tbuckley/cabot-search huggingface dataset:
Ethnic/racial and socioeconomic disparities as predictors of behavioral risk factors among 7559 cancer survivors.
Authors: Matthew Asare, Karen Michelle Mustian, Ian Kleckner, Luke Joseph Peppone, Allison Magnuson, Mohamedtaki Abdulaziz Tejani, Charles E. Heckler, Charles Stewart Kamen
Journal: Journal of Clinical Oncology (2016)

6550 Background: Health behaviors such as exercising, attending regular medical checkups, and reducing tobacco and alcohol use can improve health outcomes among cancer survivors. Race and socioeconomic disparities may affect cancer survivors’ efforts to engage in healthy behaviors after they have completed treatments. We used the 2014 Behavioral Risk Factor Surveillance System (BRFSS) dataset to evaluate the relationships between race, socioeconomic factors, and health behaviors among cancer survivors. Methods: 7559 cancer survivors provided post-treatment data on current clinical status, race (white n = 7313 and black n = 246), socioeconomic status (SES), (education, insurance, employment, income), and health behaviors (Yes/No for exercising, smoking, binge drinking, completing routine medical checkups). Descriptive statistics and logistic regressions were used to examine the associations between race, SES, and health behaviors among black and white cancer survivors. Results: Compared with white cancer survivors, black cancer survivors were less likely to engage in exercise (OR = 0.59; 95% CI, 0.45 – 0.76, p < 0.001) and binge drinking (OR = 0.52; 95% CI, 0.28 – 0.99, p < 0.001). Black survivors were also more likely to be current smokers (OR = 1.73; 95% CI, 1.23 – 2.44; p < 0.01) and to attend regular medical checkups (OR = 1.51; 95% CI, 1.04 – 2.20; p < 0.05). After controlling for SES, black cancer survivors remained less likely to exercise (ORAdj = 0.60; 95% CI, 0.42 – 0.87; p < 0.001) and more likely to attend routine checkups (ORAdj = 2.44; 95% CI, 1.33 – 4.46; p < 0.001). Black cancer survivors with no health insurance were more likely to be current smokers (OR = 2.25; 95% CI, 1.49 – 2.40; p < 0.001) and less likely to attend routine checkups (OR = 0.62; 95% CI, 0.41 – 0.92; p < 0.001). Conclusions: These findings highlight the unique importance of race in determining cancer survivors’ health behaviors. Even though SES accounts for some of the racial disparities in cancer survivors’ behaviors, race remains a significant predictor after adjusting for socioeconomic factors. Clinicians using interventions to enhance cancer survivors’ healthy behaviors should consider both race and socioeconomic factors.
Academic and Community Cancer Research United (ACCRU) RU011301I: Adjuvant ado-trastuzumab emtansine (T-DM1) for older patients with human epidermal growth factor receptor 2 (HER2)-positive breast cancer.
Authors: Rachel A. Freedman, Mei-Yin Polley, Amylou C. Dueck, Arti Hurria, Hyman B. Muss, Kathryn Jean Ruddy, Joleen Marie Hubbard, Heshan Liu, Lauren J. Rogak, Ethan M. Basch, Shaker R. Dakhil, Jason D. Huff, Madhuri Bajaj, Mary Wilkinson, Tareq Al Baghadadi, Sam Benjamin, Rex B Mowat, Clifford A. Hudis, Hope S. Rugo, Eric P. Winer
Journal: Journal of Clinical Oncology (2016)

