Patient characteristics and pre-existing chronic diseases with COVID-19 related outcomes: a real-world experience (Preprint)

BACKGROUND Significant variations in experience of the COVID-19 pandemic have been observed in the United States. However, there is currently no published study which comprehensively examines the relationship between patient characteristics and COVID-19 related health outcomes. OBJECTIVE In this study, using aggregated real-world data extracted from TriNetx electronic medical record data from 34 hospitals around United States, we intended to fill the gap. METHODS A total of 12,555 patients aged 18-80 years old who contracted COVID-19 were identified from January 20th to April 20th, 2020. RESULTS First, in the univariate analysis, we found that patients who were older (age 51-80), Black, male, and had pre-existing chronic diseases (e.g. obesity, diabetes, hypertension, and chronic kidney diseases (CKD)) had increased risk ratio (RR) of exhibiting severe outcomes, including increased C-reactive protein (CRP), decreased oxygen saturation, hospitalization, use of ventilator, and ultimately death. Next, we applied propensity score matching to match the patients based on their characteristics. We found that patients who were older, Black, male, and diagnosed with CKD had 3.69, 1.77, 1.75, and 1,61-fold increased RR of death. On the other hand, while obesity, diabetes, and hypertension had no direct relationship with death, they were associated with other severe outcomes. In further analysis by including CRP as a matching variable, death disparity by age group, race, gender, and CKD was reduced, particularly for race and CKD where a significant disparity was no longer observed. CONCLUSIONS In summary, our data show significant disparities in COVID-19 related outcomes by patient characteristics and further suggest that acute inflammation plays an important role in the disparity in COVID-19 death.

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Real-world safety of palbociclib in breast cancer patients in the United States: a new user cohort study

BMC Cancer ◽

10.1186/s12885-021-07790-z ◽

2021 ◽

Vol 21 (1) ◽

Author(s):

Daniel C. Beachler ◽

Cynthia de Luise ◽

Aziza Jamal-Allial ◽

Ruihua Yin ◽

Devon H. Taylor ◽

...

Keyword(s):

Breast Cancer ◽

United States ◽

Pulmonary Embolism ◽

Cohort Study ◽

Real World ◽

The United States ◽

Elevated Risk ◽

Breast Cancer Patients ◽

Increased Risk ◽

Serious Infections

Abstract Background There is limited real-world safety information on palbociclib for treatment of advanced stage HR+/HER2- breast cancer. Methods We conducted a cohort study of breast cancer patients initiating palbociclib and fulvestrant from February 2015 to September 2017 using the HealthCore Integrated Research Database (HIRD), a longitudinal claims database of commercial health plan members in the United States. The historical comparator cohort comprised patients initiating fulvestrant monotherapy from January 2011 to January 2015. Propensity score matching and Cox regression were used to estimate hazard ratios for various safety events. For acute liver injury (ALI), additional analyses and medical record validation were conducted. Results There were 2445 patients who initiated palbociclib including 566 new users of palbociclib-fulvestrant, and 2316 historical new users of fulvestrant monotherapy. Compared to these historical new users of fulvestrant monotherapy, new users of palbociclib-fulvestrant had a greater than 2-fold elevated risk for neutropenia, leukopenia, thrombocytopenia, stomatitis and mucositis, and ALI. Incidence of anemia and QT prolongation were more weakly associated, and incidences of serious infections and pulmonary embolism were similar between groups after propensity score matching. After adjustment for additional ALI risk factors, the elevated risk of ALI in new users of palbociclib-fulvestrant persisted (e.g. primary ALI algorithm hazard ratio (HR) = 3.0, 95% confidence interval (CI) = 1.1–8.4). Conclusions This real-world study found increased risks of several adverse events identified in clinical trials, including neutropenia, leukopenia, and thrombocytopenia, but no increased risk of serious infections or pulmonary embolism when comparing new users of palbociclib-fulvestrant to fulvestrant monotherapy. We observed an increased risk of ALI, extending clinical trial findings of significant imbalances in grade 3/4 elevations of alanine aminotransferase (ALT).

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Estimating the Population Benefits and Costs of Rituximab Therapy in the United States from 1998 to 2013 Using Real-World Data

Medical Care ◽

10.1097/mlr.0000000000000486 ◽

2016 ◽

Vol 54 (4) ◽

pp. 343-349 ◽

Cited By ~ 15

Author(s):

Mark D. Danese ◽

Carolina M. Reyes ◽

Michelle L. Gleeson ◽

Marc Halperin ◽

Sandra L. Skettino ◽

...

