bluuebunny/crossref_metadata_2025_split huggingface dataset:
Association of cancer treatment with excess heart age among young breast cancer survivors.
Authors: Vo Jacqueline B , Rosenberg Shoshana M. , Poorvu Philip Daniel , Ruddy Kathryn Jean , Tamimi Rulla , Peppercorn Jeffrey M. , Schapira Lidia , Borges Virginia F. , Come Steven E. , Nohria Anju , Partridge Ann H. 
Published: June 2021

12081 Background: Young women with breast cancer may be at increased risk for premature development of cardiovascular disease (CVD) in part due to their cancer treatment. Limited data are available on CVD risk among young breast cancer survivors. Methods: Women aged 30-40 years at diagnosis with stage 0-III breast cancer enrolled in a prospective cohort study of women diagnosed with breast cancer at ≤40 were eligible for inclusion in this analysis. Data were obtained from serial surveys and electronic medical records at breast cancer diagnosis and 5-year follow-up. We calculated “excess heart age,” which incorporates a CVD risk-based score (calculated using age, systolic blood pressure, blood pressure medication, diabetes, smoking, body mass index) to estimate the difference in years between an individual’s chronological age and their CVD-risk adjusted age. Multivariable logistic regression models (adjusting for age at diagnosis, stage, and race) were fitted to evaluate associations between treatment (radiation, endocrine therapy, anthracyclines, and trastuzumab) and having a change in excess heart age ≥2 years from baseline to 5 years. Results: Among 372 young breast cancer survivors, mean age at diagnosis was 36.6 (SD 2.89), 93% were white, and 79% were diagnosed with stage I or II breast cancer. Mean excess heart age was.32 (SD: 6.16) years at baseline, which declined to -.07 (SD 6.64) at 5-year follow-up (p=.17). At 5 years, 31% (n=114) of women experienced an increase of at least 2 years in their excess heart age since diagnosis, and their mean excess heart age was 4.34 years (range -9 to 30). In multivariable analyses, receipt of trastuzumab was associated with higher odds (OR: 1.68, 95% CI: 1.02-2.77) of experiencing an increase of ≥2 years in excess heart age between diagnosis and 5 years of follow-up. Endocrine therapy, anthracyclines, and radiation were not significantly associated with a change in excess heart age of ≥2 years at 5 years post-diagnosis. Conclusions: At 5 years post-diagnosis, approximately 1/3 of young breast cancer survivors experienced a change from baseline in their excess heart age of ≥2 years. Further research is warranted to confirm findings regarding trastuzumab and excess heart age, and potential effects on longer-term cardiac outcomes in this population. Extended follow-up of this cohort may further quantify CVD risk over time.[Table: see text]
The PROVIEW+ tool: Developing and validating a tool to predict risk of poor performance status and severe symptoms in cancer patients over time.
Authors: Seow Hsien , Sutradhar Rinku , Barbera Lisa Catherine , Tanuseputro Peter , Guthrie Dawn , Isenberg Sarina , Juergens Rosalyn A. , Myers Jeffrey A. , Brouwers Melissa C. , Tibebu Semra , Earle Craig 
Published: June 2021

12095 Background: There are numerous predictive cancer tools that focus on survival. However, no tools predict risk of low performance status or severe symptoms, which are important for patient decision-making and early integration of palliative care. The aim of this study was to develop and validate a model for all cancer types that predicts the risk for having low performance status and severe symptoms. Methods: A retrospective, population-based, predictive study using linked administrative data from cancer patients from 2008-2015 in Ontario, Canada. Patients were randomly selected for model derivation (60%) and validation (40%). The derivation cohort was used to develop a multivariable logistic regression model to predict the risk of having the reported outcomes in the subsequent 6 months. Model performance was assessed using discrimination and calibration plots. The main outcome was low performance status using the Palliative Performance Scale. Secondary outcomes included severe pain, dyspnea, well-being, and depression using the Edmonton Symptom Assessment System. Outcomes were recalculated after each of 4 annual survivor marks. Results: We identified 255,494 cancer patients (57% female; median age of 64; common cancers were breast (24%) and lung (13%)). At diagnosis, the risk of having low performance status, severe pain, well-being, dyspnea, and depression in 6-months is 1%, 3%, 6%, 13% and 4%, respectively for the reference case (i.e. male, lung cancer, stage I, no symptoms). Generally these covariates increased the outcome risk by > 10% across all models: obstructive lung disease, dementia, diabetes; radiation treatment; hospital admission; high pain; depression; Palliative Performance Scale score of 60-10; issues with appetite; or homecare. Model discrimination was high across all models. Conclusions: The model accurately predicted changing cancer risk for low performance status and severe symptoms over time. Providing accurate predictions of future performance status and symptom severity can support decision-making and earlier initiation of palliative care, even alongside disease modifying therapies.
