tbuckley/cabot-search huggingface dataset:
A phase II of everolimus and octreotide for patients with refractory and documented progressive meningioma (CEVOREM).
Authors: Thomas Graillon, Marc Sanson, Matthieu Peyre, Hadrien Peyrière, Didier Autran, Michel Kalamarides, Pierre-Hugues Roche, Stephane Fuentes, Emeline Tabouret, Maryline Barrie, Chantal Campello, Ahmed Idbaih, Henry Dufour, Olivier L. Chinot
Journal: Journal of Clinical Oncology (2017)

2011 Background: After iterative surgeries and radiotherapy (RT)/radiosurgery (RS) failure, aggressive meningiomas remain an unmet medical need. We have shown in vitro that everolimus (EVE) combined to octreotide (OCT) is active in meningiomas. Methods: Prospective multicentric single arm phase II study (NCT02333565) including pts with recurrent meningioma with documented progression ( &gt; 10% increase of tumor surface over 6 months) after surgery and RT/RS. EVE was orally administrated at 10mg/day and OCT by IM injection 30 mg/28 days. MRI was performed every 3 months with planned central review of imaging including volumetric progression at inclusion and during treatment. The primary endpoint was PFS6. The criteria for success was defined as a PFS6 &gt; 40%. Results: 20 pts were included, aged 30-75 years (median 55) with 37 progressive intra cranial meningiomas (WHO: 2 grade I, 27 grade II, 8 grade III) including 4 NF2 pts. Median KPS was 70%. All pts previously underwent at least one surgery and more than 1 in 18/20 patients. 19/20 pts were treated with radiotherapy or radiosurgery and 5 pts with prior chemotherapy. 1 pt was not evaluable at 3 months. With a median f/u of 12.3 months (2-24 months), PFS6 was 58.2% (95% CI 33.5-76.5%) and PFS12 was 38% (95% CI 16-60%). Volumetric analysis at 3 months demonstrated a decrease in tumor volume superior to 10% in 8 tumors (4 pts). Pre therapeutic growth rate was decreased of more than 50% in 29/35 tumors (18/20 pts) during the first 3 months. Inclusion (I)-to-3 months tumor growth rate (mean at 1.9%/month) was significantly lower than pre inclusion (Pre-I)-to-I growth rate (mean at 18.5%/month) (p = 0.0003). 3 highly aggressive tumors (3 pts) were separately assessed: Pre-I-to-I growth rate superior to 1000%/month was decreased to 3%, 15% and 44%/month in the first 3 months. Toxicity included 7 grade III AE (stomatitis, 3; pneumopathy, 1). AE of special interest included stomatitis (10, 50%), rash (8, 40%), abdominal pain and diarrhea (11, 55%) and nausea and vomiting (4, 20%). Conclusions: Everolimus and octreotide combination appears active in refractory aggressive and progressive meningiomas with acceptable and manageable toxicity and should request further evaluation. Clinical trial information: NCT02333565.
Pagers and Beyond in an Era of Microcommunications—What Is Old Is New Again
Authors: Kenneth D. Mandl, Elaine Khoong
Journal: JAMA Internal Medicine (2017)

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A Pediatric Case of Well-Functioning Supernumerary Kidney
Authors: Milena Pizzoferro, Cristina Lo Zupone, Mario De Gennaro, Maria Felicia Villani, Maria Carmen Garganese
Journal: Clinical Nuclear Medicine (2017)

We present an interesting image of a well-functioning supernumerary kidney evaluated with DMSA (dimercaptosuccinic acid) renal scintigraphy in a 14-year-old girl. At 2 years of age, the patient had a diagnosis of supernumerary kidney. She remained asymptomatic up to childhood age, and then a DMSA study was required to guide the following adequate surveillance strategy. DMSA study provided a clear imaging of supernumerary kidney in the left side of the abdomen showing a regular uptake and a normal function in relation to its own size.
Chemotherapy to induce T-cell subpopulation changes in advanced breast cancer patients.
Authors: Giuditta Comolli, Martina Torchio, Benvenuto Franceschetti, Irene Cassaniti, Ilario Rapposelli, Piero Marone, Alessandro Bertolini, Fausto Baldanti, Marco Danova
Journal: Journal of Clinical Oncology (2017)

