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Outcomes of Breast Cancer Patients Treated with Chemotherapy, Biologic Therapy, Endocrine Therapy, or Active Surveillance During the COVID-19 Pandemic

Marks, Douglas K; Budhathoki, Nibash; Kucharczyk, John; Fa'ak, Faisal; D'Abreo, Nina; Kwa, Maryann; Plasilova, Magdalena; Dhage, Shubhada; Soe, Phyu Phyu; Becker, Daniel; Hindenburg, Alexander; Lee, Johanna; Winner, Megan; Okpara, Chinyere; Daly, Alison; Shah, Darshi; Ramdhanny, Angela; Meyers, Marleen; Oratz, Ruth; Speyer, James; Novik, Yelena; Schnabel, Freya; Jones, Simon A; Adams, Sylvia
PURPOSE:Provide real-world data regarding the risk for SARS-CoV-2 infection and mortality in breast cancer (BC) patients on active cancer treatment. METHODS:Clinical data were abstracted from the 3778 BC patients seen at a multisite cancer center in New York between February 1, 2020 and May 1, 2020, including patient demographics, tumor histology, cancer treatment, and SARS-CoV-2 testing results. Incidence of SARS-CoV-2 infection by treatment type (chemotherapy [CT] vs endocrine and/or HER2 directed therapy [E/H]) was compared by Inverse Probability of Treatment Weighting. In those diagnosed with SARS-CoV-2 infection, Mann-Whitney test was used to a assess risk factors for severe disease and mortality. RESULTS:Three thousand sixty-two patients met study inclusion criteria with 641 patients tested for SARS-COV-2 by RT-PCR or serology. Overall, 64 patients (2.1%) were diagnosed with SARS-CoV-2 infection by either serology, RT-PCR, or documented clinical diagnosis. Comparing matched patients who received chemotherapy (n = 379) with those who received non-cytotoxic therapies (n = 2343) the incidence of SARS-CoV-2 did not differ between treatment groups (weighted risk; 3.5% CT vs 2.7% E/H, P = .523). Twenty-seven patients (0.9%) expired over follow-up, with 10 deaths attributed to SARS-CoV-2 infection. Chemotherapy was not associated with increased risk for death following SARS-CoV-2 infection (weighted risk; 0.7% CT vs 0.1% E/H, P = .246). Advanced disease (stage IV), age, BMI, and Charlson's Comorbidity Index score were associated with increased mortality following SARS-CoV-2 infection (P ≤ .05). CONCLUSION:BC treatment, including chemotherapy, can be safely administered in the context of enhanced infectious precautions, and should not be withheld particularly when given for curative intent.
PMID: 35641208
ISSN: 1549-490x
CID: 5235912

Development of a Big Data Radiation Oncology Dashboard

Yuan, Y; Winner, M; Chandras, R; Barbee, D; Xiao, J; Barton, S M; Schiff, P B; Sulman, E P
PURPOSE/OBJECTIVE(S): Healthcare data often exist in silos and in unstructured formats that limit interoperability and require tedious manual extraction. Our institution has adopted a flexible and scalable big data platform built on Hadoop that integrates data from Epic/Clarity as well as Aria and allows users to leverage modern data science tools to facilitate access. We hypothesize that a data analytics and visualization dashboard can be built using open-source tools that will (1) allow non-technical users to explore de-identified clinical data within our institutional big data platform and (2) connect with repositories of molecular data to demonstrate potential methods of integrating clinical and basic science data. MATERIALS/METHODS: De-identified patient-level radiation oncology data from the institutional big data platform (Hadoop) were extracted with the python packages pyodbc and pandas. For the purposes of this dashboard, radiation oncology specific clinical data elements were queried including the date of first radiation treatment, treatment location, treatment modality (SBRT, external beam, SRS, TBI, LDR/HDR brachytherapy), ICD10 codes, anatomic treatment site, number of fractions, treatment prescription, and dose per fraction. A python client connection with the publicly accessible instance of cBioPortal for Cancer Genomics was established using the Bravado library. Data transformation and cleaning was performed in python using panda's data frames. A web-based dashboard to facilitate user-defined visualizations was implemented using the Dash python library and interactive visualizations of subsets of extracted data were generated in real-time using the plotly plotting library.
RESULT(S): We developed a web-based dashboard that gives users without extensive programming expertise the ability to explore de-identified clinical data extracted from Hadoop. As proof of principle, the dashboard was used to visualize the clinical impact of the COVID-19 pandemic on radiation oncology patient volumes, revealing a significant decline in new radiation treatments in April and May of 2020 (-54% and -36% compared to 2019) during the initial COVID-19 surge. Furthermore, the dashboard allows users to interact with the cBioPortal for Cancer Genomics repository, which currently houses clinical and molecular data from 301 publicly available studies spanning 869 different cancer types. This interface with cBioPortal illustrates the potential for future integration of clinically meaningful sequencing results with clinical outcomes data.
CONCLUSION(S): We built an interactive web-based dashboard to enable general users' easy access to de-identified clinical data stored within the institutional big data platform. Additional data sources, including external molecular data can be connected to the dashboard allowing for future integration.
ISSN: 1879-355x
CID: 5081992

