tbuckley/cabot-search huggingface dataset:
Endostar combined with intensity-modulated radiotherapy in low-risk local advanced nasopharyngeal carcinoma: A phase II, randomized, multicentric clinical trial.
Authors: Min Kang, Shaomin Lin, Haisheng Zhu, Sihui Liao, Haixin Huang, Bin Yu, Hongqian Wang, Meilian Liu, Jinxian Zhu, Guang Huang, Tingting Zhang, Zhendong Yang, Pingting Zhou, Ziyan Zhou, Yutao Qin, Zhuxin Wei, Qinghua Du, Changhong Zhao, Mingjun Shen, Rensheng Wang
Journal: Journal of Clinical Oncology (2021)

6050 Background: A Phase II, randomized, prospective, multicentric trial was conducted to evaluate the efficacy and safety of Endostar plus radiotherapy in patients with low-risk local advanced nasopharyngeal carcinoma (NPC). This study reported the preliminary results of NCT02237924. Methods: From 09/2014 to 08/2016, patients with low-risk local advanced NPC were randomly treated with Endostar plus radiotherapy (ERT group, n=60) and concurrent chemoradiotherapy (CCRT group, n=60). Primary endpoint was the 5-year overall survival (OS) rate. The secondary endpoints were 3-year OS rate, progression free survival (PFS) rate, loco-regional recurrence free survival (LRRFS) rate and distance metastasis free survival (DMFS) rate. Results: After a median follow-up of 47 months, 3-year OS rate were 93.2% and 79.3% (p=0.032), 3-year PFS rate were 89.8% and 70.6% (p=0.011), 3-year DMFS rate were 93.2% and 80.7%, in two groups, respectively (P=0.042). 3-year LRRFS rate were 96.6% and 92.0% in two groups, respectively (but P=0.565). For short-term curative effects, CR rate were 71.2% and 60.0% for primary tumor, 74.6％and 63.3％for cervical lymph nodes, in two groups, respectively (P &lt; 0.05). Moreover, the incidences of adverse events were significantly lower in ERT group compared with in CCRT group. The grade 3/4 Hyponatraemia (0 [0%] vs 3 [5%], p=0·04), the grade 1/2 vomiting (10 [16.7%] vs 52 [86.7%], p=0.000), dry mouth (45 [75.0%] vs 56 [93.3%], p=0.012), leukopenia (22 [36.7%] vs 42 [70.0%], p=0.000) and weight loss (30 [50.0%] vs 45 [75.0%], p=0.005). No patients died of treatment-related causes. Conclusions: OS, PFS, and DMFS rates can be improved, adverse events be reduced, with better tolerability, by Endostar plus radiotherapy, when compared to concurrent chemoradiotherapy for local advanced low-risk NPC. Clinical trial information: NCT02237924. [Table: see text]
Exploring the role of digital health coaching for men with prostate cancer.
Authors: Nathan Handley, Kuang-Yi Wen, Sameh Gomaa, Kelly Jean Brassil, Lindsey Jackson, Adam P. Dicker
Journal: Journal of Clinical Oncology (2021)

