tbuckley/cabot-search huggingface dataset:
Association of Criminal Statutes for Opioid Use Disorder With Prevalence and Treatment Among Pregnant Women With Commercial Insurance in the United States
Authors: Laura E. Gressler, Savyasachi Shah, Fadia T. Shaya
Journal: JAMA Network Open (2019)

Inadequate treatment of opioid use disorder (OUD) in pregnant women increases the risk of life-threatening consequences on maternal and fetal outcomes. Untreated OUD during pregnancy is associated with higher rates of adverse outcomes among newborns.To examine the variation in the prevalence of OUD and the use of medication-assisted treatment among commercially insured pregnant women according to region and state legislature.Cohort study in which the patient cohort used was derived from a 10% random sample of enrollees within the IQVIA PharMetrics Plus adjudicated claims and enrollment database from 2007 to 2015. The database consists of a 10% random sample of private health insurance recipients in the United States and contains claims and enrollment data that are representative of the commercially insured US population. The cohort comprised women (n = 110 285) between 18 and 45 years of age with a code indicating a delivery and continuous insurance enrollment 9 months before and 12 months after delivery. Data analysis was performed from December 2017 to May 2018.Based on their state of residence, the women were classified into 4 different regions: South, Midwest, West, and Northeast. Those residing in states with statutes that imposed civil or criminal penalties for OUD diagnosis during pregnancy were placed in a separate population from those residing in states without these statutes.Diagnosis of OUD in the 9 months before delivery and the receipt of medication-assisted treatment in the 9 months before or 12 months after delivery.The 110 285 pregnant women included in the analysis had a mean (SD) age of 30.26 (5.59) years, with most (67 771 [61.5%]) falling within the 26- to 35-year age range. Of this cohort, 277 women (0.25%) had a diagnosis of OUD and 312 (0.28%) received treatment. Among the 277 women with OUD, 127 (45.9%) received treatment. The prevalence of an OUD diagnosis and receipt of treatment within regions was statistically significant (OUD diagnosis by region: Midwest, 0.05%; North, 0.09%; South, 0.06%; West, 0.06%; χ23 = 45.1148 [P < .001]; OUD treatment by region: Midwest, 0.05%; North, 0.08%; South, 0.10%; West, 0.05%; χ23 = 26.5654 [P < .001]). The prevalence of OUD diagnosis was also statistically significant when comparing women residing in states with statutes with those in states without statutes (OUD diagnosis by criminal statutes: criminalization, 0.07%; no criminalization, 0.18%; χ21 = 14.6456 [P < .001]; OUD treatment by criminal statutes: criminalization, 0.12%; no criminalization, 0.17%; χ21 = 0.0895); the receipt of treatment was not statistically significant (P = .76).These results appeared to show significant variations in the patterns of OUD diagnosis and receipt of medication-assisted treatment among pregnant women, suggesting the need to further explore the source of these variations.
Systemic immune-inflammation index (SII) as prognostic/predictive factor in patients (pts) with metastatic renal cell cancer (mRCC) treated with sunitinib.
Authors: Ugo De Giorgi, Marco Maruzzo, Matteo Santoni, Francesco Massari, Matthew James Wheater, Emanuela Scarpi, Cristian Lolli, Valeria Sotte, Simon J. Crabb, Stefano Cascinu, Umberto Basso, Giuseppe Schepisi
Journal: Journal of Clinical Oncology (2015)

