bluuebunny/crossref_metadata_2025 huggingface dataset:
The feasibility of same day pegfilgrastim-cbqv administration in breast cancer patients receiving myelosuppressive chemotherapy regimens at a northern Virginia cancer center.
Authors: Leiva Maya , Pennisi Angela , Harnden Kathleen Kiernan , Rizzo Patricia Conrad , Mauro Lauren Ann
Published: June 2021

e18687

Background: The long-acting injectable G-CSF, pegfilgrastim and its biosimilars have historically been given to patients 24 hours following the administration of myelosuppressive chemotherapy for either primary or secondary prophylaxis of febrile neutropenia (FN). Previous literature has indicated that pegfilgrastim administration prior to 24 hours post chemotherapy, may result in a deepened and prolonged neutropenia due to the increase in circulating granulocytes exposed to chemotherapy. With the onset of the COVID-19 pandemic and to reduce potential SAR-CoV-2 exposure to cancer patients on therapy, we implemented same day administration of injectable pegfilgrastim-cbqv among select breast cancer patients receiving myelosuppressive chemotherapy regimens from March 2020 – February 2021. Methods: Utilizing retrospective EHR chart reviews, 55 patients among 4 medical oncologists in our breast cancer group were identified as meeting the criteria of same day pegfilgrastim-cbqv administration. Inclusion was based on completion of at least 2 consecutive cycles of same day pegfilgrastim-cbqv 6 mg subcutaneous injection for primary or secondary prophylaxis. The selected patient charts were reviewed for the incidence and severity of FN. Among the patients who had documented FN, further subgroup analyses were done regarding baseline characteristics, timing of neutropenia, regimens, regimen sequence, and reported ADRs associated with pegfilgrastim-cbqv. Results: 9 (16.4%) of the 55 patients experienced FN (Grades 3-4) and 6 (10.9%) patients were hospitalized. There were no Grade 5 events and none had therapy discontinued due to FN. 8 (88.9%) of the patients experienced FN between cycles 1 and 2. Of note, there were no cases of COVID-19 among the 9 patients who had an episode of FN. 52 (94.5%) of the 55 patients received treatment with curative intent and 3 (5.5%) had metastatic disease on a subsequent line of therapy. The median age was 49.1 years (range 29-71) and patients were 56.4% Caucasian, 18.1% Black or African American, 12.7% Asian, and 12.7% Hispanic/Latina. Conclusions: Based on the retrospective data analysis, same day pegfilgrastim-cbqv appears to be a safe and effective option in the primary and secondary prophylaxis of FN with myelosuppressive standard of care chemotherapy used in breast cancer treatment. Though our review was limited by a relatively small sample size and confined to younger (49.1 median age) breast cancer patients, this opens the door to further re-evaluation of same day pegfilgrastim-cbqv administration in other patient populations. In a post pandemic treatment world, this slight change in practice has the potential to reduce patient financial toxicity associated with multiple medical visits, provide an alternative to on-body injector formulations, and ensure treatment adherence.
Treatment of metastatic disease with immune checkpoint inhibitors nivolumab and pembrolizumab: Effect of performance status on clinical outcomes.
Authors: Wells Leah , Cerniglia Michael , Jost Audrey C. , Britt Gregory Joseph
Published: June 2021

