliminary results from the PROVENT trial conducted before the emergence of the Omicron variant. However, there are limited real-world studies investigating the impact of Evusheld on COVID-19 in patients with cancer, especially after Omicron became the most common circulating variant in the US in Nov 2021. We assessed the impact of Evusheld on the incidence and severity of COVID-19 at our institution. Methods: We conducted a retrospective descriptive study in our institution on patients with cancer who received Evusheld between Dec 2021 and Mar 2022 with a 6 month follow-up. Primary outcome was incidence of COVID-19. Secondary outcomes included rate of hospitalization related to COVID-19 and associated mortality. Results: Of the 228 patients included in this study, 90% were White with a median age of 67 years, 67% had a hematologic malignancy, 98% were vaccinated against COVID-19, and 72.8% received the recommended 300mg dosing during the study period. Thirty-one patients (13.6%) developed COVID-19, with an average time to diagnosis of 43 days from receiving Evusheld, of whom 26 (83%) were symptomatic. Infected patients were of an average age of 60 years with a BMI of 26, and only a minority (3.2%) had prior COVID-19. Most had hematologic malignancies (77.4%), with the most common being non-Hodgkin lymphoma. Most were receiving chemotherapy (68%) at the time of diagnosis. Third of the affected patients received ani-CD20 treatment (32%). Most received only 150 mg dose (80.6%) of Evusheld. 8(33%) patients with hematological malignancy and 3 (42%) with solid malignancy received Paxlovid after diagnosis. All patients who had COVID-19 were previously vaccinated, with the majority receiving 3 doses (64.5%). Five (16%) patients were hospitalized for COVID-19, of whom 4 had hematological malignancy; one with hematological malignancy required mechanical ventilation and died. Conclusions: Overall, the incidence of COVID-19 following Evusheld was higher than in the PROVENT trial. This could be attributed to the ineffectiveness of Evusheld against new variants. Infections appeared to be more common and severe in patients with hematologic malignancies. [Table: see text]
Utilization and dispensing patterns of medical cannabis products in a state with legalized medical cannabis.
Authors: Olson Amanda Leigh , Lai Stephen Yenzen , Shete Sanjay , Harbison Kevin , Scheid Jennifer , Jankowski Mika , Tanco Kimberson Cochien
Published: June 2023

e18844

Background: The medical uses of cannabis-based products have been proposed to include treatment of pain, various neurological, gastrointestinal and psychological conditions. Cancer patients are some of the highest utilizers of medical cannabis-based products. To understand real world use and impact of cannabis-based products, we analyzed the database from 4 dispensaries of a cannabis company licensed in New York state. We aim to evaluate the dose, average THC/CBD ratios, association of various medical conditions to THC/CBD dose and cost of products to individuals receiving cannabis-based products. Methods: A retrospective analysis of anonymized data was conducted on 422,201 dispensed products from 32,845 unique individuals aged 18 years and older between 1/1/2016 and 12/31/2020. The database included patients age, gender, qualifying medical condition, type of product, medication directions and amount of product dispensed. Results: Median age was 53 years old and 52% were females. Cancer and non-cancer related pain (85%) were the most common medical condition and inhalation (57%) the most common route. Individuals received a median of 6 prescriptions with median cost of $50/product. Average THC:CBD ratios were 28:0.5mg/day and 12:0.25mg/dose. Highest average cost [mean (95% CI): $73 ($71-$75)] and average CBD/dose per product [mean (95% CI):5.89 (5.38-6.40)] were dispensed for neurological conditions. Highest average THC/dose [mean (95% CI): 14.25 (13.36-15.14)] were found as use as alternative products for those with substance use disorders. Table 1 shows the comparison of gender and route to medical condition. Conclusions: More females received medical cannabis prescriptions while males used more products. Pain was the most common reason for medical cannabis prescriptions. Neurological conditions demonstrated highest average cost and CBD/dose and prescriptions for substance use disorder demonstrated highest THC/dose for products dispensed. Products prescribed had more THC as compared to CBD and inhalation was preferred. As cancer patients increasingly utilize medical cannabis products in conjunction with tumor directed and symptom therapy it will be important to have randomized studies to help guide oncologists. [Table: see text]
Real world assessment of clinical benefit with consolidation durvalumab following chemoradiotherapy in stage III unresectable non-small cell lung cancer.
Authors: Marur Shanthi , Mangurian Mark , Wise Corey , Pozotrigo Melissa , Marur Shika , Norden Andrew D. , Toler Andrew , Bobolts Laura Rose
Published: June 2023