Association of anti-phospholipid antibodies (APL) with poor clinical outcomes in hospitalized patients with COVID-19 [Meeting Abstract]

Yaich, D; Ptak, B; Roellke, E; Miller, E; Kim, J; Gaztanaga, J; Drewes, W; Ciancarelli, J; Divers, J; Winner, M; Rapkiewicz, A; Carsons, S
Background/Purpose: Critically ill patients with COVID-19 infection have a profound hypercoagulable state and can often develop thromboses in many different vascular beds. Given the presence of anti-phospholipid antibodies among COVID-19 patients reported previously, we hypothesized that poor outcomes and thrombosis could also be promoted by autoimmunity. In this retrospective case control analysis, we aimed to evaluate associations between aPL titers, clinical outcomes and mortality in hospitalized patients admitted with COVID-19 infection.
Method(s): We analyzed 138 electronic medical records of patients who were admitted to NYU Langone Hospital -Long Island between the months of March-April 2020 with findings of COVID-19 positivity via PCR and who had aPL titers determined. Patients with elevated titers of beta-2-Glycoprotein IgG, IgM, IgA and/or cardiolipin IgG, IgM, IgA were compared to those who were not elevated. Patients with positive lupus anticoagulant titers only were excluded due to prevalent use of anti-coagulation during this time. COVID-19 positive patients with aPL titers were assessed for clinical events (including DVT, PE, MI, CVA, extremity ischemia, skin ulcerations, visceral thrombosis and ocular and line occlusions) and mortality. The control group included patients that were negative for aPL antibody titers. Associations between Anti-Phospholipid (aPL) titer positivity and clinical events was assessed by Chi-square analysis using Fisher's exact test.
Result(s): The predominant aPL species that was noted in COVID-19 patients was anti-cardiolipin IgM. Of those patients with elevated antibody titers, cardiolipin IgM, IgG, IgA, and beta2GPI antibodies were prevalent at rates of 98.9%, 26.7%, 19.2%, and 16.5%, respectively. Multiple aPL isotypes were detected in several patients. There was a positive association between aPL positivity and elevations in IL-6, CRP, D-dimer, and LDH (P< 0.05). There was an increased incidence of clinical events in patients with COVID-19 and positive aPL titers (52/83 or 62%) compared to those who were aPL negative (32/55 or 58% ), however this association was not statistically significant. No significant association was detected between positive aPL titers and gender, age, or self-identified ethnicity. An increased incidence of ARDS and a rising serum creatinine was noted in the aPL positive group (P = 0.03 and P= 0.05 respectively). A significant increase in mortality was identified for the aPL positive group (P=0.01).
Conclusion(s): These findings suggest that aPL titers may provide insight into disease prognosis and outcome in hospitalized patients with COVID-19. Despite lack of significant association with discrete thrombotic events, association of aPL positivity with rising serum creatinine and ARDS suggest that aPL may contribute to end organ dysfunction through enhanced microthrombosis, resulting in increased mortality. (Figure Presented)
ISSN: 2326-5205
CID: 5164742