e15595 Background: Systemic immune-inflammatory factors have shown a prognostic role in mRCC. Recently, a SII based on lymphocyte (L), neutrophil (N), and platelet (P) counts has been developed. In this retrospective analysis, we aim to evaluate prognostic and predictive implications of SII at baseline and changes at week 6 during first-line sunitinib in pts with mRCC. Methods: We included 211 consecutive pts with mRCC treated with first-line sunitinib for which P, N, and L data were available at start of therapy, and 6 weeks thereafter. The SII was defined as follows: SII = P x N/L. The X-tile 3.6.1 software (Yale University, New Haven, CT) was used for bioinformatic analysis of the baseline data to determine the cutoff value of SII. Progression-free survival (PFS), overall survival (OS) and their 95% confidence interval (95% CI) were estimated by Kaplan-Meier method and compared with logrank test. The impact of SII conversion on PFS and OS was evaluated by Cox regression analyses. Results: An optimal cutoff point for the SII of 730 x 109stratified the pts with mRCC into high (≥730) and low SII (<730) groups. Median age was 63 years (range, 35-88); 27.5%, 64%, 8.5% were in the favorable, intermediate and poor Motzer prognostic groups, respectively; 15 of 18 (83%) pts in the poor prognostic group had a baseline SII ≥730. The median PFS was 5.9 months (mo) (95% CI=4.0–8.0) in pts with baseline SII ≥730 and 18.7 mo (14.6–23.6) in those with SII <730, P<0.0001. The median OS was 11.9 mo (95% CI=7.6-18.2) in pts with baseline SII ≥730 and 49.4 mo (95% CI=34.5-56.2) in those with baseline SII <730, P<0.0001. Data for SII at baseline and change in SII by week 6 using a cut-off of 730 are shown in the table. Conclusions: The SII is a powerful prognostic and predictive indicator of poor outcome in pts with mRCC. Prospective validation is warranted. SII week 0 -> SII week 6 (cut-off 730) L -> L H -> L H -> H Total number of cases 126 49 29 PFS Median (mo) 18.7 8.0 2.5 HR; P 1.72; 0.0005 3.60; <0.0001 OS Median (mo) 50.1 18.2 7.0 HR; P 2.20; 0.0004 5.07; <0.0001 Note: 7 more cases with low SII at week 0 and high SII at week 6 had a median PFS of 19.7 mo and a median OS=36 mo. H, high (i.e. SII ≥730); L, low (i.e. SII <730). HR, hazard ratio.
Alliance A031501: Phase III randomized adjuvant study of MK-3475 (pembrolizumab) in muscle-invasive and locally advanced urothelial carcinoma (MIBC) (AMBASSADOR) versus observation.
Authors: Andrea B. Apolo, Jonathan E. Rosenberg, William Y. Kim, Ronald C. Chen, Guru Sonpavde, Sandy Srinivas, Amir Mortazavi, Colleen Watt, Marissa Mallek, Katherine Graap, Carlos Diaz, Meagan Odegaard, Karla V. Ballman, Michael J. Morris
Journal: Journal of Clinical Oncology (2019)

TPS504 Background: Patients with high-risk MIBC have a poor prognosis. Radical cystectomy remains the standard treatment. Yet despite substantial improvements in surgical techniques, mortality from metastatic recurrence remains high. A large number of MIBC patients are ineligible for cisplatin-based chemotherapy or have persistent muscle-invasive disease despite neoadjuvant chemotherapy (NAC). Pembrolizumab, a PD-1 inhibitor, has demonstrated significant activity and is FDA-approved for patients with advanced/chemotherapy-refractory metastatic urothelial carcinoma. We hypothesize that pembrolizumab given post-cystectomy will improve overall survival (OS) and disease-free survival (DFS) in patients with high-risk MIBC. Methods: Patients must have histologically confirmed muscle-invasive urothelial carcinoma of the bladder or upper tract, have received NAC and have ≥ pT2 and/or pN+ at surgery or be cisplatin-ineligible and have ≥ pT3 and/or pN+ at surgery or have declined adjuvant cisplatin-based therapy and have ≥ pT3 and/or pN+ at surgery. Surgery could be radical cystectomy, nephrectomy, or ureterectomy. Patients are stratified by pathologic stage, central PD-L1 status, and prior NAC. Patients are randomized to receive pembrolizumab 240 mg every 3 weeks for 1 year, or observation. The dual primary objectives are to determine DFS and OS. Secondary objectives are to determine DFS and OS in PD-L1-positive and -negative patients and assess safety. Correlative objectives are to determine whether 12 immune gene signatures, tumor molecular subtypes, diversity of T-cell receptor (TCR) clonotypes, persistence of TCR clonotypes, tumor and neoantigen burden, HLA subtypes, and plasma HGF and VEGF levels with IL-10 and IL-17 are associated with OS and DFS. Quality of Life Correlative objectives are to compare health-related quality of life as assessed by the EORTC QLQ-C30. Clinical trial information: NCT03244384.
Hazard ratio-based model weighing values of regorafenib and monoclonal antibodies in metastatic colorectal cancer.
Authors: Helmy M. Guirgis
Journal: Journal of Clinical Oncology (2015)