Efficacy of olanzapine combined with the standard triplet antiemetic therapy for cisplatin-based chemotherapy: A sub-analysis of a randomized, double-blind, placebo-controlled trial (J-FORCE).
Authors: Fujita Yukiyoshi , Abe Masakazu , Yamaguchi Takuhiro , Ueda Hiroki , Kitagawa Koichi , Okamura Jun , Hirano Katsuya , Sakata Yukio , Iihara Hirotoshi , Shimada Yasuhiro , Aoyama Takeshi , Shibata Kazuhiko , Hori Kensuke , Daga Haruko , Nakayama Toshiaki , Sakata Yasuhiko , Zenda Sadamoto , Hashimoto Hironobu 
Published: June 2021

12098 Background: In a randomized, double-blind, placebo-controlled trial (J-FORCE), we previously reported the efficacy of olanzapine (OLZ) 5 mg plus triplet antiemetic therapy for cisplatin (CDDP)-based chemotherapy-induced nausea and vomiting (CINV) in the delayed phase (24–120 h after CDDP treatment). Here, we report the results of a pre-planned subgroup analysis of this trial (in which risk factors were used as the allocation factors). This analysis was designed to determine which patients benefit more from OLZ. Methods: Subgroup analysis was performed on complete response (CR: no emesis and no rescue medication) in the acute (within 24 h of CDDP treatment) and delayed phase and time to treatment failure (TTF: time from CDDP treatment to the first vomiting or use of rescue medication). Data from 705 patients in the efficacy analysis population (354 in the OLZ group and 351 in the placebo (PLA) group) were analyzed by sex (male/female), age (≥55 years/ < 55 years), and CDDP dose (≥70 mg/m2/ < 70 mg/m2). For CR, we calculated point estimates of differences between groups and 95% confidence intervals and performed a Mantel-Haenszel test. We used the Kaplan-Meier method for the analysis of TTF, and comparisons between groups were made using a log-rank test. Results: Delayed CR (OLZ versus PLA) and risk difference (RD) of delayed CR following OLZ treatment were significantly greater than following PLA in the following subgroups: male (83.1% versus 70.5%, RD 12.6%, p = 0.001), female (70.9% versus 56.4%, RD 14.5%, p = 0.021), age ≥55 years (78.7% versus 67.6%, RD 11.1%, p = 0.003), age < 55 years (81.0% versus 57.4%, RD 23.6%, p = 0.005), and CDDP ≥70 mg/m2 (78.8% versus 65.3%, RD 13.5%, p < 0.001). TTF of all subgroups (male/female, ≥55 years/ < 55 years, and ≥70 mg/m2/ < 70 mg/m2) was significantly longer in the OLZ group than in the PLA group (HR 0.493, p < 0.001; HR 0.612, p = 0.022; HR 0.586, p < 0.001; HR 0.401, p = 0.005; HR 0.546, p < 0.001; HR 0.543, p = 0.031, respectively). Conclusions: Our results suggest a benefit of OLZ 5 mg plus triplet therapy regardless of risk factors for CDDP-based CINV. Clinical trial information: UMIN000024676. [Table: see text]
Immune cell counts and perceived cognitive impairment before and after chemotherapy among 544 women with breast cancer.