Low-Dose Tocilizumab With High-Dose Corticosteroids in Patients Hospitalized for COVID-19 Hypoxic Respiratory Failure Improves Mortality Without Increased Infection Risk

Brosnahan, Shari B; Chen, Xian Jie Cindy; Chung, Juri; Altshuler, Diana; Islam, Shahidul; Thomas, Sarun V; Winner, Megan D; Greco, Allison A; Divers, Jasmin; Spiegler, Peter; Sterman, Daniel H; Parnia, Sam
BACKGROUND:Severe hypoxic respiratory failure from COVID-19 pneumonia carries a high mortality risk. There is uncertainty surrounding which patients benefit from corticosteroids in combination with tocilizumab and the dosage and timing of these agents. The balance of controlling inflammation without increasing the risk of secondary infection is difficult. At present, dexamethasone 6 mg is the standard of care in COVID-19 hypoxia; whether this is the ideal choice of steroid or dosage remains to be proven. OBJECTIVES/OBJECTIVE:The primary objective was to assess the impact on mortality of tocilizumab only, corticosteroids only, and combination therapy in patients with COVID-19 respiratory failure. METHODS:A multihospital, retrospective study of adult patients with severe respiratory failure from COVID-19 who received supportive therapy, corticosteroids, tocilizumab, or combination therapy were assessed for 28-day mortality, biomarker improvement, and relative risk of infection. Propensity-matched analysis was performed between corticosteroid alone and combination therapies to further assess mortality benefit. RESULTS:= 0.005] without increasing the risk of infection. CONCLUSION AND RELEVANCE/UNASSIGNED:Combination of tocilizumab and corticosteroids was associated with improved 28-day survival when compared with corticosteroids alone. Modification of steroid dosing strategy as well as steroid type may further optimize therapeutic effect of the COVID-19 treatment.
PMID: 34180274
ISSN: 1542-6270
CID: 4926192

A Rare Cause of Biliary Obstruction: Intrabiliary Rupture of a Hepatic Hydatid Cyst [Meeting Abstract]

Forman, Jacqueline; Jimada, Ismail; Shapiro, Daniel; Friedel, David; Klein, Natalie; Cunha, Burke; Winner, Megan
ISSN: 0002-9270
CID: 3897712

Population-Level Incidence and Predictors of Surgically Induced Diabetes and Exocrine Insufficiency after Partial Pancreatic Resection

Elliott, Irmina A; Epelboym, Irene; Winner, Megan; Allendorf, John D; Haigh, Philip I
CONTEXT/BACKGROUND:Endocrine and exocrine insufficiency after partial pancreatectomy affect quality of life, cardiovascular health, and nutritional status. However, their incidence and predictors are unknown. OBJECTIVE:To identify the incidence and predictors of new-onset diabetes and exocrine insufficiency after partial pancreatectomy. DESIGN/METHODS:We retrospectively reviewed 1165 cases of partial pancreatectomy, performed from 1998 to 2010, from a large population-based database. MAIN OUTCOME MEASURES/METHODS:Incidence of new onset diabetes and exocrine insufficiency RESULTS: Of 1165 patients undergoing partial pancreatectomy, 41.8% had preexisting diabetes. In the remaining 678 patients, at a median 3.6 months, diabetes developed in 274 (40.4%) and pancreatic insufficiency developed in 235 (34.7%) patients. Independent predictors of new-onset diabetes were higher Charlson Comorbidity Index (CCI; hazard ratio [HR] = 1.62 for CCI of 1, p = 0.02; HR = 1.95 for CCI ≥ 2, p < 0.01) and pancreatitis (HR = 1.51, p = 0.03). There was no difference in diabetes after Whipple procedure vs distal pancreatic resections, or malignant vs benign pathologic findings. Independent predictors of exocrine insufficiency were female sex (HR = 1.32, p = 0.002) and higher CCI (HR = 1.85 for CCI of 1, p < 0.01; HR = 2.05 for CCI ≥ 2, p < 0.01). Distal resection and Asian race predicted decreased exocrine insufficiency (HR = 0.35, p < 0.01; HR = 0.54, p < 0.01, respectively). CONCLUSION/CONCLUSIONS:In a large population-based database, the rates of postpancreatectomy endocrine and exocrine insufficiency were 40% and 35%, respectively. These data are critical for informing patients' and physicians' expectations.
PMID: 28406793
ISSN: 1552-5775
CID: 3486992