e12562 Background: Recent data suggest that some anti-cancer agents may generate a stimulation of the immune system that can account for additional clinical responses. In breast cancer (BC) the immunomodulation via chemotherapy (CT) opens possible clinical applications, but: a) the variability in the immune response requires a careful pt selection and b) monitoring immunocompetence in clinical routine still represents a technical challenge.Changes in sub-populations of cytotoxic (CD8+) T-cells (as reported in aging) are not well documented in cancer pts. Methods: We utilized multi-color immunophenotyping by flow cytometry (FCM) using a high-resolution whole-blood assay in 39 pts (median age 53; 34 - 74 yrs) with advanced BC undergoing first-line, standard-dose anthracycline/taxane-based CT and in 12 older healthy women, during a 6-months study, to analyze variations in CD8+ T-cells and the effects of CT on different T-cell sub-populations. Results: In all BC pts there was a consistent decrease in absolute numbers of lymphocytes, T-cells and CD8+ T-cells, starting from the first course and persisting during all the CT program. Among the T-cells, there was a lower CD8-/CD8+ ratio, persisting over 6 months, in pts compared to controls. The proportion of CD28-CD57+ cells also remained higher among pts throughout the sampling duration. The number of CD28+CD57- and CD28-CD5- cells decreased faster during CT than CD28+CD57+ and CD28-CD57+ cells, while only CD28-CD57- cells showed a significant reconstitutive capacity after 6 months.Anti-tumor CT in BC pts can produce clinical benefits also by restoring the responsiveness of T cells and by increasing the frequency and activation of tumor specific T-cells already present in blood before CT. Conclusions: Anthracycline/taxane-based CT is able to elicit changes in the pts immune system. These changes appeared to be pronounced in BC pts, with senescent CD8+ T-cells playing an important role. The pre-treatment condition was not restored after 6 months of CT. Multi-parameter FCM is a powerful tool for detailed analysis of the immune dysfunctions during CT and it will also help the development of combined schedules of CT plus new immunotherapeutic agents.
TARGIT E(lderly): Prospective phase II study of intraoperative radiotherapy (IORT) in elderly patients with small breast cancer.
Authors: Frederik K. Wenz
Journal: Journal of Clinical Oncology (2016)

1044 Background: The purpose is to further investigate the efficacy of a single intraoperative radiotherapy treatment within elderly low risk patients with breast cancer ( ≥ 70 years, cT1, cN0, cM0, invasive-ductal histology) which is followed by whole breast radiotherapy (WBRT) only when risk factors are present. This prospective, multicentric single arm phase II study (NCT01299987) is based on the experimental arm of the randomized protocol of the international TARGIT A study. Here we present the first outcome analysis from the German centers. Methods: 273 patients from 20 German centers were recruited between February 2011 and September 2014. Forty-one patients were excluded from the analysis because of screening failure, drop-out or loss to follow-up. During breast conserving surgery a single dose of 20 Gy of intraoperative radiotherapy was given using the INTRABEAM system (Carl Zeiss Meditec, Germany). Additional postoperative WBRT (46 – 50 Gy) was prescribed only in patients with risk factors (larger size, other histology, free margin < 1 cm, lymphvessel invasion, positive nodes, multifocality/multicentricity, extensive intraductal component (EIC)). Systemic therapy was given according to international standards. The primary outcome was local relapse. Overall survival was a secondary outcome. Discontinuation of the trial is scheduled if rates of local relapse rates rise to 3/4/6% after 2.5/5/7.5 years. Results: After a median follow-up of 18.0 months in 232 patients, one ipsilateral in-breast recurrence and two deaths (non-breast cancer) were observed resulting in an actuarial local relapse free survival of 99.1% and actuarial overall survival of 98.4% after 2.5 years. Conclusions: The results of the prospective TARGIT E trial consolidate earlier reports from the randomized TARGIT A trial supporting the use of accelerated partial breast radiotherapy (APBI) in selected patients. The observed local relapse rate after 2.5 years is well below the prospectively defined stopping rules (Neumaier et al. BMC Cancer 2012). Further follow-up will be performed. Clinical trial information: NCT01299987.
Modified Glasgow prognostic score in a North American population of metastatic lung cancer patients: Baseline characteristics from the SNAP trial.
Authors: Chipman Robert Geoffrey Stroud, Paul R. Walker, Sulochana Devi Cherukuri, Nitika Sharma, Cindy Cherry, Teresa Parent, Jessica Hardin
Journal: Journal of Clinical Oncology (2017)