e18853

Background: The phase III PACIFIC trial compared the efficacy of consolidation durvalumab to placebo in newly diagnosed, unresectable stage III non-small cell lung cancer (NSCLC) who had not progressed after chemoradiotherapy (CRT). With a median follow-up of 34.2 months, the median progression free survival (PFS) was 16.9 months (13.0-23.9) compared to 5.6 months (4.6-7.7) for placebo (HR = 0.55, 95% CI,0.45-0.68). We report a real-world study that utilizes surrogate endpoints to assess duration of clinical benefit with consolidation durvalumab. Methods: OncoHealth, a digital health company, conducted a retrospective observational real-world study to assess time to treatment failure in patients with unresectable Stage III NSCLC who received consolidation durvalumab after completion of CRT between June 2018-June 2021. Data sources included electronic medical records (EMR) submitted with prior authorization (PA) requests to OncoHealth and medical claims data. With a data cut-off of 12/22/2022, real-world Time to Progression (rwTTP), and real-world Time to Next Treatment (rwTTNT) were evaluated to assess time to treatment failure. All end points were measured from durvalumab administration dates, rwTTP spanned until earliest date of clinician-assessed progression, and rwTTNT spanned until initiation of subsequent treatment. Results: Total of 281 patients with unresectable Stage III NSCLC who received durvalumab after completion of definitive CRT were identified. Median age was 71 years (range: 53 to 88), 57% male, 53% former smokers, 47% Stage IIIA, 52% non-squamous histology and 98% received concomitant platinum-based chemotherapy prior to durvalumab. Median time between completing CRT and initiating durvalumab was 41 days. With a cutoff date of 12/22/2022, and a median follow up of 28.4 months, 34% (n = 95) experienced disease progression. Sites of progression included lung, lymph nodes, adrenal, liver, bone and brain. The median rwTTP was 10.6 months (range: 2.0-38.1 months) and median rwTTNT was 12.4 months (range: 2.5-39.6 months). Conclusions: In this real-world study, the patient and disease characteristics available in EMR were comparable to those reported in the PACIFIC trial. The rwTTP and rwTTNT reported here suggest treatment failure occurred within one year of exposure to durvalumab and subsequent line of treatment was initiated shortly thereafter. Variables such as co-morbidities, performance status, treatment compliance, change of payers and barriers to treatment in real world will be further explored.
Outcomes of stage IV non-small cell lung cancer patients after failure of platinum-based chemotherapy in clinical trials and real-world settings: A literature review.
Authors: Soon Yu Yang , Furnback Wesley , Kim Jin , Chuang Jenny , Chavez Gordon , Proescholdt Christina , Koh Cloe Ying Chee
Published: June 2023

