bluuebunny/crossref_metadata_2025_split huggingface dataset:
Evaluation of the economic impact of the CCP assay in localized prostate cancer.
Authors: Crawford E. David , Cole Doria , Lewine Nicolas , Gustavsen Gary 
Published: February 2017

85 Background: Stratification of localized prostate cancer based on disease aggressiveness remains challenging, resulting in overtreatment of low-risk patients and under treatment of high-risk patients. A biopsy-based, cell cycle progression (CCP) gene expression assay can aid physicians in predicting prostate cancer aggressiveness, leading to more appropriate patient management. This study quantifies the economic impact of the CCP assay on a US commercial health plan. Methods: A fact-based economic model was developed for a hypothetical cohort of prostate cancer patients with localized disease. Patients were followed in the model for 10 years with management and progression assumptions based on published clinical data and interviews with board-certified physicians. Total cost of care was calculated for a reference scenario (current clinical practice) and a test scenario where patient management was altered based on CCP test results. Cost inputs were set for each unit of care that a patient might undergo (diagnostic/surgical/radiotherapy procedures and pharmacological therapy); costs were assigned based on published costs of care. Total cost of care was compared between the two scenarios to determine overall system economic impact. Results: The CCP test reduced costs by $2,850/patient tested over 10 years after accounting for test cost. For a health plan with 10 million members, this would translate to over $16 million in savings with two-thirds of those savings achieved in the first year after testing. The majority of savings came from increased use of active surveillance in AUA low- and intermediate-risk patients. No single model input, when changed within a range of values, caused the model to show that the test was no longer cost saving. Costs of the test scenario were never greater than the reference scenario, resulting in cost savings over the 10 years modeled. Conclusions: Use of the CCP test in a US commercial health plan has the potential to result in cost savings to payers. Savings are due to increased use of active surveillance in low- and intermediate-risk patients with less aggressive disease, but also from reduced progression rates in high-risk patients with more aggressive disease who transition to multi−modality therapy.
Impact of the 18F- PET/CT scan in the management of patients with high-risk or intermediate-risk prostate cancer at initial diagnosis or at recurrence.
Authors: Pasticier Gilles , Chicart Marine , Gross-Goupil Marine , Donon Laurence , Robert Gregoire , Ferriere Jean-Marie , Ballanger Philippe , Bernhard Jean-Christophe , Cornelis Francois , Lebras Yann , Grenier Nicolas , Ravaud Alain , Haaser Thibaut , Fernandez Philippe , De Clermont-Gallerande Henri 
Published: February 2017

87 Background: It is reported that a Fcholine Positron Emission Tomography (PET/CT) scan can change the management of the patients with prostate cancer up to 20% of the cases. The aim of this study was to evaluate the impact of 18FCholine PET/CT when its indication was taken by a multi-disciplinary staff in case of initial diagnosis or in case of recurrence. Methods: This retrospective study involved 84 patients between May 2013 and July 2014. After a selective approach 86 18F-PET/CT were performed consecutively: 37 (43%) for the initial staging and 49 (57%) in biochemical failure. The acquisition protocol included a pelvic dynamic scan after injection of 4 MBq/kg of 18FCholine followed by a whole-body scan. Mean age, PSA level and Gleason score were respectively in relapse and initial staging: 71 years (59-82), 4.9 (0.12-32.8), 7 (6-9) and 63 years (48-76), 16 (2.42-55) and 8 (6-10). Results: In initial diagnosis, prostate cancer was identified in all the patients on PET/CT. Local disease was seen in 23/37 scans (62.2%); loco-regional node involvement in 8 (21.6%) and metastatic disease in 6 (16.2%). PET/CT confirmed the therapeutic decision in 48.6% of cases and led to a therapeutic modification in 43.2% of cases,avoiding radical prostatectomy and lymphadenectomy in 25% of cases or modifying the extend of radiotherapy (25%) . In biochemical recurrence, PET/CT showed relapse in the prostatic area in 14 patients (28.6%); abnormal pelvic lymph nodes in 10 cases (20.4%) and distant metastases in 18 patients (36.7%). It failed to identify the cause of relapse in 7 cases (14.3%). PET/CT confirmed the therapeutic approach in 24.5% and led to a therapeutic change in 61.2% of cases The diagnostic performance of the FCholine PET/CT scan on nodes, according to the pathological results were: sensitivity 80 %, specificity 84.6%, positive predictive value 66.7% and negative predictive value 91.7 % Conclusions: A rigorous selection of the patients before the realization of a FCholine PET/CT scan in the management of a prostate cancer can increase the diagnostic performance and provide a better impact. In this study the treatment modification affected 54.8% of the patients.
Association between provider-level factors and lymph node dissection outcomes during radical prostatectomy: A national cancer database analysis.
Authors: Kiechle Jonathan E , Wang Elyn , Yu James B. , Gross Cary Philip , Abouassaly Robert , Cherullo Edward E , Smaldone Marc C. , Shah Nilay , Trinh Quoc-Dien , Sun Maxine , Kim Simon P. 
Published: February 2017

