tbuckley/cabot-search huggingface dataset:
On Deep Learning for Medical Image Analysis
Authors: Lawrence Carin, Michael J. Pencina
Journal: JAMA (2018)

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Survival outcomes for polish women younger than age 40 years receiving trastuzumab for HER2-positive early breast cancer: A National population-based observational study.
Authors: Beata Jagielska, Agnieszka Irena Jagiello-Gruszfeld, Konrad Talasiewicz, Andrzej Czubek, Maciej Jerzy Krzakowski
Journal: Journal of Clinical Oncology (2018)

e12659 Background: Outcomes for patients treated in clinical trials may not reflect the experience in routine clinical care. We aim to describe the real-world treatment patterns, disease-free survival (DFS) and overall survival (OS) for women younger than age 40 years receiving trastuzumab for early breast cancer (EBC) in Polish Therapeutic Programme 2008–2015. Methods: Retrospective, whole-of-population cohort study using demographic, dispensing, and medical services data for women in the Polish Therapeutic Program for HER2+MBC and were registered in the SMPT (System of Monitoring for Programme Therapy). Of 9058 breast cancer patients, 495 (5%) were younger than 40 years old. Results: Median of age was 36 years ( range: 28-40) Compared with older women, younger women were more likely to be diagnosed at later stages, had tumors that were more likely to be higher grade, larger size, estrogen receptor/progesterone receptor-negative, and lymph-node positive. In 57.58% of pts mastectomy was performed. Limphadenectomy was performed in 73.13% pts. 482 pts received adjuvant chemotherapy (taxans and anthracyclines 326 pts, anthracyclines -149, and only taxans 7 pts). The median number of Herceptin was 17. In 2.2% of patients cardiotoxicity was observed (all grade). In patients in below 40 yrs old OS values from 1 to 7 years of follow-up were 99.39%, 98.47%, 96.26%, 95.06%, 94.35%, 94.35%, 94.35% and DFS values were 95.96%, 76.81%, 67.57%, 64,80%,57.82%, 55.82%, 55.82% respectively. A significant correlation for DFS was found for age, time between diagnosis and treatment, and number of trastuzumab and chemotherapy administrations. Conclusions: These results confirmed factors that are important for overall survival, such as size of tumor, lymph node involvement and time between diagnosis and treatment start, number of trastuzumab and chemotherapy administrations. Outcomes for trastuzumab in this heterogeneous real world population were reassuringly comparable to those from clinical trials, however, in many studies, parameters for patients under 40 were not analyzed separately.
Comparison of reporting phase I trial results in ClinicalTrials.gov and matched publications.
Authors: Daniel Shepshelovich, Hadar Goldvaser, Lisa Wang, Albiruni Ryan Abdul Razak, Philippe L. Bedard
Journal: Journal of Clinical Oncology (2017)

6514 Background: The 2007 Food and Drug Administration (FDA) Amendments Act mandated reporting of results of clinical trials in ClinicalTrials.gov, a large public registry, within 12 months of completion. We compared results reported for phase I trials in ClinicalTrials.gov and matched primary publications. Methods: The ClinicalTrials.Gov database was searched for completed adult phase I cancer trials with reported results. Only trials with dose escalation of systemically administered medications were included. PubMed was searched for matching primary publications, defined as identical intervention, number of arms and enrolled subjects, published prior to November 1, 2016. Results reported in the primary publication were compared with the ClinicalTrials.gov database using a 28-point score (2 = complete agreement; 1 = partial agreement; 0 = no mention) for 14-items related to study design (4 items), outcome measures (4 items) and safety profile (6 items). The ClinicalTrials.gov database was used as the reference for results reporting. Linear regression was used to identify factors associated with incomplete reporting. Results: After a review of 583 trials in ClinicalTrials.gov, 163 matching primary publications were identified, comprising 95 (58%) phase I and 68 (42%) phase I/II trials. Publications reported outcomes that did not appear in ClinicalTrials.gov in 25% of trials. Outcomes were omitted or downgraded in publications in 39% of trials. The overall median reporting score was 23/28 (interquartile range 21-25). Items that were incompletely reported in publications were: inclusion criteria (29%), primary outcome definition (26%), secondary outcome definitions (53%), adverse events (71%), serious adverse events (80%) and dates of study start and database lock (91%). Phase I (p &lt; 0.001) and multicenter trials (p = 0.002) were associated with higher reporting scores than phase I/II and single center trials. Conclusions: Reported results in primary publications for early phase cancer trials are frequently inconsistent or incomplete compared with ClinicalTrials.gov entries. ClinicaTrials.gov may provide a more comprehensive overview of safety data from new cancer drug trials.
P05.80 Cognitive functioning in patients with non-functioning pituitary adenoma before and after endoscopic transsphenoidal resection: Individual and group results
Authors: E Butterbrod, K Gehring, E Voormolen, P Depauw, W Nieuwlaat, G Rutten, M Sitskoorn
Journal: Neuro-Oncology (2018)

