tbuckley/cabot-search huggingface dataset:
Health-Related Quality of Life (HRQOL) reporting in phase III randomized controlled trials (RCTs) of metastatic prostate adenocarcinoma (mPCa) and urothelial carcinoma (mUC).
Authors: Di Maria Jiang, Michael Donald Brundage, Christopher Sweeney, Karim Fizazi, Joaquim Bellmunt, David J. Vaughn, Thomas Powles, Nathan Perlis, Girish S. Kulkarni, Srikala S. Sridhar
Journal: Journal of Clinical Oncology (2019)

478 Background: HRQOL outcomes are increasingly used to guide patient-centered care and health policy decisions, especially when treatment has a limited impact on survival. Our aim was to systematically evaluate the quality of HRQOL reporting in phase III RCTs of mPCa and mUC. Methods: A systematic literature review identified phase III RCTs evaluating palliative systemic therapies for castrate sensitive or castrate resistant mPCa (excluding androgen-deprivation therapy) and mUC, published in English between 1985 and 2018. Supplementary material and companion publications on HRQOL were also reviewed. RCTs reporting HRQOL outcomes were scored by the Minimum Standard Checklist for Evaluating HRQOL Outcomes in Cancer Clinical Trials (range 0-11). Results: Of 44 RCTs in mPCa, 25 (56.8%) reported HRQOL outcomes. BPI-SF or BPI (14 RCTs) and McGill-Melzack pain questionnaire (6 RCTs) were the most commonly used generic instruments, whereas FACT-P (16 trials), validated in advanced PCa, was the most commonly used disease-specific instrument. Average score of HRQOL reporting in mPCa was 6.7. Of 21 RCTs in mUC, 7 (33.3%) reported HRQOL. EORTC QLQ-C30 (6 RCTs) was the most commonly used generic instrument. Only 1 trial used a disease-specific instrument, FACT-BL, which lacks validation in mUC. Average score in mUC was 6.6. Conclusions: Robust HRQOL data from phase III RCTs in mPCa and mUC remain limited, and most HRQOL reports had methodologic shortcomings. Although the disease-specific FACT-P questionnaire being used is validated in advanced PCa, mUC RCTs have yet to use a culturally validated instrument to assess HRQOL. Quality of HRQOL reporting has improved over time but needs to be better harmonized across trials. [Table: see text]
Effect of body mass index in gastric cancer patients: Analysis of Turkish national gastric cancer registry.
Authors: Aydin Ciltas, Mustafa Karaca, Dogan Uncu, Metin Ozkan, Mehmet Aliustaoglu, Salim Basol Tekin, Irfan Cicin, Murat Kocer, Faysal Dane, Berna Oksuzoglu, Abdurrahman Isikdogan, Feyyaz Ozdemir, Emin Tamer Elkiran, Aziz Karaoglu, Bulent Yalcin, Alper Sevinc, Mukremin Uysal, CEM Boruban, Mustafa Benekli, Suleyman Buyukberber
Journal: Journal of Clinical Oncology (2015)

e15056 Background: Gastric cancer (GC) remains a common cancer in Turkey. There is increasing evidence of an association between obesity and risk of GC. Body mass index has been suggested to correlate with clinicopathologic factors in GC and increase the risk of death. We initiated a Turkish National GC Registry program in October 2012 to define clinical and pathological variables of GC. We aimed to analyze the impact of BMI on clinical predictive markers in Turkish GC pts in this registry. Methods: GC patients registered in 28 medical oncology clinics were included in the analysis. Patients were stratified according to BMI: < 18.5 (underweight), 18.5-25 (normal weight), 25.1-30 (overweight), and > 30 (obese). Surgical outcomes and clinicopathologic factors were analyzed using Pearsons correlation, spearman correlation and chi-square test when appropriate. Results: 2073 patients were examined. 67.9 %(n = 1407) were male; median age (range) was 62 (23-92). Disease was localized at antrum (47.7%), gastroesophagial junction (31.4%) and other. Median BMI (range) was 23 (12-44). Of these, 160 (7.7%) with < 18.5, 1183 (57%) 18.5-25, 544 (26.2%) 25.1-30, and 185 (8.9%) > 30 (obese). There was a weak positive correlation between age and BMI (p = 0.0001). Low BMI was associated with a lower number of metastatic lymph nodes (P = NS), high number of examined total lymph node count (p = 0.0001, r:-0.08) and operability (p = 0.001). However, tumor location, size, pathologic stage, metastatic site, histopathology, obstruction, perforation were not significantly associated with BMI. Additionaly, the use of neoadjuvant chemoradiotherapy or adjuvant chemotherapy/radiotherapy was not associated with BMI. Increased BMI was associated with the use of neoadjuvant chemotherapy (p = 0.011). Conclusions: BMI does not have any impact on the clinicopathologic features of GC, but rather an indication of physical fitness. Low BMI was associated with operability and higher number of examined lymph node count. But there was no association with tumor localisation, size, pathologic stage and metastasis.