Keyword(s):

United States ◽

Real World ◽

The United States ◽

Real World Data ◽

World Data ◽

Benefits And Costs

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Improved Sexual Function with Testosterone Replacement Therapy in Hypogonadal Men: Real‐World Data from the Testim Registry in the United States (TRiUS)

Journal of Sexual Medicine ◽

10.1111/j.1743-6109.2011.02436.x ◽

2011 ◽

Vol 8 (11) ◽

pp. 3204-3213 ◽

Cited By ~ 36

Author(s):

Mohit Khera ◽

Rajib K. Bhattacharya ◽

Gary Blick ◽

Harvey Kushner ◽

D.t. Nguyen ◽

...

Keyword(s):

United States ◽

Sexual Function ◽

Replacement Therapy ◽

Real World ◽

The United States ◽

Testosterone Replacement ◽

Testosterone Replacement Therapy ◽

Real World Data ◽

World Data

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Incidence of skeletal-related events among multiple myeloma patients in the United States at oncology clinics: Observations from real-world data

Journal of Bone Oncology ◽

10.1016/j.jbo.2018.100215 ◽

2019 ◽

Vol 14 ◽

pp. 100215 ◽

Cited By ~ 4

Author(s):

Christopher Kim ◽

Sumita Bhatta ◽

Lori Cyprien ◽

Rafael Fonseca ◽

Rohini K. Hernandez

Keyword(s):

United States ◽

Multiple Myeloma ◽

Real World ◽

The United States ◽

Real World Data ◽

World Data ◽

Skeletal Related Events

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Real-world prescribing patterns in acute myeloid leukemia in the United States.

Journal of Clinical Oncology ◽

10.1200/jco.2017.35.15_suppl.e18524 ◽

2017 ◽

Vol 35 (15_suppl) ◽

pp. e18524-e18524 ◽

Cited By ~ 1

Author(s):

Bruno C. Medeiros ◽

Bhavik J. Pandya ◽

Anna Hadfield ◽

Samuel Wilson ◽

Cynthia Mueller ◽

...

Keyword(s):

United States ◽

Acute Myeloid Leukemia ◽

Real World ◽

High Intensity ◽

Myeloid Leukemia ◽

Patient Characteristics ◽

The United States ◽

First Line ◽

Low Intensity ◽

Acute Myeloid

e18524 Background: The effective treatment of patients with acute myeloid leukemia (AML) remains a challenge in clinical practice. This analysis describes the patient characteristics and real-world use of AML treatments in the United States for patients on high- and low-intensity treatment. Methods: Data from the Adelphi AML Disease-Specific Programme, a real-world, cross-sectional survey conducted between February–May 2015, were analysed. A total of 61 hematologist/hem-oncologists, across academic, non-academic and office-based practice locations, provided data on 457 AML patients. Patient characteristics were derived from physician-completed patient record forms where each physician was asked to provide treatment details, including the treatment intensity, for each line of therapy. Results: A total of 91% (n = 415) of patients included in this analysis were previously untreated for AML. Patients had a mean age of 60 years and been diagnosed with AML for a median of 5.0 months. At first-line induction therapy, over half (53%; n = 241) of the patients were initiated on a high-intensity treatment, the most common regimen being cytarabine plus anthracycline (61%; n = 147). The remaining 47% (n = 216) of patients received a low-intensity induction therapy such as low dose cytarabine monotherapy (28%, n = 61), azacitidine monotherapy (25%, n = 54), or decitabine monotherapy (21%, n = 45). Over half (55%, n = 62) of patients suited to high intensity treatment went on to receive cytarabine monotherapy during the consolidation phase of their first-line treatment. Conclusions: According to treating physicians, the large majority of patients receive traditional, well-established therapies at first-line induction for AML. Whilst cytarabine combinations dominate the high-intensity treatment setting, the hypomethylating agents, azacitidine and decitabine, are frequently used for those more suited to low-intensity treatment.

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Real-world outcomes of patients with BRAF-mutated mCRC treated in the United States.

Journal of Clinical Oncology ◽

10.1200/jco.2020.38.15_suppl.4030 ◽

2020 ◽

Vol 38 (15_suppl) ◽

pp. 4030-4030

Author(s):

Matthew Braithwaite ◽

Christopher Duane Nevala-Plagemann ◽

Kelsey Baron ◽

Benjamin Haaland ◽

Lisa M. Pappas ◽

...

