bluuebunny/crossref_metadata_2025_split huggingface dataset:
How did the COVID crisis affect use of neoadjuvant therapy for patients with breast cancer?
Authors: Chagpar Anees B. , Lannin Donald R. , Mougalian Sarah Schellhorn , Berger Elizabeth Rapp , Gross Cary Philip , Horowitz Nina Ruth , Sanft Tara B. , DiGiovanna Michael , Golshan Mehra , Pusztai Lajos 
Published: June 2021

e18708 Background: The COVID-19 pandemic has caused shifts in terms of cancer management, but the impact of this has not been well-elucidated in a contemporary cohort of patients in clinical practice in the US. We hypothesized that closure of operating rooms would increase the use of neoadjuvant therapy (NT) during the early pandemic period. Methods: The nationwide Flatiron Health database is a longitudinal electronic health record (EHR)-derived database, comprising de-identified, patient-level structured and unstructured data, curated via technology-enabled abstraction. These data originated from approximately 280 cancer clinics. We compared patients diagnosed with non-metastatic breast cancer during the early pandemic period (March 1 – June 30, 2020; group 1) with those diagnosed in the four month period prior (November 1, 2019 – February 29, 2020; group 2) and those diagnosed during the same period one year earlier (March 1 – June 30, 2019; group 3). Results: There were 174 patients in group 1, 277 in group 2, and 348 in group 3. Overall, 591 (74.1%) were ER/PR+HER2-, 100 (12.6%) were HER2+, and 106 (13.3%) were triple negative (TN). Patients in the three groups were equally likely to be ER/PR+HER2- (75.3% vs. 72.2% vs. 74.9%, p = 0.68), HER2+ (12.1% vs. 14.9% vs. 11%, p = 0.33), TN (12.6% vs. 12.7% vs. 14.2%, p = 0.83) and to be high risk by genomic testing (either Oncotype Dx or Mammaprint; p = 0.72). While there was no difference in the clinical stage (p = 0.36) nor patient age at diagnosis (p = 0.76) across the three groups, patients diagnosed during the early pandemic (group 1) were more likely to receive NT compared to those diagnosed one year earlier (group 3); 28.7% vs 16.4%, p < 0.01 (see table). The use of NT differed between the three groups in the ER/PR+her2- (p < 0.01) and her2+ patients (p = 0.05), but not in the TN patients (p = 0.61). There was no difference in the use of NT overall during the pandemic by geographic state (p = 0.32) nor practice setting (p = 0.23); NT was also similar by geographic state and practice setting when considering the ER/PR+HER2-, HER2+, and TNBC subsets. Conclusions: Despite similar clinicopathologic features as earlier time periods, there was an increased use of NT during the early pandemic when compared to the same period in the prior year. This was seen particularly in the ER/PR+HER2- group, suggesting an increased use of neoadjuvant endocrine therapy.[Table: see text]
COVID-19 disease in patients with LUNG cancer in Spain: GRAVID LunG canceR pAtients coVid19 Disease (GRAVID STUDY).
Authors: Provencio Mariano , Mazarico Jose Maria , Calles Antonio , Antoñanzas Monica , Pangua Cristina , Mielgo Xabier , Nadal Ernest , Lopez Castro Rafael , López Martín Ana , del Barco Edel , Domine Manuel , Calvo Virginia , Diz Pilar , Sandoval García Carmen , Sais Elia , Sullivan Ivana , Sala Maria Angeles , García Ledo Gema , Baena Espinar Javier , Gonzalez Cao Maria 
Published: June 2021