Comparison of Fluorescence in Situ Hybridization and Flow Cytometry (Flow-FISH) with Monochrome Multiplex Quantitative Polymerase Chain Reaction (MM-qPCR) for Telomere Length Screening in Adult Patients with Suspected Cryptic Dyskeratosis Congenita (DKC)
Authors: Monica Sofia Ventura Ferreira, Natalia Estrada, Martin Kirschner, Blanca Xicoy, Anne-Sophie Bouillon, Stefan Wilop, Steffen Koschmieder, Jens P. Panse, Tim H. Brümmendorf, Fabian Beier
Journal: Blood (2018)
Phase II study of niraparib in patients with metastatic castration-resistant prostate cancer (mCRPC) and biallelic DNA-repair gene defects (DRD): Preliminary results of GALAHAD.
Authors: Matthew Raymond Smith, Shahneen Kaur Sandhu, William Kevin Kelly, Howard I. Scher, Eleni Efstathiou, Primo Lara, Evan Y. Yu, Daniel J. George, Kim N. Chi, Jason Summa, Nishi Kothari, Xin Zhao, Byron M. Espina, Deborah S. Ricci, Jason S. Simon, Namphuong Tran, Karim Fizazi
Journal: Journal of Clinical Oncology (2019)

202 Background: New therapies are needed for patients (pts) with mCRPC progressing after androgen-receptor signaling inhibitors (ARSIs) and taxane therapies. Niraparib is a once daily highly selective inhibitor of poly (ADP-ribose) polymerase (PARP-1 and 2). Methods: GALAHAD is an ongoing open label Ph 2 study assessing niraparib (300 mg daily) in pts with DRD progressing on/after ARSIs and taxane chemotherapy. Using a validated plasma assay, DRD status was defined as pathogenic mutations (including homozygous deletions) of BRCA1/2, ATM, FANCA, PALB2, CHEK2, BRIP1 or HDAC2. Composite response rate (RR) was defined as an objective response by RECIST 1.1 for measurable disease, circulating tumor cell (CTC) conversion to &lt; 5/7.5 mL blood or prostate-specific antigen (PSA) decline of ≥50% (PSA 50 ). Here, preliminary data on RR and adverse events (AEs) are reported in pts with biallelic DRD. Results: As of 10 Sep 2018, 123 pts with mCRPC and DRD were enrolled, of whom 39 had biallelic DRD (23 BRCA1/2). The median follow-up was 5.7 mo (2.0–23.7). Table depicts RRs for pts with biallelic DRD by BRCA status. Composite and objective RRs were 65% and 38% in pts with biallelic BRCA1/2, respectively. 3/8 pts (38% [2/5 BRCA1/2 and 1/3 non-BRCA]) with measurable visceral metastases showed objective response. Among the 20 biallelic responders, the duration of treatment (tx) has exceeded 4 mo in 13 pts and 6 mo in 8 pts; 14 pts remain on tx. The most common grade 3/4 hematologic AEs were anemia (25%) and thrombocytopenia (15%) (manageable by dose reduction/interruption). The most common grade 3/4 nonhematologic AEs were asthenia (6%) and hypertension (5%). Conclusions: These results suggest niraparib has compelling activity as monotherapy for pts with treatment-resistant mCRPC, particularly those with biallelic BRCA1/2 identified by a blood assay. Clinical trial information: NCT02854436. [Table: see text]
IS BREAST ARTERIAL CALCIFICATION INDICATIVE OF CORONARY ARTERY DISEASE?