Keyword(s):

United States ◽

Real World ◽

Braf Mutation ◽

The United States ◽

Survival Outcomes ◽

Prognostic Impact ◽

Braf Mutations ◽

Real World Data ◽

World Data ◽

Significant Difference

4030 Background: BRAF mutations portend a poor prognosis in metastatic colorectal cancer (mCRC). Recent trials have hypothesized that using more aggressive triplet-based chemotherapy regimens such as FOLFOXIRI in the frontline setting may improve outcomes in this patient population. In this study, we utilized real-world data to assess whether FOLFOXIRI is being used in the United States (US) and compared survival outcomes in BRAF mutated (BRAFmt) mCRC stratified by first line (1L) therapy. Methods: The nationwide Flatiron Health EHR-derived de-identified database was reviewed for patients diagnosed with mCRC between 2013 and 2018. Patients who had documented BRAF mutation testing and received a standard 1L therapy were included for analysis. Patients who did not have a visit or medication order within 90 days of metastatic diagnosis were excluded to ensure patients were engaged with care at the data-providing institution. Kaplan-Meier and Cox proportional hazard modeling were used to compare survival outcomes stratified by BRAF mutation status and 1L therapy received. Results: A total of 4,454 patients with documented BRAF mutational status were included, of which 3,988 (89.5%) were BRAF wild type (BRAFwt) and 466 (10.5%) were BRAFmt. Median OS was 15.4 months (mo) in the BRAFmt group compared to 28.1 mo in the BRAFwt group (HR 0.48, 95% CI 0.41- 0.56, p < 0.001). Only 3% (n = 16) of BRAFmt patients received 1L FOLFOXIRI +/- bevacizumab with a median OS of 13.8 mo compared to 15.5 mo in patients receiving a chemotherapy doublet (FOLFOX, CAPEOX, or FOLFIRI) +/- bevacizumab (95% CI 4.9 – not reached vs 14.3 – 19.0, p = 0.38). In BRAFmt patients, multivariate analysis (MVA) did not detect a significant improvement in OS with the use of FOLFIRI plus bevacizumab (HR 0.88, 95% CI 0.50-1.56, p = 0.67) or FOLFOX/CAPEOX plus bevacizumab (HR 0.89, 95% CI 0.59 – 1.34, p = 0.58) when compared to chemotherapy doublet alone. A MVA comparing 1L therapies in the BRAFwt group did not detect a significant improvement in OS with bevacizumab plus chemotherapy doublet compared to chemotherapy doublet alone. When stratified by 1L treatment regimen, similar proportions of BRAFmt patients received second line therapy. Conclusions: This analysis of real-world data confirms the negative prognostic impact of BRAF mutations in mCRC and suggests that FOLFOXIRI has not been widely adopted in the management of these patients in the US. We were unable to demonstrate any significant difference in OS of patients with BRAFmt mCRC based on type of 1L therapy received.

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Real-world treatment and outcomes of frontline chemotherapy in patients with metastatic pancreatic cancer.

Journal of Clinical Oncology ◽

10.1200/jco.2021.39.15_suppl.e16249 ◽

2021 ◽

Vol 39 (15_suppl) ◽

pp. e16249-e16249

Author(s):

Salwan Al Mutar ◽

Muhammad Shaalan Beg ◽

Eric Hansen ◽

Andrew J. Belli ◽

Maegan Vaz ◽

...

Keyword(s):