e14506 Patients with wild type (WT) KRAS metastatic colorectal cancer (mCRC) treated with 1st-line cetuximab (Cet) or bevacizumab (Bev) and chemotherapy demonstrated similar overall survival (OS) (CALGB/SWOG 80405). In cost evaluation, attention is presently focused on drug value defined as cost/outcome. Hazard ratios (HR) have rarely been integrated. The aim was to design a drug model weighing cost in US$ vs. HR and survival. Regorafenib (Reg), Panitumumab (Pan), Cet and Bev were evaluated in mCRC. Methods: Previously reported OS gain over control in days (OSg) and HR were abstracted. Cost/life-year gain (LYG) was compared with cost/probability of survival (PoS) calculated as (1.0 – HR). Results: There were significant differences between cost/LYG and cost/PoS. Reg value improved with longer OS and lower HR (Table). Conclusions: Parallel use of HR and survival was feasible and helpful in weighing values of drugs with borderline outcome. At 24 weeks (w) in 1st-line, Bev cost/outcome was 30% to 57% lower than Pan and Cet in WT KRAS. Drugs OSg & HR Cost/LYG Cost/PoS Reg x 3 (28-day cycle) refractory, Grothey A, 2012 Kim TW, ESMO 2014 42 & 0.77 75 & 0.55 241,714 135,360 122,609 62,667 1st-line, FOLFOX4 + Pan x 24w, WT KRAS extended RAS, Douillard J-Y, 2010, 2013 132 & 0.83 174 & 0.78 129,895 98,541 280,165 216,491 FOLFIRI + Cet x 24w , WT KRAS 1st-line Van Cutsem E, 2009 120 & 0.80 157,608 262,680 IFL+ Bev x 24w, Hurwitz HI, 2004 141 & 0.66 73,838 85,059
Identifying factors associated with poor genitourinary cancer clinical trial accrual using a novel data extraction algorithm.
Authors: Kristian D. Stensland, Lael Suzanne Reinstatler, Alireza Moinzadeh, Matt D. Galsky
Journal: Journal of Clinical Oncology (2019)

439 Background: Poor accrual to clinical trials is the most cited barrier to efficient trial completion, yet information regarding accrual adequacy is limited. Comparisons of planned (or anticipated) accrual to actual accrual have previously been limited by siloed information. Even ClinicalTrials.gov presents only one type of accrual (actual OR anticipated) for each trial. We developed a novel approach to extract both anticipated and actual trial accrual. We apply these previously unavailable data to describe accrual adequacy and identify predictors of poor accrual. Methods: Records for all GU cancer clinical trials started since 2005 were extracted from ClinicalTrials.gov. We employed a custom Python web scraper to extract anticipated and actual accrual information and trial characteristics from the ClinicalTrials.gov archives. Logistic regression was used to identify predictors of failing to meet 50% or 85% of anticipated accrual. Results: A total of 3,976 completed or terminated genitourinary cancer trials were extracted, of which 1,322 unique trials had complete records. Only 42% of trials met their anticipated accrual goals, and 30% enrolled fewer than half of their anticipated patients (Table). Of trials reported as completed, only 54% reached their accrual goals; 17% failed to reach 50% of anticipated accrual. On logistic regression, prostate (OR 0.64, 95% CI 0.45-0.91) and testicular (OR 0.44, 95% CI 0.18-0.96) trials, as well as trials with sites within and outside the USA (OR 0.55, 95% CI 0.35-0.86) were more likely to accrue &gt; 50% of anticipated patients. Conclusions: Genitourinary cancer clinical trials frequently fail to meet anticipated accrual goals. Whether this represents overly ambitious goals or modified endpoints after a trial opens remains uncertain. These data should be transparent and applied to the interpretation of results. Future work in this regard should be used to aid in planning future trials. [Table: see text]
Postchemotherapy retroperitoneal lymph node dissection (PC-RPLND) in patients with testis cancer in the salvage setting.
Authors: Peter Albers, Alessandro Nini, Andreas Hiester, Christian Winter, Achim Lusch, Anja Lorch
Journal: Journal of Clinical Oncology (2019)

