bluuebunny/crossref_metadata_2025_split huggingface dataset:
Expanded access and early access provision: Awareness, educational needs and opportunities to improve access to care.
Authors: Krendyukov Andriy , Singhvi Sanjay , Green-Morrison Yianick , Zabransky Markus 
Published: June 2021

e18507 Background: An unmet medical need exists for many oncology patients who cannot be treated satisfactorily by available therapeutics. Despite notable efforts made by FDA and EMA to expedite development, review and approval of Innovative Medicinal Products (InMPs), there may still be a lengthy delay before oncology patients can gain access to new therapies. Expanded access (EA) in the USA and compassionate use (CU) in the European Union are pathways endorsed to improve patient access to InMPs. Recently reported data from CDER and CBER revealed that applications for EA pathways dealing with patient cohorts remain low, despite high approval rates. The challenges that practicing oncologists may face when dealing with EA or other early access provision (EAP), together with limited education, may influence the access of oncology patients to care. Methods: An on-line, fully anonymous survey reaching out to more than 3,258 practicing physicians was initiated between November 2020- January 2021. Participants were asked questions about their knowledge and understanding of EA/EAP, level of experience, decision process, interest for further educational activities and opportunities to improve process, both in general and specifically during COVID 19 pandemic. Attributes were rated on a 5-point scale. Results: Analysis of first respondents showed that 70% of practicing physicians rated their own understanding and knowledge about EA/EAP as above average (good or very good). However, only 60% of responders answered specific knowledge-based question correctly. At the same time, only 44% of practicing oncologists reported notable experience with EA/EAP in daily practice. The majority of respondents (90%) felt that availability of clinical efficacy data from comparative phase III RCTs would be considered of high importance; other evidence and study types (e.g. clinical safety, PK/PD, preclinical data) were rated substantially lower. The need for further education around better understanding of the processes and regulatory requirements, roles and responsibilities, and data collection was emphasized by 61%, 36% and 30% of respondents, respectively. During current COVID 19 pandemic, majority of respondents highlighted the need to improve and substantially adapt EA with regard to application process and documentation, InMP supply and logistics, and safety reporting process. Conclusions: Results from this survey suggest that challenges posed by the EA process, together with a lack of education, might contribute to the under-utilization of EA/EAP for oncology patients. Continuous educational efforts are required to better inform and support practicing oncologists during the EA application process and regulatory framework. Competent authorities should consider optimization and implementation of digital tools to facilitate EA applications and follow up during the COVID 19 pandemic.
Cancer treatment among the elderly in the United States: Examining the interplay of race/ethnicity and comorbidities.
Authors: Pham Tung , Connor Avonne , Suneja Gita , Rositch Anne 
Published: June 2021

e18547 Background: As the life expectancy of Americans continues to increase, so does the number of individuals who are diagnosed with cancer and other comorbidities. Management of these patients can become increasingly complicated as physicians administer multiple combinations of interventions and drug therapies. To further complicate this issue, the average number of comorbidities among racial/ethnic minority patients is higher than non-Hispanic (NH) white patients, and this disparity could adversely affect receipt of curative cancer treatment among these minority groups. Therefore, we explored the association between race/ethnicity, comorbidities, and curative cancer treatment among elderly Americans diagnosed with the four most common cancer types. Methods: SEER-Medicare linked data was used to identify 727,136 individuals over 65 years old diagnosed with breast, colorectal, lung, or prostate cancer from 1992-2011. Comorbidity burden was measured using the Charlson Comorbidity Index (CCI) and analyzed as tertiles (T1: lowest CCI score to T3: highest CCI score). Treatment with curative intent was defined as receipt of any cancer-type-specific surgery, chemotherapy, radiation, hormone, or immune therapy within 6 months of cancer diagnosis. Modified Poisson regression models were used to assess the joint association between comorbidities and race/ethnicity on cancer treatment. Results: For all cancers, the percentage of patients receiving treatment declined rapidly with increasing age, CCI scores, number of comorbidities, and advanced cancer stage. In addition, variability in receipt of treatment by race/ethnicity was observed: 76% for NH-White patients, 75% for Hispanic patients, and 68% for NH-Black patients. Taking into account age, genders (for colorectal, lung cancer), year of diagnosis, stage at diagnosis, and socioeconomic status, we found that treatment proportions among NH-Black and Hispanic patients with low CCI score (T1) were 2%-15% lower than NH-White patients with the same CCI score (all p < 0.001). Although treatment proportions decreased with increasing CCI among NH White patients (ranging from 2.5-11.3%; p < 0.01), there was little difference in treatment by CCI among NH Black and Hispanic patients (ranging from 0.5%-2%; p > 0.05). Conclusions: Our findings suggested that racial disparities may exist in cancer treatment among patients with low comorbidities. This finding was unexpected as these patients are less likely than highly comorbid patients to experience drug interactions and other complications due to concurrent disease management therapies.