e13072 Background: There is a growing body of evidence that implicates inflammation as a mechanism of disease progression and reduced survival in patients with advanced cancer (Laird B et al. Oncologist 2013;18:1050-5.). Specifically, elevated c-reactive protein (CRP) levels have been associated with a severe symptom burden including pain, dyspnea, fatigue, nausea/vomiting, impaired quality of life, and inferior overall survival (Laird B et al. Oncologist 2013;18:1050-5.). The Modified Glasgow Prognostic Score (mGPS) is a composite inflammatory score based on CRP and serum albumin with proven prognostic value in patients with advanced lung cancer (Simmons CP et al. Lung Cancer 2015;88:304-309.). There is a significant body of evidence supporting the use of the mGPS in both Europe and Asia but the significance of the mGPS in a North American population has not been completely elucidated. We present preliminary data from a group of patients from Eastern North Carolina. Methods: Serum albumin and CRP were drawn at baseline and patients were followed for clinical course and overall survival. Patients with a dx of cancer were included regardless of stage. Clinicopathological features were abstracted from the chart and compared to a similar population from Europe (Simmons CP et al. Lung Cancer 2015;88:304-309.). Statistical comparisons were done by chi-squared test. Results: Two-hundred and twenty seven patients were eligible. Of these, 110 had either stage IV NSCLC (N= 97) or extensive stage small cell lung cancer (n=13). Median CRP was 21.9 mg/L (0.01 - 329.5). Median serum albumin was 3.4 g/dl (2.3-4.6). The number of patients with mGPS of 0, 1, and 2 were 27 (24.5%), 37 (33.6%) and 46 (41.8%), respectively. As compared to the population from Europe, the chi squared statistic was 10.1229 (p = 0.0063). There was no significant association between mGPS and race (p = 0.2277) or gender (p=0.0607). Conclusions: Lung cancer patients in Eastern North Carolina possess a strikingly poor inflammatory signature with significant implications for quality of life and survival. [Table: see text]
Evolution de la prise en chargedes appendicites aigues à l'ère du scanner: est-ce un réel progrès?
Authors: E Grunnenwald, F Muscari, B Foppa, Y Fouche, J Herve, AG Weber, B Suc, G Fourtanier
Journal: Endoscopy (2006)

Etudier l'influence du scanner réalisé en urgence pour appendicite aiguë sur les délais de prise en charge et sur le taux d'appendicectomie pour appendice normale.
Tamoxifen versus aromatase inhibitors for the adjuvant treatment of breast cancer in older women: A feasibility study to examine differences in cognitive outcomes.
Authors: Emily Anne Underwood, Katarzyna Joanna Jerzak, Kathleen I. Pritchard, Mary Catherine Tierney
Journal: Journal of Clinical Oncology (2016)