Pancreatic Cancer ◽

Clinical Trial ◽

Real World ◽

Univariate Analysis ◽

The United States ◽

Metastatic Pancreatic Cancer ◽

Future Research ◽

Real World Data ◽

The Real ◽

The Impact

e16249 Background: The difference between the FOLFIRINOX and gemcitabine/nab-paclitaxel (GnP) regimens’ clinical trial designs limit the ability to generate cross-study comparisons. Therefore, there is a significant need to understand the impact of various demographic and clinical characteristics on the effectiveness of these systemic therapies in the real-world treatment setting. This study seeks to compare the real-world outcomes of patients with metastatic pancreatic cancer treated with frontline FOLFIRINOX or GnP. Methods: Patients with primary metastatic pancreatic cancer who received first-line (1L) FOLFIRINOX or GnP were identified in the COTA real-world database. The COTA database is a de-identified database of real-world data (RWD) derived from the electronic health records of healthcare providers in the United States. Real-world overall response rate (rwORR) was calculated as the proportion of patients achieving complete response (CR) or partial response (PR). Overall survival (OS) was calculated using the Kaplan-Meier method and multivariate analyses utilized Cox proportional hazards. Results: The overall qualified cohort (n=236) was stratified by 1L FOLFIRINOX (n=109) or GnP (n=127). Select patient characteristics are shown in table. Patients treated with 1L FOLFIRINOX showed greater rwORR as compared to those treated with GnP (68.8% vs. 55.9%, p=0.04). Additionally, patients treated with 1L FOLFIRINOX had longer median OS (14.4 vs 11.4 mos, respectively). In univariate analysis, patients treated with GnP had a greater chance of mortality (HR: 1.3, 95% CI: 1.0, 1.8, p=0.05). This relationship strengthened in multivariate analysis (GnP treated HR: 1.6, 95% CI: 1.1, 2.1, p=0.01). Conclusions: Due to lack of enrollment of representative patients in clinical trials and in the absence of a comparative clinical trial, real-world experience with chemotherapy regimens provide critical insights on the outcome of treatments. In our cohort, patients treated with frontline GnP had a significantly greater chance of mortality as compared to patients treated with frontline FOLFIRINOX. The FOLFIRINOX cohort also showed greater rwORR. Future research will continue to expand on treatment patterns in subsequent lines of therapy, as well as emerging therapy types, in order to better understand the optimal treatment sequence in metastatic pancreatic cancer.[Table: see text]

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Genomic/genetic testing patterns for patients with metastatic castrate-resistant prostate cancer: Results from a real-world study in the United States.

Journal of Clinical Oncology ◽

10.1200/jco.2021.39.6_suppl.49 ◽

2021 ◽

Vol 39 (6_suppl) ◽

pp. 49-49

Author(s):

Andrea Leith ◽

Amanda Ribbands ◽

Matthew Last ◽

Alicia Gayle ◽

Sarah Payne ◽

...

Keyword(s):

Prostate Cancer ◽

United States ◽

Genetic Testing ◽

Real World ◽

Patient Characteristics ◽

The United States ◽

Molecular Testing ◽

Cancer Disease ◽

The Us ◽

Castrate Resistant

49 Background: In May 2020, Olaparib was approved for HRRm mCRPC post progression on abiraterone and enzalutamide, and rucaparib was approved for BRCAm mCPRC following progression on androgen receptor targeted inhibitors and prior taxane therapy for mCRPC. HRRm are associated with approximately 25% of mCRPC and may be derived from germline or somatic origin. Somatic and germline alterations can be detected by tumour testing, but to differentiate between these, independent germline testing is needed. This study examined real-world genomic/genetic testing (GT) patterns in patients (pts) diagnosed with mCRPC in the United States (US). Methods: Data were drawn from the Adelphi Prostate Cancer Disease Specific Programme; a point-in-time survey administered to oncologists (onc), urologists (uro) and surgeons (sur) between January and August 2020 in the US. Physicians (phys) completed an attitudinal survey and a patient record form for the next four to nine mCRPC pts seen. Study variables included patient demographics, clinical factors and GT patterns. HRRm testers were defined as phys who tested for HRRm. Pts were identified as positive, negative or unknown depending on the outcome of the HRRm test. Results: A total of 72 phys (69% onc/ 29% uro/ 1% sur; 40% academic vs. 60% community) reported on 346 mCRPC pts. 41% of phys were based in the Northeast, 24% Midwest, 23% South and 13% in the West region of the US. 65 phys (90%) reported having access to overall GT; of these 5% identified as having access to germline tests only, while 94% were able to test for germline and somatic mutations. Challenges to conducting GT overall were ‘cost per test’ (50%), ‘having to send out for the tests (within country)’ (25%), ‘inadequate sample available’ (25%) and ‘patient refusal’ (25%). GT was typically conducted at identification of castrate-resistance (52%), metastases (51%) and at initial diagnosis (49%). 72% of total phys were HRRm testers; for these, patient characteristics primarily driving HRRm testing included Ashkenazi Jewish heritage (63%) and ECOG of 2-4 (58%). Other common drivers were family history, young diagnosis age and hormone therapy failure (all 46%). 132 (38% of 326) mCRPC pts were tested for HRRm; 39% of tested pts were identified with a HRRm. Most common HRRm tested were BRCA1 (90%), BRCA2 (89%) and ATM (55%). Conclusions: In this study majority of US phys had access to GT, but testing was only performed in 38% of pts with mCRPC. The higher than expected % of pts identified with an HRRm suggest that molecular testing was prioritised in high risk populations, as identified by the phys. With the recent approval of olaparib and rucaparib, GT may become more routine in clinical practice to identify eligible pts. Broader testing may also depend on addressing other barriers to testing including cost and testing logistics/practicalities.

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