TPS1586 Background: Toxicity leading to impaired quality of life is common among men receiving treatment for Prostate Cancer (PCa). Digital interventions may be beneficial in enhancing health self-efficacy in managing symptom burden. This study evaluates the feasibility and preliminary outcomes of digital health coaching intervention on men with PCa. Methods: This pilot study aims to recruit up to 100 adult, English-speaking men with PCa who in the last 2 years have required active treatment, defined as cancer management via active surveillance, surgery, radiation, androgen deprivation, chemotherapy, hormonal therapy, immunotherapy or a combination of these modalities. Men will be enrolled across the catchment area of Jefferson Health using social media and a variety of other outreach tools approved by the Institutional Review Board. Consented patients are enrolled in a 3-month digital health coaching program which combines weekly calls with up to 4 nudges of evidence-based content delivered via text or email weekly. The program focuses on a weekly health topic, such as physical, mental, social, or financial health, and managing symptoms, and empowers participants to set health goals of importance to them. Primary endpoints include feasibility, defined as 60% of participants completing the 3-month program. The main secondary endpoints measured are health self-efficacy as measured by the Cancer Behavior Inventory-Brief (CBI-B), quality of life, as measured by the Expanded Prostate Cancer Index Composite for Clinical Practice (EPIC-CP), financial toxicity as measured by the Comprehensive Score of Financial Toxicity (COST) and physical and mental health as measured by the Patient Reported Outcomes Measurement Information System-Global Health 10 (PROMIS-10). Outcomes are captured on enrollment and monthly through program completion for a total of 4 data points. Summary statistics will be used to describe patient demographic and clinical characteristics of the study population. Summary statistics will also be used to describe CBI, EPIC-CP, PROMIS and COST by assessment time. The change in CBI-B scores from baseline to 3 months will be calculated along with 95% confidence intervals. Additional LMMs will be created to assess the relationship between self-efficacy (CBI) and quality of life (EPIC-CP), financial toxicity (COST) and global health (PROMIS- SF10).
Impact of a randomized weight loss trial on breast tissue markers in breast cancer survivors.
Authors: Christina Marie Dieli-Conwright, Maura Harrigan, Brenda Cartmel, Anees B. Chagpar, Yalai Bai, David L. Rimm, Lajos Pusztai, Lingeng Lu, Tara B. Sanft, Melinda L. Irwin
Journal: Journal of Clinical Oncology (2021)

e12501 Background: Weight loss interventions are effective approaches to reduce body weight and alter serum biomarkers in breast cancer survivors, however the impact on breast tissue biomarkers is unknown. The Lifestyle, Exercise and Nutrition (LEAN) study was a randomized trial designed to test the effect of a weight loss intervention on body composition and breast tissue and serum biomarkers. Methods: Fifity-one women with a BMI ³ 25.0 kg/m 2 diagnosed with breast cancer, who had completed chemotherapy and/or radiation therapy were randomized to weight loss intervention or usual care. Breast tissue biopsies from the unaffected breast, fasting serum samples, and body composition were measured at baseline and 6-months. Ki67, insulin receptor (IR), CD68 and CD163 were measured by Automated Quantitative Analysis (AQUA) method. Mean baseline to 6-month changes were compared using ANCOVA adjusting for baseline values. Results: Pre- and post-intervention biopsies were conducted in 49 and 42 women respectively, with both pre- and post- epithelial tissue available from 25 women; epithelial tissue was unavailable in the remaining 66 women. Women were 56.8 ± 8.9 years old, diagnosed 3.3 + 3.8 years prior, primarily Stage I breast cancer (54%), with a BMI of 32.8 ± 6.0 kg/m 2 . At baseline, breast tissue levels of IR were inversely associated with both percent body fat (r = -0.47, p = .03) and serum insulin levels (r = -0.45, p = .04); serum insulin levels were inversely associated with CD68 (r = -0.47, p = .03). Significant between-group biomarker changes are presented in Table 1. At month 6, loss in percent body fat was associated with increased IR (r = -0.42, p = .05). Increased CD68 breast tissue expression was associated with reductions in serum levels of CRP (r = -0.49, p=0.02). There was no significant effect of the intervention on IR expression or Ki67 (p&gt;0.10). Conclusions: Breast tissue biopsies are feasible to collect in a clinical research setting among breast cancer survivors. A 6-month weight loss intervention led to decreased levels of CD163 in breast tissue and serum levels of leptin, and increased serum levels of adiponectin among breast cancer survivors. At baseline and month 6, changes in breast tissue biomarkers were favorably associated with serum biomarkers and body composition. Future confirmation is required to confirm the added benefit of tissue biomarkers beyond serum as an endpoint for lifestyle interventions among breast cancer survivors. Clinical trial information: NCT02110641. [Table: see text]
Abstract 11717: Increased Liver Stiffness Assessed by Magnetic Resonance Elastography Predicts Elevated Right Atrial Pressure in Patients With Heart Failure
Authors: Yoshiya Kato, Toshiyuki Nagai, Noriko Oyama-Manabe, Satonori Tsuneta, Yuta Kobayashi, Hirokazu Komoriyama, Kazunori Omote, Shingo Tsujinaga, Tadao Aikawa, Takuma Sato, Takao Konishi, Kiwamu Kamiya, Hiroyuki Iwano, Toshihisa Anzai
Journal: Circulation (2019)