Cognitive dysfunction in patients with non-functioning pituitary adenoma (NFPA) primarily pertains to memory and executive functioning. Current literature is comprised of studies employing dissimilar methodological approaches and there is little prospective research using standardized cognitive function measures before and after surgical tumor resection. This study investigated group and individual cognitive status and change over time. Forty-five patients underwent neuropsychological assessment one day before and 3 months after transsphenoidal surgery. A computerized neuropsychological test-battery (CNSVS) was used to measure cognitive functioning on 7 domains: Verbal Memory, Visual Memory, Processing Speed, Psychomotor Speed, Reaction Time, Complex Attention and Cognitive Flexibility. Analyses of cognitive status and change were conducted on group and individual level. Associations of preoperative performance with tumor expansion, categorized according to Wilson-Hardy and Knosp classifications, and hormonal deficiency were investigated in exploratory analyses. As a group, patients scored significantly lower than healthy controls on all domains except Visual memory before as well as three months after surgery. Fifty-six percent of patients showed impairment (z-score ≤ - 1.5) on at least one domain before surgery and 63% after surgery. Patients showed no significant change over time as a group, but we found almost equal proportions of patients showing reliable improvement, decline, and stable performance. Degree of suprasellar extension and cavernous sinus invasion did not show a significant relationship with pre-operative cognitive status. Hormonal deficiency was related to Verbal Memory performance. Over half of patients showed cognitive impairment before as well as after surgery and dysfunction involved processing and psychomotor speed domains in addition to memory and executive functioning. Differential patterns of reliable cognitive change over time in individual patients were masked in group-level analyses. Future studies with larger samples sizes should address predictors of peri-operative cognitive status and the varied post-surgical course.
Incidence patterns and survival of gallbladder cancer over four decades: Impact of age, ethnicity, socioeconomic status, and treatment modalities.
Authors: Hussain M. Naseri, Shiva Kumar Reddy Mukkamalla, Ahmed Mahmood, Ponnandai Sadasivan Somasundar, Vincent Anthony Armenio
Journal: Journal of Clinical Oncology (2016)

e15583 Background: Gallbladder cancer (GBC) is a rare tumor that often presents at an advanced stage and is associated with a poor prognosis. Little is known about the incidence patterns and factors that influence outcomes in GBC. Methods: GBC cases diagnosed between 1973 and 2012 were identified using Surveillance, Epidemiology and End Results (SEER) database and annual percent change (APC) in the incidence rates were calculated for the same time period. A retrospective cohort of 16547 GBC patients diagnosed from 1973 to 2008 was further analyzed using Chi-square test and Cox proportional hazards model. Results: While the overall incidence of GBC decreased over last four decades, a significant increase was observed among Blacks (Table). Subsets of population belonging to Hispanic origin and other ethnicities (including American Indians) had a significant decrease in GBC incidence. 5-year overall survival (OS) and disease specific survival (DSS) were 12.8% and 11.7%, respectively. Poor prognostic factors included age < 50 years (HR 1.115) and male gender (HR 1.082). Other multi-level variables with poor prognosis included lack of high school education, and higher grade and stage at diagnosis (p<0.0001). On the other hand, marital status, Hispanic ethnicity, higher income level and treatment were associated with better OS and DSS (p<0.005). Conclusions: Our analysis suggests an overall decrease in incidence of GBC with a significant decrease among Hispanics and American Indians, possibly due to increasing early cholecystectomy rates. However, the incidence rates of GBC seem to be increasing among Blacks. Furthermore, younger age at diagnosis was associated with poor outcomes. Additional studies are required to validate these findings and understand the molecular basis for this heterogeneity in outcomes. Year All patients Male Female ≤39 yrs 40- 64 yrs ≥65 yrs White Black Other Hispanic origin Non- Hispanic origin 1973-1991 -2* -2* -1.9* 0 -1.3* -2.3* -2.2* -0.5 -1.9* - - 1992-1999 -2.2* -0.6 -2.6* -1.7 -3.5 -1.3 -2.3* 3.7 -1.2 -3.8 -1.8 2000-2012 -0.1 0.4 -0.2 0.1 1.4* -0.3 0 2.4* -4 -2.1* 0.4 *APC is significant (p<0.05).
Prevalence of Parent-Reported Traumatic Brain Injury in Children and Associated Health Conditions
Authors: Juliet Haarbauer-Krupa, Akilah Heggs Lee, Rebecca H. Bitsko, Xinjian Zhang, Marcie-jo Kresnow-Sedacca
Journal: JAMA Pediatrics (2018)

