tbuckley/cabot-search huggingface dataset:
Double-blind, placebo-controlled, randomized, phase 2 study to evaluate the efficacy and safety of maintenance therapy with anti-TA-MUC1 monoclonal antibody PankoMab after chemotherapy in patients with recurrent epithelial ovarian carcinoma.
Authors: Jonathan A. Ledermann, Ingo von Broen, Frank Zimmermann, Johannes Nippgen, Steffen Goletz
Journal: Journal of Clinical Oncology (2014)

TPS5622 Background: PankoMab is a potent humanized glyco-engineered IgG1 recognizing the tumor-specific carbohydrate/protein epitope TA-MUC1 expressed virtually only on tumor cells of a wide variety of cancers with up to 95% expression in ovarian (OvCa), NSCL and breast cancers. Phase 1 study results were presented at ECCO 2013 (C. Sessa et al., Abstract 849). Drug was well tolerated, clinical benefit (CB: CR, PR and SD) observed in pts. with solid tumors with CB rate of 40% incl. 1 CR of 485 d out of 20 pts. with OvCa. OvCa was selected as target indication for a randomized phase 2 maintenance therapy trial of PankoMab in TA-MUC1 positive pts. Methods: Study design: Randomized, placebo-controlled, double-blind Phase 2 multinational study at 40 sites in 8 European countries. Pts. with outcome of CR, PR or SD after most recent line of chemotherapy (CT) are randomized in a 2:1 ratio for treatment with either PankoMab or placebo. Treatment regimen: 500 mg starting dose followed by 1700 mg 7 d later, to be repeated q3w. Pt. stratification by: (i) Duration of treatment-free interval of the most recent platinum based CT preceding the CT to which the pt. has just responded, (ii) Type of response to CT the patient has just received, (iii) Number of prior lines of CT. Sample size: Total of210 assuming median PFS of 4 m. in placebo and 6 m. in PankoMab arm (HR 0.67; overall 1-sided significance level 0.05). Study endpoints: Primary: PFS using modified immune related RECIST v1.1 criteria; secondary: OS, tumor response, safety, QoL, correlation of efficacy/safety with TA-MUC1 IHC score, soluble TA-MUC1 levels, Fc□ receptor status, and PK. Main entry criteria: TA-MUC1 pos. tumor samples, recurrent epithelial OvCa; 2 – 4 lines of previous CT; CR, PR, or SD after most recent CT; ≤5 wk. interval between last CT dose and randomization.; treatment-free interval of ≤12 mo. before most recent CT; sensitive or resistant but not refractory to most recent platinum based CT; ECOG PS ≤1. Current status: All sites initiated, 36 pts. pre-screened, 6 pts. enrolled, results expected 2015. EudraCT: 2013-000931-28. Clinical trial information: NCT01899599.
Feasibility and preliminary results of A Lifestyle Intervention via Email (ALIVE) in minority breast cancer survivors.
Authors: Raheem Paxton, Richard Hajek, Patricia Newcomb, Wendell Taylor, Shine Chang, Kerry S. Courneya, Deborah Parra-Medina, Lovell Jones
Journal: Journal of Clinical Oncology (2017)

e12573 Background: Prior data have indicated that minority breast cancer survivors are receptive to participating in lifestyle interventions delivered via email or the Web. In this study, we examined the feasibility and preliminary results of A Lifestyle Intervention via Email (ALIVE) in a sample of racial and ethnic minority cancer survivors. Methods: Survivors (Mean age = 52, 83% African American) were recruited and randomized to either a 3-month physical activity or a dietary condition. Descriptive statistics and mixed-effects models were computed to examine the behavioral and evaluation outcomes. Results: Forty-four of 71 survivors who participated in the baseline assessment completed the study. Survivors in the physical activity condition compared to the diet condition made greater improvements in leisure time physical activity (+272 vs. +120 Metabolic equivalent minutes per week; P &lt; 0.01) and greater reductions in sedentary time (-304 vs. -59 minutes/week; P &lt; 0.01). No significant time-by-group interactions were observed for our diet variables; however, positive trends among survivors in fruit and vegetables (+0.7 cup servings/day, P &lt; 0.01) were observed in the dietary condition. Feasibility data from survivors indicated that most survivors would recommend ALIVE to other cancer survivors (97%), were satisfied with ALIVE (82%), and felt that ALIVE was effective (73%). Survivors expressed concerns about the automated calls and functionality of the ALIVE e-mails. Conclusions: ALIVE appears to be feasible for racial and ethnic minority cancer survivors and shows promising results for implementation in larger and ethnically diverse cohorts. Functionality changes are warranted to boost adherence rates. Clinical trial information: NCT02722850.
Effect of Angiotensin Converting Enzyme Inhibitors and Angiotensin Receptor Blockers on Kidney Function in Patients with Sickle Cell Disease
Authors: Jun Choi, Naina Singh, Jin Han, Michel Gowhari, Johara Hassan, Shivi Jain, Robert E Molokie, Victor R. Gordeuk, Santosh L. Saraf
Journal: Blood (2016)
Appropriateness, Health Care Reform, and the Surgeon
Authors: Joel S. Weissman, Rachel R. Kelz, Clara N. Lee
Journal: JAMA Surgery (2017)

