bluuebunny/crossref_metadata_2025 huggingface dataset:
A randomized, double-blind, multicenter, phase III study of fosnetupitant for the prevention of chemotherapy-induced nausea and vomiting (CINV) in patients receiving doxorubicin-cyclophosphamide/epirubicin-cyclophosphamide (AC/EC) based highly emetogenic chemotherapy: CONSOLE-BC.
Authors: Tsurutani Junji , Matsuura Kazuo , Inoue Kenichi , Tanabe Yuko , Taira Tetsuhiko , Kubota Kaoru , Tamura Tomohide , Saeki Toshiaki
Published: June 2021

12094

Background: Fosnetupitant (FN) is a phosphorylated pro-drug of netupitant that has high binding affinity and selectivity for the neurokinin 1 receptor and a long half-life of 70 h. Recent studies have reported that fosaprepitant (FA) has a risk for developing injection site reactions (ISRs) in patients with breast cancer who receive doxorubicin-cyclophosphamide/epirubicin-cyclophosphamide (AC/EC)-based treatments. Previous studies have shown that FN may have a low risk of ISRs and could potentially address this unmet medical need. The present study (JapicCTI-194691) was intended to evaluate the safety profile, including ISRs, of FN in patients receiving AC/EC treatment. For exploratory purposes, we set the FA group as the exploratory arm. A separate pivotal phase 3 study (JapicCTI-194611) was conducted to verify the efficacy and safety of FN compared with FA in patients receiving cisplatin-based chemotherapy. Methods: Patients scheduled to receive AC/EC were randomly assigned 1:1 to receive FN 235 mg or FA 150 mg in a double-blind manner, in combination with intravenous palonosetron (PALO) 0.75 mg and dexamethasone (DEX) 9.9 mg on day 1. The stratification factors were age class ( < 55 years vs. ≥55 years) and site. The primary endpoint was the incidence of treatment-related adverse events (TRAEs) of FN. In addition, the ISRs were investigated as secondary endpoints. Efficacy outcomes were also evaluated as secondary endpoint. Results: Between April 2019 and March 2020, total 102 patients were enrolled in the study. Fifty-two patients were randomized to the FN group and 50 to the FA group, and all of them were treated with the study drug and evaluated for safety. The baseline characteristics were generally balanced, except for the history of motion sickness (54.9% vs. 44.9%) and non-smokers (78.4% vs. 63.3%) in the FN and FA groups, respectively, which are considered as risk factors for chemotherapy-induced nausea and vomiting. The primary endpoint, the incidence of TRAEs was 21.2% (n = 11) (95% CI 11.1% – 34.7%) in the FN group, which was similar to that in the FA group [22.0% (n = 11) (95% CI 11.5% - 36.0%) ]. Any cause or treatment-related ISRs were observed in 5.8% (n = 3) and 0% (n = 0), respectively, in the FN group and 26.0% (n = 13) and 10.0% (n = 5), respectively, in the FA group. The overall (0–120 h) complete response (no emetic event and no rescue medication) rate standardized by age category was 45.9% (n = 23) in the FN group and 51.3% (n = 25) in the FA group. Conclusions: The safety of FN in combination with PALO and DEX was favorable. Risk of ISR by FN was quite low in the AC/EC setting. Clinical trial information: JapicCTI-194691.
A phase III, randomized, double-blind, multicenter, active control study of fosnetupitant for the prevention of chemotherapy-induced nausea and vomiting (CINV) in patients receiving cisplatin-based highly emetogenic chemotherapy (HEC): CONSOLE.
Authors: Shiraishi Yoshimasa , Hata Akito , Inui Naoki , Okada Morihito , Morise Masahiro , Akiyoshi Kohei , Takeda Masayuki , Watanabe Yasutaka , Sugawara Shunichi , Shinagawa Naofumi , Kubota Kaoru , Saeki Toshiaki , Tamura Tomohide
Published: June 2021

12099

Background: Fosnetupitant (FN) is a phosphorylated pro-drug of netupitant that has high binding affinity for the neurokinin-1 (NK-1) receptor and a long half-life of 70 h. This phase 3 study is the first head-to-head study to compare two NK-1 receptor antagonists, FN and fosaprepitant (FA), in combination with palonosetron and dexamethasone for the prevention of chemotherapy-induced nausea and vomiting (CINV) in patients receiving highly emetogenic chemotherapy (JapicCTI-194611). Methods: Patients scheduled to receive cisplatin (≥70 mg/m2) -based chemotherapy were randomly assigned 1:1 to receive FN 235 mg or FA 150 mg, in combination with palonosetron 0.75 mg and dexamethasone (9.9 mg on day 1, 6.6 mg on days 2-4). The stratification factors were sex, age category (<55 vs. ≥55 years), and site. The primary endpoint was the complete response (CR; no emetic events and no rescue medication) rate, stratified by sex and age category, during the overall phase (0-120 h) to show the non-inferiority (margin, -10%) of FN to FA. The secondary endpoints were: CR rate, complete protection rate, total control rate, no nausea rate, no emetic events rate in each period [i.e., acute (0-24 h), delayed (24-120 h), overall, 0-168 h and 120-168 h], time to treatment failure, and safety, including injection site reactions (ISRs). Assessment of efficacy was continued until 168 h after the initiation of cisplatin. Some eligible patients were evaluated for safety and efficacy of FN for up to four cycles. Results: Between February 2019 and March 2020, total 795 patients were enrolled in the study. The study drug was administered to 785 patients (n=392 in FN vs. n=393 in FA), and all of them were evaluated for efficacy and safety. Baseline characteristics were generally balanced between the two groups. The adjusted overall CR rate was 75.2% in FN vs. 71.0% in FA [MH common risk difference, 4.1%; 95% CI, -2.1% to 10.3%), thus demonstrating non-inferiority of FN to FA. Regarding the other secondary endpoints of efficacy until 168 h, FN was favorable against FA, especially the CR rate during 0-168 h (73.2% in FN vs. 66.9% in FA) (Table). The incidence rates of treatment-related adverse events were 22.2% in FN vs. 25.4% in FA, whereas those of ISRs with any cause or with treatment-related were 11.0% or 0.3% in FN vs 20.6% or 3.6% in FA, respectively ( p<0.001). Conclusions: FN demonstrated non-inferiority to FA, with a favorable safety profile and lower risk for ISRs. For the period beyond 120 h after initiation of chemotherapy, FN may have the potential to improve the prevention of “beyond delayed” CINV. Clinical trial information: JapicCTI-194611. [Table: see text]
A randomized controlled trial of cognitive behavior therapy for reducing anxiety and depressive symptoms in patients with locoregional advanced nasopharyngeal carcinoma.
Authors: Liu Feng , Fu Shengnan , Chen Yanzhu , Yan Ouying , Wu Xiangwei , Han Yaqian , Jiang Cuihong , Tong Fei , Zou Ran , Peng Wanglian , Wang Hui , Liu Xiaohong
Published: June 2021

