bluuebunny/crossref_metadata_2025_split huggingface dataset:
Efficacy and safety of SER-109, an investigational microbiome therapeutic for recurrent clostridioides difficile infection: Data from ECOSPOR III, a phase 3 randomized trial.
Authors: Paskovaty Alla , Berenson Charles S. , Louie Thomas J. , Wang Elaine , Lombardi David A. , von Moltke Lisa 
Published: June 2022

12113 Background: Patients with malignancies are at increased risk for recurrent Clostridioides difficile infection (rCDI) due to their immunosuppressed state and frequent exposure to antibiotics and chemotherapy. These factors disrupt the gut microbiome creating an environment conducive to C. difficile colonization. Patients with cancer have higher rates of rCDI and worse outcomes than those without malignancy. SER-109, an investigational microbiome therapeutic, was superior to placebo in reducing rCDI at 8 weeks compared with placebo (12% vs 40%, respectively) in ECOSPOR III, a Phase 3 randomized, double-blind trial of subjects with a history of rCDI [NEJM 2022; 386:220-9]. Here, we report secondary endpoints of rCDI rates at 4, 12 and 24 weeks. Methods: Adults with rCDI (≥3 episodes in 12 months) were screened at 56 US/Canadian sites. After standard-of-care antibiotics (vancomycin or fidaxomicin per investigator discretion), subjects were randomized 1:1 to SER-109 (4 capsules x 3 days) or matching placebo. The primary endpoint was rCDI (recurrent toxin + diarrhea requiring treatment) at 8 weeks; secondary endpoints included rCDI at 4, 12 and 24 weeks. Safety was evaluated through week 24. Results: 281 subjects were screened and 182 (intention-to-treat population; ITT) were randomized (59.9% female; mean age 65.5 years). The most common comorbidities were respiratory disease (36.3%) and cardiovascular disease (32.4%). A total of 28.6% and 18.1% had a history of immunocompromise and malignancy, respectively. Significantly fewer SER-109 vs. placebo treated subjects had rCDI posttreatment compared with placebo recipients at Weeks 4, 8, 12 and 24 (Table). The absolute risk reduction between placebo and SER-109 arms ranged from 22.1% to 28.3% across the 4 timepoints. The safety profile of SER-109 through week 24 was comparable to placebo. Most adverse events (AEs) were mild to moderate gastrointestinal occurrences. More placebo-treated vs SER-109-treated subjects experienced serious AEs through week 8, while comparable proportions of subjects in both arms reported serious AEs from 8 through 24 weeks. Conclusions: In this population of subjects with comorbidities, including malignancy and immunosuppression, SER-109 significantly reduced rCDI rates through week 24 with an observed safety profile comparable to placebo. Clinical trial information: NCT03183128. [Table: see text]
Acupuncture for hot flashes in hormone receptor-positive breast cancer, a pooled analysis of individual patient data from parallel randomized trials.
Authors: Lu Weidong , Giobbie-Hurder Anita , Tanasijevic Anna , Baedorf Kassis Sylvia , Park Sung Hwan , Jeong Young Ju , Shin Im Hee , Yao Chang , Jung Hyun Jung , Zhu Zhiyuan , Bao Chao , Yang EunMee , Bierer Barbara E , Ligibel Jennifer A. 