Our website uses cookies to enhance your experience. By continuing to use our site, or clicking "Continue," you are agreeing to our Cookie Policy | Continue JAMA Surgery HomeNew OnlineCurrent IssueFor Authors Podcast Publications JAMA JAMA Network Open JAMA Cardiology JAMA Dermatology JAMA Health Forum JAMA Internal Medicine JAMA Neurology JAMA Oncology JAMA Ophthalmology JAMA Otolaryngology–Head & Neck Surgery JAMA Pediatrics JAMA Psychiatry JAMA Surgery Archives of Neurology & Psychiatry (1919-1959) JN Learning / CMESubscribeJobsInstitutions / LibrariansReprints & Permissions Terms of Use | Privacy Policy | Accessibility Statement 2023 American Medical Association. All Rights Reserved Search All JAMA JAMA Network Open JAMA Cardiology JAMA Dermatology JAMA Forum Archive JAMA Health Forum JAMA Internal Medicine JAMA Neurology JAMA Oncology JAMA Ophthalmology JAMA Otolaryngology–Head & Neck Surgery JAMA Pediatrics JAMA Psychiatry JAMA Surgery Archives of Neurology & Psychiatry Input Search Term Sign In Individual Sign In Sign inCreate an Account Access through your institution Sign In Purchase Options: Buy this article Rent this article Subscribe to the JAMA Surgery journal
BEAM or BeEAM High-Dose Chemotherapy Followed By ASCT: A Single Center Comparative Analysis of Toxicity
Authors: Vincent Ribrag, Khalil Saleh, Alina Danu, Serge Koscielny, Sylvain Pilorge, Cristina castilla-Lorente, David Ghez, Julien Lazarovici, Jean-Marie Michot, Valerie Lapierre, Kamelia Alexandrova, Julia Arfi-Rouche, Jean-Henri Bourhis
Journal: Blood (2016)
Screening for aortic aneurysm
Authors: S. Curtis
Journal: BMJ (2003)

Editor—Greenhalgh and Powell's editorial assesses the economic evaluation of the multicentre aneurysm screening study (MASS), but it masks with numbers a human tragedy at the core of the story: this is a screening study that killed people.1,2

The authors mention in passing a mortality of 6% among the 322 men who had surgery as a result of the invitation to screening. This figure represents 19 men, comparatively young at retirement age, who before receiving the invitation would have been living their lives unfettered by the knowledge that they had an aneurysm. Now they are dead.

Obviously some of these men might have died anyway from a sudden rupture, but a clear distinction needs to be made between dying naturally and at the instigation of doctors. It could be considered ethically acceptable if the study showed a convincing overall survival benefit in the screened population, but the all cause mortality at the end of the study was the same in both groups, 11%.2

Greenhalgh and Powell confidently announce that the data support a national screening programme. They do not. The National Screening Committee's criteria are not fulfilled, as there is no evidence from randomised controlled trials of overall survival benefit and no evidence that benefit outweighs the physical and psychological harm of screening.

The results of the MASS study are surprisingly similar to a recent study comparing watchful waiting with radical surgery for early prostate cancer.3 The group allocated to radical treatment had a halving of deaths related to prostate cancer, but overall no survival advantage was noted in comparison with the group who were watched.

