tbuckley/cabot-search huggingface dataset:
Safety and Patient-Reported Outcomes of Atezolizumab Plus Chemotherapy With or Without Bevacizumab Versus Bevacizumab Plus Chemotherapy in Non–Small-Cell Lung Cancer
Authors: Martin Reck, Thomas Wehler, Francisco Orlandi, Naoyuki Nogami, Carlo Barone, Denis Moro-Sibilot, Mikhail Shtivelband, Jose Luis González Larriba, Jeffrey Rothenstein, Martin Früh, Wei Yu, Yu Deng, Shelley Coleman, Geetha Shankar, Hina Patel, Claudia Kelsch, Anthony Lee, Elisabeth Piault, Mark A. Socinski
Journal: Journal of Clinical Oncology (2020)

Atezolizumab, bevacizumab, carboplatin, and paclitaxel (ABCP) demonstrated survival benefit versus bevacizumab, carboplatin, and paclitaxel (BCP) in chemotherapy-naïve nonsquamous non-small-cell lung cancer (NSCLC). We present safety and patient-reported outcomes (PROs) to provide additional information on the relative impact of adding atezolizumab to chemotherapy with and without bevacizumab in nonsquamous NSCLC.Patients were randomly assigned to receive atezolizumab, carboplatin, and paclitaxel (ACP), ABCP, or BCP. Coprimary end points were overall survival and investigator-assessed progression-free survival. The incidence, nature, and severity of adverse events (AEs) were assessed. PROs, a secondary end point, were evaluated using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)-Core 30 and EORTC QLQ-Lung Cancer 13.Overall, 400 (ACP), 393 (ABCP), and 394 (BCP) patients were safety evaluable (ie, intention-to-treat population that received one or more doses of any study treatment). More patients had grade 3/4 treatment-related AEs during the induction versus maintenance phase (ACP, 40.5% v 8.2%; ABCP, 48.6% v 21.2%; BCP, 44.7% v 11.1%). During induction, the incidence of serious AEs (SAEs) was 28.3%, 28.5%, and 26.4% in the ACP, ABCP, and BCP arms, respectively. During maintenance, SAE incidences were 20.0%, 26.3%, and 13.0%, respectively. Completion rates of the PRO questionnaires were > 88% at baseline and remained ≥ 70% throughout most study visits. Across arms, patients on average reported no clinically meaningful worsening of global health status or physical functioning scores through cycle 13. Patients across arms rated common symptoms with chemotherapy and immunotherapy similarly.ABCP seems tolerable and manageable versus ACP and BCP in first-line nonsquamous NSCLC. Treatment tolerability differed between induction and maintenance phases across treatment arms. PROs reflect a minimal treatment burden (eg, health-related quality of life, symptoms) with each regimen.
Relationship between androgen and male quality of life and psychological health
Authors: Hongjun Li
Journal: BMJ (2017)

雄激素在维持健康男性的生理和心理功能中具有重要作用，并与男性的生命质量和心理健康密切相关，主要体现在生殖功能、合成代谢、皮肤黏膜和内分泌系统，还涉及男性的认知和情绪方面。睾酮补充治疗对雄激素水平低下患者的生命质量和精神心理状态具有显著的改善作用。
Effects of epidural block anesthesia assisted sevoflurane for cesarean section on Apgar scores
Authors: Xiao-ping Tang
Journal: BMJ (2013)

To explore the feasibility of sevoflurane used in obstetric anesthesia and examine its effects on neonatal Apgar scores. A total of 60 cases of term primipara were assigned into epidural anesthesia assisted sevoflurane inhalation group (experimental group, n=30) and epidural anesthesia group (control group, n=30). In the experimental group after skin incision, the patients could not tolerate the anesthesia mask inhalation of sevoflurane. And the control group received no adjuvant drug. The maternal inhalation of sevoflurane to delivery of fetus after 1 min, 5 min, 10 min Apgar scores were analyzed. And the inhalation of sevoflurane to fetal childbirth duration were 4-10 min in two groups. The intergroup difference of newborn Apgar scores had no statistical significance (P>0.05). Epidural anesthesia assisted sevoflurane inhalation for cesarean section had no significant effect on neonatal Apgar scores.