Authors: Belcher Elizabeth , Gilmore Nikesha , Kehoe Lee , Kleckner Ian , Kleckner Amber , Gudina Abdi , Hardy Sara , Xu Huiwen , Hopkins Judith O. , Janelsins Michelle Christine 
Published: June 2021

12114 Background: In a nationwide prospective study, we found that patients with breast cancer had greater perceived cognitive impairment (PCI) before and after chemotherapy compared to controls without cancer. To gain further insight into the role that inflammation plays in cognitive function, we evaluated relationships between immune cell counts and lymphocyte:monocyte ratio with PCI at pre- and post- chemotherapy. Methods: Data were collected as part of longitudinal cohort study conducted through the National Cancer Institute Community Oncology Research Program network (NCT01382082). Self-reported PCI was scored at pre-chemotherapy (0-7 days before first chemotherapy) and post-chemotherapy (0-30 days after last chemotherapy) from the PCI sub-scale of the Functional Assessment of Cancer Therapy: Cognitive Function (possible score range 0-72). Immune cell counts were measured by complete blood count with differential at pre- and post- chemotherapy. Lymphocyte:monocyte ratio (LMR) was calculated. Separate linear regression models evaluated the association of immune cell counts and LMR with 1) pre-chemotherapy PCI and 2) post-chemotherapy PCI. Models were adjusted for age, cognitive reserve (reading score), anxiety, and depression. Results: PCI and immune cell data were available for 544 patients at pre-chemotherapy and 532 at post-chemotherapy. Subjects had a mean age of 53.1 (SD=10.8). At pre-chemotherapy, higher basophil count and higher LMR were significantly associated with worse PCI (β=5.73, SE=2.37, p<0.05; β=0.047, SE=0.02, p<0.05, respectively). Higher basophil count and higher LMR were also significantly associated with worse PCI at post-chemotherapy (β=5.84, SE=2.92, p<0.05; β=1.01, SE=0.48, p<0.05). Conclusions: These data support the hypothesis that inflammation is associated with perceived cognitive function before and after chemotherapy in adults with breast cancer. Targeting inflammatory processes may be beneficial for reducing cancer-related cognitive impairment. Funding: NCI UG1CA289961, T32CA102618, R01CA231014, DP2CA195765.
Associations between patient-centered communication and quality of life in patients with ovarian cancer.
Authors: Pozzar Rachel A. , Xiong Niya , Hong Fangxin , Wright Alexi A. , Goff Barbara Ann , Tulsky James A. , Underhill-Blazey Meghan , Hammer Marilyn J. , Berry Donna Lynn 
Published: June 2021

12120 Background: Patient-centered communication (PCC) occurs when clinicians respond to patients’ needs, preferences, concerns, and emotions. The National Cancer Institute (NCI) Framework for PCC in Cancer Care highlights the potential of PCC to improve health-related quality of life (HRQoL), but to date few studies have empirically examined associations between PCC and HRQoL in patients with ovarian cancer. We assessed associations between perceived PCC and HRQoL in patients with ovarian cancer. Methods: Cross-sectional, descriptive survey of English-speaking adults with ovarian cancer recruited both online and from one NCI-designated cancer center. We assessed perceived PCC with the Patient-Centered Communication in Cancer Care (PCC-Ca)-36 and HRQoL with the Functional Assessment of Cancer Therapy: General (FACT-G). We used simple linear regression to identify univariate associations between participant characteristics, PCC-Ca-36 total, FACT-G total, and FACT-G subscale (physical, social and family, emotional, and functional well-being) scores. We identified significant predictors of FACT-G total and subscale scores by entering variables associated with each outcome at p ≤ 0.25 into a multiple linear regression model and using backward elimination. Results: One hundred seventy-six participants completed the survey. In multivariable analyses, older age, working (vs. not working), no current treatment (vs. any current treatment), and greater perceived PCC were associated with better overall HRQoL. Working and no current treatment were associated with better physical well-being. Older age, not being cared for by a gynecologic oncologist (vs. being cared for by a gynecologic oncologist), and greater perceived PCC were associated with better social and family well-being. Older age, being recruited online (vs. in clinic), and greater perceived PCC were associated with better emotional well-being. Older age, working, rural residence (vs. not), no current treatment, and greater perceived PCC were associated with better functional well-being (all p ≤ 0.05). Conclusions: Greater perceived PCC was significantly associated with better overall HRQoL and better social, emotional, and functional well-being in this cross-sectional study of patients with ovarian cancer. The NCI Framework for PCC in Cancer Care posits that PCC promotes HRQoL by strengthening the therapeutic alliance, enhancing social support, and improving patient knowledge. Although PCC is theorized to promote patient self-management, PCC was not significantly associated with physical well-being in this sample. Future research should (a) identify mediators of the associations between PCC and HRQoL; (b) examine inter-individual variability in characteristics that may compromise HRQoL; (c) and examine associations between PCC and HRQoL over time.