Authors: Rajendra Patel, Lauren Spradley, Maulikkumar Patel, Paul Dale, Jonathan Brock, Jacob Kirkpatrick, Traci Leong, Danny Bui, Matthew Robinson, Tyler Solomon, Jalal Ghali
Journal: Journal of the American College of Cardiology (2019)
Nab paclitaxel plus gemcitabine for metastatic pancreatic adenocarcinoma after failure of folfirinox: Results of an AGEO multicenter prospective cohort.
Authors: Alix Portal, Simon Pernot, Claire Arbaud, David Tougeron, Anne Thirot-Bidault, Christelle De La Fouchardiere, Pascal Hammel, Thierry Lecomte, Johann Dreanic, Romain Coriat, Jean Baptiste Bachet, Olivier Dubreuil, Lysiane Marthey, Laetitia Dahan, Jean-Louis Legoux, Christophe Locher, Céline Lepère, Philippe Rougier, Franck Bonnetain, Julien Taieb
Journal: Journal of Clinical Oncology (2015)

4123 Background: Both Folfirinox and Nab-paclitaxel plus Gemcitabine showed a benefit in terms of survival in first-line treatment of metastatic pancreatic adenocarcinoma (MPA) when compared to gemcitabine. It could be of interest to use them consecutively, knowing that there is currently no standard for 2nd line treatments for MPA and that median Progression free survival (PFS) is consistently less than 4 months in this setting. The aim of this study was to evaluate the efficacy and tolerability of gemcitabine plus Nab-paclitaxel after Folfirinox failure in MPA. Methods: From February 2013 to July 2014, all consecutive patients (pts) from 12 French centers treated by Nab-paclitaxel plus Gemcitabine for a histologically proven MPA after failure of Folfirinox were prospectively recorded. Nab-paclitaxel plus Gemcitabine was delivered on days 1, 8, and 15 every 4 weeks, as previously reported, until disease progression, patient refusal or unacceptable toxicity Results: Nab-paclitaxel plus Gemcitabine was administered to 57 pts. They received a median number of 4 cycles (1–12). Disease control rate was 58% (n = 33) with a 18.5 % (n = 18) objective response rate (RECIST). Within the whole cohort, median overall survival (OS) was 8.8 months (95% CI: 6.2-9.7) and median PFS was 5.1 months (95% CI : 3.2-6.2). Since the start date of first line chemotherapy with Folfirinox, median OS was 18 months (95% CI: 16-21). No toxic death occured. Grade 3–4 toxicities were reported in 40% of patients and were neutropenia (12%), neurotoxicity (12%), asthenia (8%) and thrombocytopenia (8%). Conclusions: With median PFS and OS of respectively 5.1 and 8.8 months Nab-paclitaxel plus Gemcitabine seems promising with a manageable toxicity profile after folfirinox failure, in selected patients able to receive second line treatment for a MPA. These promising results have now to be confirmed in a phase III randomized trial.