12121

Background: The purpose of this randomized trial was to compare the efficacy of cognitive behavioral therapy (CBT) versus treatment as usual (TAU) on anxiety and depression, response rates and acute adverse events in patients with locoregional advanced nasopharyngeal carcinoma (NPC) receiving chemoradiotherapy. To the best of our knowledge, this is the first randomized trial evaluating the effect of CBT for depression and anxiety in patients with locoregional advanced NPC treated with chemoradiotherapy. Methods: A total of 202 patients with diagnosis of stage III-IVa (8th AJCC) NPC were randomly assigned to receive CBT plus chemoradiotherapy (CBT group, n = 101) or treatment as usual (TAU) plus chemoradiotherapy (TAU group, n = 101). Patients in the CBT group received a series of six CBT sessions for 6 weeks during concurrent chemoradiotherapy. Depression and anxiety were assessed using the Hospital Anxiety and Depression Scale (HADS) score at baseline, the completion of chemoradiotherapy, 1 and 3 months after chemoradiotherapy. Response rates and adverse events were also evaluated. This trial is registered with chictr.org.cn, number ChiCTR2000034701. Results: Patients in the CBT group showed significantly less depression and anxiety than patients in the TAU group after the completion of CBT (P < 0.01). Complete response (CR) rate was significantly higher in CBT group than in TAU group (100% vs. 93.1%，P = 0.014). Compared with the TAU group, the CBT group showed a significantly lower incidence of acute adverse events including anemia, fatigue, mucositis, insomnia and weight losing (P < 0.05). Conclusions: The addition of CBT to chemoradiotherapy significantly reduced depressive and anxiety symptoms. CBT combined with chemoradiotherapy is associated with improved response rates, with reduced incidence of acute toxic effects in patients with locoregional advanced nasopharyngeal carcinoma. Clinical trial information: ChiCTR2000034701.
Patient reported sexual concerns in routine cancer care.
Authors: Lees Brittany , Vilasagar Smitha , Brown Jubilee , Clark Peter E , McKibben Maxim , Meadors Patrick , Sabir Sasha , Smith Shannon M , York Beth , Walsh Declan
Published: June 2021

12128

Background: Sexual health is an important component of overall well-being and can be adversely impacted by chemotherapy, surgery, radiation, in addition to the psychological effects of cancer treatments. Sexual health is challenging to discuss and may be overlooked or avoided during cancer care. Methods: Patients presenting for consultation in an outpatient multisite cancer center completed electronic distress screening (EDS) between January 2017 and December 2020. The EDS contains 42 questions; demographic information, cancer symptoms and side effects, and psychosocial factors. The EDS is completed by patients before a clinical encounter for early symptom identification and intervention. We conducted a retrospective data analysis of sexual health concerns (>5; scale 0-10) and evaluated patient characteristics and clinically relevant distress (>4; NCCN Distress Tool), depression risk (>3; PhQ2), and anxiety risk (>3; GAD2). Our primary aim was to identify the prevalence of sexual health concerns. The secondary aim was to examine the relationship between sexual health and emotional well-being. Results: 57,375 EDS screens were completed. 13,950 patients (24%) reported sexual concerns or lack of interest in sex (>5) within the last 2 weeks. The frequency of these concerns at specific clinics ranged from 12% to 48%, with the highest rates at Palliative care (39%) and Psycho-Oncology (48%) clinics. Genitourinary (30%), Gynecologic (27%) and Gastroenterology (26%) reported the highest frequency of sexual concerns from cancer site specific clinics. Males reported a higher rate of sexual problems compared to females (30% vs 21%, p < 0.001), but a lower rate of relationship concern distress (12% vs 13%, p < 0.05). Patients with a risk for depression (n = 9,126) or anxiety (n = 10,809) had higher rates of self-reported sexual concerns than those with a negative screen (44% vs 21% depression, p < 0.001; 40% vs 21% anxiety, p < 0.001). Conclusions: Sexual health is a concern for approximately one-quarter of patients presenting for cancer care. Sexual health concerns were prevalent across cancer sites. Patients with positive screens for anxiety and/or depression have nearly double the rates of reported sexual health concerns. Sexual health is a current unmet need that impacts cancer patients and warrants attention.
Family members’ attitudes towards disclosure of cancer diagnosis to patients in China.
Authors: Rao Xi , Zhang Yongshen , Kong Feng-Ming Spring
Published: June 2021