Backgrounds: Elevated right atrial pressure (RAP) is a key determinant of worse clinical outcomes in patients with heart failure (HF). Magnetic resonance elastography (MRE) is a non-invasive imagin...
Melanoma genomics: a state‐of‐the‐art review of practical clinical applications*
Authors: S. Guhan, N. Klebanov, H. Tsao
Journal: British Journal of Dermatology (2021)

Our collective understanding of melanoma genomics has rapidly expanded in the past decade, bringing great promise to patients affected with the most severe and aggressive cases of melanoma. In this review, we present the practical clinical impact of genetics and genomics on modern melanoma diagnosis and treatment. Characterization of somatic driver mutations, which can be used to distinguish different subtypes of melanoma such as nonacral cutaneous melanoma (NACM), desmoplastic melanoma (DM), acral melanoma (AM), mucosal melanoma (MM) and uveal melanoma (UM), has led to the development of many targeted therapies against these tumours. Although targeted therapies exist for certain mutations, such as BRAF and KIT, other genotypes respond to newer‐generation immune therapies such as immune checkpoint inhibitors. Epigenetics also plays a critical role in melanoma pathogenesis and drug resistance, holding promise for new treatment avenues. In this review, special attention is placed on clinical trials and translational research, especially novel genomic tests aimed to benefit patients on an individualized level in the current emerging era of personalized therapy.
Improved survival supports primary endocrine therapy in patients with hormone receptor positive/ HER-2 negative metastatic breast cancer.
Authors: Robert Shenk, Lifen Cao, Jonathan T. Bliggenstorfer, James Michael Martin, Megan E. Miller
Journal: Journal of Clinical Oncology (2021)

e13034 Background: Current ASCO guidelines recommend endocrine therapy as preferred primary treatment for hormone receptor positive (HR+) metastatic breast cancer (MBC). We assessed survival outcomes of HR+/HER2- MBC patients undergoing endocrine therapy with and without chemotherapy. Methods: The National Cancer Database was queried 2004-2016 for patients with de novo HR+/HER2- MBC. Exclusion criteria were treatment with surgery or radiation at the primary site and missing oncologic and follow up data. Overall survival was compared between systemic treatment groups using multivariable cox proportional hazards regression modes. Results: 19,317 patients met inclusion criteria, among whom 2,360 (12%) received no systemic therapy, 2,617 (14%) received chemotherapy only, 10,078 (52%) received endocrine therapy only and 4,262 (22%) received both chemotherapy and endocrine therapy. Patients treated with chemotherapy only more frequently had lung (38%, p&lt;0.001) or liver (36%, p&lt;0.001) metastasis while those undergoing endocrine therapy only presented primarily with bone metastasis (82%, p&lt;0.001). Patients with multiple metastatic sites more often received endocrine therapy alone than combined therapy (44 vs. 25%, p&lt;0.001). Median overall survival was similar after combination therapy and endocrine therapy, and poorest after chemotherapy alone (33.1 vs 31.4 vs 19.8 months, p&lt;0.001). After controlling for patient, facility, and tumor characteristics, endocrine therapy alone provided superior survival benefit to chemotherapy only, though combination systemic therapy resulted in the greatest overall survival (p&lt;0.001). Conclusions: Primary endocrine therapy provided significant survival benefit over chemotherapy alone for HR+/HER2- MBC. Though combination systemic therapy may be warranted in progressive disease, our results align with recommendations for endocrine therapy as first line treatment for HR+/HER2- MBC. [Table: see text]
LGG-14. PRESENTATION CHARACTERISTICS AND TREATMENT OUTCOMES FOR PEDIATRIC OPTIC PATHWAY GLIOMAS IN QATAR
Authors: Ata Maaz, Tayseer Yousif, Mohammed Abdulmajeed, Moegamad Ederies, Pedro Neri, Abdul Kamboh
Journal: Neuro-Oncology (2021)