Evaluation of emergency department (ED) visits by oncology patients: A running comparison to admissions and ED visits under the CMS OP-35 ruling.
Authors: Alsuhebany Nada , Brown Jamie , Echave Jacquelyne , Elquza Emad , Babiker Hani M. , Abraham Ivo , McBride Ali 
Published: June 2021

e18683 Background: The incidence of emergency department (ED) visits by oncology patients has grown in recent years. Some visits are medically unnecessary or could be prevented with improved prophylactic measures. Centers for Medicare & Medicaid Services (CMS) implemented the Hospital Outpatient Quality Reporting (OQR) Program, to which hospitals must report data on quality measures of care furnished in the outpatient setting. One of the proposed measures, OP-35, evaluates admissions and ED visits by patients receiving outpatient chemotherapy, assessing for ten potentially preventable visits. These ten visit reasons included are: anemia, nausea, vomiting, dehydration, neutropenia, diarrhea, pain, pneumonia, fever, and sepsis. This study evaluated the incidence and reasons for ED visits by patients receiving outpatient chemotherapy, as well as outcomes following these visits in order to assess appropriate prophylactic treatment related to outpatient chemotherapy at our institution. Methods: This single-center, retrospective chart review was conducted at The University of Arizona Cancer Center. We collected data using an electronic medical record and included oncology patients with active cancer who had ED visits from January 1, 2018, to December 31, 2018. Data points included baseline demographics; malignancy; ED visit reason; clinic visit history; past ED visits; treatment and supportive care data; and outcome of the ED visit. Results: Study authors included 205 of the 1,659 screened encounters. Approximately 70% of the encounters involved patients with solid tumors and 30% with hematologic malignancies. Nearly 50% of hematologic malignancy patients presented to the ED for potentially preventable reasons, while 32.8% of solid tumor patients had potentially preventable visits. The most common preventable ED visit reasons in both groups were pain, fever, nausea, vomiting, and dehydration. In our analysis, over 90% of patients presenting for neutropenia and fever had received appropriate growth factor prophylaxis when indicated based on their chemotherapy regimen. Of the patients presenting for nausea or vomiting, it was determined 95.3% had received appropriate antiemetic prophylaxis. Conclusions: This study showed that the incidence of potentially preventable visits was numerically higher in the hematologic cancer group compared with the solid tumor group. In addition, this study showed that a number of patients who were admitted to the ED with nausea/vomiting or neutropenia/fever received appropriate guideline-recommended prophylactic or supportive care therapy, regardless of the OP-35 proposed CMS core measure determination that these visit reasons should be considered preventable. These findings highlight the need for CMS to further review OP-35 to include information addressing the use of appropriate supportive care in the future.
Prevalence of the concurrent administration of contraindicated medications in patients with cancer treated with tyrosine kinase inhibitors (TKIs): A pilot study from the IU Simon Comprehensive Cancer Center.
Authors: Alhaffar Dana , Han Yan , Darling Julianne , Skaar Todd C. , Fausel Christopher A. , Hanna Nasser H. 