89 Background: Lymph node counts have been proposed as a quality metric for patients undergoing radical prostatectomy (RP) and pelvic lymph node dissection (PLND). It is unclear whether surgical approach and hospital characteristics independently determine the number of lymph nodes removed at PLND. Therefore, we assessed the variation in lymph node counts from a population-based cohort of patients undergoing surgery for intermediate and high-risk prostate cancer. Methods: Using the National Cancer Database, we identified all surgically treated patients diagnosed with pre-treatment intermediate or high-risk prostate cancer from 2010 to 2011. The primary outcome was the number of lymph nodes retrieved at the time of RP. Generalized estimating equations were used to assess for differences in the adjusted number of lymph nodes retrieved after accounting for patient and hospital characteristics and surgical approach. Results: Overall, 35,876 patients were diagnosed with intermediate (61.2%) and high-risk (38.8%) prostate cancer and underwent RP and PLND. On multivariable analysis, open radical prostatectomy (ORP) and high volume and academic hospitals were independently associated with greater lymph node counts compared to robotic-assisted radical prostatectomy (RARP) and medium/low and community hospitals, respectively (all p<0.001). After adjusting for patient and hospital variables, higher adjusted lymph nodes counts were observed for ORP compared to RARP (7.1 vs. 6.1; p<0.001). Adjusted counts were also higher for high volume compared to medium/low volume hospitals (7.8 vs. 5.9; p<0.001), and academic compared to community hospitals (7.3 vs. 5.6; p<0.001). Conclusions: Among patients with aggressive prostate cancer treated with RP and PLND, lymph node counts varied by surgical approach and hospital characteristics.
Molecular and clinical characterization of 1,577 primary prostate cancer tumors to reveal novel clinical and biological insights into its subtypes.
Authors: Feng Felix Yi-Chung , Tomlins Scott , Alshalalfa Mohammed , Erho Nicholas , Yousefi Kasra , Zhao Shuang , Den Robert Benjamin , Dicker Adam , Schaeffer Edward M. , Klein Eric A. , Magi-Galluzzi Cristina , Karnes R. Jeffrey , Jenkins Robert B. , Trock Bruce J. , Demarzo Angelo , Davicioni Elai 
Published: February 2017

9 Background: Prostate cancer molecular subtypes based on ETS gene fusions and SPINK1 were originally identified through outlier gene expression profiling analysis. Such molecular subtypes may have utility in disease stratification and clonality assessment, complementing available purely prognostic tests. Hence, we determined the analytical validity of molecular subtyping in a large sample of PCa treated with radical prostatectomy. Methods: We analyzed Affymetrix Human Exon 1.0ST GeneChip expression profiles for 1,577 patients from 8 radical prostatectomy (RP) cohorts. Multi-feature random forest classifiers and outlier analysis were used to define microarray-based molecular subtypes. Results: A random forest (RF) classifier was trained and validated to predict ERG fusion status using a subset with known ERG rearrangement status defined by FISH, achieving >95% sensitivity and specificity in the validation subset. Less frequent rearrangements involving other ETS genes or SPINK1 over-expression were predicted based on gene expression outlier analysis. Across cohorts, 45%, 9% 8% and 38% of PCa were classified as ERG+, ETS+, SPINK+, and Triple Negative, respectively. Global gene expression analysis shows that the four subtypes could be collapsed into three entities (ERG+, ETS+ and SPINK+/Triple Negative) based on expression patterns and clinical characteristics similarity. A series of multivariable analyses further revealed, ERG+ to be associated with lower pre PSA and Gleason scores but more likely to have EPE and occur in patients with European American ancestry compared to the ETS+, SPINK+/Triple Negative tumors (p<0.001). In contrast, patients with ETS+ were more likely to have SVI compared to both ERG+ and SPINK/Triple Negative (p=0.01), while SPINK+/Triple Negative had higher Gleason scores and were more likely to occur in African Americans (p<0.001). Conclusions: The Decipher platform can accurately determine ERG rearrangement status and PCa molecular subtypes. Inclusion of molecular subtyping, such as m-ERG status, may enable additional precision medicine opportunities in prognostic tests
Multi-institutional registry for prostate cancer radiosurgery: An observational clinical trial.
Authors: Freeman Debra 
Published: February 2017