TPS626 Background: Tamoxifen (TAM) and aromatase inhibitors (AIs) are the mainstay endocrine therapies (ETs) for the treatment of hormone-receptor-positive (HR+) breast cancer (BC). While these ETs dramatically improve BC outcomes by reducing estrogen activity, increased awareness of the neuroprotective effects of estrogen on cognition has led to concerns regarding potential adverse cognitive effects. Cognitive concerns are heightened by the fact BC is more common among older women, who are already at greater risk of cognitive impairment (CI). While the anti-estrogen properties of TAM and AIs are unique, their differential effect on cognition remains unknown. Our overarching objective is to compare the cognitive effects of TAM and AIs in older women; however, before undertaking the large multicenter study needed to meet this goal, we are conducting a feasibility study to i) establish metrics on participation, retention, and ET adherence, and ii) inform sample size calculation for the future multicenter study. This feasibility study is designed such that all data can be rolled into the future study. Methods: Our convenience sample will consist of chemotherapy-naïve women aged 60+, prescribed TAM (n = 25) or an AI (anastrozole or letrozole; n = 50) in the adjuvant setting for a first diagnosis of HR+ BC. Consenting patients are invited to undergo baseline assessment before ET initiation and follow-up assessment after one year of treatment. Participation and retention rates will be established. ET adherence rates will be ascertained using monthly telephone self-reports. Since data from the current feasibility study will be rolled into the future multicenter study, baseline and follow-up assessments include a neuropsychological battery designed according to International Cognition and Cancer Task Force guidelines, as well as measures of mood, pain, and fatigue so that these factors may be controlled for in the future study. Differences in the proportion of women in each ET group who develop CI over the year will be used to establish parameter estimates for sample size calculation. Recruitment began in July 2015, and 40 participants have been enrolled to date. Clinical trial information: NCT02480218.
<i>HER2</i> gene amplification testing by fluorescence in situ hybridization (FISH): Comparison of the ASCO-CAP guidelines with FISH scores used for enrollment in breast cancer international research group (BCIRG) clinical trials.
Authors: Michael F. Press, Guido Sauter, Marc E. Buyse, Hélène Fourmanoir, Emmanuel Quinaux, Denice D. Tsao-Wei, Wolfgang Eiermann, Nicholas J. Robert, Tadeusz Pienkowski, John Crown, Miguel Martin, Vicente Valero, John Robert Mackey, Valerie Bee-Munteanu, Yanling Ma, Ivonne Villalobos, Anaamika Campeau, Martina Mirlacher, Mary-Ann Lindsay, Dennis J. Slamon
Journal: Journal of Clinical Oncology (2016)

515 Background: ASCO-CAP recently recommended further changes to evaluation of HER2 gene amplification by FISH. We retrospectively assessed the impact of the guidelines using annotated BCIRG-005, BCIRG-006, and BCIRG-007 clinical trial data for which we have detailed outcomes. Methods: HER2 FISH status of BCIRG-005/006/007 breast cancers was re-evaluated according to 2013/2014 ASCO-CAP guidelines, which designate five different groups according to HER2 FISH ratio and average HER2 gene copy number per tumor cell; group 1 (“ISH-positive”): HER2-to-CEP17 ratio ≥2.0, average HER2 copies ≥4.0; group2 (“ISH-positive”): ratio ≥2.0, copies<4.0; group3 (“ISH-positive”): ratio<2.0, copies ≥6.0; group 4 (“ISH-equivocal”): ratio<2.0, copies ≥4.0 and <6.0; and group 5 (“ISH-negative”): ratio<2.0, copies<4.0. We assessed correlations with HER2 protein, clinical outcomes by disease-free (DFS) and overall survival (OS) and benefit from trastuzumab therapy (hazard ratio). Results: Among 10,468 breast cancers successfully evaluated by FISH for patient trial entry, 40.8% were in ASCO-CAP ISH group 1; 0.7% in group2; 0.5% in group3; 4.1% in group 4 and 53.9% in group 5. Distributions were similar in screened compared to accrued subpopulations. Among accrued patients, FISH group 1 breast cancers were strongly correlated with IHC3+ status (p-value <0.0001); while groups 2, 3, 4 and 5 were not. However, groups 2, 4 and 5 were strongly correlated with IHC0/1+ status (all p-values <0.0001), while group 3 was not. Among patients accrued to BCIRG-005, group 4 was not associated with significantly worse DFS or OS compared to group 5. Among patients accrued to BCIRG-006, only group 1 showed significant benefit from trastuzumab therapy (DFS hazard ratio=0.71, 95% CI: 0.60-0.83; p<0.0001; OS hazard ratio=0.69, 95% CI: 0.55-0.85; p=0.0006), while group 2 did not. Conclusions: Our findings support the original categorizations of HER2-positivity by FISH status (HER2-to-CEP17 FISH ratio ≥2.0 and average HER2 gene copy number ≥4.0) in BCIRG trials and do not support the adoption of the current ASCO-CAP guidelines.
Melanoma genetic testing to promote reductions in tanning: Results from the Utah BRIGHT project.
Authors: Lisa Aspinwall, Tammy K. Stump, Jennifer M. Taber, Wendy Kohlmann, Marjan Champine, Danielle Drummond, Pamela Cassidy, Sancy Ann Leachman
Journal: Journal of Clinical Oncology (2017)