e18689

Background: While guidelines exist for appropriate use of chemotherapy in the metastatic setting based on performance status, such recommendations are less readily available for immune checkpoint inhibitors (ICIs). We sought to determine if there is a relationship between Eastern Cooperative Oncology Group (ECOG) performance status and outcomes on immunotherapy in patients treated for metastatic disease at our community-based oncology practice. Methods: 253 patients were identified as receiving nivolumab or pembrolizumab for stage IV malignancy at Cancer Centers of Colorado-SCL Health, between June 2018 and November 2020. Patients initiated on therapy after May 2020 were excluded from analysis, due to insufficient (less than 6 months) follow-up time. The remaining 183 patients were included in a retrospective cohort study comparing patients with ECOG 0, ECOG 1, and ECOG 2-4. Sex, age, type of cancer, and line of therapy were collected. Time on therapy was also calculated. Best response to therapy was determined (disease control or progressive disease). These baseline factors and outcomes were compared using ANOVA for numeric variables and chi-square tests of association for categorical variables. Time from initiation of ICI to death or hospice was also investigated and compared using a log-rank test. In addition, a multivariate Cox proportional hazards model was developed for the outcome, time to death/hospice, versus the predictors ECOG status, age, gender, and line of therapy. Hazard ratios (HR) and 95% confidence intervals (CI) were estimated. Results: Of the 183 patients included in analysis, 31.7% had an ECOG of 0, 48.6% an ECOG of 1, and 19.7% an ECOG of 2-4. Non-small cell lung cancer and melanoma represented the majority of patients in each group. Gender and line of therapy did not differ between groups. There was a significant difference in age (p = 0.02) with mean age 62, 66, and 70 in ECOG 0,1, and 2-4, respectively. 54.6% of patients remained on therapy for at least 6 months (182 days), and there was no significant difference between groups in ability to complete 6 months of therapy (p = 0.32). For ECOG 0, 1, and 2-4, disease control was achieved in 67.2%, 59.6 %, and 41.7%, respectively (p = 0.048). Analysis of time to death/hospice with a log rank test and Kaplan Meier plot showed a significant difference between groups (p < 0.001). A multivariate Cox proportional hazards model revealed that patients with ECOG 0 had significantly longer time to death/hospice compared to patients in both other groups, after controlling for age, gender, and line of therapy (ECOG 1 vs. 0: HR 2.5, CI 1.27-4.9; ECOG 2-4 vs. 0: HR 2.83, CI 1.31-6.13). Conclusions: In this single institution retrospective study of patients receiving nivolumab or pembrolizumab for metastatic cancer, ECOG 0 was associated with disease control and increased time before death or transition to hospice.
Acute thromboembolic events (TE) within 30 days of COVID-19 infection in cancer patients.
Authors: Zavras Phaedon D. , Kabarriti Rafi , Mehta Vikas , Goel Sanjay , Billett Henny Heisler
Published: June 2021

e18691

Background: Increased rates of TE have been reported in patients (pts) with coronavirus disease (COVID-19), even without prior predisposition to thrombosis. Patients with cancer are already predisposed to a hypercoagulable state. We aimed to assess whether COVID-19 further increased the risk of TE in pts with active cancer at Montefiore Medical Center, Bronx, NY. Methods: The EMR of 90 cancer pts diagnosed with COVID-19 from March 15th to April 10th, 2020 were reviewed. COVID-19 testing was performed by PCR of nasal swab samples. Active cancer was defined as disease treated <1 year. Reports of imaging studies performed <30 days of the COVID-19+ test, either for new symptoms or for other reasons, were reviewed for new arterial (ATE) and/or venous thromboses (VTE). Patient were followed for 30 days from the date of COVID-19+ test for development of TE, hospital length of stay (LOS) and mortality. Results: Of 90 pts, 11 (12.2%) were found to have 13 new TE within 30 days of COVID-19+ test, 8 (8.9%) arterial and 5 (5.6%) venous. Of the 8 ATE, 7 were new strokes and/or microvascular cerebral disease (MCD) and 1 was a spleen infarct (SI). Of the 5 VTE, 3 were deep venous thrombosis, 1 pulmonary embolism (PE) and 1 patient presented with a superficial VTE. Two patients had 2 new TE each; stroke/PE and MCD/SI, respectively. Peak D-dimer (DD) value was higher in the TE group; mean DD (SD), TE vs no TE, 7.1 (3.4) vs 6.4 (7) ug/mL, p=0.03. Pts on either prophylactic or therapeutic anticoagulation (AC) had less TE; AC vs no AC, 9.1% vs 90.9%, p=0.0003. Only 1 pt on Enoxaparin prophylaxis developed TE. Of the 20 pts on therapeutic AC, 25% were newly started due to concern for thrombosis; the rest were already receiving AC for other reasons. Mortality was higher in the TE group; HR, TE vs no TE, 2.6, 95% CI (1.2 - 5.6), p=0.009. There was no correlation of cancer type, disease stage (metastatic or not), administration of prior chemotherapy or immunotherapy, common comorbidities, patient setting (inpatient, ICU, outpatient, ED visit), LOS or ventilation status with increased incidence of TE. Conclusions: Pts with COVID-19 have high rates of TE, and this is true for our pts with cancer. A high incidence of ATE was noted. TE was associated with increased mortality.[Table: see text]
Time to discontinuation of opioids in patients with cancer after curative intent radiation.
Authors: Fernandez Elena Valerie , Slade Alexander N. , Patterson Julie , Nadpara Pramit , Mays Darcy P. , Carroll Norman
Published: June 2021