Published: June 2021

e18714 Background: Polypharmacy may result in drug-drug interactions that reduce efficacy or increase toxicities to patients. Tyrosine kinase inhibitors (TKIs), which is standard therapy for many patients with cancer, have interactions with many commonly prescribed drugs (including proton pump inhibitors [PPIs] and cytochrome inhibitors/inducers) which alter their metabolism. Methods: Retrospective study of 100 consecutively chosen patients with advanced cancer treated with TKIs were identified. Patients < 18 years of age, participating in clinical trials, or taking an investigational treatment for their cancer were excluded. TKI start date and concurrent medications were identified from chart reviews. Documentation was undertaken to record co-administration of drugs that could prolong QT interval, PPIs, and CYP3A inhibitors and inducers. QT prolonging medications were divided into those with known risk (KR), conditional risk (CR), and probable risk (PR). IUSM Clinical Pharmacology Flockhart table was utilized for cytochrome drug interactions. All three categories of cytochrome inhibitors (strong, moderate, and weak) were included in the analysis. The primary objective was to estimate the percentage of patients treated with TKIs co-administered these classes of drugs with a potential for harmful drug-drug interaction. Results: Median age of 100 pts was 57 and median duration of treatment with the TKI was 441 days. 85 of 100 pts receiving TKIs for their cancer were also prescribed at least 1 drug with the potential for drug-drug interaction, including 39 with a QT prolonging drug with known risk and 25 with a CYP3A inducer or inhibitor. 53% had documentation of EKG while on TKI treatment. Conclusions: Most patients in this chart review were co-administered TKIs with other agents with a potential for harmful drug-drug interactions. Continual monitoring of medications is necessary to optimize efficacy of TKIs and reduce the chance for harmful side effects.[Table: see text]
The real-word evidence of first-line treatment of pembrolizumab in advanced NSCLC.
Authors: Li Pin , Gadgeel Shirish M. , Poisson Laila 
Published: June 2021

e18731 Background: For advanced non-small cell lung cancer (NSCLC), evidence from clinical trials indicates the superiority of pembrolizumab (P) than chemotherapy (C) in PD-L1 positive patients and superiority of P+C than C among PD-L1 unselected patients. Meta-analysis from different clinical trials stated P+C failed to improve overall survival (OS) or progression-free survival (PFS) compared with P alone. This study used real-world data of PD-L1+ patients with advanced NSCLC to compare treatment effect of P with P+C. Methods: A retrospective analysis of adult patients diagnosed between 2015-2020 with stage IV NSCLC with PD-L1+ and without EGFR/ALK mutation was examined using de-identified Syapse Learning Health Network(LHN). We compared the patients with first-line (1L) treatment of pembrolizumab + carboplatin + chemo (P+C) and patients with 1L treatment of P only (P). Patient characteristics and survival outcomes including real-world OS (rwOS) and real-world time to next treatment (rwTTNT) were collected. Results: 485 patients were included: 231 on P+C and 254 on P. The two groups are similar in race, primary tumor histology and ECOG, and P are older in age and have more female. The median rwOS for P+C is longer than P (13.2 vs 11.0 month), 1 year survival probability is higher (55% vs 49%), but 2 year survival probability is lower (34% vs 39%). Coxph model shows no significant difference between two groups (HR=0.89, 95% CI 0.69-1.14, p=0.34). Subgroup analysis of patients age≥75 shows median rwOS for P+C is shorter than P (8.7 vs 13.2 month), 1 year survival probability is lower (46% vs 51%). Coxph model shows no significant difference between two groups (HR=1.32, 95% CI 0.81-2.16, p=0.27). In each treatment group, the median rwOS for female is longer than male (13.2 vs 7.9 month in P, 15.8 vs 12.2 month in P+C), and 1 year survival probability is higher (52% vs 45% in P, 59% vs 53% in P+C). Coxph model shows no significant difference between female and male (HR=0.81, 95% CI 0.58-1.15, p=0.23 in P; HR=0.90, 95% CI 0.62-1.30, p=0.57 in P+C). Conclusions: Among patients with PD-L1+ advanced NSCLC, there is no significant difference in rwOS for patients with 1L treatment of P+C or P alone.[Table: see text]
The impact of the COVID-19 pandemic on oncology clinical trial recruitment in an Irish cancer center.