12131

Background: Informed consent is very important aspect of treatment, in western countries, a diagnosis of malignancy should be delivered the paient directly. It was the decision of the patient for further disclosure. However, in China, people are always family centered decision making, a diagnosis of cancer is traditionally delivered to the family members, with a protective assumption. We used anonymized questionnaire to investigate the attitude of Chinese people towards to cancer diagnosis disclosure and correlated factors. Methods: This is a survey study conducted by a web system named “Wenjuan Xing”. The study questionnaires were designed in dual English and Chinese. answered by the same person. The regarding questions that answered by the same person are as following: “If your close family member is diagnosed with a malignant tumor, would you like to tell him the truth?”, “If yes/no, what’s your reason?”. Demographic information include gender, age, economic status, education level, health condition, residential region, occupation, nationality and major reasons. The survey link was placed on Wechat contact of these investigators, social media and also distributed in Oncology Center of a general hospital in Mainland China. The answers of the questions were captured directly online, data can also be exported into excel format for compiled analysis. Results: A total of 1470 people completed the survey questions from January to July 2020. The potential factors which influence disclosing diagnosis were registered, 1041 (70.8%) family members are in favor of informing the diagnosis to patients, 429 (29.2%) are not. The main reasons for disclosure diagnosis are ‘it is his or her life, he/she has to be in control’ (N=832) and she or he can plan his/her remaining life and leave the world with no regret (N=588). The famliy member who hide the diagnosis worry that paitents could not handle the stress would have poor quality of life (N=295) and die faster(N=323). 1425(96.9%) people want to know the diagnosis if they have a malignanti tumor, while 45 (3.1%) don’t want to know.The univariate analysis revealed educational level, health condition and residential region are correlated to disclosing diagnosis. The logistic regression anaylsis show a significant effort to disclosing diagnosis(OR= 1.9, 95% CI (1.4, 2.7) P<0.001).Interaction and stratified analyses were conducted according to education level and redidential region (P interaction= 0.0406). In the high education level group, people who live in other countries(America, Europe) (P=0.009 OR=29.7 CI 2.3-375.7) more likely to disclose the diagnosis compared to mainland in China. Conclusions: The majority of Chinese people want to know the diagnosis. People who have higher education level and live in western countries more likely prefer disclosure of diagnosis to patients.
Oncology patients’ perspectives on remote patient monitoring for COVID-19.
Authors: Daly Robert Michael , Lauria Tara , Holland Jessie C. , Garcia Jericho , Majeed Jibran , Walters Chasity , Strachna Olga , Chow Kimberly , Giles Caitlin E. , Kelly Meghan F , Reidy Diane Lauren
Published: June 2021

1504

Background: Oncology patients are particularly vulnerable to adverse outcomes from COVID-19 and require careful monitoring to identify early deterioration and render higher level care when indicated. Several institutions launched remote patient monitoring programs (RPMPs) to care for patients with COVID-19. We describe patients’ perspectives on a COVID-19 RPMP at a National Comprehensive Cancer Center. Methods: Adult patients who had either tested positive for COVID-19 on an outpatient microbiology test or were discharged after hospitalization for the virus were eligible. Patients enrolled in the RPMP received a daily 10-question electronic patient-reported outcome assessment of COVID-19 symptoms and their responses generated alerts to a centralized monitoring team for new or worsening symptoms. A subset of high-risk patients also received a pulse oximeter which alerted when blood oxygen levels dropped below 93%. RPM was discontinued 14 days after a patient’s positive test result and following 3 days without worsening symptoms or fever. Patients who exited the program and had completed at least one assessment were sent a patient engagement survey. The objective of the survey was to evaluate the patient’s experience with digital monitoring and symptom management for COVID-19. The assessment was structured with objective response questions, including a net promoter score, and free text questions to elicit patient perspectives on RPM value. Free text responses were analyzed using grounded theory to identify primary themes regarding perceived value. Results: The survey was distributed to 452 patients; 241 responded as of June 10, 2020 (53% completion rate). The net promoter score was 91%. The table provides responses to objective questions. Qualitative analysis of free text responses identified the primary themes regarding patient perceived value which included: 1) Security: patients appreciated that the RPMP provided a clinical safety net; 2) Connection: patients appreciated the link to their clinical team during a period of isolation; 3) Empowerment: patients appreciated that the RPMP provided education on the virus and symptom management. Conclusions: RPMPs are perceived to be of value to oncology patients with COVID-19. A key barrier to maintaining these programs is cost. Policymakers should consider how these programs can be reimbursed in the future so that they can continue to provide care to vulnerable patients and keep them at home out of the acute care setting.[Table: see text]
Identification of patients at high risk for preventable emergency department visits and inpatient admissions after starting chemotherapy: Machine learning applied to comprehensive electronic health record data.
Authors: Peterson Dylan J. , Ostberg Nicolai P. , Blayney Douglas W. , Brooks James D. , Hernandez-Boussard Tina
Published: June 2021