Traumatic brain injury (TBI) in children results in a high number of emergency department visits and risk for long-term adverse effects.To estimate lifetime prevalence of TBI in a nationally representative sample of US children and describe the association between TBI and other childhood health conditions.Data were analyzed from the 2011-2012 National Survey of Children's Health, a cross-sectional telephone survey of US households with a response rate of 23%. Traumatic brain injury prevalence estimates were stratified by sociodemographic characteristics. The likelihood of reporting specific health conditions was compared between children with and without TBI. Age-adjusted prevalence estimates were computed for each state. Associations between TBI prevalence, insurance type, and parent rating of insurance adequacy were examined. Data analysis was conducted from February 1, 2016, through November 1, 2017.Lifetime estimate of TBI in children, associated childhood health conditions, and parent report of health insurance type and adequacy.The lifetime estimate of parent-reported TBI among children was 2.5% (95% CI, 2.3%-2.7%), representing over 1.8 million children nationally. Children with a lifetime history of TBI were more likely to have a variety of health conditions compared with those without a TBI history. Those with the highest prevalence included learning disorders (21.4%; 95% CI, 18.1%-25.2%); attention-deficit/hyperactivity disorder (20.5%; 95% CI, 17.4%-24.0%); speech/language problems (18.6%; 95% CI, 15.8%-21.7%); developmental delay (15.3%; 95% CI, 12.9%-18.1%); bone, joint, or muscle problems (14.2%; 95% CI, 11.6%-17.2%); and anxiety problems (13.2%; 95% CI, 11.0%-16.0%). States with a higher prevalence of childhood TBI were more likely to have a higher proportion of children with private health insurance and higher parent report of adequate insurance. Examples of states with higher prevalence of TBI and higher proportion of private insurance included Maine, Vermont, Pennsylvania, Washington, Montana, Wyoming North Dakota, South Dakota, and Colorado.A large number of US children have experienced a TBI during childhood. Higher TBI prevalence in states with greater levels of private insurance and insurance adequacy may suggest an underrecognition of TBI among children with less access to care. For more comprehensive monitoring, health care professionals should be aware of the increased risk of associated health conditions among children with TBI.
Clinical characteristics and treatment outcome in a large multicenter observational cohort of pdgfra exon 18 mutated gastrointestinal stromal tumor (GIST) patients.
Authors: Sheima Farag, Neeta Somaiah, Haesun Choi, Birthe Heeres, Wei-Lien Wang, Hester Van Boven, Petra M Nederlof, Robert S. Benjamin, Winette TA van der Graaf, Dirk J. Grunhagen, Pieter Boonstra, An K.L Reyners, Hans Gelderblom, Neeltje Steeghs
Journal: Journal of Clinical Oncology (2016)