e18859

Background: To report the outcomes of therapeutic regimens being evaluated for patients with stage IV non-small cell lung cancer (NSCLC) that has progressed on or after platinum-based chemotherapy in clinical trial and real-world settings. Methods: A systematic literature review was undertaken to identify clinical trials and real-world studies evaluating treatments for stage IV NSCLC after progression with platinum-based chemotherapy. Studies were included in the review if they were published between September 2017 and September 2021, in English, and included an outcome of interest. The outcomes of interest were overall response rate, progression-free survival, overall survival, the incidence of grade 3-4 adverse events, and discontinuation due to adverse events. Results: A total of 23 studies were identified, comprising of 17 clinical trials and six real-world studies. The total sample size ranged from 12 to 1,253 patients in clinical trials and 11 to 383 patients in real-world studies. A total of 28 and six treatment regimens were evaluated within the clinical trials and real-world studies respectively. Six clinical trials evaluated outcomes in the second-line setting, one in the third-line, three in a mix of second-line and above, and seven did not report the specific treatment line(s). There were no real-world studies exclusively in the second-line setting, one in the third-line, three in a mix of second-line and above, and two did not report the specific treatment line(s). Ramucirumab + docetaxel was the only treatment regimen evaluated in both the clinical trial and real-world studies. In the real-world studies, nivolumab was the most common treatment evaluated (n = 3). The real-world studies were conducted in India (n = 2), China, Colombia, Germany, and the United States. The overall response rate (ORR) ranged from 3% to 66% and a rate of > 15% was reported for one or more treatment regimens in 86% (12/14) of clinical trials. ORR ranged from 10% to 36% in real-world studies. Median progression-free survival ranged from 1 to 5 months in clinical trials and 3 to 8 months in real-world studies. In clinical trials, a median PFS of > 6 months was observed in 71% (10/14) of studies. Median overall survival (OS) ranged from 5 to 15 months in clinical trials and 3 to 18 months in real-world studies. Discontinuation due to adverse events ranged from 3-15% in clinical trials and 9-20% in real-world studies. Conclusions: Patients with stage IV NSCLC that has progressed on or after platinum-based chemotherapy experienced a limited response and a high burden of adverse events with the treatment regimens evaluated in both the clinical trial and real-world settings.
A population-level analysis of survival in patients with ALK+ anaplastic large cell lymphoma (ALCL) in the era of novel therapies.
Authors: Mishra Rahul , Dima Danai , Durmaz Arda , Mian Agrima , Mukherjee Sudipto , Caimi Paolo Fabrizio , Jagadeesh Deepa
Published: June 2023

e18863

Background: The introduction of novel therapies such as brentuximab vedotin (BV), has changed the treatment paradigm of ALK+ALCL in both upfront and relapsed/refractory settings. We sought to compare differences in the survival trends of patients with ALK+ ALCL in the routine clinical practice, before and after approval of BV (year 2011). Methods: We used SEER-17 registry to identify adult patients using international classification of disease code for oncology assigned to ALK+ ALCL (9714/3) between 2000-2019.We excluded patients (pts) with diagnosis on autopsy or from death certificate, unknown survival time, any other malignancy, cause of death other than non-Hodgkin lymphoma, or survival of < 2 months from diagnosis. Follow-up period was until December 2019. Demographics and treatment details were extracted using SEER Stat v8.4.0.1. Comparisons were made between pts diagnosed in 2000-2010 (pre-BV) vs 2011-2019 (post-BV) using R v4.0. 2. Chi-squared test was used to calculate difference between categorical variables. Kaplan-Meier method and log-rank test were used to estimate overall survival (OS). A multivariate cox proportional hazard (CPH) model, adjusted for sex, radiation, and time-dependent covariates was used to estimate impact of time-period on survival. Results: A total of 1794 pts (n = 956 pre-BV, and 838 post BV) with ALK+ ALCL were identified. The majority were male (1099, 61%), white (78%), and had median age of 49 (IQR: 34-62) years at diagnosis. The baseline characteristics of pts diagnosed during the two time periods were similar (Table). 3-year (y) and 5y OS (95%CI) were 81% (78.1-83.7) and 79% (75.9-81.9) in post-BV vs 61% (58.0-64.2) and 58% (55.5-61.7) during pre-BV period (P < 0.0001, log rank test). Multivariate model showed increased risk of death in the pre-BV vs post-BV period particularly among those surviving > 6 months after diagnosis [log(HR), (95%CI)] = [1.12 (0.86-1.38)]. Conclusions: Using data from nationwide cohort, we demonstrated an improvement in the OS trend of pts with ALK+ ALCL treated in the era of novel targeted therapies, compared to those treated in pre-BV era. [Table: see text]
The same outcome of cancer patients treated with radiotherapy or chemoradiotherapy regardless COVID-19 status.
Authors: Zhang Zhenyu , Li Ping , Zhou Juan , Lin Qinghai , Peng Xun , Meng Xue , Hu Man , Zhao Miaoqing , Ru Kun
Published: June 2023