Published: June 2022

12124 Background: Hot flashes are a common side effect of endocrine therapy in breast cancer patients (pts). In a coordinated multinational study, we evaluated the impact of acupuncture on hot flashes and related symptoms in hormone receptor-positive breast cancer pts undergoing adjuvant endocrine therapy in the USA, China, and South Korea. Methods: Parallel randomized trials were conducted at three sites: Dana-Farber Cancer Institute, USA; Jiangsu Hospital of Traditional Chinese Medicine, China; and Daegu Catholic University Medical Center, Republic of Korea, using the same inclusion/exclusion criteria, randomization, and measures. Breast cancer pts receiving adjuvant endocrine therapy and having ≥14 hot flashes per week were randomized equally to acupuncture (A) or usual care (UC); randomization was stratified by number of hot flashes per day (2-6 or 7+). Pts in arm A received a standardized acupuncture protocol twice per week for 10 weeks; pts in the UC arm received usual care. Symptoms were assessed at baseline and week 10. The primary endpoint was change in the Endocrine Symptom Subscale (ESS) of the Functional Assessment of Cancer Therapy-Endocrine Systems (FACT-ES). Secondary endpoints included changes in the FACT-Breast (FACT-B) and Daily Hot Flash Score (DHFS), a measure incorporating hot flash frequency and severity. Target enrollment was 160 pts (USA 80, China 40, Korea 40) providing 84% power to detect a clinically meaningful change in the ESS. Analyses were intention-to-treat. A pooled analysis of individual patient data was performed using linear models adjusted for site and baseline number of hot flashes. Results: Between Jan. 2019 and June 2021, 158 female pts with stage 0-III breast cancer were randomized from the USA (n=78), China (n=40), and South Korea (n=40). Median age was 48 years (range: 25 to 73). At baseline, pts reported similar numbers of hot flashes between study arms (6.2± 4.3 vs. 6.5± 3.8 per day). At week 10, pts in arm A reported statistically significant improvements in ESS score, FACT-B total score and DHFS compared with the UC arm (Table). The reduction in the DHFS from baseline in arm A was 53%. There were no serious adverse events. Conclusions: Acupuncture led to statistically and clinically meaningful improvements in hot flashes, endocrine symptoms, and breast cancer-specific quality of life in women undergoing adjuvant hormonal therapy for breast cancer in the USA, China and South Korea. Clinical trial information: NCT00797732, ChiCTR2100045888, KCT0003618. [Table: see text]
Association between the Affordable Care Act Medicaid expansion and survival in young adults newly diagnosed with cancer.
Authors: Ji Xu , Shi Kewei , Castellino Sharon M. , Mertens Ann C. , Zhao Jingxuan , Yabroff K. Robin , Han Xuesong 
Published: June 2022

1502 Background: Medicaid expansion through the Affordable Care Act (ACA), implemented by 26 states in January 2014 and 13 more states in later years, has been shown to improve insurance coverage and early diagnosis of cancer in young adults (YAs). Little is known about whether these improvements translate to a survival benefit in this population. We evaluated the association between the ACA Medicaid expansion and 2-year overall survival among YAs newly diagnosed with cancer. Methods: Using the National Cancer Database, we identified 345,414 YAs aged 18-39 years diagnosed with cancer between 2010 and 2017. YAs diagnosed pre-expansion were followed through September 30, 2013 or three months before Medicaid expansion implementation for late-expansion states, and YAs diagnosed post-expansion were followed through December 31, 2019. We applied the difference-in-difference (DD) method to estimate changes in 2-year overall survival before and after Medicaid expansion, in expansion- versus non-expansion states, controlling for key sociodemographic factors. DD analyses were performed for YAs overall, and stratified by cancer type, stage at diagnosis, race/ethnicity, comorbidity, and facility type. Results: Among all YAs, 2-year overall survival increased more in expansion states (90.39% pre-expansion to 91.87% post-expansion) than in non-expansion states (88.98% pre-expansion to 90.05% post-expansion), resulting in a net increase of 0.53 percentage points (ppt; 95% confidence interval [CI] = 0.11 to 0.95 ppt). The increase in 2-year overall survival in expansion states versus non-expansion states was greatest among subgroups of patients with female breast cancer (DD = 1.20 ppt; 95% CI = 0.28 to 2.13 ppt) and patients with stage IV disease at diagnosis (DD = 2.51 ppt; 95% CI = 0.28 to 4.74 ppt). Additionally, greater improvement in 2-year overall survival associated with the expansion was seen among racial/ethnic minority YAs (including Hispanic, non-Hispanic Black, and non-Hispanic others; DD = 0.98 ppt; 95% CI = 0.10 to 1.86 ppt) than their non-Hispanic White peers (DD = 0.41 ppt; 95% CI = -0.06 to 0.89 ppt), among patients treated in community cancer programs (DD = 1.10 ppt; 95% CI = 0.32 to 1.88 ppt) than academic comprehensive cancer programs (DD = 0.12 ppt; 95% CI = -0.52 to 0.77 ppt), and among patients with two or more comorbidities (DD = 6.37 ppt; 95% CI = 0.68 to 12.06 ppt) than patients with no comorbidity (DD = 0.48 ppt; 95% CI = 0.04 to 0.91 ppt). Conclusions: We provide the first evidence on the association between ACA Medicaid expansion and improved overall survival among YAs newly diagnosed with cancer. Survival benefits are notable among racial/ethnic minority patients and patients with high healthcare needs, and by patients’ treatment facility type.