e18709 Background: Patients with cancer may be more susceptible to infection and at increased risk of more severe COVID-19 disease; however, prognostic factors are not yet clearly identified. The LunG canceR pAtients coVid19 Disease (GRAVID) study aimed to describe clinical characteristics, outcomes, and predictors of poor outcome in patients with lung cancer and COVID-19. Methods: In this large nationwide study, we reviewed medical records of patients with lung cancer and confirmed COVID-19 diagnosis from 65 Spanish hospitals. Clinical features, treatments and disease outcomes were collected. The primary endpoint was to determine all-cause mortality; secondary endpoints were hospitalization and admission to intensive care units (ICU). Risk factors for poor prognosis were identified by univariate and multivariate logistic regression models. Results: Overall, 447 patients were included for analysis. Mean age was 67·1 ± 9·8 years; 332 (74·3%) were men, and 383 (85·7%) current/former smokers. NSCLC was the most frequent type of cancer (377, 84·5%), consisting mainly of adenocarcinoma (228, 51·0%), and stage III metastatic or unresectable disease (354, 79·2%). Two-hundred and sixty-six (59·5%) patients were receiving anticancer treatment, mostly first-line chemotherapy. In total, 350 (78·3%) patients were hospitalized for a mean of 13·4 ± 11·4 days, nine (2·0%) patients were admitted to the ICU, and 146 (32·7%) died. Advanced disease and the use of corticosteroids to treat COVID-19 during hospitalization were predictors of mortality. Hospitalized, non-end-of-life stage patients with lymphocytopenia and high LDH had an increased risk of death. Severity of COVID-19 correlated to higher mortality, ICU admission, and mechanical ventilation rates. Conclusions: Due to their underlying comorbidities and immunocompromised status, patients with lung cancer and COVID-19 show high hospitalization and mortality rates. These outcomes, alongside the identification of prognostic factors, may inform physicians on the risks and benefits in this population, in order to provide individualized oncological care.
Real-world patterns and predictors of first-line maintenance use among patients with newly diagnosed advanced ovarian cancer: Is there an opportunity for change?
Authors: Liu Jinan , Thaker Premal H. , Sah Janvi , Maiese Eric M. , Bee Oscar , Hurteau Jean , Chan John 
Published: June 2021

e18710 Background: With the advent of poly(ADP-ribose) polymerase inhibitors (PARPi), options for first-line (1L) maintenance therapy in ovarian cancer (OC) have evolved in the US. This study described the use of 1L maintenance and assessed predictors of 1L maintenance use among PARPi-eligible patients (pts) with OC in a real-world setting. Methods: This retrospective cohort study included pts with newly diagnosed stage III/IV epithelial OC who received 69 cycles of 1L platinum-based chemotherapy (PBC) and primary or interval debulking surgery following neoadjuvant chemotherapy between Jan 1, 2016, and Feb 29, 2020, from the nationwide Flatiron Health electronic health recordderived deidentified database. The end of the last cycle of 1L PBC was defined as the index date. Those pts who started second-line chemotherapy within 2 months of the index date were excluded. Logistic regression was used to analyze variables with regard to 1L maintenance use. Results: In total, 463 pts were included; 21% received maintenance therapy, 79% received active surveillance. Baseline characteristics are shown in the table. Overall maintenance therapy use increased over the study period, from 7.7% to 37.7%. Pts with BRCA wild type were significantly less likely to receive maintenance therapy (odds ratio [OR]: 0.30; 95% CI, 0.160.59) than pts with BRCA mutation. Pts treated in 2018 (OR: 2.73; 95% CI, 1.255.98) and 2019 (OR: 8.78; 95% CI, 4.1518.55) were significantly more likely to receive maintenance therapy than pts treated in 2017. Age, race, practice type, ECOG score, and residual disease status were not significant predictors of 1L maintenance use. Conclusions: Nearly 40% of pts with advanced stage OC received upfront maintenance therapy with an increasing trend over time, particularly in those with biomarker guidance. Research is warranted toward addressing barriers to the appropriate use of maintenance therapy.[Table: see text]
Verification of statistical oncological endpoints on encrypted data: Confirming the feasibility of real-world data sharing without the need to reveal protected patient information.
Authors: Geva Ravit , Waissengrin Barliz , Mirelman Dan , Bokstein Felix , Blumenthal Deborah T. , Wolf Ido , Pelles Sharon , Duchin Zohar , Liram Lior , Polyakov Yuriy , Blatt Marcelo 
Published: June 2021