Supporters of screening put a positive spin on these results,4 but the result justified the United Kingdom's decision not to roll out a national screening programme for prostate cancer. Likewise, the results of the MASS study do not justify screening for aortic aneurysm.
South American thieves are targeting European hospitals
Authors: Ned Stafford
Journal: BMJ (2017)

Thefts of endoscopy equipment from hospitals in Germany have risen sharply in recent weeks, with eight hospitals reporting thefts worth €2.4m (£2.1m; $2.7m) between 14 May and 7 June, a new report says.1

The thieves are thought to be affiliated with South American organised crime networks, says the Ecclesia Group, a European insurance broker headquartered in Germany that provides coverage for hospitals.

The group’s report said that hospitals in at least 11 other European countries have been victims of medical equipment thefts linked to South American crime rings, mainly based in Colombia.

Hospitals have been reporting thefts of equipment thefts to Ecclesia since 2014, and thefts have occurred in 11 of Germany’s 16 states, with total losses of nearly €16m. One case reported in the German press involved …
Traitement en urgence des occlusions tumorales recto-coliques gauches par prothèse métallique expansive. Une étude prospective multicentrique
Authors: P Bichard, E Germain, R Dumas, M Giovannini, JL Payen, D Sautereau, B Filoche, T Ponchon, D Coumaros, E Ben Soussan, F Mal, A Rolachon
Journal: Endoscopy (2006)

Le traitement chirurgical du cancer recto-colique en occlusion est associé à une morbidité et une mortalité élevées. Les prothèses coliques métalliques expansives (PCME) ont montré leur efficacité dans le traitement palliatif du cancer colique. Le but de ce travail prospectif multicentrique était d'évaluer l'efficacité des PCME placées par voie endoscopique pour le traitement en urgence des occlusions recto-coliques gauches néoplasiques.
Junk Food Ads Reach Children Despite Food Industry Self-regulation
Authors: Jennifer Abbasi
Journal: JAMA (2017)

Our website uses cookies to enhance your experience. By continuing to use our site, or clicking "Continue," you are agreeing to our Cookie Policy | Continue JAMA HomeNew OnlineCurrent IssueFor Authors Publications JAMA JAMA Network Open JAMA Cardiology JAMA Dermatology JAMA Health Forum JAMA Internal Medicine JAMA Neurology JAMA Oncology JAMA Ophthalmology JAMA Otolaryngology–Head & Neck Surgery JAMA Pediatrics JAMA Psychiatry JAMA Surgery Archives of Neurology & Psychiatry (1919-1959) Podcasts Clinical Reviews Editors' Summary Medical News Author Interviews More JN Learning / CMESubscribeJobsInstitutions / LibrariansReprints & Permissions Terms of Use | Privacy Policy | Accessibility Statement 2023 American Medical Association. All Rights Reserved Search All JAMA JAMA Network Open JAMA Cardiology JAMA Dermatology JAMA Forum Archive JAMA Health Forum JAMA Internal Medicine JAMA Neurology JAMA Oncology JAMA Ophthalmology JAMA Otolaryngology–Head & Neck Surgery JAMA Pediatrics JAMA Psychiatry JAMA Surgery Archives of Neurology & Psychiatry Input Search Term Sign In Individual Sign In Sign inCreate an Account Access through your institution Sign In Purchase Options: Buy this article Rent this article Subscribe to the JAMA journal
Flexible sigmoidoscopy in the randomized prostate, lung, colorectal, and ovarian (PLCO) cancer screening trial: Colorectal cancer survival by trial arm.
Authors: Maryam Doroudi, Paul F Pinsky
Journal: Journal of Clinical Oncology (2016)