524 Background: Although the use of PC-RPLND in testis cancer patients in the salvage setting has been reported, existing data characterizing histologic findings are poor. Methods: 179 PC-RPLNDs after salvage chemotherapy were selected from a prospective database of 504 RTRs (434 patients, 2003-2018). Uni- and multivariate analyses were used to assess the impact of preoperative positive markers, residual diameter, and type of salvage chemotherapy (either conventional salvage [CTX] or high dose chemotherapy [HDC]) on vital cancer histology (including teratoma with malignant transformation) at PC-RPLND. Results: Median age was 37 years (IQR 30-45). 11.5% of patients underwent thoraco-abdominal PC-RPLND and adjunctive surgeries were needed in 41.7%. Clavien-Dindo &gt; II complications were registered in 5% of cases. After stratification for CTX and HDC, AFP only, β-HCG only, and both markers elevated were seen in 27.8%, 7.8%, and 2.2%, and 33%, 18.2% and 5.7% of patients, respectively. Overall, necrosis, postpubertal teratoma, and vital cancer were found in 30%, 29%, and 42%, respectively. Vital cancer was found in residual tumor sizes of &lt; 2 cm and ≥ 2 cm in 41.2% and 32.9%, respectively. After stratification for CTX and HDC, patients after CTX had lower rates of necrosis (26% vs. 34%, p = 0.2) but not of vital cancer (42% vs. 42%, p = 0.9). The predictors of vital cancer were represented by the presence of AFP elevation only (OR 4.7, p = 0.001) and both markers elevated (OR 8.6, p = 0.02). Conclusions: In the salvage setting, the rate of vital cancer in residual tumor is three times higher as compared to the first-line setting. Presence of AFP elevation only or both markers elevated represent predictors of vital cancer. PC-RPLND has to be performed after salvage chemotherapy independent of the residual tumor diameter. [Table: see text]
Diagnostic Value of Native T1 Mapping in Arrhythmogenic Right Ventricular Cardiomyopathy
Authors: Mimount Bourfiss, Niek H.J. Prakken, Jeroen F. van der Heijden, Ihab Kamel, Stefan L. Zimmerman, Folkert W. Asselbergs, Tim Leiner, Birgitta K. Velthuis, Anneline S.J.M. te Riele
Journal: JACC. Cardiovascular imaging (2019)
Metacure: Multi-arm multimodality therapy for very high risk localized and low volume metastatic prostatic adenocarcinoma.
Authors: Min Yuen Teo, Mary-Ellen Taplin, James Andrew Eastham, Hannah Benoliel, Adam S. Kibel, Sean Matthew McBride, Paul L. Nguyen, Anuradha Gopalan, Rosina Lis, Howard I. Scher
Journal: Journal of Clinical Oncology (2019)

TPS349 Background: Therapeutic advances in the management of metastatic castration-resistant prostate cancer (mCRPC) have not been matched in non-castrate states. A key obstacle is the traditional paradigm in which therapies with significant benefit in mCRPC are then studied in patients (pts) with localized, rising PSA or early metastatic disease using time-to-event (TTE) outcomes (e.g. biochemical recurrence, radiographic progression or death). These trials are costly, lengthy and often give inconclusive results that do not change practice nor provide a methodology to rank regimens based on efficacy. A new strategy is needed that gives a rapid efficacy readout and prioritizes approaches for large-scale testing. Methods: Metacure is a multi-arm, multi-stage randomized Phase 2 trial in which novel systemic therapies are studied in the context of a multimodality approach, which includes radical prostatectomy + pelvic and retroperitoneal lymph node dissection, if applicable, stereotactic radiotherapy (RT) to osseous metastases, and an option for adjuvant RT based on risk factors. The arms include combinations of ADT + apalutamide +/- abiraterone acetate and prednisone. Non-castrate prostate cancer pts with high probability of relapse or death from disease ranging from very high risk localized to low-volume metastatic disease are eligible. The primary endpoint is pathologic complete response and minimal residual disease. The secondary endpoint is undetectable PSA with non-castrate levels of testosterone. Both are binary endpoints that circumvent interpretations of the clinical relevance of TTE outcomes, providing a read-out of success or failure in a shorter time frame with fewer pts. The uniform entry criteria and continuous randomization enables ranking and prioritization of the strategies evaluated for further development in large-scale trials so that only the most effective ones move forward. This multicenter trial is managed by the Prostate Cancer Clinical Trials Consortium, funded by Janssen and is currently open and actively accruing. Future plans include opening a cohort of pts with aggressive non-castrate disease harboring DNA damage repair alterations. Clinical trial information: NCT03436654.
Abstract P359: Pervasive Discrimination and Allostatic Load in African-American and White Adults
Authors: Miriam E Van Dyke, N. K Baumhofer, Natalie Slopen, Mahasin S Mujahid, Cheryl R Clark, David R Williams, Tené T Lewis
Journal: Circulation (2019)