1511

Background: Acute care use is one of the largest drivers of cancer care costs. OP-35: Admissions and Emergency Department Visits for Patients Receiving Outpatient Chemotherapy is a CMS quality measure that will affect reimbursement based on unplanned inpatient admissions (IP) and emergency department (ED) visits. Targeted measures can reduce preventable acute care use but identifying which patients might benefit remains challenging. Prior predictive models have made use of a limited subset of the data available in the Electronic Health Record (EHR). We hypothesized dense, structured EHR data could be used to train machine learning algorithms to predict risk of preventable ED and IP visits. Methods: Patients treated at Stanford Health Care and affiliated community care sites between 2013 and 2015 who met inclusion criteria for OP-35 were selected from our EHR. Preventable ED or IP visits were identified using OP-35 criteria. Demographic, diagnosis, procedure, medication, laboratory, vital sign, and healthcare utilization data generated prior to chemotherapy treatment were obtained. A random split of 80% of the cohort was used to train a logistic regression with least absolute shrinkage and selection operator regularization (LASSO) model to predict risk for acute care events within the first 180 days of chemotherapy. The remaining 20% were used to measure model performance by the Area Under the Receiver Operator Curve (AUROC). Results: 8,439 patients were included, of whom 35% had one or more preventable event within 180 days of starting chemotherapy. Our LASSO model classified patients at risk for preventable ED or IP visits with an AUROC of 0.783 (95% CI: 0.761-0.806). Model performance was better for identifying risk for IP visits than ED visits. LASSO selected 125 of 760 possible features to use when classifying patients. These included prior acute care visits, cancer stage, race, laboratory values, and a diagnosis of depression. Key features for the model are shown in the table. Conclusions: Machine learning models trained on a large number of routinely collected clinical variables can identify patients at risk for acute care events with promising accuracy. These models have the potential to improve cancer care outcomes, patient experience, and costs by allowing for targeted preventative interventions. Future work will include prospective and external validation in other healthcare systems.[Table: see text]
Risk for SARS-CoV-2 infection in patients with breast cancer treated with chemotherapy, biologic therapy or active surveillance: Patient outcomes from multicenter institution in New York.
Authors: Budhathoki Nibash , Kucharczyk John , D'Abreo Nina , Kwa Maryann J. , Plasilova Magdalena , Dhage Shubhada , Hindenburg Alexander A. , Lee Joanna , Winner Megan , Daly Alison , Soe Phyu Phyu , Ramdhanny Angela , Schnabel Freya Ruth , Oratz Ruth , Speyer James L. , Novik Yelena , Meyers Marleen Iva , Jones Simon , Adams Sylvia , Marks Douglas Kanter
Published: June 2021

1513

Background: In high-risk estrogen-receptor positive, HER2 positive, or triple negative breast cancer (BC), chemotherapy can increase cure rates in early-stage disease and prolong survival in setting of advanced disease. Real world data specific to BC is needed to counsel patients (pts) with BC on their risk for SARS-CoV-2 infection and mortality in the context of the SARS-CoV-2 pandemic. Methods: In this retrospective study, we abstracted clinical data including demographics, tumor histology, cancer treatment, and COVID-19 testing results status from the electronic medical record of 3778 BC patients who received cancer care from 02/01/2020 – 05/01/2020 in New York City at our cancer center. The primary endpoint of the study was incidence of SARS-CoV-2 infection by treatment type (cytotoxic chemotherapy (CT) vs non-cytotoxic therapies (endocrine and/or HER2 directed therapy (E/H)) diagnosed by either serology, RT-PCR, or documented clinical diagnosis. Probability of Treatment Weighting (IPTW) and Mann-Whitney Test were used to assess risk of SARS-CoV-2 infection by treatment and assess outcomes based on oncologic and non-oncologic risk factors respectively. Results: 3062 patients met inclusion criteria with 379 pts in CT, 2343 pts in E/H and 340 in NT groups. During study period 641 patients (20.9%) were tested by either PCR or serology with 64 patients (2.1%) diagnosed with COVID-19. All pts who tested positive by PCR and subsequently had serology testing were positive for IgG. The weighted risk of SARS-COV-2 infection was 3.5% in CT vs. 2.7% in E/H (p=0.523). 27 patients (0.9%) expired over follow up, with 10 deaths attributed to SARS-CoV-2 infection. The weighted risk for death was 0.7% with CT vs. 0.1% with E/H, p=0.24 (Table A). Age, BMI,CCI and advanced cancer stage were associated with increased mortality following SARS-CoV-2 infection (Table). Conclusions: CT was not associated with increased risk of infection with SARS-CoV-2 infection or death following infection. BC cancer treatment, including CT, can be safely administered with enhanced infectious precautions and should not be withheld particularly when given for curative intent.[Table: see text]
Growth in eligibility criteria content and failure to accrue among National Cancer Institute (NCI)-affiliated clinical trials.
Authors: Peterson John Stuart , Plana Deborah , Bitterman Danielle Sara , Johnson Skyler B , Kann Benjamin Harris
Published: June 2021