TPS629 Background: Receipt of adjuvant chemotherapy + trastuzumab is particularly important for pts with HER2+ breast cancers because of the significantly improved outcomes that trastuzumab-based chemotherapy regimens provide. However, many older pts do not receive HER2-directed therapy. T-DM1 has a favorable toxicity profile and proven efficacy in advanced disease, and is a promising therapy option for treating older pts. Methods: In this phase II, single-arm, multicenter, open-label protocol at 15 U.S. ACCRU centers, we will administer adjuvant T-DM1 to pts aged ≥ 65. T-DM1 will be administered at 3.6 mg/kg IV every 21 days for one year. Longitudinal geriatric assessments (GA), biomarkers of aging, and patient-reported outcomes (PRO-CTCAE) will be collected. Specific Aims: The primary endpoint is 5-year invasive disease-free survival (IDFS). Secondary endpoints include overall survival, toxicity, and site of first recurrence. Correlative endpoints include associations of toxicity and clinical endpoints with GAs, biomarkers of aging, and PROs. Eligibility: The main study inclusion criteria are the following: age ≥ 65, HER2+, stage I-III breast cancer [(a) node-positive OR (b) T2N0 tumor if ER/PR-positive, OR (c) T1cN0 tumor if ER/PR-negative], status post-surgical excision, life expectancy > 5 yrs, ejection fraction ≥ 50%, and provider/patient preference to avoid standard chemotherapy-trastuzumab. Statistical Methods: The primary efficacy analysis will be 5-year IDFS. In addition, the 5-year IDFS experience will be summarized with a Kaplan-Meier estimate and corresponding 90% confidence interval. A secondary efficacy analysis will use the log-rank test to compare the IDFS experience of this trial population to a similar population in a historical control cohort who received adjuvant chemotherapy + trastuzumab (Perez, et. al JCO). Additional goals are to characterize toxicity and assess the feasibility and clinical impact of PRO-CTCAE collection in older pts receiving T-DM1. Accrual: Accruing; goal N = 200 Contact information: Rachel Freedman, MD, MPH (rafreedman@partners.org) Clinical trial information: NCT02414646.
Diagnostic usefulness of skin tests in IgE-mediated allergy to clavulanic acid
Authors: A. Ariza, F. Pineda, C. Mayorga, V. Garcia-Lopez, G. Davila, A. R. Alcorta, J. J. Laguna, N. Cabanes, N. Blanca, G. Canto, C. Senent, P. S. Skov, R. Palacios, M. Blanca, M. J. Torres
Journal: Allergy (2014)
Impact of features of brain lesion in prognosis.
Authors: Carlos Castaneda Altamirano, Miluska Castillo Garcia, Carolina Belmar Lopez, Luis A. Bernabe, Joselyn Sanchez, Renato Galvez, Enrique Orrego, Pamela Garcia- Corrochano
Journal: Journal of Clinical Oncology (2017)

e13549 Background: Brain metastasis (BM) is an event with poor prognosis. Different scores predict outcome in patients with BM. One of them is Graded Prognostic Assessment (GPA) score and includes clinical features like age and performance status of the patients. The frequency of patients with available tissue from brain lesions is increasing because of improvement of surgical techniques. It allows to include the evaluation of pathological features in order to improve prognosis determination. Our study aims to evaluate if tumoral proliferation and lymphocyte infiltration in brain lesions can improve prognostic accuracy of clinic-pathological features in patients with BM. Methods: We obtained BM samples from 113 cases that came to the Instituto Nacional de Enfermedades Neoplasicas from 2001 to 2015. We evaluated clinicopathological features from patient files and prospectively evaluated pathological features: Ki67 and lymphocytes in 64 BM lesions from slides scanned in a BX63-Olympus. The image analysis software use for calculating KI67 index and CD3 was Tissuemorph, with a median count of 5135 cells and 5391 cells, respectively. We calculated GPA score and evaluated the value to add pathological features of BM. We also evaluated distribution of mononuclear cells. Results: Median age at first diagnosis of BM was 52 years (range 11–75 years), 35.4% were male. BM at debut and extra-brain disease was found in 33.6% and 39.3%. The most frequent primary tumor location was breast (31%) and lung (18.6%). Most frequent procedure for brain lesion was biopsy (9.8%), subtotal resection (8.9%) and total resection (81.3%). Distribution of lymphocytes was perivascular in 57 cases. Median ki67 and CD3 TIL were 30 and 44, respectively. GPA 0-1, 1.5-2.5, 3 and 3.5-4 were found in 18 (16.2%), 61 (55.0%), 27 (24.3%) and 5(4.5%), respectively. Higher GPA (p = 0.196) had a trend to shorter survival. Higher ki67≥ 15% (p = 0.013) index was associated with shorter survival. The CD3 lymphocytes count was not associated with survival (p = 0.754). Adding ki67 index to GPA was associated with better outcome (p = 0.033). Conclusions: Our results find that patients with high ki67 index in brain lesions carry a worse prognosis and adding this information to GPA score can improve prognostic accuracy of the tool.
THU0118 What is the role of steroids in inducing diabetes mellitus in patients with rheumatoid arthritis? an observational cohort study
Authors: A Emamifar, R Hviid Larsen, R Asmussen Andreasen, IM Jensen Hansen
Journal: Annals of the Rheumatic Diseases (2017)