e18692

Background: Many providers expect that cancer survivors would be able to discontinue opioids soon after treatment, although this has not been well studied. The time cancer survivors that received curative intent radiation (CIR) remain on opioids and associated factors were examined. Methods: Electronic medical record data of cancer survivors between January 1, 2008 and December 31, 2018 and Kaplan Meier survival models were used to estimate time to discontinuation (TTD) of opioids. Cox proportional hazards models were employed to identify factors associated with TTD. Results: Median TTD was 16.8 months (95% CI: 13.1-19.1 months) following CIR and shorter for patients without opioid exposure prior to therapy (new persistent opioid use [NPOU]; 13.0 months, 95% CI: 10.0-17.3 months) compared to patients with opioid exposure prior to therapy (chronic opioid use [COU]; 21.4 months, 95% CI: 17.5-28.8 months) (p-value = 0.0004). NPOU (HR: 1.35, 95% CI: 1.07-1.71) compared to COU and head and neck (HR: 1.60, 95% CI: 1.01-2.53) in comparison to breast cancer were associated with shorter TTD. Surgery (HR: 0.68, 95% CI: 0.50-0.91), death (HR: 0.55, 95% CI: 0.34-0.91), alcohol use (HR: 0.63, 95% CI: 0.42-0.95) and nicotine use (HR: 0.78, 95% CI: 0.62-0.98) were associated with longer TTD. Conclusions: Cancer survivors receive opioids for almost 1.5 years after CIR. Patients receiving surgery and using alcohol or nicotine are at higher risk. Patients with NPOU or head and neck cancers have shorter TTD. Evidence-based guidelines for opioid use in cancer survivors are warranted due to opioid use following CIR.
Treatment patterns among patients with advanced/recurrent endometrial cancer in the United States.
Authors: Maiese Eric M. , Émond Bruno , Liu Jinan , Lafeuille Marie-Hélène , Lefebvre Patrick , Ghelerter Isabelle , Wu Caterina , Hurteau Jean , Thaker Premal H.
Published: June 2021