1515

Background: Cancer clinical trial accrual across diverse socioeconomic and demographic groups is a national priority, yet up to 20% of trials fail due to poor accrual. Eligibility criteria content may contribute to poor accrual, but effects are challenging to measure. We sought to evaluate growth of eligibility criteria within NCI-affiliated cancer trials and the impact on trial accrual over the past decade. Methods: We conducted a retrospective study with the Aggregate Analysis of ClinicalTrials.gov (AACT) (abstracted: 02/02/2021). We included NCI-affiliated, interventional Phase II or III trials that initiated between 01/01/2008 and 12/13/2018. We excluded active and recruiting trials that lacked accrual data on the Cancer Trials Support Unit website. Trials whose status was “Withdrawn”, “Terminated”, or “Suspended” due to low accrual, or had less than 50% target accrual after two years active were deemed accrual failures. Eligibility criteria were extracted from inclusion and exclusion criteria and complexity was estimated by the number of unique content words, calculated by removing duplicates and stop words from the word count. Association of unique word count with accrual failure was evaluated by univariable and multivariable logistic regressions, adjusting for other predictors of low accrual identified in earlier research. Results: Of 1197 trials included, 231 (19.3%) failed due to low accrual. Eligibility criteria increased in length from a median of 214 (IQR [23, 282]) unique content words in 2008 to 417 (IQR [289, 514]) in 2018. The rate of trial accrual failure increased with unique word count decile from 11.8% in the first decile (12 to 112 words) to 29.4% in the tenth decile (445 to 750 words) (P = 0.004). On multivariable analysis, unique word count remained independently associated with low accrual (OR: 1.07 per decile, 95%CI [1.01-1.13], P = 0.02), as did Phase III and metastatic disease settings (Table). Conclusions: Eligibility criteria content has increased dramatically in the last decade in NCI-affiliated trials. Increasing eligibility criteria content associates strongly with accrual failure, even after adjusting for multiple known predictors of accrual. These findings underscore the need for efforts to simplify eligibility criteria to improve trial accrual. Further investigation is ongoing to determine specific criteria qualities that portend accrual failure.[Table: see text]
The validity of progression-free survival (PFS) 2 as a surrogate endpoint for overall survival (OS) in randomized controlled trials (RCTs) of advanced solid tumors.
Authors: Woodford Rachel , Zhou Deborah , Kok Peey-Sei , Lord Sally , Marschner Ian , Friedlander Michael , Lee Chee Khoon
Published: June 2021

1516

Background: OS is the gold-standard endpoint for treatment efficacy in oncology RCTs. However, prolonged follow-up is required to obtain mature data, which impedes regulatory approval of potentially beneficial therapies. Furthermore, increasing therapeutic options including cross over to investigational agents at disease progression often confound OS findings. PFS-2, defined as time from randomization to progression on second-line therapy, has been proposed as a potential surrogate endpoint for OS. Using a meta-analytic approach, we aimed to assess the association between OS and PFS-2, and its validity compared with other surrogate endpoints. Methods: We performed an electronic literature search to identify RCTs of systemic therapies that reported PFS-2 as a pre-specified endpoint with defined follow up protocols. Articles were screened for eligibility and outcome data were extracted. Correlations in the relative treatment difference between treatment arms for OS vs PFS-2, PFS-1, and objective response rate (ORR) were assessed as the comparison of hazard ratios (HR) and odds ratio (OR) respectively. Results: 38 eligible RCTs comprising of 44 analysis units, with 19,031 patients across 8 unique tumor types were identified. The majority received targeted therapies (72.2%), followed by immunotherapy (IO; 26.3%). The correlations of HR-OS/HR-PFS-2, HR-OS/HR-PFS-1 and HR-OS/OR-ORR were r = 0.67 (95% CI 0.08-0.69), r = 0.12 (95% CI 0.00-0.13) and r = 0.21 (95% CI 0.00-0.33) respectively. Correlations between OS with surrogates was assessed in different subgroups according to post-progression survival times (SPP), types of treatment agents and rate of subsequent therapy after progression (table). Conclusions: Across diverse tumors and therapies, treatment effect on PFS-2 has modest to strong correlation with OS, but poor correlations were observed between OS-PFS-1 and OS-ORR respectively. Across all subgroups, PFS-2 performs consistently better than traditional surrogates of PFS-1 and ORR, validating and providing support for use in future RCTs.[Table: see text]
Patient factors associated with time to medication receipt of oral anti-cancer drugs.
Authors: Lichtenstein Morgan RL , Beauchemin Melissa , Doshi Sahil , Raghunathan Rohit , Law Cynthia , Accordino Melissa Kate , Elkin Elena B. , Wright Jason Dennis , Hershman Dawn L.
Published: June 2021

1519

Background: The past decade has seen a dramatic increase in the number of Food and Drug Administration approvals of oral anti-cancer drugs (OACDs). Most OACD prescriptions require coordination between providers, payers, specialty pharmacists, and financial assistance organizations, which can delay drug receipt. We evaluated median time to OACD receipt (TTR) from initial OACD prescription submission and assessed clinical and process-related factors associated with TTR. Methods: We prospectively collected data on all new OACD prescriptions for adult oncology patients at a large, urban outpatient cancer center from 1/1/2018 to 12/31/2019. We collected patient demographic, medical, and insurance data; prescription submission and delivery dates; and interactions with payers and financial assistance groups. TTR was defined as the number of days from OACD initial prescription to patient receipt of the drug. We estimated the median TTR across all patients and used multivariable logistic regression to identify factors associated with TTR above the median. Results: The cohort included 1080 patients who were prescribed 1269 new OACDs. Of these prescriptions, 84% (N=1069) were received, and 71% (N=896) required prior authorization. The median patient age was 66, 44% identified as Non-Hispanic White (White), 25% of patients had commercial insurance, 16% had Medicaid alone, and 58% had Medicare alone or in combination with another plan. The median TTR per patient was 7 days (IQR 0 – 142; 25% ≥ 14 days and 5% ≥ 30 days). In unadjusted analyses, insurance and race/ethnicity were associated with TTR. Compared with patients covered by Medicaid, those with Medicare and supplemental insurance (a partial, not free-standing plan) had nearly 2.5 times the odds of TTR >7 days controlling for other factors. Race/ethnicity showed a trend toward longer TTR with Non-Hispanic Black (Black) patients having a longer TTR compared to White patients, controlling for other factors. We did not observe statistically significant effects of either comorbidity or prior authorization requirement on TTR. Conclusions: Though the majority of oncology patients prescribed OACDs receive the drug, 71% of prescriptions required prior authorization and a quarter of patients waited at least two weeks. Disparities in TTR are primarily driven by financial factors, specifically insurance type.[Table: see text]
Patient navigation plus hospital at home to improve COVID-19 outcomes for cancer patients.
Authors: Ragon Brittany K. , Sumrall Ashley Love , Blackley Kris , Osunkwo Ify , Moyo Tamara Kay , Kabrich Laura , Leonard Kelly , Masten Ben , York Beth , Murphy Stephanie , Kersten Brian , Batchelor Thomas , Rivet Carly , Parala-Metz Armida , Shahid Zainab , Chai Seungjean , Musselwhite Laura W. , Walsh Declan
Published: June 2021