e18866

Background: COVID-19 has spread all over the world and infects people including cancer patients. The aim of this study is to explore the influence of COVID-19 infection on various cancer patients in China. Methods: A total of 167 cancer patients receiving radiotherapy or chemoradiotherapy from July 2022 to February 2023 were included in this study. Tumor types included lung, breast, esophageal, nasopharyngeal, cervical, pancreatic, thymus, rectal, bladder, testicular cancers, and glioblastoma, etc. The patients were divided into three groups: no COVID-19 infection during the therapy cycle (group A, n = 52), therapy beginning at least 10 days after the first positive COVID-19 tests (group B, n = 43), and therapy beginning less than 10 days after the first positive COVID-19 tests (group C, n = 72). The COVID-19 variants in this study were BA5.5.6, BA.5.2, and BF.7. Results: Some infection-related parameters were increased in COVID-19 positive cancer patients, such as SAA (group A vs group B, p= 0.0006; group A vs group C, p= 0.0004), hsCRP (group A vs group B, p= 0.0043; group A vs group C, p= 0.0144), ferritin (group A vs group B, p= 0.0417; group A vs group C, p= 0.0319) and PA (group A vs group C, p= 0.011), yet IL-6 and PCT were of no difference among three groups. Similarly, the serum markers for the myocardial and hepatic lesions, such as LDH (group A vs group B, p= 0.0064; group A vs group C, p= 0.0369), HBDH (group A vs group B, p= 0.0116; group A vs group C, p= 0.0414), and CHE (group A vs group B, p= 0.0303; group A vs group C, p= 0.0256), were raised in both group B and group C, but AST, CK, CK-MB, ADA, GGT, cTnT, and proBNP showed no difference between COVID-19 positive and negative cancer patients. The cancer patients receiving radiotherapy or chemoradiotherapy showed no differences in the lowest WBC, Hgb, platelets, NLR (Neutrophil to Lymphocyte Ratio), and lymphocyte subtype counts among three groups. Nevertheless, the leukopenia was apparent in group C (group A vs group C, p= 0.0031; group B vs group C, p= 0.0194), and no obvious difference between group A and group B. Finally, the dropout rates in three groups were nearly the same (group A, 4/52; group B, 6/43; group C, 6/72), and the causes of treatment interruption varied, including pneumonia, deep venous thrombosis, mucosal damage, headache, diarrhea, agranulocytosis, esophageal fistula, etc. Moreover, the completion rate of treatment was not affected by the radiation dose or antitumor drugs in COVID-19 infected cancer patients. Conclusions: This study found that COVID-19 infection did not change the completion rate of radiotherapy or chemoradiotherapy in cancer patients, although some hematological and serum parameters altered during the treatment and infection. In contrast to NCCN guidelines, cancer patients positive for COVID-19 could be treated safely by radiotherapy or chemoradiotherapy.
The broader impact of specialized outpatient cancer rehabilitation on health and quality of life among breast cancer survivors.
Authors: Pergolotti Mackenzi , Wood Kelley C , Kendig Tiffany
Published: June 2023