e18725 Background: Healthcare data sharing is important for the creation of diverse and large data sets, supporting clinical decision making, and accelerating efficient research to improve patient outcomes. This is especially vital in the case of real world data analysis. However, stakeholders are reluctant to share their data without ensuring patients’ privacy, proper protection of their data sets and the ways they are being used. Homomorphic encryption is a cryptographic capability that can address these issues by enabling computation on encrypted data without ever decrypting it, so the analytics results are obtained without revealing the raw data. The aim of this study is to prove the accuracy of analytics results and the practical efficiency of the technology. Methods: A real-world data set of colorectal cancer patients’ survival data, following two different treatment interventions, including 623 patients and 24 variables, amounting to 14,952 items of data, was encrypted using leveled homomorphic encryption implemented in the PALISADE software library. Statistical analysis of key oncological endpoints was blindly performed on both the raw data and the homomorphically-encrypted data using descriptive statistics and survival analysis with Kaplan-Meier curves. Results were then compared with an accuracy goal of two decimals. Results: The difference between the raw data and the homomorphically encrypted data results, regarding all variables analyzed was within the pre-determined accuracy range goal, as well as the practical efficiency of the encrypted computation measured by run time, are presented in table. Conclusions: This study demonstrates that data encrypted with Homomorphic Encryption can be statistical analyzed with a precision of at least two decimal places, allowing safe clinical conclusions drawing while preserving patients’ privacy and protecting data owners’ data assets. Homomorphic encryption allows performing efficient computation on encrypted data non-interactively and without requiring decryption during computation time. Utilizing the technology will empower large-scale cross-institution and cross- stakeholder collaboration, allowing safe international collaborations. Clinical trial information: 0048-19-TLV. [Table: see text]
Treatment response among patients with multiple myeloma initiating daratumumab across different lines of therapy: A real-world chart review study.
Authors: Atrash Shebli , Thompson-Leduc Philippe , Tai Ming-Hui , Kaila Shuchita , Gray Kathleen , Ghelerter Isabelle , Lafeuille Marie-Hélène , Lefebvre Patrick , Rossi Adriana C. 
Published: June 2021

e18737 Background: Daratumumab (DARA), a CD38 monoclonal antibody, has been approved for the treatment of multiple myeloma (MM) among previously-treated patients since 2015, and among newly-diagnosed patients since 2018. This study aimed to describe real-world treatment response among patients initiating DARA across different lines of therapy since 2018. Methods: A retrospective chart review of adult patients with MM initiating DARA (monotherapy or as part of a combination regimen) between 1/2018 and 5/2020 was conducted at two clinical sites in the US (Levine Cancer Institute & Weill Cornell Medical College). De-identified patient-level data were abstracted in an electronic case report form. Treatment patterns, overall response rate (ORR) and proportion of patients with very good partial response (VGPR) or better were reported using descriptive statistics and stratified by line of therapy (first line [1L], second line [2L] or third line or later [3L+]). Results: A total of 202 patient charts were extracted. Patients were, on average, 65.3 years old at MM diagnosis and 68.1 years old at DARA initiation; 109 (54.0%) were male; 104 (51.5%) were White and 65 (32.2%) were Black or African American; 64 (31.7%) received a stem cell transplant (SCT) prior to the line of DARA initiation. Twenty-one (10.4%), 53 (26.2%) and 128 (63.4%) patients initiated DARA in 1L, 2L and 3L+, respectively. Median follow-up time was 6.2 months for 1L patients and 13.8 months for 2L+ patients. The most common 1L regimen was DARA with bortezomib, lenalidomide ± dexamethasone (DVRd; n=10, 47.6%) followed by DARA with lenalidomide ± dexamethasone (DRd; n=8, 38.1%). The most common 2L regimen was DRd (n=15, 28.3%) followed by DARA with pomalidomide ± dexamethasone (DPd, n=13, 24.5%) and DARA with bortezomib ± dexamethasone (DVd, n=13, 24.5%). The most common regimen in 3L+ was DPd (n=62, 48.4%). Among patients initiating DARA in 1L, 2L or 3L+ the ORR was 100.0%, 81.6% and 76.0%, and the proportion of patients achieving VGPR or better was 73.3%, 65.8% and 51.0%, respectively (Table 1). Median time to treatment response ranged between 2.6 and 2.8 months post-initiation. Conclusions: In this study, patients initiated on DARA had high ORR and rates of VGPR or better, including an ORR of 100% among 1L DARA users. These findings suggest that DARA-based regimens are an effective treatment option across all lines of therapy, with highest response rate in 1L. [Table: see text]
Real-world data on usage of scalp cooling for chemotherapy associated alopecia in the United States.
Authors: Williams Nicole Olivia , Paxman Richard , Thornhill Emma , Kassem Mahmoud , Grimm Michael , Dulmage Brittany , Cathcart-Rake Elizabeth , Ruddy Kathryn Jean , Pariser Ashley , Gatti-Mays Margaret Elena , Cherian Mathew Amprayil , VanDeusen Jeffrey Bryan , Stover Daniel G. , Sardesai Sagar D. , Wesolowski Robert , Ramaswamy Bhuvaneswari , Loprinzi Charles L. , Lustberg Maryam B. 
Published: June 2021