Abstract Objectives To review the presentation characteristics and treatment outcomes for pediatric optic pathway gliomas (OPG) in Qatar. Methods Retrospective review of data for children with OPG from January 2009 to February 2021. Presenting features, diagnostic imaging and indications for treatment were reviewed. Progression free survival (PFS) and overall survival(OS) were computed using standard statistical methods. Medical notes were also reviewed for visual outcomes. Results Nineteen patients were diagnosed with OPG during the study period. There were 10 (52%) females. Median age was 29 months (range 6–186) months. Eleven (57%) tumors were related to neurofibromatosis Type 1 (NF-1). Nine (47%) of OPG were located in optic nerves, 5 (26%) were chiasmatic/suprasellar, while the remaining 5(26%) involved a combination of structures. Seven(36%) children presented with oculo-visual symptoms. Another 7 were diagnosed on screening imaging for NF-1. Seven(36%) children had debulking surgery/biopsy, while the remaining patients were diagnosed on neuro-imaging alone. Thirteen (68%) patients were treated with chemotherapy and 2 received additional radiotherapy. Indications for non-surgical treatment included visual impairment (46%) and large/progressive tumor (54%). Carboplatin based regimes were used as first line chemotherapy for 76 % of patients. Five (38%) patients required more than one lines of treatment. OS and PFS at 36 months were 100% and 48%. Baseline visual assessment showed 5 children each (26%) had unilateral and bilateral visual impairment, while 9 (48%) had normal vision. Of the 6 children receiving chemotherapy for visual impairment, 2 (33%) showed improvement. Of the 7 children treated for large/progressive tumors, 3 (42%) showed partial response, 2(28%) had progressive disease and 1 had stable disease after the first line therapy. Conclusions Our results are in-keeping with international data for optic pathway gliomas. Early referral and diagnosis may improve visual outcomes for this group of tumors.
Use of Medications for Alcohol Use Disorder in the US
Authors: Beth Han, Christopher M. Jones, Emily B. Einstein, Patricia A. Powell, Wilson M. Compton
Journal: JAMA Psychiatry (2021)

Treatment rates for alcohol use disorder (AUD) are low 1 (eg, 7.6% in 2019 2 ).The US Food and Drug Administration has approved 4 evidence-based medications for treating
Effect of first-line pembrolizumab treatment in individuals with advanced non-small cell lung cancer and poor performance status.
Authors: Rajwanth Veluswamy, Jiayi Ji, Liangyuan Hu, Xiaoliang Wang, Cardinale B. Smith, Minal Kale
Journal: Journal of Clinical Oncology (2021)