1524

Background: Reports suggested cancer patients were at greater risk for increased morbidity and mortality from COVID-19. A process to mitigate these risks was established at Levine Cancer Institute (LCI) in partnership with Atrium Health’s (AH) Hospital at Home (HAH) initiative. This virtual health navigation process employed expertise from the departments of Hematologic Oncology and Blood Disorders, Oncology, and Supportive Oncology, including a specialized nurse navigation team, to rapidly identify COVID-19 positive LCI patients, monitor them under physician supervision, and escalate care as needed with AH HAH program. Methods: AH Information Services created an automated list of LCI COVID-19 positive patients with a daily database. Each patient was reviewed by a nurse navigator. Review included hematologic or oncologic diagnosis, outpatient or inpatient status, and any COVID-19 symptoms. Once a malignant diagnosis was confirmed, a diagnosis-specific navigator contacted and screened the patient with a COVID assessment tool. Documentation was forwarded to the primary oncologist/hematologist. The tool scored patients for surveillance and treatment needs. A score of 0-2 prompted phone assessment every 48-72 hours, and score of 3-5 required every 24-48 hour calls with physician involvement when appropriate. If score of ≥6, care was escalated to LCI nurse/physician for admission to AH acute care HAH or conventional inpatient admission. Results: From inception on 3/20/2020 to data review date of 12/2/2020, 974 LCI patients were identified as COVID-19 positive and reviewed for nurse navigation (Table). Of the 974, 488 were navigated. Given limited resources, patients with benign conditions were not assigned a navigator, though a similar process was created for sickle cell disease. Of the 974, 75 are now deceased. Only 25 are deceased among the 488 navigated. Conclusions: The COVID-19 pandemic presented unprecedented circumstances to our patients and their clinicians. LCI expeditiously put policies and procedures in place to mitigate the intersection of COVID-19 and cancer. The multidisciplinary response strategy liaising between AH HAH and LCI followed, assessed, and assisted LCI COVID-19 positive patients. With our embedded nurse navigation team’s specialized attention along with enhanced physician oversight and close collaboration with AH HAH, opportunities for care escalation or adjustments in cancer-focused care were promptly identified. Analysis is ongoing to elucidate the lower mortality rate observed among navigated patients.[Table: see text]
Socio-economic disparities and accessibility to age-appropriate screening tools.
Authors: Soror Noha , Keruakous Amany
Published: June 2021

1529

Background: Pervasive racial and ethnic health disparities continue to be reported throughout the U.S. population. An increasing number of studies have discussed racial disparities in cancer statistics as well as socio-economic differences. The purpose of this study is to investigate sociodemographic health care disparities and the prevalence of cancer diagnosis in the context of challenges in medical services accessibility due to financial burden. Methods: Analysis of pooled cross-sectional data using 2017 Behavioral Risk Factor Surveillance System (BRFSS). Differences between our comparison groups were computed using chi square test for categorical values and t-test for continuous variables. Demographic factors were analyzed through weighted regression for accessibility to cancer treatment and prior cancer screening. Results: We report data from a total of 436,198 respondents to the 2017 BRFSS survey, with cancer prevalence 9.8% and higher prevalence of cancer among females and elderly population (70 years and older). Racial disparities differed significantly between respondents with and without history of cancer, with higher prevalence in Hispanic and multiracial minorities, 19% and 14%, respectively. We also report, differences in annual income are significantly associated with increased cancer prevalence in lower socioeconomic populations. Nineteen percent of participants who had annual income less than 25k were diagnosed with cancer. Additionally, analyzing the association between delayed medical care due to financial burden and its correlation with accessibility to age-appropriate cancer screening tools. We report significant differences in receipt of cancer screening among respondents, with consistently lower probabilities of receiving age-appropriate screening tools among participants who experienced delays in medical care due to cost, that applies to all screening tools. Among respondents who did not receive screening mammograms, 17% reported delays in medical care due to medical cost. Twelve percent of participants who did not receive screening colonoscopy suffered delays in medical care due to cost. Also, among participants who did not receive screening for prostate cancer with PSA testing, 11% reported delays in medical care due to cost. Conclusions: Health care disparities in cancer screening continue to persist including differences in socioeconomic classes and access to medical services. In this study, we report that patients with delayed access to medical services due to cost are not adequately receiving age-appropriate screening for cancer. Given the deleterious effects of delayed diagnosis and treatment of cancer, it is important that public health and clinical professionals utilize tools to improve cancer screening accessibility to minorities with socio-economic disparities.
Comparison of clinician and model estimates of risk for hospitalization during systemic therapy for advanced cancer.
Authors: Emery Lukas P , Muralikrishnan Sivraj , Tosteson Anna , Schrag Deborah , Brooks Gabriel A.
Published: June 2021