e18693

Background: Among patients (pts) with endometrial cancer (EC), response rates for platinum-based regimens in the first-line (1L) setting range from 40% to 62% in clinical trials. This study describes patient characteristics, treatment patterns, time to next treatment (TTNT), and overall survival (OS) among pts with advanced/recurrent EC treated with a platinum-based regimen in a real-world setting in the US. Methods: This retrospective study used Optum Clinformatics Extended Data Mart de-identified databases from January 1, 2007, to December 31, 2019. Adult pts with advanced/recurrent EC who initiated a 1L platinum-based regimen and subsequently initiated second-line (2L) antineoplastic therapy were identified. Prior to initiation of 1L, a 12-month washout period of continuous enrollment without use of antineoplastic agents (except hormonal agents) was imposed. Kaplan-Meier (KM) rates were used to report TTNT and OS from 2L, third line (3L), and fourth line (4L), separately. Results: A total of 1878 pts with advanced/recurrent EC initiated 2L therapy following a platinum-based regimen in 1L. Among them, 739 (39.4%) pts initiated 3L and 330 (17.6%) initiated 4L or later (4L+) therapy. Median pt age was 68.0 years. More pts received platinum-based regimens (56.4%) in 2L than other options (Table). Few pts (3.3%) received immunotherapy. Among pts receiving 3L, a similar percentage of pts were treated with platinum-based (33.2%) and other chemotherapy regimens (33.8%); few pts received immunotherapy (3.0%). Among pts receiving 4L+, the most frequent treatment option was other chemotherapy (46.1%). Median TTNT was 17.7, 10.6, and 8.4 months for 2L, 3L, and 4L pts, respectively. KM rates of OS following initiation of 2L therapy at 1, 2, 3, and 4 years were 68.4%, 49.6%, 41.3%, and 33.6%, respectively, with a median OS of 23.5 months. Conclusions: Among pts with advanced/recurrent EC treated with platinum-based therapy in 1L, platinum-based regimens remain prevalent treatment choices in later lines of therapy. In this study, immunotherapy was used infrequently in 2L, 3L, and 4L+. The median TTNT decreased in later lines of therapy. This study highlights a critical need for novel, more effective treatment options in later lines of therapy to optimize outcomes among pts with advanced/recurrent EC.[Table: see text]
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]
A comprehensive Memorial Sloan Kettering Cancer Center real-world data model: Core clinical data elements.
Authors: Shah Neil J. , Bahadur Nadia , Esposito Lauren , Niederhausern Andrew , Nichols Chelsea , Pillai Anjali , Gandhi Fenil , Barton Laura , Chan Kimberly , Estrada Latasha , Goldberg Joshua , Capreol Grace , Bochner Bernard H. , Kollmeier Marisa , Al-Ahmadie Hikmat A. , Brown Samantha , Lee Jasme , Rosenberg Jonathan E. , Philip John , Bakker Theodora
Published: June 2021

e18755

Background: The 2016 21st Century Cures Act supports the use of Real-World Data (RWD) for regulatory decision/approval. Due to technological advances, a vast amount of health-related data are now available, but most are not standardized nor readily useable for research. Also, currently available standardized RWD models are not applicable across cancer types or oncology specialties (surgery, medical oncology, radiation oncology, pathology, radiology, etc.). To address these deficiencies Memorial Sloan Kettering Cancer Center (MSKCC) built a comprehensive, pan-cancer, pan-specialty RWD model. Methods: The Core Clinical Data Element (CCDE) data model incorporates aspects of existing academic and biopharma data models, including PRISSMM framework, ASCO’s mCODE, and NAACCR tumor registry model. The data model encompasses 11 domains that are critical to the understanding of the patient’s cancer journey, including: demographic, comorbidities, diagnosis, pathology, imaging, genomics, cancer surgeries, radiation oncology treatments, medical oncology treatments, cancer status/progression, and additional health information. To align with current standards, we are using ICD-10, ICDO3, CTACE V5.0, HL7, SNOMED and LOINC code sets. Further, this adaptable model allows for 5-10 disease specific elements to accommodate for disease heterogenicity and capture the differences among cancer types. Results: The CCDE database includes 1,126 of total data elements. MSKCC has 52,704 patients with MSK-IMPACT (Next-Generation sequencing platform with 505 genes panel) testing of which, we have identified 1,132 bladder cancer patients with at-least one year of cancer care follow-up for the initial curation cohort. Patients were identified as having an OncoTree bladder tumor type code that is assigned by a pathologist who attests the diagnosis by reviewing results from clinical tests on tumor specimens. To the date, 641 patients including 46,415 curated forms have been curated (Table). Conclusions: The comprehensive MSKCC’s CCDE data model standardizes the common and critical pan-cancer and pan-specialty elements for RWD. The dataset resulting from this curation efforts will provide robust structured and unified genomic and phenomic data across tumor types for future research enabling greater collaboration across various cancer types as well as oncology specialties.[Table: see text]
Delays in time to antibiotics in inpatient oncologic neutropenic fever do not predict decreased overall survival.
Authors: Villars Jordan , Gardner Christopher Anand , Zhan Tingting , Binder Adam F
Published: June 2021