Key words: 
Anesthesia, inhalation; Apgar score
Randomized phase II trial comparing the efficacy of standard-dose with high-dose twice-daily thoracic radiotherapy (TRT) in limited disease small-cell lung cancer (LD SCLC).
Authors: Bjorn Henning Gronberg, Kristin Toftaker Killingberg, Øystein Fløtten, Maria Moksnes Bjaanæs, Tesfaye Madebo, Seppo Langer, Tine Schytte, Odd Terje Brustugun, Jan Nyman, Kristin Stokke, Tarje Onsøien Halvorsen
Journal: Journal of Clinical Oncology (2020)

9007 Background: Concurrent chemoradiotherapy is the standard treatment of LD SCLC. Some patients are cured, but most relapse and better treatment is needed. 45 Gy in 30 fractions BID is the most recommended TRT-schedule. Studies suggest that a higher TRT-dose might prolong survival, but hitherto, this has not been confirmed in randomized trials. We aimed to investigate whether high-dose BID TRT of 60 Gy in 40 fractions was feasible, tolerated, and improved survival. Methods: Patients &gt; 18 years, performance status (PS) 0-2 and confirmed LD SCLC were to receive 4 courses of platinum/etoposide and were randomized to BID TRT of 60 or 45 Gy. Responders were offered prophylactic cranial irradiation of 25-30 Gy. Primary endpoint was 2-year survival; secondary endpoints were toxicity, progression free survival (PFS), and overall survival (OS). To demonstrate a 25% improvement of 2-year survival from 53% to 66% with a one-sided α = .10 and β = .80, 75 patients were required on each arm. Results: Between 2014-2018, 176 patients were enrolled at 22 Scandinavian hospitals. 160 completed TRT per protocol and were eligible for the present analyses (60 Gy: n = 84, 45 Gy: n = 76). Median age was 65, 58% women, 90% PS 0-1. There were no significant differences in grade 3–4 esophagitis (60 Gy: 19%, 45 Gy: 18%, p = .92) or grade 3–4 pneumonitis (60 Gy: 4%, 45 Gy: 0%, p = .10). There was a trend towards more neutropenic infections on the 45 Gy arm (60 Gy: 21%, 45 Gy: 36%, p = .05). There were no significant differences in other grade 3-4 toxicity. Three patients died during the study treatment period (60 Gy: one neutropenic infection and one aortic dissection; 45 Gy: one thrombocytopenic bleeding). There were no statistically significant differences in response rates (60 Gy: 88% [95% CI 81-95], 45 Gy: 85% [95% CI 76-93], p = .52) or median PFS (60 Gy: 20 months [95% CI 11-29], 45 Gy: 14 months [95% CI 10-19], p = .31). Significantly more patients on the 60 Gy arm were alive after 2 years (60 Gy: 73% [95% CI 63-83], 45 Gy: 46% [95% CI 36-60], p = .001), and they had a significantly longer median overall survival (60 Gy: 42 months [95% CI 32-51], 45 Gy: 23 months [95% CI 17-28], HR .63 [95% CI .41-.96], p = .031). Conclusions: LD SCLC patients who received BID TRT of 60 Gy had a statistically significant and numerically substantial benefit in terms of 2-year survival (primary endpoint) and median overall survival compared with those who received BID TRT of 45 Gy. The higher TRT dose did not cause more toxicity than the standard dose. Clinical trial information: NCT02041845.
Chemotherapy response score as a prognostic tool in advanced-stage endometrial cancer patients treated with neoadjuvant chemotherapy.
Authors: Ina Jani, Ricardo R. Lastra, Katherine Brito, Chuanhong Liao, Isabel Lazo, Nita Karnik Lee, Seiko Diane Yamada
Journal: Journal of Clinical Oncology (2020)