The initial outcome of deploying a mortality prediction tool at community oncology practices.
Authors: Ye Ping , Butler Brandon , Vo Duc , He Bo , Turnwald Brian , Hoverman John Russell , Indurlal Puneeth , Garey Jody S. , Hoang Susan Nga 
Published: June 2022

1521 Background: Hospice improves the quality of life and care for cancer patients and reduces the likelihood of unwanted death in the hospital. Advance Care Planning (ACP) allows physicians to proactively initiate hospice and end-of-life discussions with identified patients, promoting timely hospice care enrollment. We developed a machine learning (ML) model to predict 90-day mortality risk for patients with metastatic cancer. The tool was designed to enable earlier ACP discussions leading to increased hospice enrollment. This study assesses the ML tool usage on ACP documentation in a community oncology setting. Methods: Twelve practices across the nation were included in the study, all participating in the Oncology Care Model. Five practices implemented the ML tool during 10/26/2020-9/30/2021, with patients scored every two weeks to provide insights on mortality risk. Patients identified as high-risk were evaluated for ACP utilization, obtained from timely EMR data and historical claims. Seven practices did not implement the ML tool and served as the control for the study. Results: A total of 1,663 patients were predicted to have a high risk of mortality at the 12 practices during the timeframe. The median age was 74 years. 53% of patients were males, and 47% were females. ACP documentation varied among the practices. The range was 19.4%-55.8% among ML tool participating practices and 7.4%-31.0% among non-participating practices. The weighted mean of ACP utilization was 34.4% for participating practices and 14.0% for non-participating practices. Compared with non-participating practices, the ACP rate increased significantly by 2.5-fold for participating practices (p-value = 0.03, two-sided T-test). Conclusions: This initial outcome study showed improved ACP documentation after deploying a mortality prediction tool in a community oncology setting. We are currently working on propensity score matching and regression analysis to reduce the effect of confounding factors such as practices, patient demographics, diagnosis, and treatment. Future studies will evaluate the impact of mortality tool use on other outcomes, including hospice enrollment, emergency department visits, and hospital admission. Implementing the mortality prediction tool is an ongoing effort with more practices planned to adopt.
The promising use of hospital at home in an oncology setting.
Authors: Kier Melanie Wain , Lubetsky Sara , Schiller Gabrielle , Siu Albert L. , Ornstein Katherine A. , Smith Cardinale B. 
Published: June 2022

1523 Background: Hospitalization at Home (HaH) is an emerging clinical model that delivers the essential elements of acute hospital-level care in the home and has demonstrated efficacy largely for inpatient medical conditions. Few programs have implemented HaH for patients with active cancer diagnoses. There is little data evaluating the impact of HaH on cancer outcomes, patient experience or cost effectiveness. In 2019, the Mount Sinai Health System (MSHS) expanded its HaH program to include oncology patients. Here, we describe our institution’s experience of HaH in oncology. Methods: We performed a retrospective chart review for solid tumor, myeloma and lymphoma patients at MSHS from August 2019 to November 2021 enrolled in HaH. Patient eligibility for HaH required meeting established institutional HaH admission criteria. Demographics, cancer diagnosis, social situation, indication for antecedent ED or inpatient stay, and HaH admission were extracted from the electronic medical record. Our primary endpoint was rate of successful HaH admission, with success defined as discharge from HaH for complete recovery from the acute condition or transition to hospice. We also evaluated patient social support and home resources. Results: We enrolled 19 patients with multiple myeloma (n = 7), lymphoma (n = 1), and solid tumor (n = 11). Sixty-three percent (n = 12) were male, 74% (n = 14) were age 65 or older, and 42% (n = 8) were white. Patients were enrolled in HaH either from an inpatient service (n = 15) or from the emergency room (n = 4). While on the inpatient service, 6 of the 15 patients had received chemotherapy. Post-chemotherapy monitoring was the primary reason for HaH admission. Successful HaH admissions occurred for 79% (n = 15) of patients. The mean duration of HaH admission was 4.5 days (range 1-10 days). Three patients opted to re-enroll in HaH planned care at a later point. There were no significant issues with provider home visits, access, medication delivery, lab draws, or social support. Conclusions: The MSHS Oncology HaH program successfully cared for 79% of our cohort demonstrating the functionality of expanding the program to patients with cancer. We continue to increase enrollment for oncology patients. Further studies to assess patient outcomes, cost savings, and re-hospitalization rates when compared to the standard in hospital only care for oncology patients will help determine the benefits and preferred population to utilize oncology HaH.
