tbuckley/cabot-search huggingface dataset:
Randomized phase II study of sorafenib with or without everolimus in patients with radioactive iodine refractory Hürthle cell thyroid cancer (HCC) (Alliance A091302/ ITOG 1706).
Authors: Eric Jeffrey Sherman, Nathan R. Foster, Yungpo Bernard Su, Ardaman Shergill, Alan Loh Ho, Bhavana Konda, Ronald A Ghossein, Ian Ganly, Gary K. Schwartz
Journal: Journal of Clinical Oncology (2021)

6076 Background: HCC is a rare subtype of follicular cell thyroid cancer that has been poorly studied in the past. Recent genomic studies have shown the PI3K/Akt/mTOR pathway is frequently altered in HCC. In addition, a phase II study of sorafenib (S) and everolimus (E) showed promising data in HCC. A study to evaluate this was initiated through Alliance and the International Thyroid Oncology Group. Methods: Patients (pts) were randomized to either sorafenib and everolimus (SE) vs. sorafenib alone (S). Inclusion criteria included; (1) diagnosis of HCC (confirmed through central review), no prior S or E, refractory to radioactive iodine, progressive disease by RECIST over prior 14 months. Primary endpoint was a comparison of progression-free survival (PFS) between SE and S using a stratified 1-sided log-rank test with 0.20 significance level and a power of 80%. 28 events were needed at final analysis. Secondary endpoints consisted of overall survival (OS), confirmed response rate (RR), and adverse events. Results: 35 pts were randomized from 10/2014 to 9/2019, 34 of which were evaluable for analysis (17-SE; 17-S) because 1 patient cancelled prior to receiving treatment. Median age was 66.5 years and 74% were male. ECOG performance status (PS) was 0 (47%) and PS 1 (53%). 41% had prior systemic treatment for HCC. No significant differences in baseline characteristics were observed between treatment arms. Median follow-up in 22 alive patients was 39.2 months (range: 15.1-64.9). Seven (21%) patients remain on treatment. PFS was significantly improved in the SE arm as compared to the S arm (HR=0.65 (95% CI: 0.26, 1.57); median PFS: SE=24.7 months (95% CI: 6.1-no upper), S=10.9 months (95% CI: 5.5-no upper); stratified 1-sided p=0.1662). OS was similar between the arms (2-sided p=0.4138). Confirmed response rate was similar between arms as well (SE: 18% (3 partial response (PR) vs. S: 24% (3 PR, 1 complete response)); Fisher’s exact p=1.00). Grade 3 adverse event (AE) rates (regardless of attribution) were similar between arms (SE: 77% vs. S: 77%; p=1.00). Each arm had 1 patient with at least one grade 4 AE (SE patient: cardiac arrest, tracheal obstruction, encephalopathy; S patient: mucositis oral) and no grade 5 AEs. Conclusions: PFS was improved with the addition of E to S in this small randomized multi-institutional phase II study done. Accrual was difficult, but these promising results suggest that this combination should be further studied. Support: U10CA180821, U10CA180882, U24CA196171; https://acknowledgments.alliancefound.org ; Novartis/GSK; ClinicalTrials.gov Identifier: NCT02143726. Clinical trial information: NCT02143726.
A cross-sectional study on global disparities in information experiences of patients with lymphoma/CLL.
Authors: Olufunmilayo Bamigbola, Natalie Dren, Lorna Warwick
Journal: Journal of Clinical Oncology (2021)