The association between the coronavirus disease 2019 (COVID-19) pandemic and quality of life and depression symptoms in patients with advanced lung cancer.
Authors: Heuer Lauren , Post Kathryn Elizabeth , Gallagher Emily R. , Trotter Chardria , Elyze Madeleine , Vyas Charu , Plotke Rachel , Greer Joseph A. , Temel Jennifer S. , El-Jawahri Areej 
Published: June 2021

12122 Background: It is unclear whether patients with cancer experience greater distress as a result of the COVID-19 pandemic. Thus, we assessed the relationship of the COVID-19 pandemic with quality of life (QOL) and depression symptoms in patients newly diagnosed with advanced lung cancer. Methods: We conducted a cross-sectional study of patients with advanced lung cancer enrolled in two multisite randomized supportive care trials. We enrolled adult patients within 12 weeks of diagnosis of advanced lung cancer and an Eastern Cooperative Oncology Group (ECOG) Performance Status from 0 to 3 across 23 institutions in the United States. At the time of enrollment, participants completed the Functional Assessment of Cancer Therapy-Lung (FACT-L), which includes four wellbeing subscales (i.e., physical, social, emotional, and functional) as well as lung cancer symptoms, and the Patient Health Questionnaire-9 (PHQ-9) to assess their QOL and depression symptoms, respectively. We compared QOL and depression symptoms between participants enrolled prior to COVID-19 (i.e., those enrolled in the following time periods: March 2018 to January 2019 and March 2019 to January 2020) and during the COVID-19 pandemic (March 2020 to January 2021). We used linear regression models adjusting for age, race, gender, and time since diagnosis of advanced cancer to examine the relationship between the period of enrollment and patients’ QOL and depression symptoms. Results: A total of 860 patients were included in this analysis (665 participants enrolled prior to COVID-19 and 195 participants during COVID-19). The two cohorts did not differ significantly with respect to baseline demographic factors [Mean age 65.4 (SD = 11.4), 51.9% female]. In multivariate regression models, enrollment during COVID-19 was not associated with physical (B = -0.16, SE = 0.52, P = 0.763), social (B = -0.48, SE = 0.39, P = 0.217), emotional (B = -0.16, SE = 0.41, P = 0.693), functional (B = -0.83, SE = 0.55, P = 0.128) wellbeing, or lung cancer symptoms (B = -0.11, SE = 0.44, P = 0.806). Enrollment during COVID-19 was not associated with overall QOL (FACT-L: B = -1.32, SE = 1.69, P = 0.436) or depression symptoms (PHQ-9: B = -0.02, SE = 0.45, P = 0.973). Conclusions: Despite the prevailing belief that COVID-19 has negatively impacted QOL and distress in patients with cancer, we found no differences in QOL or depression symptoms in patients newly diagnosed with advanced lung cancer during the COVID-19 pandemic compared to those diagnosed prior to the pandemic. These findings suggest that factors other than the COVID-19 pandemic, such as patients’ experience with their cancer, contribute to their QOL and depression symptoms.
The surgical oncology clinical trial landscape: A cross-sectional analysis of ClinicalTrials.gov from 2008-2020.
Authors: Perera Nirosha D. , Turner Brandon E. , Shen Jolie Z. , Wong Bonnie O. , Litt Henry K. , Stavins MaKenna A. , Bellomo Tiffany R. , Saleki Massoud , Bell Alexander , Ionescu Ruxandra , Shyu Margaret , Wang Max M. , Tao Jacqueline , Sarsour Nadeen , O'Keefe Ryan M , Takasugi Jordan M. , Steinberg Jecca R. , King Roderick , Mahipal Amit , Wren Sherry M. 