Long COVID-19 in patients with cancer: Report from the National COVID Cohort Collaborative (N3C).
Authors: Sharafeldin Noha , Madhira Vithal , Song Qianqian , Bates Benjamin , Mitra Amit Kumar , Liu Feifan , Bergquist Timothy , Su Jing , Hsu Fang-Chi , Topaloglu Umit 
Published: June 2022

1540 Background: Post-acute sequelae of SARS-CoV-2 or long COVID, is characterized by persistence of symptoms and/or emergence of new symptoms post COVID-19 infection. As evidence accumulates and national initiatives arise to address this increasingly prevalent syndrome, characterization of specific patient groups is still lacking including patients with cancer. Using a nationally representative sample of over 4.3M COVID-19 patients from the National COVID Cohort Collaborative (N3C), we aim to describe characteristics of patients with cancer and long COVID. Methods: We employed two approaches to identify long COVID patients within N3C: i) patients presenting to a long COVID clinic at four N3C sites and ii) patients diagnosed using the recently introduced ICD-10 code: U09.9 Post COVID-19 condition, unspecified. We included patients with at least one positive COVID-19 diagnosis between 1/1/2020 and 2/3/2022. Patients had to survive at least 90 days from the date of their COVID-19 diagnosis. Analyses were performed in the N3C Data Enclave on the Palantir platform. Results: A total of 1700 adult patients with long COVID were identified from the N3C cohort; 634 (37.3%) were cancer patients and 1066 were non-cancer controls. The most common represented cancers were skin (21.9%), breast (17.7%), prostate (8.3%), lymphoma (8.0%) and leukemia (5.7%). Median age of long-COVID cancer patients was 64 years (Interquartile Range: 54-72), 48.6% were 65 years or older, 60.4% females, 76.8% non-Hispanic White, 12.3% were Black, and 3% Hispanic. A total of 41.1% were current or former smokers, 27.7% had an adjusted Charlson Comorbidity Index score of 0, 18.6% score of 1 and 11.2% score of 2. A total of 57.2% were hospitalized for their initial COVID-19 infection, the average length of stay in the hospital was 9.6 days (SD: 16.7 days), 9.1% required invasive ventilation, and 13% had acute kidney injury during hospitalization. The most common diagnosis among the non-cancer long COVID patients was asthma (26%), diabetes (17%), chronic kidney disease (12%), heart failure (9.4%), and chronic obstructive pulmonary disease (7.8%). Among long COVID patients, compared to non-cancer controls, cancer patients were more likely to be older (OR = 2.4, 95%CI: 1.1-5.4, p = 0.03), have comorbidities (OR = 4.3, 95%CI: 2.9-6.2, p < 0.0001), and to be hospitalized for COVID-19 (OR = 1.3, 95%CI: 1.0-1.7, p = 0.05), adjusting for sex, race/ethnicity, body mass index and smoking history. Conclusions: In a nationally representative sample of long COVID patients, there was a relative overrepresentation of patients with cancer. Compared to non-cancer controls, cancer patients were older, more likely to have more comorbidities and to be hospitalized for COVID-19 warranting further investigation to identify risk factors for long COVID in patients with cancer.
Demographic and laboratory determinants of humoral immune responses and impact of different anti-SARS-CoV-2 vaccine platforms in patients with cancer: A systematic review and meta-analysis.