e18796 Background: There is limited evidence supporting the optimal use of immune checkpoint inhibitors (ICIs) in NSCLC patients with poor performance status (PS), as clinical trials exclude these patients. In this study, we use real-world oncology data to determine the impact of first line pembrolizumab vs. no treatment in high PD(L)-1 expressing cancers in individuals with advanced NSCLC and ECOG PS ≥2. Methods: We performed a retrospective cohort study of patients with advanced NSCLC with ECOG PS ≥2 between 09/01/2014 and 02/18/2020, using the nationwide Flatiron Health electronic health record (EHR)-derived de-identified database. Patients were included if they were PD(L)-1 high (≥50%) and had clinical and treatment information recorded within 90 days of diagnosis. Real-world overall survival (rwOS) was defined as time from diagnosis to death (censored at last EHR activity). Median rwOS was estimated using weighted Kaplan-Meier methods. A marginal Cox structural model with inverse probability of treatment weighting was used to adjust for selection bias and estimate the effectiveness of pembrolizumab. The inverse probability weights were estimated using an ensemble machine learning technique, Super Learner, based on age, gender, race, practice type and smoking history. Adjusted hazard ratios (aHR) were estimated using weighted Cox proportional hazards models. Stratified analysis was conducted by ECOG PS (2 vs &gt;2). Results: 217 (16%) individuals with advanced NSCLC and high PD(L)-1 expression received no treatment, compared to 546 (39%) individuals who received 1L pembrolizumab. The no-treatment group had a lower proportion of ECOG 2 compared to the pembrolizumab group (Table). Median rwOS in the no-treatment group was 2.4 months, compared to 7.1 months in the pembrolizumab group (p&lt;0.001). In unadjusted survival analyses in the entire cohort and in cohorts stratified by ECOG status, treatment with pembrolizumab was associated with a significantly lower risk of death (hazard ratio [HR]: 0.38, 95% Confidence Interval [CI]: 0.31-0.45). In adjusted analyses, individuals treated with pembrolizumab had improved survival (HR: 0.40, 95% CI: 0.35-0.45). Conclusions: Our analysis of real-world clinical oncology data demonstrated that 1L treatment with pembrolizumab was associated with significantly improved rwOS among individuals with ECOG ≥ 2. [Table: see text]
Acalabrutinib ± obinutuzumab versus obinutuzumab + chlorambucil in treatment-naïve chronic lymphocytic leukemia: Elevate-TN four-year follow up.
Authors: Jeff Porter Sharman, Miklos Egyed, Wojciech Jurczak, Alan Skarbnik, John M. Pagel, Manali K. Kamdar, Talha Munir, Gillian Corbett, Laura Maria Fogliatto, Yair Herishanu, Versha Banerji, Steve E. Coutre, Patricia Walker, Karin Karlsson, Paolo Ghia, Ann Janssens, William G. Wierda, Priti Patel, Min Hui Wang, John C. Byrd
Journal: Journal of Clinical Oncology (2021)

7509 Background: Early results from ELEVATE-TN (NCT02475681) at a median follow-up of 28.3 mo demonstrated superior efficacy of acalabrutinib (A) ± obinutuzumab (O) compared with O + chlorambucil (Clb) in patients (pts) with treatment-naïve (TN) chronic lymphocytic leukemia (CLL) (Sharman et al. Lancet 2020;395:1278-91). Results from a 4-year update are reported here. Methods: Pts received A±O or O+Clb. Crossover to A monotherapy was permitted in pts who progressed on O+Clb. Investigator-assessed (INV) progression-free survival (PFS), INV overall response rate (ORR), overall survival (OS), and safety were evaluated. Results: 535 pts (A+O, n=179; A, n=179; O+Clb, n=177) were randomized with a median age of 70 y; 63% had unmutated IGHV and 9% del(17p). At a median follow-up of 46.9 mo (range, 0.0–59.4; data cutoff: Sept 11, 2020), the median PFS was not reached (NR) for A+O and A pts vs 27.8 mo for O+Clb pts (both P&lt;0.0001). In pts with unmutated IGHV, the median PFS was NR (A+O and A) vs 22.2 mo among O+Clb pts (both P&lt;0.0001). In pts with del(17p), the median PFS was NR (A+O and A) vs 17.7 mo for O+Clb ( P&lt;0.005). Estimated 48-mo PFS rates were 87% for A+O, 78% for A, and 25% for O+Clb. Median OS was NR in any treatment arm with a trend towards significance in the A+O group (A+O vs O+Clb, P=0.0604); estimated 48-mo OS rates were 93% (A+O), 88% (A), and 88% (O+Clb). ORR was significantly higher with A+O (96.1%; 95% CI 92.1–98.1) vs O+Clb (82.5%; 95% CI 76.2–87.4; P&lt;0.0001); ORR with A was 89.9% (95% CI 84.7–93.5; P=0.035 vs O+Clb). Complete response/complete response with incomplete hematologic recovery (CR/CRi) rates were higher with A+O (26.8%/3.9%) vs O+Clb (12.4%/0.6%); 10.6%/0.6% had CR/CRi with A. Common adverse events (AEs) and AEs of interest are shown in the Table. Overall treatment discontinuation rates were 25.1% (A+O), 30.7% (A), and 22.6% (O+Clb); the most common reasons were AEs (12.8%, 12.3%, 14.7%, respectively) and progressive disease (4.5%, 7.8%, 1.7%). Most pts (77.4%) completed O+Clb treatment. Conclusions: With a median follow-up of 46.9 mo (̃4y), the efficacy and safety of A+O and A monotherapy was maintained, with an increase in CR since the interim analysis (from 21% to 27% [A+O] and from 7% to 11% [A]) and low rates of discontinuation.[Table: see text]
A patient reported outcomes of treatments for desmoid tumors: An international natural history study.
Authors: Danielle Braggio, Amanda Lucas, Lynne Hernandez, Kelly Mercier
Journal: Journal of Clinical Oncology (2021)