11011 Background: PDGFRA D842V-mutated GISTs are known for their insensitivity to imatinib. However, in clinical practice responses have been observed in some patients. We describe the natural history and treatment outcomes in a large cohort of PDGFRA exon 18 mutated GIST patients treated in routine clinical care. Methods: A retrospective cohort study was performed in GIST patients harboring a PDGFRA exon 18 mutation. Primary outcome parameter was radiological response according to Choi's criteria as assessed by two independent radiologists (patient selection criteria: measurable disease, imatinib treatment, neo-adjuvant or palliative intent). Secondary outcome measure was pathologic response determined on the resection specimen (patient selection criteria: neo-adjuvant imatinib treatment, tumor resection). Results: Seventy-one patients with PDGFRA exon 18 mutation were identified. Of these patients, 48 patients (69%) had a PDGFRA D842V mutation. Twenty-two D842V-mutated GIST patients received imatinib treatment, of which 16 had measurable disease. According to Choi criteria, two out of 16 (12.5%) D842V-mutated GIST patients had partial response, 3 patients (18.8%) had stable disease and 9 patients (56.3%) had progressive disease as best response. Of the 23 patients with non-D842V mutations, 14 received imatinib treatment and 8 had measurable disease. Six out of 8 (75%) patients with non-D842V exon 18 mutations showed partial response and 2 (25%) had stable disease as best response. Median time to progression in D842V-mutated GIST patients was 8.0 months (range 0-42) compared to 24.5 months (range 3-132) in non-D842V mutated GIST patients. One patient with non-D842Vexon 18 mutation (I843_D846del) with PR by Choi criteria showed a good pathologic response defined as > 50% decrease in cellularity. Conclusions: Patients with PDGFRA D842V-mutated GIST do have a small chance of responding to imatinib treatment. Given the lack of alternative treatment options in, in our opinion, imatinib should not be universally denied in patients harboring this mutation.
Retrospective analysis of 115 unselected patients with mantle cell lymphoma: Single center experience.
Authors: Guldane Cengiz Seval, Bugu Bulat, Fulya Ozel, Onur Tasci, Isinsu Kuzu, Sinem Civriz Bozdag, Selami Kocak Toprak, Meltem Kurt Yuksel, Pervin Topcuoglu, Muhit Ozcan, Gunhan Gurman, Taner Demirer, Osman Ilhan, Hamdi Akan, Meral Beksac, Onder Arslan
Journal: Journal of Clinical Oncology (2018)

e19525 Background: The aim of this retrospective single-center study was to evaluate the clinical characteristics and response to treatment of mantle cell lymphoma (MCL), an uncommon subtype of B-cell malignancy previously considered to have a poor prognosis. Methods: This single center retrospective study included 263 adult patients diagnosed with MCL between December 2005 and March 2017. Outcome was determined as response to treatment, progression free survival (PFS) and overall survival (OS) by Kaplan-Meier analysis using SPSS (IBM SPSS Statistics 21; IBM Corp., Chicago, IL) statistical tool kit. We also compared the PFS and OS according to simplified MIPI (s-MIPI) index. Results: A total of 115 patients met the predetermined criteria for inclusion. There were 28 (24.3%) female and 87 (75.7%) male patients. The median age at diagnosis of MCL was 66 years (range, 31-89 years). The median time of follow-up was 23.3 months (range, 3-139.3 months). The median s-MIPI was 6 points (range 2-11). Most patients were in the high-risk group (61.2%). Induction chemotherapy was administered in 113/115 patients and remaining two patients have deceased after diagnosis. Altogether 97 out of 115 patients (84.3%) were treated with a combination of chemotherapy and anti-CD20 monoclonal antibody rituximab. One elderly patient received Rituximab immunotherapy only. The majority (56.5%) of the patients received CHOP with rituximab as induction chemotherapy. Forty-eight patients (41.7%) had bone marrow involvement and 21 (18.2%) had extra-nodal involvement. In total 24 patients (36.4%) achieved a complete remission (CR) with an overall response rate of 45.5% after the induction therapy. During follow up 45 relapses and 20 deaths were noted. Infection was the most common cause of death (50%). According to the long-rank test, estimated 5-year OS was not significantly different between intermediate-risk and high-risk s-MIPI categories (72.4%±1.2% vs 72.6%±0.7%; p=0,202). Estimated 5-year PFS was significantly different between intermediate-risk and high-risk s-MIPI cohorts (47.1%±1.3% vs 30.2%±0.9%; p=0,033). No patient died or progressed in the low-risk group. Conclusions: In conclusion, we have confirmed the validity of the simplified MIPI for the prognosis of patients with MCL.
Platelet count and transfusion dependence as prognostic factors of engraftment in autologous stem cell transplantation.
Authors: Forat Lutfi, William Paul Skelton, Yu Wang, Emma Rosenau, Hemant S. Murthy, Randy Brown, John R. Wingard, Maxim Norkin
Journal: Journal of Clinical Oncology (2018)