e18881

Background: After diagnosis and treatment, women with cancer often experience significant functional decline from which most do not recover. Functional deficits, especially when persistent, are related to poorer health and quality of life (QOL). Interventions to mitigate declines in function, health and QOL are necessary given their known associations with morbidity and mortality yet are understudied and underutilized. While there is evidence supporting cancer rehabilitation’s (Physical or Occupational therapy, PT/OT) ability to improve physical function and upper extremity disability among breast cancer survivors (BCS), the impact of cancer PT or OT on health and QOL is unknown. To understand this broader impact, we examined the rehabilitation needs and outcomes of BCS who attended specialized, community-based cancer PT/OT. Methods: In this retrospective study, we extracted case characteristics and patient-reported outcomes (PRO) measures of health, function and QOL from a national sample of BCS who attended cancer-specialized outpatient PT or OT. We examined ICD-10 codes to identify rehabilitation needs. PROs collected at baseline and discharge from rehabilitation included: Patient Reported Outcome Measuring System (PROMIS) global physical health, global mental health, physical function, and ability to participate in social roles and activities. To examine change from baseline to discharge we used paired t-tests ( p< .05) and calculated effect size (Cohen’s d). Results: PT/OT patients (N = 2,706; PT, n = 2,245; OT, n = 461) were 99.6% female, 58.33±12.50 years old and attended approximately 10 (IQR: 7.0 – 17.0) sessions. Needs included: muscle atrophy, weakness or ataxia (PT: 44%, OT: 32%); lymphedema (PT: 40%, OT: 56%); upper extremity impairment (PT: 44%, OT: 28%); pain (PT: 44%, OT: 25%); and scar tissue or fibrosis (PT: 15%, OT: 16%). At discharge, all health, function and QOL-related outcomes improved significantly (p < .001) in both PT and OT. Specifically, significant gains in PROMIS global physical health (PT: M∆ = 3.56±7.21, d= 0.49; OT: M∆ = 2.26±7.03, d= 0.32), global mental health (PT: M∆ = 2.01±6.91, d= 0.29; OT: M∆ = 1.34±7.20, d= 0.19), physical function (PT: M∆ = 2.81±7.45, d= .38, M∆ = 1.91±7.39, d= .26), and participation in social roles & activities (PT: M∆ = 3.24±9.09, d= .36; OT: M∆ = 1.91±8.41, d= .23) were observed. Conclusions: BCS presented to community-based outpatient rehabilitation with a variety of needs yet, despite this variety, demonstrated significant improvement in self-perceived health, physical function and QOL. Significant gains were reported for both PT and OT interventions. For providers working with BCS, these results can be used to increase awareness of the role of cancer rehabilitation and support referral to these services. Future research should evaluate the impact of specialized PT/OT on individuals with other cancer types.
Healthcare resource utilization (HCRU) and costs among adult patients with lung cancer with broad panel genomic testing and clinically relevant or non-clinically relevant genomic variants.
Authors: Moore Kristin , Diessner Brandon , Le Lisa , Yuan Tze-An , Cao Feng , Horstman Thomas , Landis Christina , Johnson Michael P , Sainski-Nguyen Amy
Published: June 2023

e18889

Background: Lung cancer is the second most common cancer diagnosed in the United States. An estimated 236,740 new cases of lung cancer were diagnosed in 2022. Use of genomic testing to drive treatment decisions can lead to improvements in patient survival. However, the HCRU and costs of genomic testing are just being understood and little is known about the impact of the clinical relevance of those genomic findings. Methods: This retrospective analysis utilized administrative claims and enrollment information with linked genomic sequencing results from Optum’s de-identified Market Clarity Data and Clinicogenomics Database. Adult lung cancer patients newly diagnosed between 01 January 2016 – 30 June 2021 with evidence of treatment and genomic sequencing results post diagnosis were eligible for the study. Patients were required to have at least 6 months of continuous enrollment prior to and after their diagnosis date, unless death occurred, and were followed until death, disenrollment, or study end. Cohorts were created based on presence of clinically relevant variants with an FDA-approved treatment for lung cancer. Unadjusted all-cause HCRU and costs during follow-up were reported as per-patient per-month (PPPM). Results: This study identified 2,190 patients, of which 999 (45.6%) had clinically relevant variants. Age, insurance type, and geographic region did not appear to differ substantially between groups, though those with clinically relevant variants were more likely to be female (57.4% vs. 46.0%). During follow-up, the average number of PPPM ambulatory visits was similar between groups (5.89 vs. 5.58, p = 0.08), but the average number of emergency room visits (0.29 vs. 0.23, p < 0.01) and inpatient stays (0.12 vs. 0.11, p = 0.03) were higher among those with clinically relevant variants. Additionally, those with clinically relevant variants had higher average PPPM all-cause medical costs ($20,948 vs. $19,097; p = 0.02) and pharmacy costs ($3,073 vs. $2,083, p = 0.02). Conclusions: Average PPPM emergency room visits, inpatient stays, medical costs and pharmacy costs were higher among lung cancer patients with clinically relevant variants compared to those with non-clinically relevant variants. Future research should evaluate HCRU and costs attributable to targeted therapy. [Table: see text]
Antidepressant adherence trajectory before cancer diagnosis and risk of antidepressant discontinuation after cancer diagnosis among middle-aged US adults.
Authors: Onasanya Oluwadamilola , dosReis Susan , Damachi Udim , Camelo Castillo Wendy
Published: June 2023