<h3>Background</h3> Patients with Rheumatoid Arthritis (RA) are at increased risk of Diabetes Mellitus (DM) probably due to immune system activation or RA treatment with steroids.[1] However the pathology of DM in RA is not fully understood. <h3>Objectives</h3> To define the prevalence of DM in our RA patients population. Furthermore, to clarify the role of steroid treatment to induce DM in the RA patients. <h3>Methods</h3> All patients with diagnosis of RA who were registered in Danish Danbio Registry at time of study, Nov 2016, were included. To find the concurrent DM, patients9 medical records including past medical history and lab tests (Hemoglobin A1c and Blood Sugar) were reviewed. In addition, year of DM as well as RA diagnoses were extracted from Fyns Diabetes Database and Danbio respectively to the extent that data were available. Patients9 drug histories were searched for information about steroid treatment if diagnosis of RA was made prior to diagnosis of DM. <h3>Results</h3> Of 1035 patients with diagnosis of RA, 104 (10%) patients had DM. Of 104 RA patients with DM, data regarding the year of diagnosis for both RA and DM was found in 55 patients which of them 15 patients were diagnosed with RA before DM, one patient was diagnosed with both DM and RA at the same year and 39 patients were diagnosed with RA after DM. However, only one patient, of those who were firstly diagnosed with RA, was prescribed prednisolone during the time period between diagnoses of RA and thereafter DM. Of 15 patients with prior diagnosis of RA to DM, 13 patients were diagnosed according to 1987 classification criteria (Old) for RA and 2 patients were diagnosed according to 2010 classification criteria (New). Out of 39 patients where DM was diagnosed before RA, 10 patients was diagnosed based on the old criteria and 29 patients was diagnosed based on the new RA criteria [Fig 1A and 1B]. Patients with firstly diagnosed DM were more often diagnosed according to the new RA criteria and, on the contrary, patients with latterly diagnosed DM were more often diagnosed with old RA criteria (p&lt;0.001). <h3>Conclusions</h3> The prevalence of DM in this RA population (10%) was about twice of Danish population (5.7%). The role of steroid treatment in which to what extent increases the risk of DM is not clear, however in this study it was negligible, why we propose that the pathology of DM in RA patients most importantly deals with the role of immune system activation namely Tumor Necrosis Factor alpha and not the treatment modality i.e. steroids. <h3>References</h3> Jiang P, Li H, Li X. Diabetes mellitus risk factors in rheumatoid arthritis: a systematic review and meta-analysis. Clin Exp Rheumatol 2015;33:115–21. <h3>Acknowledgements</h3> We thank Mrs. Maryam Mousavi for her contribution to data collection. <h3>Disclosure of Interest</h3> None declared
Long-Term Survival and Absence of Late Relapses in Patients Who Underwent Allogeneic Stem Cell Transplantation for Advanced Cutaneous T-Cell Lymphoma
Authors: Lori A Leslie, Lori A. Leslie, Tatyana A Feldman, Alan P Skarbnik, David H. Vesole, Scott D. Rowley, Andrew L. Pecora, Andre Goy, Michele L. Donato
Journal: Blood (2016)
Mobilized Peripheral Blood Stem Cells Versus Unstimulated Bone Marrow As a Graft Source for T-Cell–Replete Haploidentical Donor Transplantation Using Post-Transplant Cyclophosphamide
Authors: Asad Bashey, Mei-Jie Zhang, Shannon R. McCurdy, Andrew St. Martin, Trevor Argall, Claudio Anasetti, Stefan O. Ciurea, Omotayo Fasan, Sameh Gaballa, Mehdi Hamadani, Pashna Munshi, Monzr M. Al Malki, Ryotaro Nakamura, Paul V. O’Donnell, Miguel-Angel Perales, Kavita Raj, Rizwan Romee, Scott Rowley, Vanderson Rocha, Rachel B. Salit, Melhem Solh, Robert J. Soiffer, Ephraim Joseph Fuchs, Mary Eapen
Journal: Journal of Clinical Oncology (2017)