e18095 Background: Chemotherapy response score (CRS) applied to omental metastases obtained at the time of interval debulking surgery (IDS) has been used to quantify response to neoadjuvant chemotherapy (NACT) in advanced stage ovarian cancer patients. The score has been correlated with both progression free survival (PFS) and overall survival (OS). This CRS score has not been studied in advanced stage endometrial cancer. The aim of the current study is 1) to apply the CRS to omental and adnexal metastases obtained at IDS of advanced stage endometrial cancer patients and 2) to investigate the association between the CRS score and surgical outcome, PFS and OS. Methods: Patients with clinical stage III-IV endometrial cancer (endometrioid, serous, clear cell, carcinosarcoma) were identified through the endometrial cancer database, billing data and tumor board notes (2003-2019) from the University of Chicago. Patients were included if they received NACT followed by IDS (R0 no gross residual, optimal &lt; 1 cm residual or suboptimal ≥ 1 cm residual disease). Patients who received pre-operative radiotherapy were excluded. Pathology specimens from primary and metastatic sites were reviewed by the study pathologist blinded to clinical outcome. Histologic specimens from the omental and adnexal metastases were assigned a single quantitative score of 1 (no/minimal tumor response), 2 (appreciable tumor response with viable tumor) or 3 (complete/near complete response) using the CRS system as previously described by Bohm et al (JCO 2015; 33:2457-63). Results: A total of 40 patients were available for analysis. Median age 63.5, median BMI 32 kg/m 2 . There is a significant association between omental CRS and optimal IDS (p = 0.029) but no significant association between the adnexal CRS and optimal IDS (p = 0.145). Cox regression analysis identified CRS omentum [2: HR = 0.095, p = 0.001; 3 HR = 0.088, p = 0.004] and CRS adnexa [2: HR = 0.24, p = 0.007] predictive of PFS. There was not enough evidence to comment on any association between CRS with OS. Conclusions: Omental CRS2, CRS3 are associated with optimal IDS. Omental CRS2, CRS3 and adnexal CRS2 are prognostic for improved PFS in stage III – IV endometrial cancer patients after neoadjuvant chemotherapy. [Table: see text]
Clinical and pathological characteristics of primary Sj(o)gren's syndrome-associated neurological lesions
Authors: Shan Jin, Xia Cao, Xiao-ling Wang, Jing Li, Bing-zhen Cao
Journal: BMJ (2010)

Objective To explore clinical and pathological characteristics of neurological lesions in primary Sj(o)gren's syndrome (pSS).Methods Ten patients diagnosed as pSS with nervous system involvement were analyzed retrospectively with autoimmune antibody test,cerebrespinal fluid examination and Schivmer's test,six pSS patients with peripheral nervous system lesions (PNS-pSS) were examined with electromyography and nerve conduction velocity and four pSS patients with central nervous system lesions (CNS-pSS) were examined with cranial MRI to analyze their clinical and pathological characteristics.Salivary gland biopsy was performed for all the ten patients,sural nerve biopsy for those with PNS-pSS and brain biopsy or spinal autopsy for those with CNS-pSS.Results Clinically,six patients with PNS-pSS presented symmetrical sensory-motor peripheral neuropathy or pure sensory peripheral neuropathy and four patients with CNS-pSS presented multiple sclerosis,subacute transverse myelitis,encephalitis,pituitary stroke and acute meningitis with varied lesions in the myelin sheath and axon by electromyography and motor nerve conduction velocity.Cranial MRI showed lesions in the white matter of the brain,spinal cord and abnormal signals in the pituitary.Pathologically,sural nerve biopsy showed typical vasculitis and nonvasculitis characterized as degeneration of the axon and myelin sheath,salivary acinar gland biopsy showed its atrophy and infiltration with lymphocytes,and brain biopsy showed demyelination of the brain and spinal white matter,as well as infiltration of lymphocytes surrounding the veins,typical vasculitis and bleeding and necrosis of the pituitary.Conclusions Both central and peripheral nervous systems can be involved in pSS,with complicated clinical manifestations.Electrophysiology,cerebrospinal fluid tests and histopathological examinations by biopsy are essential in diagnosis for neurological lesions in patients with pSS.Inflammatory reaction of the blood vessels and tissues mediated by cell immunity may be involved in mechanism of its neurological lesions.