1582 Background: Predictive genetic testing for familial cancer may alert people to highly elevated risk prior to disease onset. Genetic test reporting has been shown to improve uptake of prophylactic screening and procedures, but whether test reporting also promotes increased performance of primary preventive behavior is unknown. Methods: Unaffected adult participants ( N= 124) from high-risk melanoma families, ages 16-69 (mean = 35.24, 52% men) were enrolled. Participants from families that carried a CDKN2A/p16 mutation received a personal genetic test result and counseling about management recommendations whereas control participants from families without a CDKN2A/16 mutation received equivalent counseling and management recommendations based on family history alone. Photoprotection outcomes were compared between CDKN2A/p16 participants (31 carriers, 44 noncarriers) and the no-test control group ( n= 49), allowing the effects of receiving a genetic test result to be distinguished from the effects of counseling alone. Assessments were seasonally timed to capture tanning during the summer months. Melanin Index (MI) scores, measures of skin tanning obtained through reflectance spectroscopy, were assessed at the dorsal wrist and face. Tanning of the dorsal wrist and face were calculated by subtracting baseline MI scores at an unexposed site on the same individual. Results: Multilevel model analyses examined changes in tanning over time while controlling for clinician-rated skin type, age, gender, date of assessment, and group differences in phenotypic factors and family medical history. Participants who received positive test results were significantly less tan at the wrist one year after their previous summer baseline ( b= -.11, p&lt; .001). No-test controls and noncarriers had no change in tanning. The magnitude of decrease in tanning measurements observed among CDKN2A/ p16 carriers approximated one skin type. Facial tanning did not differ from baseline for any group. Conclusions: A positive melanoma genetic test result promotes reduced UVR exposure. Future research should examine why positive genetic test reports were more motivating to patients than equivalent counseling based on family history.
S88 Neither uk tuberculosis infection testing guideline appears cost-effective in a contemporary hiv infected population
Authors: S Capocci, J Sewell, C Smith, I Cropley, S Bhagani, A Solamalai, S Morris, I Abubakar, MA Johnson, MCI Lipman
Journal: Thorax (2016)

<h3></h3> UK guidelines advise testing for latent tuberculosis infection (LTBI) in people with known HIV. Both National Institute for Health and Care Excellence (NICE) 2011 and 2016, and British HIV Association (BHIVA) guidelines use targeted testing, in comparison to those from other countries, notably the United States. None of these have been compared for cost-effectiveness in a contemporary HIV population. We sought to determine the cost-effectiveness of each UK guideline from an NHS perspective, plus alternatives, using prospective data. All patients with a new HIV diagnosis attending an ambulatory HIV clinic, plus a sample of those with known HIV were approached; and offered a symptom questionnaire, chest radiograph (CXR), tuberculin skin test (TST), blood interferon gamma release assay (IGRA) and induced sputum for mycobacterial culture (IS). The uptake and results were used to calculate the cost-effectiveness of thirty different testing strategies using univariate, multivariate and probabilistic sensitivity analyses (PSA). 219 subjects, representative of the total clinic population, took part. 73% were male, 28% black African and 95% on antiretroviral therapy (ART). During testing, 2 cases (0.9%) of subclinical TB and 14 (6%) of LTBI were detected. Half the patients with LTBI completed preventive treatment. Over a median of 28 months follow up, no new cases of active TB were identified. When compared to no testing, only three of the thirty strategies were below the maximum NICE threshold for cost-effectiveness &lt;£30,000/QALY gained. Testing black Africans with just TST or IGRA cost £23,429/QALY and £28,971/QALY respectively, whilst testing black Africans plus those from countries with a TB incidence of &gt;20/100,000 (‘middle incidence’, MI) cost £25,218/QALY and £32,410/QALY using TST alone or IGRA alone respectively. NICE, BHIVA, or more extensive strategies, were not cost-effective. (Table) Using PSA, no testing was most likely cost-effective up to £30,000/QALY. In a contemporary HIV population with very high uptake of ART, neither current UK guideline is cost-effective. Testing black Africans, or black Africans and people from middle TB incidence countries appear at best marginally cost-effective. Future UK guidance needs to reflect changing health demographics, improved outcomes for people in HIV care, and clinical pragmatism.