Introduction: Self-reported experiences of discrimination have been associated with a range of important clinical disease outcomes; however, most studies have focused on discrimination assessed using a single scale which may fail to capture the pervasive nature of experiences of discrimination in the lives of certain groups. We sought to examine associations between reports of “pervasive” discrimination—conceptualized by combining multiple scales assessing discriminatory experiences-- and an indicator of homeostatic dysfunction, allostatic load (AL), among African-Americans and Whites. We also examined whether associations were stronger among African-Americans than Whites. AL was chosen as it is a measure of cumulative “wear and tear” on the body caused by stressors (i.e., discrimination) and has been associated with cardiovascular-related outcomes. Hypothesis: We hypothesized that pervasive discrimination would be associated with higher allostatic load, and that associations would be stronger among African-Americans compared to Whites. Methods: We conducted linear regression models using data from 215 African-American and 985 White adults (57% female; mean age=54.7 years) in the Midlife in the United States II (MIDUS II) Biomarker Project. A pervasive discrimination score was created by combining three discrimination scales (Everyday Discrimination, Lifetime Discrimination, and Workplace Discrimination), resulting in a score measuring 0-3 domains of discrimination, and an AL score was created based on a set of 24 biomarkers representing 7 biological systems (including inflammation, lipid metabolism, and cardiovascular, among others). Results: African-Americans had higher pervasive discrimination and AL scores than Whites (p&lt;0.001). In models fully-adjusted for demographics and other relevant covariates, raceхpervasive discrimination interaction was observed (p&lt;0.05). A pervasive discrimination score of 2 vs. 0 was associated with a greater increase in AL among African-Americans (b=0.32; p&lt;0.001) compared to Whites (b=0.18; p&lt;0.001). Conclusions: African-Americans report more pervasive discrimination than Whites. This pervasive discrimination in turn, has a greater impact on multisystemic physiological dysregulation in African-Americans compared to Whites. Findings suggest that measuring discrimination by combining multiple forms of discriminatory experiences may be particularly important for studying the health effects of discrimination among African-Americans.
Timeliness of care among elderly women with breast cancer.
Authors: Ami Vyas, Suresh Madhavan, Usha Sambamoorthi, Xiaoyun (Lucy) Pan, Michael Regier, Hannah Hazard
Journal: Journal of Clinical Oncology (2015)

e17720 Timeliness of Care Among Elderly Women with Breast Cancer Background: Previous studies about timeliness of breast cancer (BC) care are limited as they did not define timeliness of diagnosis and treatment according to the published opinion-based guidelines. The objectives of this study are to determine the timeliness of BC care based on published opinion-based guidelines and to evaluate the factors associated with timeliness of BC care in elderly women. Methods: The study cohort consisted of elderly women age > 66 diagnosed with incident BC between 2003 and 2006 (N = 36,276) from the Surveillance, Epidemiology and End Results (SEER)-Medicare database. Based on the published guidelines, timely diagnosis was measured as < = 35 days from the initial consultation for breast abnormality to BC diagnosis and timely treatment was measured as < = 28 days from BC diagnosis to the initiation of treatment. Multivariable logistic regressions were conducted to determine factors associated with timely BC care in these women. Results: About 71% of the study cohort received timely diagnosis of BC and 73% received timely treatment of BC as per the published guidelines. Age 80 and above, white race , non-metro residence, higher census tract education, distant stage of BC, moderately and poorly differentiated grade of tumor, tumor size > 3 cm, no comorbidity and low primary care physician visits were significantly associated with timely diagnosis of BC. While, age 66 to 74 years, white race, non-metro residence, earlier stages of BC, tumor size < 3 cm, no comorbidity, high PCP visits, and lower number of hospitals with oncology services in the area of residence were significantly associated with timely treatment of BC. Conclusions: Twenty nine percent and 27% of the elderly women were not diagnosed and treated, respectively, in a timely fashion as per the published guidelines. Improving timely diagnosis in elderly women at early stages and with smaller tumor sizes and timely treatment in those at advanced stages with larger tumor sizes is warranted.
Acute Neurotoxicity during ALL Therapy Is Associated with Treatment Intensity, Age and Female Sex - an Analysis of SAE Reports from the UKALL 2003 Trial
Authors: Qurat-ul-Ain Wahid, Lina Hamadeh, Sheena McGowan, Rachael Hough, Ajay Vora, Anthony V. Moorman, Christina Halsey
Journal: Blood (2018)