Authors: Martins-Branco Diogo , Loizidou Angela , Nader Marta Guilherme , Tecic Vuger Ana , Debien Veronique , Ameye Lieveke , Brandão Mariana , Punie Kevin , Spilleboudt Chloe , Willard-Gallo Karen , Awada Ahmad , Piccart-Gebhart Martine J. , de Azambuja Evandro 
Published: June 2022

1543 Background: Patients (pts) with cancer have increased mortality from COVID-19 and their vaccination is crucial to prevent severe infection. We aimed to identify demographic and laboratory determinants of humoral immune responses to COVID-19 vaccination in pts with cancer and investigate differences in responses based on the vaccine platform. Methods: We searched for records in PubMed, Embase, and CENTRAL up to 28/09/21, as well as conference proceedings from ASCO and ESMO 2021. We included studies of pts ≥16 yr with a cancer diagnosis, who were vaccinated against SARS-CoV-2. Studies were excluded if ≥10% of the participants had other causes of immunosuppression or baseline anti-SARS-CoV-2 spike protein antibodies (Ab)/previous COVID-19 (PROSPERO ID: CRD42021282338). For this subgroup analysis of studies that reported a proportion of pts with cancer and positive Ab titers at any timepoint following complete vaccination, a random-effects model was used to estimate the humoral response rate (HRR) with 95% confidence intervals (CI). Results: We included 64 records, reporting data from 10,511 cancer pts. The HRR in the overall population and by subgroup are shown in Table. Elder patients with hematologic cancers (59%, CI 47-70%, N = 667) and patients with lymphopenia (50%, CI 25-75%, N = 111) or hypogammaglobulinemia (36%, CI 19-57%, N=226) were the subgroups with lower HRR. Male (77%, CI 69-84%, N = 2,659) and Asian (84%, CI 54-96%, N = 37) pts showed a trend to lower HRR when compared with females and other races, respectively. Pts vaccinated with mRNA vaccine platforms (79%, CI 74-83%, N = 9,404) had numerically higher HRR than those receiving the adenovirus vaccines (28%, CI 19-40%, N = 74). Conclusions: This study highlights demographic and laboratory determinants of weaker immune responses to SARS-CoV-2 vaccination, permitting better identification of more vulnerable pts. Despite the small number of pts included receiving adenovirus vaccines, these data also suggest prioritizing mRNA platform vaccination in pts with cancer. [Table: see text]
Association between remotely-monitored activity, patient-reported outcomes, and physical function in patients with advanced pancreatic cancer.
Authors: Gresham Gillian , Liu Eileen , Diniz Marcio A. , Barnhill Katherine , Nikravesh Nima , Welborn Amelia , Shirazipour Celina , Asher Arash , Osipov Arsen , Hendifar Andrew Eugene 
Published: June 2022

1572 Background: Patients with pancreatic ductal adenocarcinoma (PDAC) experience significant functional decline over the course of their treatment, which can negatively impact their quality of life (QOL) and clinical outcomes. There are currently no standardized methods to monitor physical function (PF) in PDAC patients outside the clinic setting. The use of wearable technology to obtain continuous and objective activity data combined with routine collection of patient-reported outcomes (PROs) provides an opportunity to monitor PF and intervene in a timely matter. Methods: We conducted a single-site, single-arm prospective study in advanced stage 3 and 4 PDAC patients between 2019 and 2/2022. Patients used a wrist-worn wearable activity monitor (Fitbit) continuously for 8 weeks and completed NIH PROMIS surveys (PF, pain, fatigue, sleep disturbance, and emotional distress) at baseline, week 4 and week 8. ECOG performance status (PS), hand grip strength, and timed 15-foot walk test were also assessed at each timepoint. Pearson correlation coefficients were calculated for activity data (step counts, distance, stairs, time spent sedentary and in light, moderate, or vigorous activity, sleep), PROs, and functional outcomes. Multivariable regression models, adjusted for age, sex, and cancer stage, were fit to evaluate associations between activity metrics, PROs, and functional outcomes. Multivariable cox proportional hazard models were fit to evaluate the impact of activity levels on survival. Results: A total of 40 patients consented onto study: 50% female, median age: 67 years (range 47-85), 92% ECOG 1. Baseline activity data are summarized in Table. Statistically significant correlations between step counts and PF T-scores (coeff: 0.6, p = 0.001) and lower pain scores (coeff: -0.53, p = 0.002) were observed. Increased stairs count and time spent in moderate and high physical activity were also positively correlated with increased PF (p<0.001). No statistically significant correlations were observed between hand grip strength, activity metrics or PROs. Fewer average step counts and worse PF scores were significantly associated with poor survival with hazard ratios (HR) of 1.44 per 1000 steps (95% CI 1.06, 1.97, p = 0.02) and 1.69 (95% CI 1.1-2.56, p = 0.017), respectively, after adjusting for age, sex, stage, and ECOG PS. Conclusions: Findings from this research suggest that the use of wearable technology for remote monitoring of daily activity is feasible and may be used to supplement functional assessment and predict outcomes in PDAC patients. Larger trials are needed to validate findings. [Table: see text]