Abstract MP47: Diabetes, Prediabetes, and Short-Term Cardiovascular Risk and Death in Older Adults
Authors: Olive Tang, Kunihiro Matsushita, Josef Coresh, A. Richey Sharrett, John W McEvoy, Beverly G Windham, Christie M Ballantyne, Elizabeth Selvin
Journal: Circulation (2019)

Background: Studies in middle-age adults have established prediabetes and diabetes as major cardiovascular disease (CVD) risk factors. Whether these associations persist among older adults is less clear. Methods: Older adults in the Atherosclerosis Risk in Communities (ARIC) Study who attended visit 5 (2013-2015; n = 5,791; ages 66-90) were followed for recurrent global CVD events (fatal or non-fatal myocardial infarction, stroke, and heart failure) and all-cause mortality. We used Cox proportional hazards and negative binomial regression to quantify and compare the independent associations of prediabetes (hemoglobin A1c [A1c]: 5.7-6.3%) and diabetes (prior diagnosis, medication use, or A1c ≥ 6.4%), traditional CVD factors, subclinical CVD (assessed using high sensitivity cardiac troponin [hs-cTnT]), and short-term risk of clinical outcomes in this older population. Results: Over a median follow-up of 4.6 years, there were 5,442 global CVD events (32% with at least one event) and 660 deaths. Diabetes, but not prediabetes, was significantly associated with both outcomes ( Table ). After adjustment for traditional risk factors, diabetes of shorter duration was no longer significantly associated with global CVD; however, diabetes of longer duration, renal disease, and subclinical CVD remained significantly associated with both outcomes. Higher risks of global CVD events and mortality were observed in Blacks compared to Whites. Conclusions: Prediabetes and short-term diabetes were not major independent predictors of short-term CVD events or death in older adults, especially compared to hypertension, kidney disease, long-term diabetes, and subclinical and prevalent CVD. Our results support focusing on these latter risk factors in older adults.
Prognostic significance of tumor subtypes in male breast cancer: A population-based study.
Authors: Jose Pablo Leone, Julieta Leone, Ariel Osvaldo Zwenger, Julian Iturbe, Carlos Teodoro Vallejo, Bernardo Amadeo Leone
Journal: Journal of Clinical Oncology (2015)

1072 Background: Male breast cancer (MaBC) is an uncommon disease, information about prognostic factors is controversial and few reports have studied the role of tumor subtypes. The aim of this study was to analyze the characteristics of each tumor subtype in MaBC and its association with prognosis compared with other factors. Methods: We evaluated men with microscopically confirmed invasive breast cancer between 2010 and 2011 with known estrogen receptor (ER) and progesterone receptor (PR) (together hormone receptor [HR]) status and human epidermal growth factor receptor 2 (HER2) status reported to the Surveillance, Epidemiology, and End Results (SEER) program, which registers HER2 status since 2010. Patients (pts) with other primary either before or after breast cancer were excluded. Tumor subtypes were classified as: HR+/HER2-, HR+/HER2+, HR-/HER2+ and triple negative (TN). Pt characteristics were compared between tumor subtypes. Univariate and multivariate analyses were performed to determine the effect of each variable on overall survival (OS). Results: We included 657 pts. Median age was 65 years (range 29-97). Median follow-up was 10 months (range 0-23). At diagnosis 82.6% were ductal, 46.4% T1, 56.1% N0, 7.6% M1, 14% had breast conservation and 22% adjuvant radiotherapy. Tumor subtype distribution was: 84% HR+/HER2-, 12.2% HR+/HER2+, 1.2% HR-/HER2+ and 2.6% TN. Pts with TN tumors were younger (p = 0.007), had higher grade (p = 0.0001), presented with more advanced stage (p = 0.01), more likely to have mastectomy (p = 0.001) and to die from breast cancer (p = 0.0003). Univariate analysis showed that HER2+ was associated with shorter OS (p = 0.04) and TN pts had worse prognosis (p < 0.0001). In multivariate analysis, pts who had no surgery, those with stage IV and those with TN tumors had significantly worse OS (table). Conclusions: In this cohort, we observed significant differences in pt characteristics according to tumor subtype. HER2+ and TN represented a small proportion of cases. In addition to stage and surgery, tumor subtype has clear influence on OS in MaBC. Univariate p Multivariate p Age NS Race NS Grade NS ER 0.0004 PR 0.0002 HER2 0.04 Stage < 0.0001 0.004 Surgery < 0.0001 0.007 Radiation 0.03 NS Tumor subtype < 0.0001 0.001
Abstract P269: Combined Associations of Objective Sleep Efficiency and Overweight With the Prevalence of Hypertension in Japanese Adults
Authors: Takumi Hirata, Tomohiro Nakamura, Mana Kogure, Akira Narita, Ken Miyagawa, Kotaro Nochioka, Naho Tsuchiya, Taku Obara, Naoki Nakaya, Shinichi Kuriyama, Atsushi Hozawa
Journal: Circulation (2019)

Introduction: Poor sleep efficiency is a risk for prevalent hypertension, and also overweight is one of the major risk factors for hypertension. Generally, overweight participants have poor sleep efficiency, and thus, overweight may modify the association between poor sleep efficiency and hypertension. However, there are no previous reports to examine the impact of overweight on the association between poor sleep efficiency and hypertension. Hypothesis: Poor sleep efficiency is associated with increased with prevalent hypertension, particularly in individuals with non-overweight. Methods: We conducted a cross-sectional study of 779 participants aged 20 years or older who lived in Miyagi prefecture, Japan. All the participants were recruited from June 2017 to March 2018. Sleep efficiency was measured by HSL-101 sleep sensor, and then we classified all the participants into four groups according to their sleep efficiency (good; ≥90%/poor; &lt;90%) and the presence or absence of overweight which was defined as BMI of 23 kg/m 2 or higher based on the Western Pacific Region of WHO criteria for Japanese. Hypertension was defined as morning home blood pressure ≥135/85 mmHg or receiving treatment for hypertension. Multivariable logistic regression models were used to obtain odds ratios (ORs) and 95% confidence intervals (CIs) to assess the combined associations of poor sleep efficiency and overweight with prevalent hypertension. Models were adjusted for sex, age, alcohol drinking status, smoking status, average daily steps, urinary sodium/potassium ratio, and sleep duration. Results: Of the 779 participants (68.3% women, mean age 61.0 years), 252 (32.3%) had poor sleep efficiency, 331 (42.5%) had overweight, and 303 (38.9%) had hypertension. The prevalence of poor sleep efficiency was higher in men (41.7% in men vs. 28.0% in women), and the individuals with poor sleep efficiency had a higher proportion of overweight (52.8 % in participants with poor sleep efficiency vs. 37.6 % in those with good sleep efficiency) and shorter sleep duration. In a multivariable analysis, compared with individuals with good sleep efficiency and non-overweight for hypertension, the adjusted ORs (95% CIs) of those with poor sleep efficiency and non-overweight, good sleep efficiency and overweight, and poor sleep efficiency and overweight for hypertension were 1.79 (1.08 to 2.98), 2.99 (1.99 to 4.49), and 4.15 (2.56 to 6.71), respectively. Conclusions: Poor sleep efficiency was associated with increased prevalence of hypertension even in individuals with non-overweight, and additionally the risk of poor sleep efficiency for prevalent hypertension in individuals with overweight was relatively higher than that in individuals with non-overweight.
Clinical, radiological, and pathological features in liver explants with hepatocellular carcinoma.