e18890

Background: For middle-aged adults taking antidepressants before cancer diagnosis, concerns exist about drug-drug interactions between antidepressants and antineoplastics. Clinical guidelines recommend detailed assessment of the new cancer survivor's past history of antidepressant use before considering antidepressant discontinuation. We aimed to determine whether, in real-world settings, the risk of antidepressant discontinuation after cancer diagnosis is associated with survivors’ past antidepressant adherence trajectories. Methods: A retrospective cohort of 45 to 64-year old individuals with incident cancer diagnosis (index date) and ≥2 antidepressant fills in the 9 months before index date, IQVIA PharMetrics Plus for Academics claims, 2006-2020. Antidepressant adherence in the 9-month baseline was measured as monthly proportion of days covered (PDC) before tamoxifen initiation. Group-based trajectory modeling (GBTM) was used to identify clusters of survivors with distinct antidepressant adherence trajectories pre-index date i.e., we calculated polynomial functions of monthly PDCs and compared 2 to 6-group finite mixture models to determine which model best fit the data, based on the Bayesian Information Criterion, expert-adjudged parsimony and ≥10% of the sample in each trajectory group. Antidepressant discontinuation after cancer diagnosis was defined as a 45-day gap in antidepressant supply. Survivors were censored at first of either antidepressant discontinuation, loss of enrollment or 1 year post-index date. Cox regression compared the hazard of antidepressant discontinuation by trajectory group, adjusted for demographics, mental disorder and cancer type. Results: We identified 7,293 middle-aged cancer survivors with prior antidepressant use; females 72%, mean age (SD) 56 (7) years. GBTM identified 4 adherence trajectory groups (consistently high, steady increase, declining, and recent start); metastatic cancer being characteristic of the latter 3 groups relative to the consistently high group. Antidepressant discontinuation was lowest in the consistently high group (26% [mean months-to-discontinuation: 9]) and highest in the declining (68% [5]) and recent start (51% [6]) groups, p < .01. Hazard ratios [95% CI] of discontinuation were significantly higher in the declining (2.7 [2.3 – 3.2]), recent start (1.9 [1.7 – 2.0]) and steady increase (1.5 [1.4 – 1.6]) groups, relative to the consistently high group. Conclusions: Middle-aged cancer survivors with past trajectories of consistently high adherence to antidepressants experience lower risk of antidepressant discontinuation after cancer diagnosis in real-world practice. However, concern remains about the unintended health outcomes of relatively higher antidepressant discontinuation among survivors diagnosed with metastatic cancer.
Difference in persistence between tablets and capsules.
Authors: Zaidi Shehla , Rutter Cliff , Avalos-Reyes Elisea , Shah Dipti , McAuliff Kelly , Grover Rashmi , Feczko Lucia , Liu Chen , Kipping Emily , Johnson Kjel Andrew
Published: June 2023