98 Background: To report on the design, methodology and early outcome results of a multi-institutional registry study of prostate cancer radiosurgery. Methods: The Registry for Prostate Cancer Radiosurgery (RPCR) was established in 2010 to further evaluate the efficacy and toxicity of prostate radiosurgery (SBRT) for the treatment of clinically localized prostate cancer. Men with prostate cancer were asked to voluntarily participate in the Registry. Demographic, baseline medical and treatment-related data were collected and stored electronically in a HIPAA-compliant database, maintained by Advertek, Inc. Enrolled men were asked to complete short, multiple choice questionnaires regarding their bowel, bladder and sexual function. Patient-reported outcome forms were collected at baseline and at regular intervals (every 3-6 months) following treatment. Serial PSA measurements were obtained at each visit and included in the collected data. Results: From July 2010 to July 2013, nearly 2,000 men from 45 participating sites were enrolled in the registry. The majority (86%) received radiosurgery as monotherapy. At 2 years follow-up, biochemical disease free survival was 92%. No Grade 3 late urinary toxicity was reported. One patient developed Grade 3 gastrointestinal toxicity (rectal bleeding). Erectile function was preserved in 80% of men <70 yeats old. Overall compliance with data entry was 64%. Conclusions: Stereotactic radiosurgery is an alternative option to conventional radiotherapy for the treatment of organ-confined prostate cancer. The Registry for Prostate Cancer Radiosurgery represents the collective experience of multiple institutions, including community-based cancer centers, with outcome results in keeping with published, prospective trials of prostate SBRT.
In search of the optimal outcome measure for patients with advanced cancer and gastrointestinal obstruction: A qualitative research study.
Authors: Badgwell Brian D. , Williams Loretta A. , Bruera Eduardo 
Published: February 2017

100 Background: Gastrointestinal obstruction (GIO) is the most common indication for palliative surgical consultation in patients with advanced cancer. The purpose of this study was to delineate the symptom burden and experience of patients with GIO. Methods: Twenty patients with advanced cancer and GIO described symptoms at the time of surgical consultation. We used content analysis of interview transcripts and symptoms were ranked by frequency and compared to a general symptom assessment survey (MD Anderson Symptom Inventory). Results: Malignancy type included colorectal (N = 9), gastric (N = 4), urothelial/renal (N = 3), and other (N = 4), while site of obstruction was small bowel in 11 (55%), gastric outlet in 3 (15%), and large bowel in 6 (30%). Thirteen patients (65%) had received chemotherapy within 6 weeks. Imaging evidence of a primary/recurrent tumor, carcinomatosis, or ascites was documented in 13 (65%), 11 (55%), and 16 (80%) patients, respectively. Thirty symptoms were identified on qualitative interviewing. MD Anderson Symptom Inventory symptoms of pain, nausea, and vomiting were frequently noted. Frequently mentioned GIO-specific symptoms included bloating, cramping, not having a bowel movement, and inability to eat. Conclusions: Qualitative research methodology can identify symptoms of importance to patients which can be used to assess improvement after treatment of GIO. Expert panel rating will be used to develop the final symptom item list prior to psychometric testing of the survey.
Determining priority symptoms of women with recurrent ovarian cancers: A Gynecologic Oncology Group study.
Authors: Donovan Heidi AS , Wenzel Lari B. , Ward Sandra , Sereika Susan M. , Edwards Robert P. , Spring Michael , Bender Catherine M , Penson Richard T. , Hagan Teresa 
Published: February 2017

