bluuebunny/crossref_metadata_2025_split huggingface dataset:
Uncertainty, post-traumatic stress, and quality of life in non-muscle-invasive bladder cancer survivors.
Authors: Jung Ahrang , Nielsen Matthew Edward , Smith Sophia Kustas , Crandell Jamie , Palmer Mary Happel , Bryant Ashley Leak , Mayer Deborah 
Published: September 2018

e16027 Background: More than 74,000 people are diagnosed with bladder cancer every year in the US, and approximately 75% of them have non-muscle-invasive bladder cancer (NMIBC). Having a NMIBC with high recurrence rates and frequent surveillance cystoscopies followed by repeated treatment can be a source of uncertainty and post-traumatic stress disorder (PTSD) symptoms affecting survivor’s quality of life (QOL). This study was to explore the impact of cancer, cancer treatment, and surveillance procedures on uncertainty, PTSD symptoms, and QOL in patients with NMIBC. Methods: NMIBC patients, diagnosed between 2010 – 2014, were eligible for this study. Of the 5979 NMIBC population identified through North Carolina Central Cancer Registry and met the criteria, 2000 patients were randomly selected. Data were collected by postal mail survey from October to December, 2016. The Mishel Uncertainty in Illness Scale-Survivor (MUIS-S), the PTSD Checklist for DSM-5 (PCL-5), the EORTC QLQ-C30, and QLQ-NMIBC24 were used to measure uncertainty, post-traumatic stress, and QOL, respectively. Descriptive statistics, partial correlations, ANOVA, and t-test were performed. Results: 396 NMIBC survivors returned their surveys (response rate 22%). Subjects averaged 3.5 years post-diagnosis and 72.8 years of age; the majority were male (71.7%) and white (94.4%). The mean score for uncertainty was 53.3±12.0, which means moderate uncertainty. Subjects who scored at or above 33 for PCL-5 were 4.3%, which indicates having PTSD. The mean scores for QOL dimensions (global health status, function, and symptom) were 73.3±21.9, 84.6±18.5, 15.5±17.1, respectively (possible range 0-100, higher score of global health and function = better, higher score of symptom = worse). There were significant correlations between uncertainty, PTSD symptoms, and all QOL dimensions (all p < 0.001). Conclusions: Higher levels of uncertainty and PTSD symptoms were inversely related with QOL. Thus, future work should continue to explore the antecedents of uncertainty and PTSD symptoms and to identify the relationships among antecedents, uncertainty, PTSD symptoms, and QOL for intervention studies in high risk NMIBC survivors.
The enrollment status of patients with brain metastases in metastatic renal cell carcinoma: A query of clinicaltrials.gov.
Authors: Le Tri Cao , Brugarolas James 
Published: September 2018

e16070 Background: Clinical trials routinely exclude patients with brain metastases in metastatic renal cell carcinoma (mRCC). However, the degree to which such patients are excluded has not been documented. Routine exclusion of such patients limits applicability of trial results and obfuscates potential benefit in this subpopulation. This study aims to systematically determine the status of central nervous system (CNS) disease exclusion, with or without leptomeningeal disease, in clinical trial enrollment in interventional studies of mRCC. Methods: ClinicalTrials.gov was systematically queried to characterize the CNS exclusion criteria among open, interventional trials in mRCC. Results: Of 121 open trials, 29 (24%) strictly excluded patients with CNS metastasis. 69 trials (57%) enrolled patients with CNS metastasis with contingencies (i.e. prior CNS-directed local therapy, and/or lack of neurologic symptoms). Two trials (2%) enrolled patients with CNS metastasis without exception. 21 trials (17%) did not specify enrollment criteria with respect to CNS disease. In multivariate analysis of the effect of trial phase, location, sponsor, treatment type, and histologic subtype on CNS exclusion criteria, only location had a statistically significant effect. Trials performed exclusively within the United States had higher odds of excluding patients with CNS metastases than global trials (OR = 8.889, 95% CI: 1.405-56.251, p = 0.023) or trials performed exclusively outside of the United States (OR = 2.778, 95% CI: 1.054-1.758, p = 0.053). Conclusions: Due to the high rate of exclusion of patients with brain metastases in mRCC, many trial results cannot be reliably generalized to this subpopulation. Consideration should be given to looking at the effect of new systemic therapies on patients with CNS metastases to clarify benefit or harm in this subpopulation.
Impact of margin status on survival after radical nephrectomy for renal cell carcinoma (RCC).
Authors: Morris Lindsay Kaye , Altahan Alaa , Mays John , Giri Upama , Wiedower Eric , Vaena Daniel A. , Fleming Martin D. , Martin Michael Gary 
Published: September 2018