e18517 Background: Patient-centricity remains a cornerstone in the care of patients with lymphoma and CLL, as informed patients are consistently associated with better outcomes and experiences. This study uses the Lymphoma Coalition (LC) 2020 Global Patient Survey (GPS) on Lymphomas and CLL to describe the global differences in the top choices for medical information among patients with lymphoma, as well as differences in their understanding of this information relating to various aspects of their care. Methods: Globally, 9,179 patients from 89 countries took part in the LC 2020 GPS. The countries were grouped into regions, and the regions with greater than 200 patients were included in the analysis (Table). The demographics of the regions were examined, and descriptive analyses of questions relating to information source preferences, information provision at diagnosis (addressing treatment options; process and stages of care; managing treatment side effects), and corresponding levels of patient understanding were performed in IBM SPSS v27. Results: Doctors were the first choice for medical information for patients in each region (SA-82%, AS- 75%, EU-69%, OC-63%, NA-61%). In EU, NA and SA, websites were the most prevalent second and third choice for information (27% and 28%; 30% and 32%; 35% and 27%, respectively). In AS, patient advocacy organisations were the most prevalent second and third choices for information (32% and 40%, respectively), while in OC, the most prevalent second and third choices were nurses (27%) and patient advocacy groups (32%) respectively. Over a fifth of NA patients were not given information on the process and stages of care and how to manage side effects of treatment (21% and 29%, respectively). About a third of patients from SA (32%) reported not getting information on treatment options. Over half of OC patients reported being given information on and completely understanding the different treatment options (51%), processes and stages of care (53%) and how to manage treatment side-effects (58%). Patients from AS were the most prevalent in reporting across the three categories, that they were given information but did not understand it (10%, 7%, 5%, respectively). Conclusions: Globally, patients with lymphoma use various avenues to source the medical information they need, and they differ in their information experiences. Access to appropriate and adequate medical information remains an essential aspect of a successful patient experience and LC advocates that this information be contextual and accessible to all patients with lymphoma. [Table: see text]
Abstract 10659: Elevation of Neutrophil to Lymphocyte Ratio and Monocyte to Lymphocyte Ratio Are Associated With Recurrence of Atrial Fibrillation After Pulmonary Vein Isolation
Authors: Masamichi Yano, Masami Nishino, Hiroaki Nohara, Taku Toyoshima, Naoko Higashino, Kohei Ukita, Akito Kawamura, Kyosuke Yanagawa, Hitoshi Nakamura, Yutaka Matsuhiro, Koji Yasumoto, Naotaka Okamoto, Akihiro Tanaka, Yasuharu Matsunaga, Daisuke Nakamura, Masaki Yamato, Yasuyuki Egami, Ryu Shutta, Jun Tanouchi
Journal: Circulation (2019)

Background: Previous reports demonstrated early recurrence of atrial fibrillation (ERAF) after pulmonary vein isolation (PVI) was closely related with the inflammatory process. Neutrophil to lympho...
A phase II study of neoadjuvant immunotherapy combined with chemotherapy (camrelizumab plus albumin paclitaxel and carboplatin) in resectable thoracic esophageal squamous cell cancer (NICE study): Interim results.
Authors: Zhigang Li, Jun Liu, Ming Zhang, Jinchen Shao, Yang Yang, Hongxuan Li, Zhichao Liu, Renquan Zhang, Bentong Yu, Hezhong Chen
Journal: Journal of Clinical Oncology (2021)

4060 Background: We conducted a phase II trial of preoperative chemotherapy with albumin paclitaxel and carboplatin combined with camrelizumab (NICE regimen), in patients with locally advanced esophageal squamous cell carcinoma (ESCC) with multiple lymph nodes metastasis. Initial results were analyzed to assess the efficacy and safety of this strategy. Methods: This was a prospective, multicenter, open, single arm, phase II trial. Eligible patients were histologically confirmed thoracic ESCC, staged as T1b-4a, N2-3 (≥ 3 stations), and M0 or M1 lymph node metastasis (confined to the supraclavicular lymph nodes) according to the 8th edition of American Joint Committee on Cancer. Patients received neoadjuvant treatment (NICE regimen) with intravenous camrelizumab (200 mg, day 1) plus albumin paclitaxel (100 mg/m2, day 1, 8, 15) and carboplatin (area under curve 5, day 1) of each 21-day cycle, for two cycles before surgery. The primary endpoint is pathological complete response (pCR) rate in the per-protocol population, which included all patients who had tumor resection and received at least one cycle of neoadjuvant treatment. Secondary endpoints include R0 resection rate, adverse events and disease-free survival. Safety was assessed in the modified intention-to-treat population. Results: Of the planned 60 patients enrolled, 55 (91.7%) patients have received the full two-cycles NICE regimen successfully, 4 patients didn’t receive the complete neoadjuvant therapy due to intolerance (3 patients) and drop out (1 patient), 1 patient died due to pneumonia on the second cycle of neoadjuvant therapy. Grade 3-5 treatment-related adverse events (TRAEs) rate was 53.3% and TRAEs resulting in discontinuation rate was 6.7%. The common grade 3-5 TRAEs included lymphopenia (50%), thrombocytopenia (10%), pneumonia (5%) and thyroid dysfunction (3.3%). At the time of writing, 47 patients underwent surgery within 27-85 days (median 36 days) after NICE treatment, in which 7 patients had delays to surgery due to TRAEs. All patients achieved radical (R0) resection. There was no in-hospital and postoperative 30-day mortality. pCR (ypT0N0) was identified in 20 (42.5%) of 47 patients and 5 (10.6%) patients had complete pathological response of the primary tumor but residual disease in lymph nodes alone (ypT0N+). Conclusions: Preoperative NICE regimen has achieved satisfatory initial results of disease response in locally advanced thoracic ESCC. A phase III randomized controlled trial is required to demonstarate the possible survival improvement. Trial registration: ChiCTR1900026240 Clinical trial information: ChiCTR1900026240.
Development and preliminary validation of the patient-reported Chronic Itch Burden Scale assessing health-related quality of life in chronic pruritus
Authors: J. Theunis, C. Nordon, B. Falissard, M. Orri, V. Mengeaud, L. Misery
Journal: British Journal of Dermatology (2021)