Key words: 
Sj(o)gren's syndrome; Neurologic manifestation; Pathological conditions,signs and symptoms
“Stop scaring the children”: a call for resilient and tenacious optimism
Authors: Abhik K. Banerjee
Journal: Journal of Clinical Investigation (2020)

Welcome everyone to the 2020 Business Meeting of the American Physician Scientists Association (APSA). My name is Abhik Banerjee, and I serve as the 2019–2020 President for the organization. As you are aware because of the COVID-19 pandemic, we had been forced to cancel our 2020 Association of American Physician (AAP)/American Society for Clinical Investigation (ASCI)/APSA Joint Meeting at the Fairmont Chicago, originally scheduled on April 3 to 5, 2020. The safety of our membership is our top priority, and our organization is currently navigating through the aftermath of the cancelled meeting. Despite not being able to facilitate an in-person meeting for trainees of all stages of their physician-scientist career development, we are committed to continue to be the student physician-scientist’s leading voice for improving educational opportunities, advancing patient-oriented research, and advocating for the future of translational medicine. In keeping with our organization’s mission and based on several trainee requests, APSA has elected to provide Annual Meeting–related content online via the GoToMeeting platform over the originally scheduled weekend. Despite the rapidly changing public health crisis our country faces, our organization remains steadfast in our commitment to advocate for trainees’ needs, and we hope you take advantage of the excellent programming our volunteers have coordinated over these next two days.
Pembrolizumab in combination with the oncolytic virus pelareorep in patients progressing on systemic chemotherapy for advanced pancreatic adenocarcinoma: A phase II study.
Authors: Devalingam Mahalingam, Aparna Kalyan, Sheetal Mehta Kircher, Victoria Maurer, Masha Kocherginsky, Jiahui Xu, Pedro Antonio Hermida de Viveiros, Elena Vagia, Grey A Wilkinson, Matthew C. Coffey, Mary Frances Mulcahy, Al Bowen Benson, Bin Zhang
Journal: Journal of Clinical Oncology (2020)

e16789 Background: Pelareorep is an intravenously delivered oncolytic reovirus that can induce a T-cell-inflamed phenotype in pancreatic ductal adenocarcinoma (PDAC). Analysis of tumor tissue from patients treated with pelareorep have shown reovirus replication, T-cell infiltration, and upregulation of PD-L1. We hypothesized that pelareorep in combination pembrolizumab in patients with PDAC would lead to improved response, effective T-cell recognition of tumor antigens and expand peripheral T-cell repertoire. Methods: This investigator-initiated phase II study enrolled PDAC patients who progressed after first-line treatment. Patients received pelareorep at a dose of 4.5x10 10 TCID 50 IV on Days 1, 2, 3 &amp; 8of Cycle (C) 1, and Days 1 &amp; 8 with C2 onwards. Pembrolizumab was administered on Day 1 of each 21-day cycle at 200 mg IV. Primary objective was overall response rate (ORR) by RECIST v 1.1 criteria. Secondary objectives included evaluation for reovirus replication and immune analysis in peripheral blood and tumor biopsies. The study was designed using Simon’s two-stage design with 90% power and one-sided alpha = 0.025 to compare 10% vs. 35% ORR. A total of ≥2/11 responses were needed to proceed to stage 2. Results: Thirteen patients were enrolled. Disease control was achieved in 30% of the 12 efficacy-evaluable patients. One patient achieved partial response. Three additional patients achieved stable disease. Treatment was well tolerated, with mostly grade 1 or 2 treatment-related adverse events, including flu-like symptoms. Viral replication was observed in on-treatment tumor biopsies. T-cell receptor sequencing from peripheral blood revealed a high degree of peripheral repertoire turnover and creation of new T-cell clones during treatment. Immune correlation with efficacy analysis is ongoing. Conclusions: Pelareorep with pembrolizumab showed manageable safety profiles and modest efficacy in an unselected PDAC population. The study will not proceed to stage II, however further evaluation of anti-tumor activity of pelareorep and anti-PD-1 therapy is now planned in biomarker defined patients. Clinical trial information: NCT03723915 .
Application of standardized patients in intensive training of clinical skills for general practice trainees and its effectiveness
Authors: 寿涓, 祝蟮珠, 江孙芳, 张向杰, 彭明辉
Journal: BMJ (2011)