e16084 Background: Data is limited regarding outcomes in patients with RCC with positive surgical margins. We sought to evaluate the impact of margin status after radical nephrectomy (RN) on relapse free survival (RFS) and overall survival (OS). Methods: A retrospective study was conducted evaluating patients with RCC having undergone RN at Methodist University Hospital in Memphis, Tennessee, between January 2009 and December 2013. Patients were identified from the tumor registry at this institution, and IRB approval obtained. Patient and tumor characteristics and survival were analyzed by GraphPad Prism, Microsoft Excel and IBM SPSS. Results: 156 patients that underwent RN for RCC were identified; 12 patients (7.7%) had positive margins and 144 had negative margins. Mediation duration of follow-up was 3.4 years. 5 of 12 patients with positive margins relapsed, versus 20 of 144 with negative margins (41.7% v. 13.9%, p = 0.022) with a RR of 3.10 (95% CI 1.417-6.799). Among those who relapsed, there was a statistically significant difference in time to relapse between patients with positive and negative margins (mean number of days to relapse 275 versus 621, respectively, with p = 0.038). On multivariate analysis of age, gender, ethnicity, laterality, tumor histology, margin status, and tumor size, margin status was not a statistically significant determinant of OS at 1, 3, and 5 years (p = 0.051, 0.124 and 0.185 respectively) or RFS at 1, 3, and 5 years (p = 0.372, 0.271 and 0.242 respectively). Pearson correlation analysis showed significant correlation between tumor size and margin status, R = 0.478, p < 0.001. Conclusions: Positive margins were associated with earlier time to relapse among patients following RN. However, in multivariate analysis, margin status was not a statistically significant determinant of OS or RFS. In the current era of multiple available agents in RCC capable of cytoreduction, the risk factors that are predictive of a positive surgical margin at RN should be considered in the design of neoadjuvant systemic therapy trials, with the goal of improving long-term outcomes.
Statin use and survival in patients with metastatic castration-resistant prostate cancer treated with abiraterone acetate or enzalutamide.
Authors: Buonerba Carlo , Sonpavde Guru , Pond Gregory Russell , Pagliuca Martina , Rossetti Sabrina , Facchini Gaetano , Scagliarini Sarah , Daniele Bruno , Federico Piera , Morelli Franco , Cartenì Giacomo , Ferro Matteo , Lucarelli Giuseppe , Bellelli Teresa , De Placido Sabino , di Lorenzo Giuseppe 
Published: September 2018

e16503 Background: Statins have been associated with favorable effects in various solid malignancies. In prostate cancer, statins may synergize with novel anti-androgen agents enzalutamide and abiraterone via pharmacokinetic interactions and by decreasing substrate availability for androgen de-novo biosynthesis. Methods: Medical records of patients with metastatic castration-resistant prostate cancer (mCRPC) between September, 2011 and August, 2016 were reviewed at multiple participating centers. Results: 187 men received abiraterone, while 129 received enzalutamide. Patients treated with enzalutamide had a more advanced disease, with a median overall survival (OS) of 7.8 vs. 18 months in the abiraterone cohort. In the abiraterone cohort, statin use was a statistically significant prognostic factor for longer OS (HR = 0.40, 95% CI = 0.27 to 0.59, p < 0.001) and statin users vs. non users had greater 30% PSA declines rates at 12 wks(77.9 vs. 52.9%, p < .01) In the enzalutamide cohort, statin use was not prognostic for survival or PSA declines. Conclusions: Our study suggests a prognostic effect of statins plus abiraterone but not enzalutamide for mCRPC. The mechanism of this interaction warrants elucidation but may include enhancing the anti-tumor activity of abiraterone as well as cardioprotective effects. [Table: see text]
Prostate-specific antigen (PSA) trajectories correlate with overall survival (OS) in men treated with abiraterone acetate plus prednisone (AA+P) or placebo plus prednisone: A post-hoc analysis of COU-AA-301 trial data.
Authors: Pilon Dominic , Behl Ajay S. , Kamstra, Rhiannon , Xiao Yongling , Lafeuille Marie-Helene , Lefebvre Patrick , Freedland Stephen J. 
Published: September 2018