Summary Background Chronic pruritus (CP) significantly affects patients’ health-related quality of life (HRQoL). Very few self-reported HRQoL questionnaires exploring CP have been developed according to international guidelines, thus limiting their use in preauthorization trials. Objectives To develop a self-reported HRQoL questionnaire in patients with CP owing to psoriasis, atopic dermatitis, seborrhoeic dermatitis of the scalp or idiopathic dermatitis, and to explore the preliminary psychometric properties of the questionnaire. Methods The study was performed in France. A conceptual framework was developed based on a structured literature review and expert insight, and was improved using three focus groups involving 19 participants. A 50-item questionnaire was created and tested with 21 participants using cognitive debriefings; 11 items were removed. A cross-sectional study including 251 participants was performed to explore the preliminary psychometric properties of the 39-item questionnaire. Dimensionality was explored using principal component analysis. Cronbach’s alpha and correlation coefficients (interitem, item-total score and item-dimension score) were measured. The number of items was reduced through expert consensus. Results In the 39-item version, three main dimensions were identified (Cronbach’s alpha = 0·94) and all correlation coefficients were &amp;gt; 0·34. Upon review, 13 items were deleted owing to poor quality and six items were deleted by the team, generating a 20-item version. The questionnaire’s factorial structure was best reflected with a two-dimension solution, i.e. (i) social and emotional repercussions and (ii) relation to others, fear of judgement. Conclusions The Chronic Itch Burden Scale patient-reported questionnaire explores broad aspects of HRQoL that are relevant for patients with various skin diseases. Its good cross-sectional validity makes it useful for trials and practitioners.
Risk of coronavirus disease 2019 (Covid-19) contraction and severe infection in home- or healthcare professionals
Authors: Mikkel Porsborg Andersen, Lauge Østergaard, Matthew Phelps, Jawad Haider Butt, Lars Køber, Gunnar Gislason, Helle Collatz Christensen, Christian Torp-Pedersen, Morten Schou, Emil L. Fosbøl, Kristian Kragholm
Journal: Journal of Infection (2021)
Successful management of membranous duodenal stenosis by endoscopic balloon dilation and membrane resection with an insulated-tip knife
Authors: Xing Wang, Haifeng Liu, Guogang Ye, Zhibao Lv, Zhihong Hu
Journal: Endoscopy (2021)

A 14-month-old girl was admitted to our department because of repeated nonbilious vomiting for > 3 months and malnutrition. Upper gastrointestinal radiography showed partial obstruction of the duodenum ([Fig. 1]). Gastroscopy confirmed a membranous duodenal stenosis with an opening of about 3 mm in diameter, and no view of the duodenal papilla above the membrane ([Fig. 2 a]). We performed both balloon dilation and membrane resection ([Video 1]).
Long-term quality of life and nutritional results after laparoscopic sentinel node navigation surgery versus laparoscopic standard gastrectomy for early gastric cancer: Secondary outcomes of a multicenter, randomized phase 3 trial (SENORITA).
Authors: Bang Wool Eom, Hong Man Yoon, Young-Woo Kim, Jae Seok Min, Ji Yeong An, Hoon Hur, Young-Joon Lee, Gyu Seok Cho, Young-Kyu Park, Mi Ran Jung, Ji-Ho Park, Woo Jin Hyung, Sang-Ho Jeong, Myeong-Cherl Kook, Mira Han, Byung-Ho Nam, Keun Won Ryu
Journal: Journal of Clinical Oncology (2021)