e20001 Background: Delayed engraftment (DE) is a well-described complication after allogeneic transplant, however the incidence and risk factors of DE in recipients of autologous stem cell transplant (ASCT) is not well studied. Methods: 1162 patients (pts) receiving ASCT at the University of Florida (UF) from 1996 to 2016 were retrospectively reviewed for DE, defined as platelet count ≤50,000 μl, hemoglobin ≤8 g/dL, or ANC ≤1000 mm3. Patients with prior ASCT or those lost to follow up were excluded. This study was approved by the UF IRB. Results: Of 1162 pts analyzed, 239 (20.6%) were found to have DE at 1 month after ASCT. These 239 pts were analyzed at 3, 6, and 12 month intervals with 107/239 (44.8%) engrafting by 3 months. For patients with DE, there was a statistically significant difference in pre-transplant platelet level (p < 0.0001), transfusion dependence (p = 0.0004), and CD34+ cell count (p = 0.0057). Pts were then subdivided into those with pre-transplant platelets ≥ 150,000/µl and those < 150,000/µl, and CD34+ cell count ≥3x106/kg and those < 3 x106/kg. Multivariate analysis showed that CD34+ cell count ≥3x106/kg, transfusion dependence, and platelets ≥150,000/µl were statistically significant predictors of DE (Table 1). Conclusions: DE is a frequent complication after ASCT, which often persists for > 3 months following ASCT. Pts with pre-transplant platelets ≥150,000/µl were 3 times less likely to have DE at 3 months compared to all others, and those who were transfusion dependent were significantly more likely to have DE at 3 months compared to all others (OR = 0.29). Based on this analysis, if CD34+ cell dose is ≥3x106/kg (as 85% of pts were), pre-transplant platelets and transfusion dependence may be used as an early predictive model to identify patients at risk for DE. Table 1. Multivariate analysis variable OR: 95% CI: P-value: CD34+ (≥3 vs < 3 x106/kg) 5.411 (1.907, 15.357) 0.0015 Pre-transplant Platelet Count (≥150 vs < 150 x103/µl): 3.114 (1.455, 6.663) 0.0034 Transfusion dependence (Yes vs No): 0.250 (0.093, 0.672) 0.0060
Supersaturated polymeric micelles for oral silybin delivery: the role of the Soluplus–PVPVA complex
Authors: Chunliu Zhu, Shuang Gong, Jinsong Ding, Miaorong Yu, Ejaj Ahmad, Yi Feng, Yong Gan
Journal: Acta Pharmaceutica Sinica B (2018)

Increasing the degree of supersaturation of drugs and maintaining their proper stability are very important in improving the oral bioavailability of poorly soluble drugs by a supersaturated drug delivery system (SDDS). In this study, we reported a complex system of Soluplus-Copovidone (Soluplus-PVPVA) loaded with the model drug silybin (SLB) that could not only maintain the stability of a supersaturated solution but also effectively promote oral absorption. The antiprecipitation effect of the polymers on SLB was observed using the solvent-shift method. In addition, the effects of the polymers on absorption were detected by cellular uptake and transport experiments. The mechanisms by which the Soluplus-PVPVA complex promotes oral absorption were explored by dynamic light scattering, transmission electron microscopy, fluorescence spectra and isothermal titration calorimetry analyses. Furthermore, a pharmacokinetic study in rats was used to demonstrate the advantages of the Soluplus-PVPVA complex. The results showed that Soluplus and PVPVA spontaneously formed complexes in aqueous solution via the adsorption of PVPVA on the hydrophilic-hydrophobic interface of the Soluplus micelle, and the Soluplus-PVPVA complex significantly increased the absorption of SLB. In conclusion, the Soluplus-PVPVA complex is a potential SDDS for improving the bioavailability of hydrophobic drugs.