e16528 Background: Treatment options for men with metastatic castration-resistant prostate cancer (mCRPC) have been expanding. AA+P is one therapy that prolongs OS in men with mCRPC. However, it remains challenging to predict the prognosis of men shortly after starting therapy. We identified patterns of PSA change over time (trajectories) for men in the COU-AA-301 trial and examined the association between PSA trajectory and OS. Methods: Data from both treatment arms of the COU-AA-301 trial were used, restricting to men with ≥6 months of follow-up. Log PSA at the first 2 visits post-randomization (84 and 168 days) was used in a modelling procedure to stratify men into 3 groups, each comprised of men with a differing PSA trajectory. Univariate Cox regression assessed the association between trajectory group and OS. Among AA+P patients, predictors of a better trajectory group were identified using multivariate multinomial logistic regression. Results: A total of 913 men (634 AA+P; 279 placebo) were included in the analysis. Group 1 had the lowest mean PSA at both visits post-randomization while Group 3 had the highest. The percent of men in each group and associations with OS are shown in the table. AA+P treated men were more likely to be in a favorable group. Versus Group 1, risk of death was 2.8 and 4.9 times higher in Group 2 and 3, respectively. Exploratory modelling among AA+P patients identified that older age and higher baseline log PSA were among the most important predictors of being assigned to a worse PSA trajectory group (Group 2 or 3 vs 1). Conclusions: In a post-hoc analysis of COU-AA-301 trial data, 3 PSA trajectories over the first 6-months post-randomization were identified and correlated with OS. AA+P treated men were more likely to have a favorable PSA trajectory. The findings suggest that AA+P may be associated with PSA changes post-initiation that may in turn predict survival, although further study is needed. [Table: see text]
Real-world study of patients with metastatic castration-resistant prostate cancer (mCRPC) treated with enzalutamide (ENZA) or abiraterone acetate plus prednisone (AA+P): Patient characteristics and treatment persistence.
Authors: Moses Kelvin A. , Penson David F. , Schultz Neil M. , Shi Fei , Wilson Samuel , Brown Bruce A. , Barlev Arie , Flanders Scott 
Published: September 2018

e16542 Background: As the use of oral therapies in mCRPC increases, it is crucial to understand treatment persistence as it may be used as an effectiveness outcome. This study evaluated treatment persistence in chemotherapy-naïve and post-chemotherapy patients with mCRPC treated with ENZA and AA+P in the United States. Methods: A retrospective claims database analysis identified mCRPC patients treated with ENZA or AA+P from January 1, 2010, to November 30, 2015 . The Clinformatics Data Mart database (OptumInsight, Eden Prairie, MN) included Medicare and commercially insured patients. Treatment persistence (time from first dose to discontinuation [gap > 30 days without index drug]) was assessed in subpopulations of chemotherapy-naïve and post-chemotherapy patients using Kaplan Meier plots with log-rank test. Hazard ratios (HR) [ENZA only/AA+P only] with 95% confidence intervals (CIs) were calculated using a Cox proportional hazards model. Results: In total, 2792 patients with mCRPC received ENZA (n = 827) or AA+P (n = 1965) after September 1, 2012, including subsets of ENZA-only (n = 689) and AA+P-only (n = 1329) patients. Mean age was 74 years and 75% were enrolled in a Medicare plan; 1689 patients with mCRPC were chemotherapy-naïve and 329 were post-chemotherapy. Overall, baseline characteristics were similar between the cohorts except for a higher comorbidity burden in the ENZA-only cohort. Median persistence in chemotherapy-naïve patients was longer with ENZA (ENZA only: 240 days [95% CI 197, 272] versus AA+P only: 186 days [95% CI 180, 212]) (HR 0.86; p = 0.02). In the post-chemotherapy cohort, median persistence was similar (ENZA only: 131 days [95% CI 107, 180] versus AA+P only: 127 days [95% CI 97, 172]) (HR 1.06; p = 0.64). Conclusions: In this real-world mCRPC analysis, treatment persistence was significantly longer in chemotherapy-naïve patients treated with ENZA only versus AA+P only; in post-chemotherapy patients, persistence was not statistically different. Treatment persistence may be utilized an as indicator of treatment effectiveness in clinical practice.
Use of PSA kinetics to determine CT-PET PSMA uptake in recurrent or metastatic prostate cancer.
Authors: Sella Avishay , Kovel Svetlana , Sella Tal 
Published: September 2018