Purpose T-cell-replete HLA-haploidentical donor hematopoietic transplantation using post-transplant cyclophosphamide was originally described using bone marrow (BM). With increasing use of mobilized peripheral blood (PB), we compared transplant outcomes after PB and BM transplants. Patients and Methods A total of 681 patients with hematologic malignancy who underwent transplantation in the United States between 2009 and 2014 received BM (n = 481) or PB (n = 190) grafts. Cox regression models were built to examine differences in transplant outcomes by graft type, adjusting for patient, disease, and transplant characteristics. Results Hematopoietic recovery was similar after transplantation of BM and PB (28-day neutrophil recovery, 88% v 93%, P = .07; 100-day platelet recovery, 88% v 85%, P = .33). Risks of grade 2 to 4 acute (hazard ratio [HR], 0.45; P < .001) and chronic (HR, 0.35; P < .001) graft-versus-host disease were lower with transplantation of BM compared with PB. There were no significant differences in overall survival by graft type (HR, 0.99; P = .98), with rates of 54% and 57% at 2 years after transplantation of BM and PB, respectively. There were no differences in nonrelapse mortality risks (HR, 0.92; P = .74) but relapse risks were higher after transplantation of BM (HR, 1.49; P = .009). Additional exploration confirmed that the higher relapse risks after transplantation of BM were limited to patients with leukemia (HR, 1.73; P = .002) and not lymphoma (HR, 0.87; P = .64). Conclusion PB and BM grafts are suitable for haploidentical transplantation with the post-transplant cyclophosphamide approach but with differing patterns of treatment failure. Although, to our knowledge, this is the most comprehensive comparison, these findings must be validated in a randomized prospective comparison with adequate follow-up.
Efficacy and safety of crizotinib in patients (pts) with advanced <i>MET</i> exon 14-altered non-small cell lung cancer (NSCLC).
Authors: Alexander E. Drilon, D. Ross Camidge, Sai-Hong Ignatius Ou, Jeffrey William Clark, Mark A. Socinski, Jared Weiss, Gregory J. Riely, Maria Winter, Sherry C. Wang, Katherine Monti, Keith D. Wilner, Paul K. Paik
Journal: Journal of Clinical Oncology (2016)

108 Background: MET alterations leading to exon 14 skipping occur in ~4% of lung carcinomas, resulting in MET activation and sensitivity to MET inhibitors in vitro. Crizotinib, initially developed as a MET inhibitor, is currently approved for the treatment of ALK-positive NSCLC. We present crizotinib antitumor activity and safety data in pts with advanced MET exon 14-altered NSCLC. Methods: Pts with MET exon 14-altered NSCLC were enrolled into an expansion cohort of the ongoing phase I PROFILE 1001 study (NCT00585195) and received crizotinib at a starting dose of 250 mg BID. Responses were assessed using RECIST v1.0. Results: As of the data cut-off of Oct 30, 2015, 18 pts with MET exon 14-altered NSCLC had enrolled and 17 received treatment (15 response-evaluable, 2 not yet evaluable). Two pts discontinued treatment (1 due to an AE, 1 preferred another treatment formulation). Median age was 68 y (range 59−87). Tumor histology was as follows: 71% adenocarcinoma, 18% sarcomatoid adenocarcinoma, 6% adenosquamous carcinoma, and 6% squamous cell carcinoma. 65% were former and 35% never-smokers. Duration of treatment ranged from 0.5 to 9.1+ mo, with 88% of pts (15/17) still ongoing. Evidence of antitumor activity per RECIST was documented in 10/15 pts: 5 with confirmed PRs (all seen at the first scheduled tumor assessment at 8 wk ± 1 wk) and 5 with unconfirmed PRs (3 pts remained evaluable). Median PFS could not be calculated, with no deaths or PD by the data cut-off. Treatment-related AEs (TRAEs) were reported in 82% of pts; the most common were edema (35%) nausea (35%), vision disorder (29%), bradycardia (24%), and vomiting (24%). Most TRAEs were grade 1/2 in severity. One grade 3 TRAE (edema) and no grade 4/5 TRAEs were reported. Accrual of pts with MET exon 14-altered NSCLC continues. Updated data with a cut-off of Feb 2016 will be presented. Conclusions: Crizotinib has antitumor activity in pts with MET exon 14-altered NSCLC. The drug has a generally tolerable AE profile, consistent with that previously reported for pts with ALK-positive or ROS1-rearranged NSCLC. Further study of crizotinib in this pt population is warranted. Clinical trial information: NCT00585195.
Breast cancer mortality and mammography screening in Europe, the United States of America, Canada, and Australia.
Authors: Cécile Pizot, Mathieu Boniol, Peter Boyle, Philippe Autier
Journal: Journal of Clinical Oncology (2016)