e18739 Background: Hair loss is a well-known side effect of chemotherapy. The Paxman Hair Loss Prevention System, a scalp cooling device, has been shown to be effective in reducing chemotherapy induced alopecia in patients receiving chemotherapy (Nangia, JAMA, 2017). The National Comprehensive Cancer Network and the European Society for Medical Oncology guidelines have recommended scalp cooling as category 2A and 2B options, respectively. Methods: The real world use of scalp cooling using the Paxman device, as documented by orders through the Paxman Hub during the years of 2017-2020 was summarized. Descriptive statistics were used to summarize demographics and utilization. Results: Data from 6649 patients who used scalp cooling were reviewed. Patients with breast cancer were the most common users of scalp cooling (78%, n=5197) followed by gynecology (12%, n=775), gastrointestinal (3%, n=201), lung (1%, n=81) and genitourinary (1%, n=52). The majority of patients were between the ages of 45-65 (55%), followed by 65-74 (18%), older than 75 (5%), and 25-44 (2%). Average number (#) of cycles of cooling completed was 6.53 (range of average # of cycles 4.50-12). Scalp cooling with this device was commonly used in 39 out of 50 states. Conclusions: This is the largest report of scalp cooling usage in the real world setting in the USA, including scalp cooling usage in older adults. Uptake of scalp cooling across various cancers has not been uniform and this deserves further study.
Covid-19 infection in patients with a history of everolimus use.
Authors: Pehlivan Metin , Aydiner Adnan 
Published: June 2021

e18744 Background: The COVID-19 infection, declared as a pandemic by WHO in March 2020, continues its effects all over the world. Cancer patients also get COVID infection and in some patients this infection is mortal. In our study, we examined the course of COVID-19 infection in patients who actively or in the past used Everolimus. Methods: Patients who used everolimus actively or in the past were examined in our study. Patients who survive after the first cases seen in Turkey March 11, 2020 ; were evaluated in terms of whether they had COVID-19. Demographic characteristics and primary malignancies of the patients were examined. Patients who had COVID-19 infection and died were identified. Results: Our study consists of 50 patients in total. 14 (28%) of the patients were male and 36 (72%) were female. The average age of the patients is 56.72 (28-82), the average age of the male patients is 52.8 (28-80) and the average age of the female patients is 57.58 (36-82). 17 of the patients were treated for breast cancer, 11 for neuroendocrine tumor, 7 for tuberous sclerosis, 5 for renal cell carcinoma, 4 for thymic carcinoma, 2 for thymoma, 2 for ovarian ca, 2 for perivascular ecrine tumor. While it is the most common breast cancer in women (47.2% of female patients), neuroendocrine tumor is the most common in male patients (35.7% of male patients). While 13 patients were actively using everolimus (26%), 37 patients (74%) had discontinued everolimus treatment for 1 year or more.5 of our patients were diagnosed with COVID-19 infection (10% of all patients). 2 of these five patients are actively using everolimus. Of those diagnosed with COVID-19, 3 are women and 2 are men.The average age of the patients is 50.08 (43-66). While 3 patients had mild illness (60%), 2 patients (40%) died. One of the deceased patients is female and one is male. The female patient had a history of using everolimus for breast cancer, while the male patient died at the age of 52 while actively using everolimus for thymoma. Conclusions: Everolimus is a MTOR inhibitor used in many malignancy treatments. In our study, we found that 10% of our patients had COVID infection and 2 of our patients died due to COVID-19. In the group that discontinued everolimus treatment for a year or more, 1 patient died due to COVID-19, and 1 patient in the group still receiving everolimus treatment. Studies with larger patient populations are needed to determine whether everolimus carries an additional risk of COVID-19 infection.
Treatment changes in prostate cancer patients on active treatment during the COVID-19 pandemic in a community cancer center in New York City.
Authors: Snyder Rose , Meghal Trishala , Wood Andrew , Schulman Ariel , Becker Kevin Douglas , Huang Yiwu , Lipshitz Jay Steven , Mo Lan , Xu Yiqing 
Published: June 2021