e18894

Background: More recently, pharmaceutical companies have developed capsule and tablet forms of their drugs to allow a choice on dosage form. As both capsules and tablets should be bioequivalent, adherence rates between members prescribed capsules and tablets should be the same. This study compares persistency between capsule and tablet forms of enzalutamide and palbociclib. Methods: This retrospective cohort study included adult Caremark members who received enzalutamide and palbociclib between 03/01/2021 and 03/01/2022 with continuous eligibility for six months prior and 12 months post-index into the study. Members were excluded if they had a > 60-day gap in fill or switched from a capsule to a tablet or vice versa during the study period. Adherence was measured using the prescription-based proportion of days covered (PDC) and defined as the sum of days with medication on hand divided by the number of days between index fill and exhaust of last fill. Continuous variables were compared with the student’s t-test and Mann-U tests; categorical variables were compared with a chi-square test. Logistic regression was utilized to assess adherence differences in capsules vs. tablets; p-values < 0.05 were significant. Results: 5,997 members were included in the enzalutamide cohort; there were no insurance type or region differences (all p > 0.05) between members receiving capsules and tablets. There were no significant differences in mean PDC (mean (SD) 0.963 (0.080) vs. 0.964 (0.073); p = 0.521) or adherence rates (94.2% vs. 95.2%); p = 0.215) between members receiving capsules and tablets. After adjusting for the variables in the model, there was no difference in adherence rates between tablets and capsules. Members less than 65 years of age had significantly lower adherence rates (odds ratio (OR)) 0.5 (95% confidence interval (CI), 0.35-0.71) compared to those aged 65-74. 5,361 members were included in the palbociclib cohort; there were significant differences in age, gender, type of insurance and region (all p < 0.05) between members receiving capsules and tablets. There were no significant differences in PDC (0.962 (0.072) vs. 0.960 (0.072); p = 0.534) or adherence rates (94.9% vs. 94.9%); p = 1.0) between members receiving capsules and tablets. Conclusions: In this study, capsule and tablet forms of enzalutamide and palbociclib had similar adherence rates when adjusting for confounders.
The impact of receipt of systemic anticancer therapy (SACT) near the end of life (EOL) on cost among oncology practices participating in CMS' Oncology Care Model (OCM).
Authors: Adelson Kerin B. , Canavan Maureen , Sheth Karna , Scott Jeffrey A. , Westvold Sarah
Published: June 2023

e18923

Background: Chemotherapy administered near the EOL is associated with higher costs due to downstream care that occurs when patients do not transition to hospice, such as hospitalizations and ICU use. Since 2015 rates of systemic therapy at the EOL have remained stable, while chemotherapy has been replaced with costly immunotherapy. Recently, we showed receipt of immunotherapy at the EOL is also associated with higher rates of acute care use than among patients who don’t receive by SACT near the EOL. Using data from practices participating in OCM, we evaluated the relationship between receipt of chemotherapy, immunotherapy, or no systemic therapy at the EOL and categories of cost. Methods: We used anonymized Integra Connect data for OCM episode claims attributed to 8 multi-site OCM practices from July 2016-December 2021 to identify decedents capable of making treatment decisions. We stratified patients by SACT type received within 30 days of death (immunotherapy (IO), chemotherapy (CT), or none) and used t-tests to compare the mean episode costs. We evaluated differences in overall costs as well as those billed under Medicare subgroups: Part A, inpatient acute care use and other services including (hospice, SNF, HHA), Part B, infusion drug administered in the ambulatory setting and medical and ED costs, and Part D, oral pharmacy costs. Results: Among 14,169 OCM decedents overall mean cost within 30 days of death was $22,215. Overall cost within 30 days of death was higher for patients receiving some form of SACT (IO: $26,072 or CT: $23,259) compared with no SACT $19,296 (table) all p < 0.01). Patients who received no SACT at EOL had significantly lower Part B and D compared with both IO and CT respectively (all p < 0.01). Additionally, patients who received CT had lower average part B costs $8,081 compared with patients who received IO within 30 days of death $13,951 p < 0.01. Conclusions: Overall costs for patients who received IO or CT within 30 days of death were significantly higher than patients who received no SACT within 30 days of death. While IO patients had nearly twice as high mean Part B costs per episode compared with CT patients, CT patients had higher mean Part D costs per episode. Further research should explore whether these findings are generalizable to patients outside of OCM. [Table: see text]
Cost-effectiveness analysis of a circulating tumor DNA-based molecular residual disease assay to guide adjuvant chemotherapy decisions in patients with resectable early stage colorectal cancer.
Authors: Schneider John , Bresnahan Ryan , Chami Nadine , Brackstone Muriel , Hannouf Malek B.
Published: June 2023