1576 Background: Since the 1990s, important changes in the detection and management of breast cancer have taken place and subsequent declines in mortality are observed in most high income countries. Breast cancer mortality trends were analysed from 1989 to 2012 in 31 European countries and in the United States of America (USA), Canada and Australia to investigate the role of of screening on the observed declines. Methods: Age-standardised breast cancer mortality rates were calculated using data in the WHO database. Percent changes in mortality trends were assessed over the period 1989-2012. Data on mammography screening were available in the literature and countries were classified according to screening implementation: early, delayed, late and uncommon screening. Results: From 1989 to 2012, mortality reductions of 20% or more were observed in twenty-five countries overall. Mortality reductions in countries that implemented nationwide screening in the late 1980s with high participation rates (early screening) were similar or lower than in countries where nationwide screening was implemented 12-15 years later (delayed screening) or where participation in 2005 was still low (late screening). With similar mortality rates in 1987-89, lower mortality reductions were observed in Finland (-19.4%) and Sweden (-26.6%), where national screening programmes were launched in the late 1980s, than in Portugal (-26.8%), Spain (-34.4%) or Norway (-38.7%) where screening was introduced 12-15 years later and more progressively. Similar reductions were observed in the Netherlands (-36.3%), where early screening was implemented, and in Denmark (-34.9%) or Ireland (-34.9%) with late screening. Moreover, mammography screening was mainly implemented in women aged 50-69 years but the largest decline in mortality was observed in women less than 50 in the 31 European countries and in the USA, Canada and Australia. Conclusions: Downward trends in breast cancer mortality prevail in most European countries and in the USA, Canada and Australia. Differences in mortality reductions between countries seem to be less influenced by screening programs and may have more to do with advances in breast cancer management.
Indemnity provider calls for urgent reform of negligence payouts
Authors: Clare Dyer
Journal: BMJ (2017)

The spiralling cost of clinical negligence claims in England will become unsustainable unless the government reforms the system as a matter of urgency, a leading doctors’ indemnity organisation has argued at the launch of a new campaign.1

The Medical Protection Society (MPS) points to statistics showing that the NHS in England will be paying out £2.6bn (€3bn; $3.3bn) a year by 2022 if spending continues to rise at the rate it has done over the past five years. Over that period payouts went up by 72%, and current annual spending equates to the cost of training 6500 new doctors.2

But the spending spiral has been accelerated by a new rule that came into effect in …
Changes in numbers of randomized (RCT) versus non-randomized (NRCT) clinical trials from 2004-2016: Evidence of shifting cancer drug development pathway.
Authors: Laura Vidal Boixader, Kelly Kevelin Curtis, Jim Wahl, Nicholas Kenny, Keren Rachel Moss
Journal: Journal of Clinical Oncology (2017)

2543 Background: Trials using randomized designs have been conducted for decades to demonstrate efficacy of novel anti-cancer drugs (NACD). Recently, several NACD have shown high antitumor activity in early phase studies, prompting suggestions that NRCT could expedite drug development. We sought to determine what changes have occurred in numbers of NACD RCT vs NRCT conducted from 2004-2016. Methods: We reviewed a database of NACD clinical trials conducted by INC (excluding phase I and I/II trials) and classified them by RCT vs NRCT, grouped by year (≤ 2010 or &gt; 2010). We queried Citeline Trialtrove database for industry sponsored, phase 2 trials (P2T) initiated from 2006-2016 and examined numbers of RCT vs NRCT by year.A more detailed analysis of non-small cell lung cancer (NSCLC) clinical trials based on drug type category - Immunooncology (IO) vs. all other mechanims of action (NIO) was performed. Results: 190 INC-conducted trials were reviewed. 58 trials (31%) were performed ≤ 2010 and 132 trials (69%) &gt; 2010. Over this period, NRCT (n = 107, 56%) outnumbered RCT (n = 83, 44%). Whereas RCT outnumbered NRCT from 2004-2010 (74% vs 52%), after 2010, NRCT outnumbered RCT (58% vs 42%). Citeline Trialtrove search revealed 4776 industry sponsored P2T initiated from 2006-2016. The total number of P2T started annually was highest in 2007 (n = 621), decreasing to a low of 375 in 2016. The proportion of phase 2 RCT demonstrated an increase from 27% (n = 166) in 2006 to a peak plateau of 37-39% from 2011-2014, followed by a drop to 33% in 2015 and 29% in 2016. Among IO studies, RCT declined in 2015-6 vs. previous years, and a decreased for all NACD in 2016 vs. previous years also was noted. For studies in NSCLC, declines in RCT were evident from 2015-6 vs. previous years ( 45% in 2007-14 vs. 25% in 2015-6). Conclusions: Our data indicate a trend toward fewer trials of NACD using randomized designs and more studies using non-randomized designs, with overall fewer P2T initiated in the past year. This change reflects shifts in NACD development pathways, related to a better understanding of cancer biology, drive to develop personalized treatment and a more flexible regulatory drug approval process.