Objective To explore application of standardized patients (SPs) in intensive training of clinical competency for general practice trainees. Methods Fifty-three general practice trainees in Shanghai Zhongshan Hospital were enrolled in the study, randomly assigned to intervention and control groups. Control group proceeded in routine clinical rotation, while intervention group accepted intensive training course with SPs as trainers. Three months after intervention, clinical skills of the two groups were compared in a simulated medical environment. Results There was no statistically significant difference in their baseline characteristics between the two groups (P ＞0.05). Competency in history taking, physical examinations,communication with patients, comprehensive consultation, medical record writing as well as case-analysis,improved significantly in intervention group after intervention, as compared to those before it ( P ＜ 0. 01 ),with the highest score of communication skill of 82 ± 10. Although competency of history taking, physical examinations, comprehensive consultation, medical record writing also improved significantly three months later in control group as compared to their baselines (P ＜ 0. 01 ), while no statistically significant difference in their communication skills was found ( P ＞ 0. 05 ). Scores of skills in physician-patient communication,comprehensive consultation as well as medical record analysis were significantly higher in intervention group than those in control one after intervention ( P ＜ 0. 01 ), but no significant difference in physical examinations was found between the two groups ( P ＞ 0. 05 ). Conclusions Application of SP in intensive training course for clinical competency can remarkably improve their competency in interpersonal communication and comprehensive consultation for general practice trainees.

Key words: 
Teaching ;  Patient,simulation ;  Clinical skills ;
Rifampin-induced acute renal failure: report of one case and review of literature
Authors: Xuesong Gao, Xueqin Zheng, null Abulimiti·Maitusong, Ruihong Zhang, Xuefei Duan
Journal: BMJ (2016)

A 61-year female patient with pulmonary tuberculosis and a history of rifampin administration was admitted on April 2014. After treatment with antibiotics and rifampin she presented acute renal failure (ARF) with anemia and thrombocytopenia. The patients received steroid treatment, made significant improvement and discharged. Literature searching showed that 21 cases with rifampin-induced ARF were reported in 5 years in China. Among 21 patients, 19 cases recovered after withdrawal of rifampin and proper treatment, 1 case progressed to chronic renal failure and 1 case died. We conclude that rifampin-induced ARF is not rare, especially in those rifampin re-exposure patients; and the clinical symptoms and renal function should be monitored closely when patients taking rifampin.


Key words: 
Rifampin; Acute kidney injury
Distress screening through PROMIS at an academic cancer center and network site: Implementation of a hybrid model.
Authors: Mohana Roy, Joel W. Neal, Kelly Bugos, Christopher Sharp, Patricia Falconer, Eben Lloyd Rosenthal, Douglas W. Blayney, Shiva Modaressi, Ashley Robinson, Kavitha Ramchandran
Journal: Journal of Clinical Oncology (2020)

2021 Background: The NCCN guidelines recommend routine distress screening of patients with cancer, but the implementation of such programs is inconsistent. Up to one in three such patients experience distress, however fewer than half of them are identified and referred for supportive services. Methods: We implemented a hybrid (electronic and paper) distress screening tool, using a modified version of the PROMIS-Global Health questionnaire. Patients received either an electronic or in-clinic paper questionnaire to assess overall health and distress at the Stanford Cancer Center and its associated integrated network site. Iterative changes were made including integration with the electronic health record (EHR) to trigger questionnaires for appointments every 60 days. A consensus “positive screen” threshold was defined, with data collected on responses and subsequent referrals placed to a supportive care services platform. Results: Between June 2015 and December 2017, 53,954 unique questionnaires representing 12,744 distinct patients were collected, with an average completion rate of 58%. Approximately 30% of the questionnaires were completed prior to the visit electronically through a patient portal. The number of patients meeting the positive screen threshold remained ~ 40% throughout this period. Following assessment by the clinical team, there were 3763 referrals to cancer supportive services. Among the six most common referral categories, those with a positive screen were more likely to have a referral placed (OR 6.4, 95% CI 5.8-6.9 p- &lt; 0.0001), with a sensitivity of 80% and a specificity of 61%. However, 89% of responses with a positive screen did not have a referral to supportive care services. Conclusions: The hybrid electronic and paper use of a commonly available patient reported outcome tool, as a high throughput distress screening tool, is feasible at a multi-site academic cancer center. Our positive screen rate for referrals was sensitive and consistent, but with a low positive predictive value. This screening also resulted in variable clinical response and overall increased clinical burden. Future directions for our group have included refining the threshold for a positive screen and implementation of a real-time response system, especially to address acute concerns.