Liver-Directed Therapy in Metastatic Colorectal Cancer

Wilson, Ana; Ronnekliev-Kelly, Sean; Winner, Megan; Pawlik, Timothy M.
Approximately 50-70 % of patients with colorectal cancer ultimately develop colorectal liver metastases. Determining which patients may benefit from aggressive treatment has historically been achieved through clinical predictive models. However, factors such as radiographic response to neoadjuvant therapy should also be taken into consideration. Recently, molecular markers have emerged as an adjunct to clinical-pathologic factors and provide a surrogate for tumor biology. With improved understanding of tumor biology, the likelihood of recurrence can be better predicted. However, when feasible, the best chance for cure entails surgical resection as a part of multimodal therapy, and select patients can achieve prolonged median survival. Alternatively, ablation techniques may be used in conjunction with surgery or as isolated therapy in patients who are not candidates for surgical resection. Transarterial therapy may also provide clinical benefit in certain patient subsets with unresectable disease. These strategies have allowed for a more tailored approach to patients with colorectal liver metastases.
ISSN: 1556-3790
CID: 3502202

The Level of Estrogen and Progesterone Receptor Immunoreactivity Correlates With Time to Disease Recurrence in Hormone Receptor-Positive Breast Cancer [Meeting Abstract]

Winner, Megan; Rosman, Martin; Mylander, Charles; Jackson, Rubie Sue; Pozo, Marcos; Umbricht, Christopher; Tafra, Lorraine
ISSN: 1068-9265
CID: 3502212

Associations Between Patient Perceptions of Communication, Cure, and Other Patient-Related Factors Regarding Patient-Reported Quality of Care Following Surgical Resection of Lung and Colorectal Cancer

Ejaz, Aslam; Kim, Yuhree; Winner, Megan; Page, Andrew; Tisnado, Diana; Dy, Sydney E Morss; Pawlik, Timothy M
BACKGROUND:The objective of the current study was to analyze various patient-related factors related to patient-reported quality of overall and surgical care following surgical resection of lung or colorectal cancer. METHODS:Between 2003 and 2005, 3,954 patients who underwent cancer-directed surgery for newly diagnosed lung (30.3%) or colorectal (69.7%) cancer were identified from a population- and health system-based survey of participants from multiple US regions. Factors associated with patient-perceived quality of overall and surgical care were analyzed with multivariable logistic regression models. RESULTS:Overall, 56.7% of patients reported excellent quality of overall care and 67.9% of patients reported excellent quality of surgical care; there was no difference by cancer type (P > 0.05). Factors associated with lower likelihood to report excellent quality of overall and surgical care included female sex, minority race, and the presence of multiple comorbidities (all odds ratio [OR] <1, all P < 0.05). Patients who had higher levels of education (overall quality: OR 1.62; surgical quality: OR 1.26), higher annual income (overall quality: OR 1.29; surgical quality: OR 1.23), and good physical function (overall quality: OR 1.35; surgical quality: OR 1.24) were all more likely to report excellent quality of overall and surgical care (all P < 0.05). Furthermore, patients who reported their physician as having excellent communication skills (overall quality: OR 6.49; surgical quality: OR 3.74) as well as patients who perceived their cancer as likely curable (overall quality: OR 1.17; surgical quality: OR 1.11) were more likely to report excellent quality of overall and surgical care (all P < 0.05). CONCLUSION/CONCLUSIONS:Patient-reported quality of care is associated with several factors including race, income, and educational status, as well as physician communication and patient perception of likelihood of cure. Future studies are needed to more closely examine patient-physician relationships and communication barriers, particularly among minority patients and those with lower income and educational status.
PMID: 26608194
ISSN: 1873-4626
CID: 3502232

Reply to Patient perceptions regarding the likelihood of cure after surgical resection of lung and colorectal cancer [Letter]

Winner, Megan; Kim, Yuhree; Pawlik, Timothy M
PMID: 26335580
ISSN: 1097-0142
CID: 3502222