e18765

Background: Neutropenic fever (NF) is relatively common oncologic emergency. Present expert consensus is that anti-pseudomonas gram-negative antibiotics should be administered within 60 minutes of detecting NF. To date studies investigating this relationship in neutropenic fever patients have been either limited in size, or have failed to reliably establish a relationship between time to antibiotics (TTA) and clinical outcomes.While some studies have shown an association between TTA and outcomes in NF patients admitted from the Emergency Department, such studies do not control for the time that patients may have been febrile in the community. To address these factors, we conducted a retrospective study on the effect of TTA on mortality in oncologic patients who developed NF as inpatients. Methods: We performed retrospective chart review of all cases of NF at an NCI designated Cancer Center between 7/1/2016 and 3/27/2019. NF was defined as temperature of 101˚ F on one occasion, or 100.4˚ F sustained over 60 minutes, with an absolute neutrophil count (ANC) less than 500. TTA and survival were calculated via chart abstraction; patients lost to follow up within 180 days were censored to the 180-day mortality group. Relationship between TTA and overall survival (OS) was analyzed via multivariable Cox regression. We excluded patients that had non-cancer related NF, were transferred from another institution with NF, were admitted from the ED with NF, or transitioned to hospice. Only the first instance of NF in any admission was analyzed. Results: A total of 187 eligible cases were identified during the study period, mean age was 57.6 +/- 13.6, 100 (53.5%) cases were in males, 114 (61.0%) cases in Caucasians, 53 (28.3%) in Black People. The 3 most common disease subtypes were acute leukemia (42.8%), plasma cell dyscrasias (27.8%), and lymphoma (16.6%). TTA showed no significant correlation with OS at any timeframe studied. Low Charlson Comorbidity Index ( < 3) correlated with increased survival through ̃360 days, however the effect was non-significant at longer timeframes. Immediate antibiotic treatment ( < 40 mins) correlated with poorer patient prognosis and significantly decreased OS (HR 3.08;CI: 1.30-7.28; p 0.010). Conclusions: TTA was not associated with OS in our study. For inpatients with NF, even hours long TTA may not be long enough to result in adverse clinical outcomes. Unlike NF patients presenting to the ED, where true TTA may often be many hours or even days prior to arrival, a few hours-long TTA in the hospital may not be sufficiently long enough to cause significant patient harm. Interestingly, in our cohort, those who received antibiotics quickly had adverse outcomes. It may be that in patients who were clinically unstable, TTA was shorter given the urgency of the situation. Ultimately, this study’s findings question the applicability of the 60-minute guideline when used in the inpatient setting.
Patterns and costs of hospital-based cancer care in the last year of life: A national data linkage study in England.
Authors: Luta Xhyljeta , Diernberger Katharina , Bowden Joanna , Droney Joanne , Hall Peter S , Marti Joachim
Published: June 2021