Authors: McLaughlin Ronan Andrew , Madigan Valerie , O'Grady Maureen , Mahgoub Thamir Andrew , Kalachand Roshni Andrew , Osman Nemer , Korpanty Greg , Coate Linda E. 
Published: June 2021

e18756 Background: The COVID-19 pandemic has created unprecedented disruptions to cancer clinical trial research across the world due to a temporary global suspension of patients’ recruitment to cancer clinical trials. Access to clinical trials permits better treatment options and best clinical practice standards for patients with cancer. We present the impact of the COVID-19 pandemic on cancer clinical trial activity at the Cancer Clinical Trials Unit (CCTU) at the Mid-Western Cancer Centre, University Hospital Limerick (UHL). Over the last 4 years 28 clinical trials, both interventional and translational, have opened here, across a variety of primary disease sites, with 5 trials opened in 2017, 11 in 2018, 7 in 2019 but only 2 in the first 10 months of 2020 until 3 further trials were opened in December. Methods: CCTU records were reviewed to identify the number of patients screened and consented to participate in cancer clinical trials at UHL in 2020, which were compared directly with corresponding numbers for 2019. Results: In 2019, 17 clinical trials were open and recruiting at the CCTU, UHL. During 2020, 19 trials were recruiting although during the 1st surge of the COVID-19 pandemic recruitment was essentially suspended and CCTU staff were redeployed throughout the hospital. 1st Six months 2020 vs 2019 In the six months from January 2020 until the end of June 2020, 99 patients were screened and only 15 (15.2%) signed informed consent to participate in a cancer clinical trial. When these figures are directly compared with the first six months of 2019, there is a 33% reduction in patients screened for participation (147 vs 99) and a 60% reduction in patients consented (37 vs 15) to clinical trials. 12 Months 2020 vs 2019 In total during 2019, 376 patients were screened for inclusion to participate and 49 (13%) patients signed informed consent to participate in a clinical trial within CCTU at UHL. In 2020, 914 patients were screened for participation with 51 patients consented to participate (5.6%). The majority (45/51 (88%)) of patients consented to cancer clinical trials in 2020 at the CCTU, UHL were recruited to translational based studies and only 6 (12%) consented to interventional studies compared with 2019 when 30/49 (61%) consented to translational and 30/49 (39%) to interventional studies. Conclusions: During the COVID-19 pandemic, the percentage of patients consented to participation in a clinical trial reduced significantly, as compared to the previous year (5.6% vs 13%). Fewer interventional studies have recruited patients during 2020. As we enter the third surge of COVID-19 infections in Ireland, we must continue to monitor and identify effective strategies to navigate the ever-changing situation for cancer clinical trials, in an attempt to maintain access to high quality cancer clinical trial opportunities for our patients.
Description of asymptomatic cancer patients with COVID-19 infection: Experience of the ACHOCC-19 study in one Latin American country.