1530

Background: Patients receiving treatment for advanced cancer are at substantial risk for unplanned hospitalization. A validated two-variable risk model can identify patients at increased risk for hospitalization. However, little is known about how model-based estimates of hospitalization risk compare with assessments of treating clinicians. Methods: We identified patients initiating a new line of systemic therapy for advanced non-hematologic cancer. For each patient, we assigned three categorical estimates of 30-day hospitalization risk. The first risk estimate was generated by a validated two-variable risk prediction model with inputs of pretreatment plasma sodium and albumin (PMID: 30995122); continuous risk scores were converted to risk tertiles. We solicited a second risk estimate by real-time survey of a treating oncology clinician; clinicians were instructed to estimate hospitalization risk as low, intermediate, or high, as compared with other patients. A third hybrid risk estimate retained the highest risk category from either the clinician or model risk assessment. We describe the agreement of clinician and model-based estimates of 30-day hospitalization risk, and we compare the sensitivity and specificity of clinician, model, and hybrid high-risk assessments, using McNemar’s test. We compared discrimination of the three risk estimates via the area under the ROC curve (AUC). Results: We identified 104 patients with valid clinician and model hospitalization risk estimates and complete 30-day follow-up. The most common cancer type was lung cancer (27%), the median age was 68 years, and 62% of patients were male. 30-day hospitalization occurred in 21 patients (20.2%). There was moderate to poor agreement between clinician and model categorical estimates of hospitalization risk (weighted kappa = 0.245). The proportion of patients identified as high-risk by the clinician, model, and hybrid assessments was 15.4%, 26.0%, and 33.7%. Sensitivity and specificity of the high-risk categorization for 30-day hospitalization were 38% and 90% for the clinician assessment, 57% and 82% for the model assessment (NSS for comparison with clinician assessment), and 76% and 77% for the hybrid assessment (greater sensitivity [p = 0.008] and lesser specificity [p = 0.001] than clinician assessment). The AUC values for the clinician, model, and hybrid assessments were 0.674, 0.757, and 0.764, respectively. Conclusions: Compared with the estimate of a treating clinician, a two-variable risk model exhibited similar sensitivity and specificity for 30-day hospitalization risk. A hybrid risk assessment incorporating information from the risk model significantly improved on the sensitivity of the clinician risk assessment. Future research should test strategies to prevent hospitalizations by targeting interventions to high-risk patients.
Choosing unwisely: Low-value care in older adults with a diagnosis of myelodysplastic syndrome.
Authors: Mukherjee Sudipto , Dong Weichuan , Stange Kurt C , Cullen Jennifer , Markt Sarah C. , Sekeres Mikkael A. , Koroukian Siran M.
Published: June 2021

1532

Background: In tandem with the Choosing Wisely initiative, ASCO’s Cost of Care Task Force has proposed a list of low-value (LV) procedures and therapies that may be of limited benefit to patients. Myelodysplastic syndrome (MDS) is the most common myeloid malignancy in the US. A complete diagnostic evaluation (CDE) of MDS requires a bone marrow biopsy, fluorescence in situ hybridization and chromosomal analysis. As a potential LV procedure, we evaluated receipt of CDE in MDS patients with isolated or no cytopenias and no transfusion dependence. Methods: Using national 2011-2014 Medicare data, we identified fee-for-service Medicare patients 66 years of age or older with an MDS diagnosis, one or no cytopenias, and no blood transfusions in the 16 weeks before or after an MDS diagnosis (n = 16,779). We examined the following variables that may have provided a clinical context to (or not to) pursue CDE – demographics (age, race, sex); number of Elixhauser comorbid conditions ( < 5 vs >5); nursing home status, prior history of lymphoma, myeloma, MGUS and other cancers; chronic kidney disease (CKD); colonoscopy; and therapies received including erythropoiesis stimulating agents (ESAs), hypomethylating agents (HMAs) or lenalidomide. We conducted Classification and Regression Tree (CART) analysis, a machine learning approach to identify combinations of factors in patients with little clinical justification for CDE, and Cox proportional hazards regression analysis to compare survival outcomes between those with or without CDE. Results: Over half of our study population (51%) received CDE. Of those, 46.6% were 80 years of age or older, 4.8% were nursing home residents; and 33.6% had 5 or more chronic conditions. Results from CART analysis showed that among patients with an isolated cytopenia (e.g., isolated anemia), 46.0% of patients >80 years (n = 860), and 57.7% (n = 1,156) of those in the 66-79 age group underwent CDE in the absence of CKD, colonoscopy, HMA, or ESA. Among those with no cytopenia (n = 3890), 866 patients received CDE in the absence of HMA, ESA, or history of lymphoma or progression to leukemia. In adjusted analyses, no survival benefit was associated with receipt of CDE (p = 0.24). Conclusions: A substantial number of patients with an MDS diagnosis, isolated or no cytopenias, and no transfusion dependence received a CDE in the absence of other diagnoses, procedures, or therapies that may have explained the clinical decision to perform CDE. These procedures entail costs, pain and anxiety, but do not appear to yield useful information to guide clinical management, as evidenced by the comparable survival outcomes between patients who did and did not undergo CDE. To promote patient-centered care, careful patient selection that reduces unnecessary CDE in MDS patients should be a priority in clinical decision-making.
The impact of COVID-19 on clinical cancer care: An individual-patient level analysis.
Authors: Drewett Lynsey M , Pugh Sian Alexandra , Kieran Rosalind , Nair Binu , Attia Hossameldin , Sabar Muhammad Iftikhar , Milne Isabel , Saunders Sharon , Bragg Jennie , Whitehorn Deborah , Lay Jonathan , Rueda Oscar M , Harris Fiona , Welsh Sarah Joanne , Doherty Gary , Basu Bristi , Abraham Jean , Beddowes Emma , Corrie Philippa Gail , O'Carrigan Brent
Published: June 2021