4054 Background: Laparoscopic sentinel node navigation surgery (LSNNS) has been suggested as an alternative to laparoscopic standard gastrectomy (LSG) in early gastric cancer patients to improve long-term quality of life (QOL) and nutritional outcomes. Here, we present 3-year results of patient-reported quality of life (QOL) and nutrition, secondary endpoints of SENORITA trial. Methods: SENORITA is a prospective multicenter randomized phase 3 trial. Patients diagnosed with early gastric cancer of 3 cm or less were randomly allocated (1:1) to LSNNS for stomach preservation or LSG. The primary endpoint was 3-year disease-free survival. In this study, we analyzed QOL assessed using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) and EORTC stomach module (STO22) and nutritional parameters at 3, 12, 24, and 36 months after surgery. Linear mixed model analyses was used to evaluate differences between the two groups. This trial is registered with ClinicalTrials.gov, NCT01804998. Results: From March 2013 to March 2017, a total of 580 patients were randomly assigned and 527 patients were included in the modified intention-to-treat analysis population (258 in LSNNS and 269 in LSG group). QOL questionnaires were available for 99.4% of patients at baseline and then for 92.2%, 83.2%, 72.8%, and 66.9% at 3, 12, 24, and 36 months after surgery, respectively. The LSNNS group had higher physical function score than the LSG group at all time points (p = 0.002). However, there were no significant differences in other scales of EORTC QLQ-C30. Regarding EORTC QLQ-STO22, pain, eating restriction, anxiety, and taste scores were lower (better QOL) at all time points in the LSNNS group than in the LSG group (p = 0.002, &lt; 0.001, &lt; 0.001, and &lt; 0.001, respectively). The summary score of EORTC QLQ-STO22 was also higher in the LSNNS group representing better QOL (p &lt; 0.001). Body mass index, hemoglobin and total protein were significantly higher in the LSNNS group compared with the LSG group. Conclusions: The LSNNS group had better physical function and less symptoms, including pain, eating restriction, anxiety, and taste change compared with the LSG group. Moreover, the nutritional parameters were better maintained in the LSNNS group than in the LSG group. These findings showed benefits of stomach preserving surgery in LSNNS and can be used to help decision making about treatment for patients with early gastric cancer. Clinical trial information: NCT01804998.
CD4 T-Cell Exhaustion: Does It Exist and What Are Its Roles in Cancer?
Authors: Alexandra M. Miggelbrink, Joshua D. Jackson, Selena J. Lorrey, Ethan S. Srinivasan, Jessica Waibl-Polania, Daniel S. Wilkinson, Peter E. Fecci
Journal: Clinical Cancer Research (2021)

Abstract In chronic infections and in cancer, persistent antigen stimulation under suboptimal conditions can lead to the induction of T-cell exhaustion. Exhausted T cells are characterized by an increased expression of inhibitory markers and a progressive and hierarchical loss of function. Although cancer-induced exhaustion in CD8 T cells has been well-characterized and identified as a therapeutic target (i.e., via checkpoint inhibition), in-depth analyses of exhaustion in other immune cell types, including CD4 T cells, is wanting. While perhaps attributable to the contextual discovery of exhaustion amidst chronic viral infection, the lack of thorough inquiry into CD4 T-cell exhaustion is particularly surprising given their important role in orchestrating immune responses through T-helper and direct cytotoxic functions. Current work suggests that CD4 T-cell exhaustion may indeed be prevalent, and as CD4 T cells have been implicated in various disease pathologies, such exhaustion is likely to be clinically relevant. Defining phenotypic exhaustion in the various CD4 T-cell subsets and how it influences immune responses and disease severity will be crucial to understanding collective immune dysfunction in a variety of pathologies. In this review, we will discuss mechanistic and clinical evidence for CD4 T-cell exhaustion in cancer. Further insight into the derivation and manifestation of exhaustive processes in CD4 T cells could reveal novel therapeutic targets to abrogate CD4 T-cell exhaustion in cancer and induce a robust antitumor immune response.
Palliative care service utilization and advance care planning issues for adult glioblastoma patients: A systematic review.
Authors: Adela Wu, Gabriela Ruiz Colon, Rebecca Aslakson, Erqi L. Pollom, Chirag B Patel
Journal: Journal of Clinical Oncology (2021)