e18929

Background: An ongoing prospective study in patients with stage II or III colorectal cancer (CRC) has demonstrated ctDNA testing to be prognostic of recurrence risk and predictive of adjuvant chemotherapy (ACT) benefit. From the perspective of a US payer, we aimed to investigate the cost effectiveness of incorporating ctDNA analysis using the commercially available molecular residual disease (MRD) assay (Signatera™) into standard practice to aid in adjuvant chemotherapy decision-making, where traditional high-risk clinicopathological (CP) features have not shown a significant benefit of ACT in Stage II CRC. Methods: We developed a decision model to project lifetime clinical and economic consequences of different adjuvant treatment-guiding strategies. The model was parameterized using a follow-up of up to 2-years from a recently published data from GALAXY study and the cost data from the US literature. GALAXY is an observational arm of the ongoing CIRCULATE-Japan study (UMIN000039205) that analysed pre-surgical and post-surgical ctDNA in patients with stage II-IV resectable CRC. Costs are presented in 2023 US dollars. Future costs and benefits were discounted at 3%. Results: Compared to the CP predictors alone-based strategy, ctDNA analysis using the MRD assay in combination with CP predictors-based strategy led to an increase of 0.8 life years and 0.7 quality adjusted-Life Years (QALY) and cost savings of $9,771 per patient. Conclusions: The addition of MRD detection by ctDNA to traditional CP predictors aids in adjuvant chemotherapy decision-making in patients with stage II or III resectable CRC and is likely to be cost effective in the US healthcare system. ctDNA testing should therefore be considered for adoption in this disease setting.
Outcomes of myeloid malignancies in patients previously treated with PARP inhibitors for solid malignancies: A single institution experience.
Authors: Almanza-Huante Emmanuel , Bataller Alex , Urrutia Samuel , Gener-Ricos Georgina , Briski Robert , Kanagal-Shamanna Rashmi , Lu Karen H. , Westin Shannon Neville , Yap Timothy A. , Takahashi Koichi , Ravandi Farhad , Alvarado Valero Yesid , Kadia Tapan M. , Sasaki Koji , Kantarjian Hagop M. , Garcia-Manero Guillermo
Published: June 2023

e19000

Background: Treatment with Poly(ADP-ribose) Polymerase proteins (PARP) has improved the survival of patients (pts) with solid malignancies harboring a homologous recombination deficiency (HRD). The association between PARP inhibitors (PARPi) and the development of myeloid neoplasms post cytotoxic therapy (MN-pCT) has been reported. We aim to describe the characteristics and outcomes of pts who develop MN-pCT after treatment with PARPi. Methods: Pts treated with PARPi at a single institution from July 2014 to August 2022, who developed MN-pCT (AML, MDS or CMML), were retrospectively evaluated. Diagnosis of MN-pCT was defined according to the 5th edition of the WHO criteria. Clinical and demographic characteristics along with cytogenetics and molecular features were analyzed. HRD was assessed by NGS on peripheral blood with a 13-gene panel. Results: 1462 pts were treated with PARPi at MDACC. Of these, 15 (1%) developed MN-pCT. These include 9 (60%) with MDS, 5 (34%) with AML, and 1 (7%) with B/Myeloid Mixed-Phenotype Acute Leukemia (MPAL). The median age was 62 (46-74) years and 14 (93%) were female. The most frequently used PARPi was olaparib in 9 (60%) pts. All pts had also previously received platinum-based agents and taxanes. Pts with 19 different solid tumors were included; 11 (85%) had active concomitant solid tumors at the time of MN-pCT. The median time from PARPi treatment to myeloid neoplasm (TTM) was 20.7 months (9.3-39.9). Cytogenetics and molecular features were available in 14 pts (93%). Eight (57%) had complex karyotype. The median number of mutations were 2 (0-4). TP53mut was present in 9 (64%) pts with a median VAF 47.3% (11.9-76.6%) of whom 6 (67%) were biallelic. The ORR to antileukemic therapy was 66% (n = 8): 3 (38%) had CR, 2 (25%) had PR, 2 (25%) had mCR with HI and 1 (13%) had isolated HI. The patient with B/myeloid MPAL was not evaluable for response. Of the responders, 7 (88%) pts relapsed at a median of 2.8 months (1.5-4.2). The median OS and EFS on the whole cohort were 7.8 (3.2-12.4) and 5.3 (3.8-6.7) months respectively. Conclusions: Development of MN-pCT in pts treated with PARPi is rare but most outcomes are very poor. Prospective analysis to evaluate pts at higher risk of developing MN-pCT is warranted in order to select pts who might benefit from novel therapies without increasing the risk of secondary myeloid malignancies. [Table: see text]