1533

Background: At the outset of the COVID-19 pandemic, concerns for the safety of patients receiving anti-cancer treatment coupled with pressures on healthcare services prompted review of standard clinical care pathways in the UK. Revised consensus treatment guidelines were generated. Individual patient-level data regarding actual treatment modifications implemented in clinical practice are lacking. Methods: All anti-cancer treatment plans of patients with breast, lung, renal, hepatopancreatobiliary, CNS cancers and melanoma attending a single academic cancer centre in the UK between 16 March and 31 May 2020 were reviewed and any modifications to standard practice were documented. The effect of patient (age, ECOG performance status [PS], sex) and cancer (site, stage, treatment intent) characteristics on likelihood of treatment modifications were analysed using univariable and multivariable models. Results: Treatment plans for 925 patients were reviewed: median patient age was 63 (range 19-97); 66% were female; 73% were PS 0-1; 45% were on a curative pathway. Overall, 47% of all patients had one or more modifications made to their treatment plans: 53% of surgeries (primarily being delayed); 41% of radiotherapy (primarily reduced fractions delivered); 39% of systemic therapy prescriptions. 96-100% of all systemic therapy modifications resulted in treatment de-escalation, excluding endocrine therapy used as a bridge to defer primary breast cancer surgery. Biological therapy was predominantly interrupted (49%), immunotherapy was mostly omitted entirely (36%), and chemotherapy varied between interruptions (39%) or omissions (31%). Relative to the likelihood of modification to chemotherapy, surgery was significantly more likely to be modified (OR 1.69 95%CI 1.20-2.38). Chemotherapy, radiotherapy, biological therapy and immunotherapy were all modified to a similar degree. Multivariate analysis identified PS ≥2 (OR 1.79, 95% CI 1.18–2.75), but not patient age, as a predictor of treatment modification. Some tumour types were less likely to undergo any modification: stage 1-3 lung (OR 0.13, 95%CI 0.04-0.37), stage 4 lung (OR 0.26 95%CI 0.24–0.60) and stage 4 renal cancer (OR 0.22 95%CI 0.09-0.52). Conclusions: This single centre analysis demonstrated almost half of cancer patients had their treatment modified, the overwhelming majority resulting in treatment de-escalation. The impact of the treatment modifications on overall cancer patient outcomes remains to be determined.
Patterns in cancer management changes for patients with COVID-19 in northern California.
Authors: Glover Michael , Wu Julie , Kwon Daniel H , Zhang Sylvia , Henry Solomon , Wood Douglas , Rubin Daniel , Borno Hala , Small Eric Jay , Schapira Lidia , Koshkin Vadim S , Shah Sumit
Published: June 2021

1535

Background: The COVID-19 pandemic affected oncology practice in ways that are still evolving. In particular, COVID-19 has led to changes in cancer treatment for patients (pts) infected with COVID, which may have long-term implications for both COVID and cancer-related outcomes. In this retrospective analysis, we describe changes in cancer management over time for cancer pts diagnosed with COVID-19 at two academic institutions in Northern California. Methods: Adult and pediatric pts diagnosed with COVID-19 receiving active cancer management, defined as therapy/surgery/diagnostics within 3 weeks of COVID diagnosis, were identified through the EMR. Patients whose care was affected by COVID-19 were identified and analyzed for significant intra-group differences with regards to management type, treatment intent, and the time of COVID-19 diagnosis (“early” was defined as March to June 2020 and “late” as July 2020 to January 2021). The duration and characteristics of such changes were compared across subgroups. Chi-squared test was used to compare the incidence of delays between subgroups. Results: Among 134 COVID-positive pts on active cancer management, 83 (62%) had significant changes in management that consisted primarily of treatment delays. More delays were identified in patients treated with curative intent earlier in the course of the pandemic compared to later (OR 4.1, p=0.022). This difference was not seen among pts treated with palliative intent. In addition, pts on oral (PO) therapy were significantly less likely to have treatment changes than those on IV/IM therapy (OR 0.32, p=0.005). This difference was driven by a decrease in management changes for those on PO therapy in the later time period (OR 0.27, p=0.026). Pts diagnosed later were more likely to have delays due to clinical reasons rather than institutional policy (OR 6.2, P<.005). The median delay in both time frames was 21 days. Comparison of subgroups is shown in the table. Conclusions: We found significant changes in management of cancer pts with COVID-19 that evolved over time. Oncologists have become increasingly willing to continue therapy for cancer pts treated with curative intent and pts on oral therapy. Changes in cancer therapy have become more frequently related to patient clinical status, and less so due to institutional policies. It will be important to analyze how these changes in management are ultimately reflected in cancer outcomes in order to equip patients and oncologists to react to the next pandemic.[Table: see text]