Authors: Ospina Serrano Aylen Vanessa , Bruges Maya Ricardo Elias , Mantilla William Armando , Triana Ivan Camilo , Ramos Pedro , Aruachan Sandra , Quiroga Alicia , Munevar Isabel , Ortiz Juan , Llinas Nestor , Pinilla Paola , Vargas Henry , Idrobo Henry , Russi Noguera July Andrea , Manneh Kopp Ray , Rivas Giovanna Patricia , Gonzalez Florez Hector Alirio , Santa Daniel Andres , Insuasty Jesus , Lopes Gilberto 
Published: June 2021

e18761 Background: Cancer has been described as a risk factor for worse prognosis in people with Covid-19. However, there are few studies informing on the characteristics of cancer patients that have asymptomatic SARS-cov2 infection. The ACHOCC-19 study included asymptomatic patients. Methods: Analytical cohort study of patients with cancer and SARS-cov2 infection in Colombia. From April 1 to October 31, 2020, we collected data on demographic and clinical variables related to cancer and COVID-19 infection. We describe the characteristics and outcomes of patients who had no symptoms of COVID19. Association between outcomes and prognostic variables was analyzed using logistic regression models. Results: We included 742 patients, of which 205 (27.6%) were asymptomatic. Of these 62.2% were older than 61 years, 66% were women, 1.42% were smokers. The most frequent malignancy was breast cancer (25%), followed by colon-rectum (14.6%), sarcoma/soft tissues (5.66%) and lung cancer (5.19%). Patients were more likely to be asymptomatic if they had fewer comorbidities (0-1 comorbidities: 84% asymptomatic, 2 comorbidities: 10.85%, more than 2 comorbidities: 5.15%). 90.5% lived in urban areas and 53.37% had low income. 35.4% of patients had metastatic disease, 8.7% had progressive cancer, 40% had stable disease or partial response. No patient had an ECOG PS of 4 or more, and only 1.91% had ECOG 3. In logistic regression analysis statistically significant associations for having symptomatic disease included: man, presence of 1, 2 or > 2 comorbidities, ECOG 1,2 or 3 and cancer in progression. On the other hand, the statistically significant ORs for having asymptomatic disease were age between 18 and 30 years old, cancer in remission and receiving non-cytotoxic treatment. Table sumarizes ORs and their respective 95% CIs of the variables adjusted in the logistic regression model. Conclusions: In our stumdy, cancer patients had a higher probability of asymptomatic COVID-19 infection if they were women, between the ages of 18 and 30 years, had cancer in remission , ECOG 0 and no comorbidities. This is the first cohort of patients with cancer and asymptomatic covid 19 with a significant sample size in Latin America.[Table: see text]
Insurance data of patients receiving sequential immune checkpoint inhibitors: A single center experience.
Authors: Awidi Muhammad , Ranjit Rojer , Connell Brendan James , Gil Brigitte , Dalbo Natalie , Maher Lewena , Daves Seanna , McDonald Stephanie , Tsoukas Philip , Voner Linda , Gunturu Krishna Soujanya 
Published: June 2021

e18835 Background: Immune checkpoint inhibitors (ICI) up regulate T cell activity promoting tumor cell death and revolutionized modern oncology. The use and number of indications for ICI is growing at an unprecedented speed. Combination and sequential ICI therapies have been shown to be beneficial in certain types of cancer. There is no significant data to support non-FDA approved sequential use of ICI when patients develop toxicities or progression which could result in a significant financial burden on the patient and the health care system. We conducted a retrospective review of cancer patients receiving ICI at our institution and evaluated the insurance status of these patients who received sequential ICI. Methods: We retrospectively reviewed Oncology patients’ charts who received ICI between January 1, 2014 to December 18, 2018. We identified patients receiving sequential ICI, to be defined as patients who received a second ICI, following an initial ICI therapy. Insurance status was evaluated for patients receiving sequential therapy. Commercial insurance was defined as either private or non-Medicare/Medicaid. Results: Out of total 437 patients receiving ICI, 15 patients received sequential ICI. 11 patients were transitioned to a secondary ICI following disease progression (73%), three had immune related adverse events and one was switched per standard of care. Nine patients (60%) had commercial insurance and six patients (40%) had medicare/medicaid. Of those, one had urothelial carcinoma and was switched to pembrolizumab from atezolizumab due to disease progression. One patient had melanoma and received nivolumab following ipilimumab when data from the CHECKMATE 238 were published. Three patients with melanoma were transitioned from ipilimumab to nivolumab, two had disease progression and one had autoimmune dermatitis. Two patients had lung adenocarcinoma and were switched from nivolumab to pembrolizumab due to disease progression. One patient had small cell lung cancer and received pembrolizumab following nivolumab due to disease progression. One patient had squamous cell lung cancer and was switched to pembrolizumab from nivolumab following disease progression. Conclusions: With the rapid growth and advancement of ICI indications, there is limited data available on the benefits of sequential ICI to our patients in the clinical setting. We report a small percentage of oncology patients receiving sequential treatment with or without FDA approval and explore their insurance status. Majority of our patients who transitioned to a second ICI due to progression had commercial insurance. Larger prospective studies are needed to evaluate sequential ICI efficacy and tolerability and cost effectiveness.