101 Background: The purpose of this study is to recommend a core set of priority symptoms to be assessed in research and clinical settings for women with recurrent ovarian cancers. Methods: We used baseline data of 497 women with recurrent ovarian, fallopian, or primary peritoneal cancer participating in a symptom management randomized clinical trial (GOG-0259) to identify a core index of patient-reported priority symptoms. We used the Symptom Representation Questionnaire to assess priority rankings of 28 symptoms based on four criteria: (1) symptom prevalence, (2) patient-reported symptom severity, (3) percentage of women identifying each symptom as one of top three symptoms “I would like to get better control over”, and (4) the association between symptom severity and functional wellbeing as measured by the Functional Assessment of Cancer Therapy - Ovarian. Final priority ranking included all symptoms that were ranked in the top 10 for any of the four criteria. Results: Of the original 28 symptoms, 19 were ranked in the top 10 for at least one criterion: fatigue, sleep disturbance, pain, anxiety, peripheral neuropathy, constipation, abdominal bloating, drowsiness, mood swings, memory problems, weight gain, nausea, sexual concerns, vomiting, hair loss, lymphedema, lack of appetite, shortness of breath, and depression. Fatigue, sleep disturbance, and pain were each ranked one of the top 10 symptoms for all four criteria. Anxiety, peripheral neuropathy, and constipation were each ranked in the top 10 for three of the 4 criteria. Conclusions: We propose a core index of 19 patient-reported symptoms to be systematically assessed among patients with recurrent ovarian cancer. These symptoms are common, severe, poorly managed, and/or interfere with survivors’ functioning and can be efficiently assessed in 1-2 minutes. Systematic assessment in clinical and research settings could advance understanding about the predictors and consequences of poorly managed symptoms and could lead to more proactive, personalized interventions to improve functional well-being in this at-risk patient population.
Randomized trial of inpatient palliative care in patients hospitalized for hematopoietic stem cell transplantation (HCT).
Authors: El-Jawahri Areej , LeBlanc Thomas William , VanDusen Harry , Traeger Lara , Greer Joseph A. , Pirl William F. , Jackson Vicki A. , Telles Jason , Rhodes Alison , Chen Yi-Bin Albert , Temel Jennifer S. 
Published: February 2017

103 Background: During HCT, patients experience physical and psychological symptoms that negatively impact their quality of life (QOL). We assessed the impact of an inpatient palliative care intervention on patient QOL, symptom burden, and mood during HCT hospitalization and at 3 months post-HCT. Methods: We randomized 160 patients with hematologic malignancies admitted for autologous or allogeneic HCT to an inpatient palliative care intervention (n=81) integrated with transplant care compared to transplant care alone (n=79). We used the Functional Assessment of Cancer Therapy-Bone Marrow Transplant (FACT-BMT) to assess QOL, the Hospital Anxiety and Depression Scale (HADS) and Patient Health Questionnaire (PHQ-9) to assess mood, and Edmonton Symptom Assessment Scale (ESAS) to measure symptoms at baseline, week-2, and 3 months post-HCT. We measured post-traumatic stress (PTSD) symptoms using the PTSD checklist at baseline and 3 months post-HCT. We used linear regression models controlling for baseline values to assess the intervention effects on outcomes at week-2 and 3 months post-HCT. Results: Between 8/2014 and 1/2016, we enrolled 160/186 (86%) of potentially eligible patients. At week-2, the intervention led to improvements in QOL, depression, anxiety, and symptom burden. At 3 months post-HCT, the intervention led to improvements in QOL, depression, and PTSD [Table 1]. PHQ-9 scores at week-2 and HADS-anxiety scores at 3 months did not differ significantly. Conclusions: Palliative care improved QOL, depression, anxiety, and symptom burden in patients hospitalized for HCT with notable sustained effects 3 months post-HCT. Involvement of palliative care for patients with hematologic malignancies can improve their outcomes and substantially reduce the morbidity of HCT. Clinical trial information: NCT02207322. [Table: see text]
Changes in opioid type and dose among cancer patients referred to outpatient palliative care.
Authors: Haider Ali , Baidoo Joseph , Meng Yee Choon , Zhukovsky Donna S. , Tanco Kimberson Cochien , Stewart Holly A , Edwards Tonya , Joy Manju P , Kuriakose Leela , Lu Zhanni , Liu Diane D , Williams Janet L. , Bruera Eduardo 
Published: February 2017