e18769

Background: Delivery of high quality cancer care is associated with rising costs, both in earlier stages of the illness trajectory and at the end of life. A significant portion of the costs and health care utilisation occurs in the last year of life. Most publications to date have focused on costs in hospital. Little is known about the costs of care for cancer patients across the entire health service. The aim was to examine primary, secondary and acute health care utilisation and cost in the last 12 months of life and how these differ by cancer diagnosis and other patient characteristics among decedent patients aged 60 and over. Methods: We conducted a retrospective cohort study of people aged 60 years and over (N=26,077) who died in England between 2010 and 2017. We used routinely collected and linked data from primary care (Clinical Practice Research Datalink (CPRD) secondary and acute care, (Hospital Episode Statistics (HES), and death data (Office for National Statistics (ONS)). This provided a nationally representative sample of the English population. We analysed of healthcare utilisation and resource use amongst decedents by gender, primary cause of death, age, geography, socio-economic status and comorbidities. Results: Overall, 90.2 % of the cancer decedents were admitted in the hospital at least once in the last 12 months of life. About 50% of patients we admitted to hospital in the last month of life with 37.6 being admitted to the hospital more than once in the last month of life. The health care utilisation and costs increased sharply in the last month of life. life. The mean number of hospital admissions in the last year of life was 3.7 (SD, 5.8). Those dying of haematological cancers (N=2093) had highest number of hospital admissions (mean:7.2, SD:10.8) and longer average hospital stay (mean:36.7, SD:33.0) (mean:12.0, SD:14.4). Use of outpatient services was highest in the group dying of haematological cancers (mean:12.0, SD:14.4) whereas those dying of prostate cancer (N= 2197) had higher number of emergency (mean:2.0, SD: 1.9) and GP visits (mean:30.8, SD: 20.7). Healthcare costs were highest among haematological cancers and lowest among those dying of breast cancer. Proximity to death and comorbidities were the main contributors of end-of-life care health care utilisation and costs. Conclusions: This study uses large linked datasets (linked to the whole spectrum of hospital episode statistics) providing a comprehensive picture of healthcare services accessed by cancer patients at end of life in England. There is significant variation in use and cost of care for cancer patients in the last year and month of life. Further analysis of variation according to hospice, palliative, and social care service provision may identify strategies to address this variation.
Real-world clinical practice: Toxicities of maintenance PARP inhibitors in recurrent ovarian cancer—The Royal Marsden experience.
Authors: Ali Zohra , Appadu Laura , Kitetere Ellen , Wampfler Julian , Yang Dorothy , Jupp Philippa , George Angela , Banerjee Susana N.
Published: June 2021

e18770

Background: Maintenance therapy with PARP inhibitors (PARPi) in recurrent high grade ovarian cancer is standard of care for patients who have responded to second or subsequent lines of platinum-based chemotherapy. The increased access to PARP inhibitors (Olaparib, Niraparib and Rucaparib) has provided the opportunity to explore the real-world toxicities in routine clinical practice, toxicity management and the consequent impact on maintenance therapy outcomes. Methods: Patients with relapsed ovarian cancer that received maintenance PARP inhibitor therapy in routine clinical practice between April 2015 and April 2020 were identified. Electronic patient records were reviewed retrospectively to retrieve details of any reported toxicities (occurring at any time during therapy) and their management. Data was entered into and analysed in a Microsoft Excel spreadsheet. Results: 99 patients who received second or subsequent line maintenance PARPi therapy were included (median age 63.6 years). 36% had a germline BRCA1/2 mutation, 6% had a somatic BRCA1/2 mutation and 58% were BRCA wild-type. 69% received 2nd line maintenance therapy; 22% and 9% received a maintenance PARP inhibitor following 3rd or 4+ line therapy respectively. 56% had not received previous maintenance therapy; 43% had received Bevacizumab. 48% patients commenced maintenance therapy at full dose. 13% of patients experienced no toxicities. 60% of patients experienced G1-2 toxicities, with 42% experiencing >2 episodes; most common toxicities were fatigue, nausea/vomiting and thrombocytopenia. 26% of patients experienced >G3 toxicity, with 9% experiencing >2 episodes, 4% of which were recurring toxicities; most common toxicities were hypertension, neutropenia and anaemia. 64% of patients developed toxicity within the first cycle of treatment; 39% had a dose interruption, 56% of which were < 2 weeks duration. 59% patients required a dose reduction from their starting dose due to toxicities. There was no significant difference in median PFS between patients who had been dose reduced compared to those who received full starting dose (p > 0.05). Conclusions: In keeping with phase III clinical trials, our real-world experience is that most PARPi toxicities are low grade and occur early in treatment. Toxicities can be effectively managed with brief dose interruptions and dose reductions, without adverse impact on survival outcomes.