e18750 Background: The surge of the SARS coronavirus-2 (COVID-19) pandemic posed great challenges in the oncology community for optimal management of cancer patients. We sought to analyze the treatment changes experienced by the prostate cancer patients in March, April and May 2020 and to compare these treatment decisions to the published guidelines. Methods: We focused on patients currently receiving androgen deprivation therapy (ADT) with leuprolide acetate, and/or oral anti-androgen agents (Androgen receptor axis targeted agent, ARAT), or chemotherapy. Electronic medical records were reviewed, and the oncologists and nurse practitioners were interviewed to understand the decision-making process. Results: Seventy-five patients were included, median age 72 years old (range 47-95). All were taking ADT, and 21 were also taking ARAT, and 3 were also receiving chemotherapy. The incidence and indications for their ADT treatments and schedule changes are shown in the table below. Twenty-seven patients (36%) experienced delays in their ADT treatment, and the percentage of treatment change was similar in categories of metastatic hormone sensitive prostate cancer (mHSPC), metastatic castration resistant cancer (mCRPC), biochemical recurrence as well as stage IVA post surgery. Four patients were receiving neoadjuvant ADT planned prior to definitive radiation, and none had schedule change. One patient with mHSPC and 2 patients with mCRPC continued chemotherapy as planned. One patient declined recommended chemotherapy for mCRPC. Two patients were given q 3 months dose of ADT instead of q 1m, while all the rest were already receiving q3 months dosing. Among the 27 patients who had schedule change, 12 (44.4%) patients had a discussion with their providers first, and 15 patients (55.6%) did not keep their treatment appointment. Conclusions: About one third of patients changed ADT injection schedule with a similar percentage in patients with mHSPC, or mCRPC or Biochemical recurrence, or IVA after surgery. Every 3 months dosing of ADT recommended by NCCN significantly decreases exposure to COVID -19, delaying or skipping treatment was still encountered due to health concern or travel limitations. On the other hand, all patients receiving neoadjuvant ADT, or chemotherapy stayed on schedule. Although NCCN guideline recommended delaying myelosuppressive therapy, palliative chemotherapy for symptomatic, refractory patients may still be a priority.[Table: see text]
Risk factors for hospitalization for cancer patients with SARS-CoV-2 infection.
Authors: Shahid Zainab , Baldrige Emily , Trufan Sally , Schepel Courtney , Tan Antoinette R. , Hwang Jimmy J. , Musselwhite Laura W. , Kim Edward S. , Chai Seungjean , Sumrall Ashley Love , Ragon Brittany K. , Voorhees Peter Michael , Grunwald Michael Richard , Ghosh Nilanjan , Usmani Saad Zafar , Copelan Edward Alan , Raghavan Derek 
Published: June 2021

e18753 Background: Cancer patients are more susceptible to developing severe disease associated with SARS-CoV-2 infection. Herein, data from a high-volume cancer center is presented highlighting risk factors associated with hospitalization with COVID-19 disease. Methods: Cancer patients in the Levine Cancer Institute COVID19 database who were tested for SARS-CoV-2 due to clinical illness from March 1, 2020 to October 29, 2020 with 90 days follow-up are described here. Patients’ demographic and clinical information were retrospectively entered into a REDCap database from chart reviews. Differences in distributions were identified between hospitalized and non-hospitalized patients using the chi-squared test with uni- and multivariable logistic regression models. Statistical significance was set at p<0.05. Results: 228 patients with SARS-CoV-2 infection were identified, of whom 103 (45%) were hospitalized. Median age was 63 years (range 28-95). Race distribution for infection showed White 65%, followed by Black 26.8% and Hispanic ethnicity 16.7% , with a similar distribution for hospital admission. Median length of stay was 10 days (range 1-91) with no readmissions within 90 days. The most common underlying malignancies were breast (29.8%), hematologic (21.1%) and genitourinary (12.3%). The most common preexisting conditions included hypertension (55.7%), diabetes (27.2%) and cardiac disease (3.9%). The most common presenting symptoms were cough (50.2%), fever (38.4%), fatigue (37.8%) and shortness of breath (36.4%). Maximum oxygen requirements for hospitalized patients were ambient air (34%), nasal canula (34%), high/medium flow nasal canula (10%), non-invasive ventilation (13%) and mechanical ventilation (10%). Case fatality rate was 10% with diagnosis of COVID-19, including 21.4% of those admitted to the hospital and 51.7% of those admitted to the ICU. Univariable logistic regression analysis showed that age, sex, prior chemotherapy, upper gastrointestinal cancers, hematologic cancers, number of medical conditions, cardiac disease, chronic lung diseases, hypertension, and diabetes increased risk of hospitalization. Table shows results of multivariate analysis. Conclusions: The COVID-19 pandemic has caused high case fatality rates in our cancer patients. We identified age, cardiac disease, hematologic malignancy and receipt of chemotherapy within 4 weeks of diagnosis as risk factors for hospitalization. These data may help in prioritizing early intervention in vulnerable subgroups to improve survival outcomes. [Table: see text]