1549 Background: Colorectal cancer (CRC) is the third most common cancer and the third leading cause of cancer deaths in the United States. The results of the randomized Prostate, Lung, Colorectal, and Ovarian (PLCO) Cancer Screening Trial conducted in the U.S. and the U.K. Once-Only randomized trial of flexible sigmoidoscopy (FSG) indicated that FSG screening is effective in reducing CRC incidence and mortality. However, it is not clear what fraction of the observed mortality reduction was actually due to early detection of CRC, as opposed to detection and removal of CRC precursors (adenomas). A mortality effect due to early detection per se should be revealed by a survival advantage for CRC cases in the screened versus control arm of PLCO. Methods: PLCO randomized 154,900 men and women to either an intervention (n = 77,445) or usual care (n = 77,455) arm. Eligible participants were 55 to 74 years of age at enrollment and had no history of trial cancers and no current treatment for cancer. Intervention arm individuals received screening for all gender-relevant PLCO cancers, including FSG for CRC at baseline and at 3 or 5 years. The median duration of the follow-up was 11.9 years with a maximum of duration of 13 years in each arm. CRC incidence and all-cause mortality data were obtained from participants’ medical records released to PLCO. CRC-specific survival was analyzed using Kaplan-Meier curves and proportional hazards modeling. Results: Kaplan-Meier curves demonstrated no significant difference in CRC-specific survival rates between arms (log-rank test, p = 0.12). In the intervention arm (n = 1008 cases), the 5 and 10 year CRC-specific survival rates were 76.1% and 70.1%, respectively, compared to corresponding usual care arm (n = 1291 cases) rates of 72.0% (5-year) and 66.6% (10-year). Within the intervention arm, interval cases (those diagnosed within 5 years after a negative screen) and those never receiving screening in PLCO had worse survival (HRs = 3.41 and 3.31, respectively) when compared to screen-detected cases. Conclusions: CRC-specific survival in PLCO was comparable across arms. This raises questions about the mortality benefit of early detection per se of CRC. Clinical trial information: NCT00002540.
Phase 1, open-label, dose-escalation and expansion study of ABT-165, a dual variable domain immunoglobulin (DVD-Ig) targeting both DLL4 and VEGF, in patients (pts) with advanced solid tumors.
Authors: Michael S. Gordon, John J. Nemunaitis, Ramesh K. Ramanathan, George W. Sledge, Lan Wang, Xiaolin Fan, Monica Motwani, Shekman Wong, Susan Morgan-Lappe, Suhasini Iyer, Louie Naumovski, John H. Strickler
Journal: Journal of Clinical Oncology (2016)

2507 Background: Targeting angiogenesis through vascular endothelial growth factor (VEGF) pathway has been a successful clinical strategy in multiple malignancies. Delta like ligand-4 (DLL4) is a NOTCH pathway ligand involved in angiogenesis and maintenance of tumor initiating cells (TICs). ABT-165 is a DVD-Ig that inhibits both VEGF and DLL4 thereby potentially suppressing both tumor angiogenesis and TICs. Methods: In a 3+3 dose-escalation (DE) design, ABT-165 was administered IV at doses ranging from 2.5 to 7.5 mg/kg once every 14 days (2 doses in 28-day cycle) (NCT01946074). After an amendment to address hypertension (HTN), at least 6 subjects per cohort were enrolled in subsequent DE cohorts starting at a dose of 1.25 mg/kg. Cohorts were preferentially enriched for ovarian cancer (OC) pts. Tumor and cardiac assessments were performed every 2 cycles. Results: As of January 6, 2016, 54 pts received at least one dose of ABT-165. The PK demonstrated target-mediated disposition with preliminary mean half-life ranging from 4.9 to 8.9 days. Biomarkers were consistent with engagement of both VEGF and DLL4 with NOTCH pathway modulation. No maximum tolerated dose was identified within the 28-day dose limiting toxicity (DLT) window; however, safety concerns beyond Cycle 1 precluded DE above 7.5 mg/kg. DLTs included grade 3 HTN and headache (HA). Treatment-related adverse events (AEs) occurring in ≥ 10% pts (including all dose levels and all grades) were: HTN (55.6%), HA (24.1%), fatigue (18.5%), diarrhea (14.8%) and nausea (11.1%). Other AEs of interest with respect to mechanism of action included proteinuria (9.3%), pulmonary HTN (7.4%), gastrointestinal perforation (GIP) (3.7%) and stroke (1.9%). 4/13 (30.8%) heavily pretreated OC pts had partial response, 1 of which (anti-VEGF naïve) was on treatment for 14 Cycles. Conclusions: ABT-165 displayed anti-VEGF-like toxicity including HTN and GIP. ABT-165 monotherapy has demonstrated anti-tumor activity in refractory OC. Long-term consequences of dual VEGF and DLL4 inhibition need to be evaluated. An ongoing phase Ib study will investigate combination of ABT-165 and chemotherapy. Clinical trial information: NCT01946074.
Complications of anticoagulant therapy in patients with brain metastases.
Authors: Joshua David Gruhl, Heidi Horstman, Lynette Smith, Apar Kishor Ganti, Nicole A. Shonka
Journal: Journal of Clinical Oncology (2016)