e16561 Background: CT-PET PSMA has recently been approved to more accurately detect the extent of prostate cancer. Here we examined PSA level and kinetics (PSA doubling time-PSADT) as a predictor of positive up-take in patients evaluated for suspected recurrent disease. Methods: We retrospectively collected data on 75 patients evaluated by CT-PET PSMA. Mann-Whitney U test and student's T Test (SPSS 20) were applied to test for differences in median in PSA and PSADT level. PSADT was calculated by Memorial Sloan Kettering Cancer Center calculator. Results: Seventy five patients underwent CT-PET PSMA. Their median age was 71 (52-94) years. Uptake was detected in 61(81%) patients; 37 (49%) patients with metastatic disease (lymph nodes, bones, visceral) and 24 (32%) patients with only localized disease (prostate, prostatic bed after prostatectomy). Median Gleason 8 (6-10). CT-PET was positive in 56%, 80% and 96% of patients with PSA levels of ≤1, 1-2 and > 2 ng/ml, respectively, and 86%, 91% and 78% of patients with PSADT 1-2, 3-6 and > 6 months, respectively. Only median PSA levels were significantly associated with any uptake: 6.05 + 24.08 vs. 0.36 + 4.31 ng/ml, p < 0.001. Only median PSADT was statistically associated with metastatic disease compared to only local disease: 7.2 + 14.86 vs. 20.3 + 35.48 months, p < 0.001. Similar results outcome were obtained using student's t-test (data not shown). Gleason score did not predict for CT-PET PSMA outcome. Conclusions: The decision to perform CT-PET PSMA in prostate cancer patients suspected to have recurrent or metastatic disease should be based on PSA levels. PSADT is an independent marker for positive metastatic uptake.
Self-reported health outcomes of veterans with prostate cancer: The impact of PTSD or PTSD-like symptoms.
Authors: Tchou Wen-Wei , Bevilacqua Lisa A , Romeiser Jamie L , Vanner Elizabeth A , Agrawal Nikita , Ni Xiaoann , Lyon Jennifer A , Shroyer A. Laurie W 
Published: September 2018

e16589 Background: The impact of PTSD on the health of veterans with prostate cancer is unknown. Methods: From September 2015 to October 2016, patients with prostate cancer at a Veterans Administration Hospital completed self-report surveys assessing their overall health status. Survey findings for patients with PTSD were compared to those without PTSD. Patients were considered PTSD+ if they had a diagnosis of PTSD in their Electronic Medical Record (EMR) or scored ≥50 on the PTSD Checklist—Civilian Version (PCL-C). Health outcomes included scores on the following measures: VR-36 (Physical Component Score [PCS] and Mental Component Score [MCS]), Beck Depression Index (BDI), Beck Anxiety Index (BAI), and Pain Visual Analogue Scale (VAS). Results: A total of 104 veterans (18 PTSD+) completed all surveys. The average age was 74.6 ±7.8. 82.7% of patients were Caucasian. PTSD+ Veterans were significantly younger (p<0.001). No PTSD-related differences were found for race/ethnicity, BMI, or VR-36 PCS scores. PTSD+ patients had lower overall VR-36 MCS scores (36.9±12.8 vs. 52.7±10.5; p<0.001), and higher Pain VAS scores (3.9±2.6 vs. 2.1±2.2; p<0.01). PTSD+ patients were more likely to meet criteria for depression (61.1% vs. 8.1%; p<0.01) and anxiety (55.6% vs. 4.7%; p<0.01), and to have a history of suicidality (18.75% vs. 0.00%; p<0.01). Conclusions: Compared to PTSD- veterans with prostate cancer, PTSD+ patients were more likely to self-report increased symptoms of depression, anxiety, and pain as well as overall poorer mental health status. Further research is warranted to identify opportunities to improve mental health care for PTSD+ veterans with prostate cancer. [Table: see text]
A population registry trend analysis of neoadjuvant chemotherapy and incidence of ovarian, peritoneal and fallopian tube carcinomas in England 2004-2015.
Authors: Elleray Rebecca , Chen Cong , Kehoe Sean 
Published: September 2018