Authors: Julie Haewon Rowe, Stephanie Linscheid, Venkateswar Surabhi, Eduardo Matta
Journal: Journal of Clinical Oncology (2015)

e15116 Background: The role of radiology in hepatocellular carcinoma (HCC) is expanding beyond screening and staging. Recent literature demonstrates the use of imaging in conjunction with gene expression analysis in determining the biological activity of HCC. Understanding the pathogenesis of HCC have lagged behind due to reliance on radiographic diagnosis, rather than pathologic confirmation. Given these limitations, correlation of radiologic features with gene signatures from primary liver explants of HCC patients will uncover disease features that can predict indolent or aggressive disease. Methods: We conducted a retrospective review of HCC patients who underwent liver transplantation at the Memorial Hermann TMC-University of Texas Health Science Center at Houston from January 2004 to December 2013. Clinical, pathological, and radiological features were gathered. Two board-certified radiologists (VS, EM) reviewed imaging to evaluate for unique characteristics that have been linked to genetic signatures associated with poor prognosis, venous invasion, and metastasis. Using SAS software, a univariate logistic regression was performed. Results: Of the 122 patients reviewed, 107 were evaluable. The median age was 57 years old (range 39-80); 79% were male. Sixty percent of patients had either hepatitis B or C. The median alpha-fetoprotein (AFP) at diagnosis was 16.5ng/mL (range 0.8-9,652). A majority were either Child Pugh A (34%) or B (46%). Of the 107 patients, 21 patients were deceased, with HCC as the cause of death in 11 of them. Among the deceased (n = 21) versus living (n = 86) patients, 52% of the deceased had HCC recurrence versus 4% of the living patients (P < 0.0001). Among the imaging characteristics examined (e.g., well-circumscribed versus ill-defined, macrovascular invasion, tumor margin score, infiltration, abutment, bulge, or presence of internal arteries, capsule, or hypodense halos), there was no significant difference between the deceased and living patients. Conclusions: Radiologic characteristics are not distinguishable in living versus deceased HCC patients who have undergone liver transplantation. Further studies on radiogenomics are needed in this patient population.
Ten year treatment complication outcomes of radical prostatectomy versus external beam radiation therapy versus brachytherapy for 1,503 patients with intermediate risk prostate cancer.
Authors: Barry W. Goy, Raoul J. Burchette
Journal: Journal of Clinical Oncology (2019)

e16599 Background: To compare 10 year treatment complication outcomes of radical prostatectomy(RP) vs external beam radiation therapy(EBRT) vs brachytherapy(BT) for patients with intermediate risk prostate cancer(IRPC). Methods: A retrospective analysis was performed on 1,503 IRPC patients who underwent treatment from 2004 to 2007, using univariate comparisons. 819 underwent RP, 574 underwent EBRT, and 110 underwent BT using iodine-125. Urinary and rectal complications for RP were graded as severe if patients required ≥ 3 pads/diapers per day, required chronic use of condom catheter or penile clamp, daily self-catheterization, placement of sling or artificial urinary sphincter, or developed rectal fistula/incontinence. Complications for EBRT and BT were graded as severe if they were classified as grade 3 or 4 on the Radiation Therapy Oncology Group grading system for late effects. For erectile dysfunction, the prevalence of patients requiring injections, pumps or penile implants were calculated after a minimum of 1 year of follow up. Results: Median follow up was 10.0 years for RP, 9.6 for EBRT, and 9.8 for BT. Neoadjuvant androgen deprivation therapy was given in 0.6% for RP patients vs 58.9% of EBRT vs 12.7% of BT, p &lt; 0.0001. Median age for RP vs EBRT vs BT was 62.1, 70.8, 65.3, p &lt; 0.0001. The 10-year prevalence of severe urinary complications for RP vs EBRT vs BT was 10.1%, 12.5%, 4.6%, p = 0.04. The percentage of patients having a pre-treatment American Urological Association(AUA) urinary score for RP vs EBRT vs BT was 7.3%, 11.5%, 97.3%, p &lt; 0.0001. The 10-year prevalence of severe rectal complications for RP vs EBRT vs BT was 0.5%, 1.6%, 0.0%, p = 0.06. The 10-year prevalence of erectile dysfunction devices for RP vs EBRT vs BT was 24.3%, 6.6%, 8.2%, p &lt; 0.0001. Conclusions: After 10 years of follow-up, BT had the lowest rate of severe urinary complications, which may due to using the AUA score to avoid implanting those who had significant baseline obstructive voiding symptoms. EBRT had a higher rate of severe rectal complications. RP had the highest probability of undergoing treatment using erectile dysfunction devices, despite having younger patients.