2078 Background: Anticoagulation has long been viewed as carrying excessive risk of intracranial hemorrhage (ICH) in patients with brain metastases. However the data evaluating the exact incidence of ICH in patients on anticoagulant therapy (ACT) are sparse. This study was conducted to determine the incidence of ICH associated with ACT in adult patients with brain metastases Methods: Consecutive patients with brain metastases occurring from 2006-2014 were identified from a single institution database. Patients were categorized as having no outpatient anticoagulant therapy versus having outpatient anticoagulation therapy of greater than 1 month. Chi-square tests and Fisher's exact test were used to compare rates of ICH by groups. Statistical analyses were carried out using SAS 9.3. Results: A total of 125 patients with brain metastases were analyzed. Of these, 64 had primary non-small cell lung cancer (51.2%), while the other primary sites included, breast (12%), melanoma and small cell lung cancer (7.2%) Overall, 12/125 (9.6%) patients had evidence of ICH. Neither the primary tumor site nor the number of brain metastases was associated with the development of ICH. Eight of 67 (11.94%) patients on outpatient ACT had evidence of ICH, compared with 4 of 58 (6.9%) patients not on ACT; however, this difference was not statistically significant (p = 0.33). In the subset of patients on enoxaparin, there was no difference in the incidence of ICH for daily versus twice daily dosing (p = 1.0). Those treated with stereotactic radiosurgery in addition to whole-brain radiotherapy (SRS+WBRT) were significantly more likely to experience ICH (p = 0.0014), however these were within the metastatic lesion and none of these events required any further intervention than ACT cessation. Conclusions: Treatment of metastases with SRS+WBRT was significantly correlated with ICH independent of ACT. Our finding that ACT does not significantly increase risk for ICH supports its use in these patients.
US medical groups denounce Senate health repeal bill
Authors: Michael McCarthy
Journal: BMJ (2017)

Most major US medical groups have denounced the Senate bill to “repeal and replace” the 2010 Affordable Care Act, which was released by the Senate Republican leadership late last week. The groups charge that the legislation would increase the number of people without insurance and force those with coverage to pay higher premiums and more out of their own pockets for skimpier plans.

The Republican bill, called the Better Care Reconciliation Act, rolls back or alters many of the provisions of Barack Obama’s 2010 act and includes a major restructuring of Medicaid, the joint state and federal health insurance plan for poor, disabled, and elderly people, which experts say …
Clinical implications of next-generation sequencing in the treatment of brain cancer at a large academic institution.
Authors: Veronica Mariotti, Miguel Gonzalez Velez, Ricardo Daniel Parrondo, Lori Ann Leslie
Journal: Journal of Clinical Oncology (2017)

e13521 Background: The use of next-generation sequencing (NGS) in clinical practice has increased the treatment (tx) options for cancer patients (pts). The expansion of genomic libraries used by NGS databases has resulted in increased identification of targetable genomic alterations (GAs). The aim of this study was to identify the clinical implications of genomic library expansion in the detection of GAs in pts with brain cancer at a large academic institution. Methods: We retrospectively analyzed 71 consecutive pts with brain cancer at the John Theurer Cancer Center that had NGS performed between 02/2014 and 09/2016. GAs were identified using the FoundationOne assay (Foundation Medicine, Cambridge, MA). GAs, number (n) of available genomic-directed tx and n of clinical trials were reviewed. The NGS assay interrogated 236 genes and introns of 19 genes until 09/2014, and subsequently was expanded to include 315 genes and introns of 28 genes. We compared median survival, n of GAs found, n of available trials, and n of tx available in pts who received NGS until 09/2014 (G1, n = 33) with pts who received NGS after 9/2014 (G2, n = 38). Results: Median survival was 30 months (range 19.9-40.1), median age was 62 years (range 26-82), the median n of GAs/sample was 5 (range 1-11). There was a significant positive correlation between n of GAs/sample and n of available trials and tx (r = .5, p = .00 and r = .3, p = .00, respectively). There was a negative correlation between survival and n of GAs (r = -.3, p = .02). G1 harbored 142 GAs with a median n of 4 GAs/sample (range 1-10), while G2 harbored 170 GAs with a median n of 5.5 GAs/sample (range 0-11). There was an absolute increase of 19.7% in GAs in G2 compared to G1. There was no difference in median overall survival. Conclusions: The expansion of genomic libraries increased the detection of GAs, and was positively correlated with the n of tx and clinical trials available for brain cancer pts. Survival was not affected by the expansion of the genomic library, but higher n of GAs was correlated with shorter survival. Expansions of NGS databases lead to increased n of potential tx options for brain cancer pts. Further studies are needed to investigate the impact of NGS targeted tx on survival.