2036 Background: Glioblastoma (GBM) is a devastating disease with a median survival under 2 years and a 10-year survival rate of 0.71%. As patients with GBM suffer simultaneously from both a terminal cancer and a neurodegenerative disease, proactive provision of advance care planning (ACP) and palliative care (PC) seem appropriate. We conducted a systematic review exploring the published literature on the prevalence of ACP, healthcare services utilization at the end of life (EOL, including PC services), and location of death among adults with GBM, and the experiences of their caregivers. Methods: We systematically searched PubMed, Embase, Scopus, and Cochrane Library from database inception until 12/20/2020, using search terms including ‘glioblastoma’, ‘end of life’, ‘advance care planning’, and ‘advance directive’. Preferred reporting items for systematic reviews and meta-analyses (PRISMA) guidelines were followed. Inclusion criteria were quantitative and qualitative studies written in English of adults with GBM and their caregivers, with at least 20 subjects. Included studies were assessed for quality using the Newcastle-Ottawa Scale. Results: We screened 344 article abstracts and 39 full text articles to yield a final cohort of 16 articles that fit inclusion criteria. These studies reported the experiences of 10,706 GBM patients and 123 caregivers. All were nonrandomized studies conducted in six countries with all but two published in 2014 or later. Across studies, ACP documentation varied from 4-55%, PC referral was pursued in 39-40% of cases, and hospice referrals were made for 66-76% of adult GBM patients. Hospitalizations frequently occurred at the EOL, 20-56% of patients spent over 25% of their overall survival time hospitalized, and 39-64 % of deaths occurred in the home setting. Caregivers commonly reported restrictions on their ability to work (60%), financial barriers to care (29%), and feeling unprepared (29%). Conclusions: Despite having both a terminal disease and neurocognitive decline, a majority of adults with GBM do not pursue ACP or have access to PC. There is a dearth of focused and high-quality studies on ACP, PC, and hospice use among adults with GBM. Prospective studies that address these and additional aspects related to end-of-life care in this population, such as healthcare costs and inpatient supportive care needs, are needed.
Treatment pattern and outcomes of leptomeningeal carcinomatosis in India: CRSF201901 study.
Authors: Gautam Goyal, Ashish Singh, Manu Prasad, Nirmal Vivek Raut, Vikas Talreja, Arun Chandrasekharan, Kushal Gupta, Bharat Bhosale, Rushabh Kiran Kothari, Bhavesh Pradip Poladia, Joydeep Ghosh, Avinash Talele, Sameer Shrirangwar, Ashay Karpe
Journal: Journal of Clinical Oncology (2021)

e14012 Background: Leptomeningeal carcinomatosis (LCM) is a rare event and has a dismal prognosis. Limited data is available from India on LCM. Hence we did this country wise audit of LCM. Methods: This was a retrospective, multicentric audit of adult (age ≥ 18 years) patients with diagnosis of LCM, conducted across India in 2020 for patients treated from 2010 to 2020. Baseline characteristics, previous treatments, cancer sites, LCM diagnosis details, treatment pattern and overall survival (OS) were collected. Descriptive statistics were performed and Kaplan Meier analysis was performed for estimation of OS. Results: We had 84 patients diagnosed with LCM. The diagnosis of LCM was confirmed in 52 (61.9%) and probable 32 (38.1%) patients. The mean age was 51.8 years (SD-10.8) and we had 46 (54.8%) females. The three most common site of malignancy were lung, breast and gastrointestinal with 45 (53.6%), 22 (26.1%) and 9 (10.7%) patients. The ECOG PS at the presentation of LCM was 1, 2 in and 3-4 in 41 (48.8%), 28 (33.3%) and 15 (17.9%) respectively. LCM was seen at diagnosis in 2 patients (2.4%) and at progression in rest. The status of the extracranial disease at the occurrence of LCM was progressive disease in 39 patients (46.1%). The treatment offered was best supportive care in 24 patients (28.6%), systemic therapy only in 27(32.1%), systemic therapy and intrathecal therapy in 22 (26.2%) and only intrathecal therapy in 11(13.1%). Among 33(39.3%) patients receiving IT methotrexate was used in 23 (27.4%) and the combination of methotrexate, AraC and hydrocortisone was used in 10 (11.9%). The CSF clearance rate was assessed in 24 (28.6%) patients and the clearance rate was 13.1% (n=11). The median duration of therapy was 4 weeks (IQR 1-14). The median os was 90 days (95% CI 46.2-133.8). Conclusions: LCM has a grave prognosis and nearly 1/3rd patients are treated with best supportive care. Intrathecal therapy though part of all guidelines is administered in 39% of patients. This data can serve as a benchmark for further improvement to facilitate studies for further improving the outcomes.