e17037 Background: Two important developments in ovarian cancer have occurred over the last decade: i) EORTC 55971 and CHORUS trials reporting neoadjuvant chemotherapy as a management strategy in advanced disease and ii) recognition of fallopian tubes as the origin of many ovarian cancers. This study examines how these have impacted on care and registry data. Methods: The National Cancer Registry and Analysis Service (NCRAS) database identified women registered with ovarian, peritoneal and fallopian tube carcinomas during 2004-15. Treatment was defined as surgical intervention or chemotherapy starting within 6 months of diagnosis. Women were grouped into: Neoadjuvant chemotherapy, Primary surgery, Chemotherapy only, Surgery only or No record of therapy. Groups were analysed by year, FIGO stage and age. Results: 66,768 women were registered with an invasive carcinoma. Disease stage was not recorded in 44%. Of the remaining (n = 36,779) 32.1% stage I/II and 67.9% had stage III/IV disease. Of the 66,768 cases, 12.5 % had Neoadjuvant chemotherapy, 28.7% Primary surgery, 15.2% Surgery only, 19.7% Chemotherapy only and 23.2% No recorded therapy. Chemotherapy only was commonest at 36% in Stage IV, whereas primary surgery was in Stage III disease at 38%. No therapy was recorded in 11% and 25% of stage III and IV disease respectively. Neoadjuvant chemotherapy use trebled with time: comparing the rate in 2004-6 to 2013-15, there was an increase from7.7% to 21.7% ( p< 0.001). Those diagnosed with primary peritoneal cancer were significantly more likely ( p< 0.001) to have neoadjuvant chemotherapy compared to other groups. Cancers of the primary peritoneal and fallopian tube make up an increasing proportion of cases from 6% in 2004 to 13% in 2015. Conclusions: This is the largest reported study assessing trends in primary therapy and cases of ovarian, peritoneal and fallopian tube cancers during a time of novel developments. Neoadjuvant chemotherapy is becoming embedded in clinical practice. The reporting and analysis of ovarian cancer should include peritoneal and fallopian tube for consistent categorisation.
Prognostic influence of BRCA 1 somatic mutations in African Amercian versus Caucasian ovarian cancer patients.
Authors: Singh Sareena , Swarer Karen , DiFeo Analisa , Sawady Joram , Syriac Susanna , Resnick Kimberly Erin 
Published: September 2018

e17054 Background: Racial disparities in outcomes exist between African-American (AA) and Caucasian (C) patients (pts) with high grade epithelial ovarian cancer (EOC). Not all disparity is explained by socio-economic and access related issues. Many argue that differences in tumor biology also play a role. Germline BRCA mutations confer a protective effect in these pts. Immunohistochemistry (IHC) for BRCA 1 is being developed to detect somatic BRCA1 mutations. Parp-inhibitors have been approved for use in pts with germline and/or somatic BRCA mutations. We describe the first comparison of the prognostic implications of BRCA1 somatic mutation status in tumor samples taken from AA and C EOC pts who underwent primary surgery followed by systemic chemotherapy. Methods: IHC staining of whole tumor sections from AA and C pts was performed using a commercially available monoclonal antibody against BRCA1 (Calbiochem). Staining was scored as: loss, retention, or equivocal in the presence of a positive control. Retention was described as wild-type and loss or equivocal as mutation. Standard statistical analyses were used to correlate race, BRCA1 status, and survival. Results: Tumor from 33 pts (16AA and 17C) was stained and scored. Most pts had Stage III (66.7%) disease and high grade serous subtype (82%). Stage, histology, and debulking status did not differ between groups. Overall, loss of BRCA 1 occurred 16/33 (48.5%) tumors. BRCA1 was mutated more frequently in tumors from AA pts (11/16) compared to C pts (5/17) (p=.024). BRCA 1 mutation conferred a protective effect, with a trend towards improved progression free survival: 9.5 vs 15.8 mos in AA (p=0.44) and 16.5 vs. 21 mos in C pts (p=0.97). No statistically significant difference in OS was seen. Conclusions: We demonstrate that IHC for BRCA 1 mutation is feasible in a standard hospital pathology laboratory. Race based differences in somatic BRCA 1 mutation exist; mutational differences are associated with a trend in improved PFS. A larger cohort is needed to elucidate the true effect of this status on outcome. Conceivably, knowledge of BRCA 1 tumor status could be used to improve outcomes in AA pts who may be able to achieve survival numbers comparable to C pts.