106 Background: Opioid prescriptions are regulated at both federal and state levels. Examples of such regulations include use of risk evaluation and mitigation strategies (REMS), mandatory sharing of prescription data with state prescription drug monitoring programs and the reclassification of hydrocodone as schedule II opioid in October 2014. One possible consequence of such changes would be earlier referral to palliative care (PC) for opioid management. Alternatively, primary oncologist may treat patients with weak opioids or use strong opioids with lower daily dose. We hypothesized that during the last six years, the number of referrals to outpatient PC has increased and the morphine equivalent daily dose (MEDD) has decreased. Methods: We reviewed 750 randomly selected patients who were seen as a new consultation from the year 2010 to 2015. Data was collected on demographics, cancer type and stage, referring specialty, symptom assessment, cancer pain classification, performance status, opioid type and MEDD. Data were also collected on first subsequent PC visit among eligible patients. MEDD over the 6 years was evaluated using general linear regression method, adjusted for covariates. Results: Hydrocodone was the most common opioid prescribed by the referring team throughout the six-year period. After reclassification, its use declined from 43% in 2014 to 33% in 2015. Tramadol use increased from 9% in 2014 to 19% in 2015 (p < 0.0001). Median MEDD upon referral was 78mg/day in 2010 and progressively decreased to 40mg/day in 2015 (p < 0.0001). Year to year referral increased 24% in the first quarter of 2015 (after hydrocodone rescheduling), compared to 17% in 2014 (p 0.0014). Conclusions: Over the past 6 years, there has been an increase in number of referrals to PC and a decline in MEDD upon referral. Likewise, an increase in weak opioids like tramadol has also been observed. These findings suggest oncologists are sending early referrals before further opioid dose titration and rotations are considered. Further opioid regulations will likely impact the integration of PC services in comprehensive cancer care.
Strategies for introducing outpatient specialty palliative care in gynecologic oncology.
Authors: Hay Casey M. , Lefkowits Carolyn , Bakitas Marie , Crowley-Makota Megan , Urban Renata , Duska Linda R. , Clark Leslie Horn , Creasy Stephanie L. , Schenker Yael 
Published: February 2017

111 Background: Concern that patients will react negatively to the idea of palliative care is cited as a barrier to timely referral. Strategies to successfully introduce specialty palliative care to patients have not been well-described. We sought to understand how gynecologic oncologists introduce outpatient specialty palliative care. Methods: We conducted a national qualitative interview study at six geographically diverse academic cancer centers with well-established palliative care clinics between September 2015 and March 2016. Thirty-four gynecologic oncologists participated in semi-structured telephone interviews focusing on attitudes, experiences, and practices related to outpatient palliative care. A multidisciplinary team analyzed interview transcripts using constant comparative methods to inductively develop and refine a coding framework. This analysis focuses on practices for introducing palliative care. Results: Mean participant age was 47 years (± 10). Mean interview length was 25 minutes (± 7). Gynecologic oncologists described three main strategies for introducing outpatient specialty palliative care: first establish a strong primary relationship and trust with patients in order to alleviate fear and increase acceptance of referral; focus initial palliative care referral on symptom control to gain a “foot in the door”, facilitate early relationship-building with palliative care clinicians, and dissociate palliative care from end-of-life; and normalize and explain palliative care referral to decrease patient anxiety and confusion. These strategies aimed to decrease negative patient associations and encourage acceptance of early referral to palliative care specialists. Conclusions: Gynecologic oncologists have developed strategies for introducing palliative care services to alleviate patient concerns. Future research should examine patient perception of these strategies and assess impact on rates of acceptance of outpatient specialty palliative care referral.