Published: June 2021

1561 Background: Surgical interventions are studied less often than medical or radiation interventions in oncology clinical trials. We characterized surgical oncology trials registered on ClinicalTrials.gov, analyzed funding sources and identified features associated with early discontinuation and results reporting. Methods: We employed a cross-sectional study design with descriptive, logistic regression, cox regression, time series and survival analyses. We downloaded all 270,172 studies registered on the Aggregate Analysis of the ClinicalTrials.gov database from October 1, 2008 to March 9, 2020. After excluding non-interventional trials, applying cancer/oncology specific Medical Subject Heading terms to the remaining trials and excluding phase 1 trials, 27,915 trials were identified for manual review. Primary exposure variables were trial focus: neoplasia site and treatment modality (surgical interventions included investigations of outcomes from surgical resection or intra-operative/peri-operative changes), and funding: industry, U.S. government, academic. Results: 26,815 trials were found to have true oncology content; 1,661 (6.2%) involved surgical oncology, representing 311,789 patients. Funding sources were: 82.7% by academic institutions, 10.9% by industry, and 6.2% by U.S. government. The most studied neoplasia sites were colorectal (17.4% of trials), breast (10.7%), gastric (10.5%), hepatic (8.6%), lung (7.5%), brain/CNS (6.7%) and cervical (6.6%). U.S. government funded surgical oncology trials had the lowest risk of early discontinuation (adjusted HR 0.50, 95% CI: 0.26-0.99, p<0.047) and the highest odds of results reporting (adjusted OR 1.08, 95% CI: 0.55-2.11, p=0.83) (Table 1). Conclusions: There is a paucity of surgical oncology clinical trials compared to other treatment modalities, especially in context of surgery’s role in overall cancer care. From 2008-2020 only 6.2% of trials focused on surgical oncology, and U.S. government funded trials displayed the lowest hazard of early discontinuation and highest odds of results reporting. Stakeholders should look to government funded trials as models of improvement, but must increase representation and results dissemination of surgical oncology trials to guide treatment recommendations. Surgical oncology trial features and associated early discontinuation/results reporting. [Table: see text]
The TIME Trial Network to facilitate rapid clinical trial activation, patient screening, and enrollment in molecularly targeted trials.
Authors: OLeary Stephanie , Shulman Megan , Ritt Kevin , Degele Meghan , Protomastro Ewelina , Clauson Jennifer , Franzen Amy , Anderson Ian Churchill , Barve Minal A. , Oubre David N. , Priego Victor , Saverimuthu Angela , Senecal Francis Mark , Vaddepally Raju Kumar , Blackwell Kimberly L. , Cooney Matthew M. 
Published: June 2021

1563 Background: Clinical trials that require patients to have specific actionable mutations based on next generation sequencing (NGS) present unique problems, such as recruiting patients with rare mutations, low enrollment rates, and distance between patients and trial sites. Such barriers can slow the pace of trial enrollment and delay the development of new therapeutic options. Methods: Tempus Labs has partnered with experienced research sites and pharmaceutical companies with molecularly targeted clinical trials to create the TIME Trial Network. The study portfolio includes pharmaceutical sponsored phase I-III clinical trials across solid tumors and hematological malignancies, targeting actionable mutations. This network was established to ensure rapid just-in-time (JIT) activation of trials by streamlining start-up activities (i.e., execution of CTAs and study budgets/financial exhibits, regulatory paperwork, SIV planning and conduct, drug and study supply shipments, submission to the central IRB, and sponsor-specific requirements). Rapid activation begins upon receipt of an activation form from a site partner. “Site Activated” describes a site that has fulfilled all regulatory, documentation, contracting requirements, and has sponsor approval to screen and enroll patients. Results: In Q4 2020, JIT activations were completed for 6 unique interventional clinical trials across 10 sites in 8 US states in the TIME Trial Network. On average, sites were activated in 9.4 business days. Patients enrolled had rare NGS mutations and were from geographically diverse locations. In one urgent case, trial activation, patient consent, screening, and treatment were achieved in 5 business days. In total, 91.7% of patients consented to trial. The average timeline from activation to consent was 4.5 days (range 0 - 24 days), with half of patients consenting within 1 business day. 45.5% of patients who consented to trial received the study drug within 1 day of consent; 2 patients dosed on day of consent. Conclusions: Over a 3-month period, on average, TIME Trial sites were activated in 9.4 days (compared to the 20+ week industry-wide average), and patient consent was completed in 4.5 days. Rapid JIT activations through the TIME program provide significant improvements in trial enrollment timelines and increase access to therapies nationwide. JIT activations may be especially useful for rural, underserved communities, as sites can enroll diverse patient populations and help address the equity gap in clinical trials across ethnic groups.[Table: see text]