11560 Background: The Desmoid Tumor Research Foundation (DTRF) launched the natural history study (NHS) in 2017. At this time, there are no standard-of-care options for this rare sarcoma. The treatments, clinical descriptors, and the patient reported outcomes to pharmacologic agents are described here within. Methods: The web-based natural history study launched September 2017 in collaboration with the National Organization of Rare Disorders. It contains 15 surveys covering diagnostics, disease, treatment, care management, and quality of life. Treatment types included in the DTRF NHS were pharmacology, surgery, radiation, high-intensity focused ultrasound (HiFU), and active surveillance (watch and wait). Results: While surgery was once the primary intervention for desmoid tumor patients, the NHS participants reported that 47.6% had received active surveillance or no systemic treatment at diagnosis. This is most common for desmoid tumors located in abdominal wall (54/103; 52.4%). There were 87 reported cases of complete surgical resection, 38 incomplete resections, and 23 bowel resections. 9 amputations were reported; 8 participants reported recurrent disease following the removal of the limb. The non-surgical interventions, such as radiation and HiFU, were mostly described for participants with chest wall tumors (15 pts) and joints/extremities (10 pts). Many options for systemic therapies were described including sorafenib (44/284; 15.5%), sulindac (36/284; 12.7%), and anti-hormonal agents tamoxifen and toremifene (34/285; 10.9%) were described. Targeted agents, such as gamma secretase inhibitor, pazopanib, and sorafenib, were greater in the United States than the non-US country participants (21% vs 9%). Multiple lines of treatments were reported by 81 participants, surgery is greatest as the first intervention for all tumor locations (49/81, 60%), with the exception of those with head/neck tumors who received chemotherapy (6/11, 55%). Analysis has started to evaluate the efficacy of systemic treatments from these NHS data. The table describes the participant reported outcomes of anti-hormonal agents, chemotherapeutics, non-steroidal anti-inflammatories, and targeted agents. Both chemotherapies and targeted agents were reported to have 38.1% response rates from the participants with 34.3% and 23.8% of participants reported progressive disease on therapy, respectively. Conclusions: Desmoid tumor NHS study participants reported the use of many treatment modalities demonstrating a range of frequency of use by tumor location and efficacy. Data collection through the DTRF NHS is ongoing.[Table: see text]
Abstract 14194: The Role of Hyperhf Score to Predict Heart Failure and Related Cerebrovascular Events
Authors: Hyun-Bin Park, Jae-Man Lee, Ji-Hun Song, Jaewon Oh, Jong-Chan Youn, Hyungseop Kim, Geu-Ru Hong, Seok-min Kang, In-Cheol Kim
Journal: Circulation (2019)

Background: Heart failure (HF) and related cerebrovascular events are major concerns in hypertrophic cardiomyopathy (HCM). Methods: We investigated the role of an adjunctive risk model, the HYPertr...