tbuckley/cabot-search huggingface dataset:
Impact of education about early palliative care (ePC) and a tool for timely identification of eligible patients on a clinical trial (CT) of ePC.
Authors: Susanne Zwahlen, Monica Fliedner, Steffen Eychmüller
Journal: Journal of Clinical Oncology (2018)

e22211 Background: Reasons why CT’s of ePC interventions have prolonged recruitment time frames have been researched mainly qualitatively. Confronted with a slow recruitment in our ePC multicenter CT in advanced cancer, our objective was to identify recruitment barriers, as well as to implement actions to overcome them. The impact of these changes on recruitment was monitored. Methods: Data from all patients screened at the main study site (University Hospital Bern) between October 2013 and August 2017 were analyzed for: reporting department, dates of contact, eligibility status, as well as consent status. Data from the initial recruitment until March 2014 was used to identify main recruitment barriers. Changes to the recruitment process were implemented and all data from March 2014 onwards was used to estimate the impact of these adaptations. Results: The three main barriers identified were: Logistic, motivational, or related to eligibility criteria. Logistic barriers were overcome by changing from voluntary referral by the treating physician to systematically screening outpatient clinics of medical oncology, radio-oncology, gyneco-oncology and the internal medicine ward. Motivational barriers were addressed through education and dedicated study staff. Eligibility criteria were widened to include two more tumor entities. The new screening procedure increased the number of eligible patients invited to participate from 1 per month to 4.4 per month. The study consent rate increased from 16.7% to at least 42% per study recruiter. The widening of the eligibility criteria led to an increase of 0.5 recruitments per month. Overall, the accrual rate increased from 1 patient during a 5 month period to 2.5 patients per month at the main study site. Together with the other study sites we reached an accrual rate of 3.6 patients per month. The recruitment target of 150 patients was completed in August 2017. Conclusions: Education and dedicated staff in order to increase the acceptance of ePC, as well as a tool for timely identification of eligible patients improved recruitment in our ePC CT. We suggest that these same factors can support the successful integration of ePC into standard oncology.
Randomized, open-label, phase 2/3 study of daratumumab (DARA) with or without JNJ-63723283, an anti-PD-1 monoclonal antibody, in relapsed/refractory multiple myeloma (RRMM).
Authors: Jan Van Droogenbroeck, Philip Vlummens, Noa Lavi, Ka Lung Wu, Jiayu Fu, Huaibao Feng, Robin L. Carson, Wendy Crist, Jordan Schecter, Yael Cohen
Journal: Journal of Clinical Oncology (2018)

TPS8057 Background: DARA, a human CD38 monoclonal antibody, is approved for treatment of RRMM. DARA produces deep clinical responses in RRMM and induces T-cell expansion through reduction of immune suppressive cell populations (CD38+ myeloid-derived suppressor cells and regulatory T and B cells). JNJ-63723283 (JNJ-283) is a fully human monoclonal antibody that binds to PD-1 and enhances the induction of T cell-mediated pro-inflammatory cytokines and reduces tumor volume in preclinical models. JNJ-283 in combination with DARA may improve clinical responses in RRMM by enhancing the anti-tumor and immunomodulatory effects of DARA through PD-1 blockade. This study will assess the efficacy, safety, and pharmacokinetics of DARA ± JNJ-283 in patients (pts) with RRMM. Methods: This is an ongoing, multiphase, multicenter study of DARA (16 mg/kg intravenous [IV] QW for Cycles 1-2, Q2W for Cycles 3-6, and Q4W thereafter; 28-d cycles) ± JNJ-283 (240 mg IV Day 2 and 15 of Cycle 1 and then Q2W thereafter). Eligible pts (≥18 years of age) must have received ≥3 prior lines of therapy, including a proteasome inhibitor (PI) and an immunomodulatory drug (IMiD), or have disease that is double refractory to both a PI and an IMiD. Pts must have demonstrated evidence of response to ≥1 prior treatment regimen. Pts previously treated with anti-CD38 therapy, including DARA, or anti-PD-1 and anti-PD-L1 antibodies are excluded. Approximately 6 pts will be enrolled in Part 1 (safety run-in cohort of DARA + JNJ-283). If < 2 pts experience a dose-limiting toxicity, the study will proceed to Part 2 (Phase 2) in which 80 pts will be randomized 1:1 to the 2 treatment arms. The primary endpoint is overall response rate, and secondary endpoints include safety, ≥complete response and ≥very good partial response rates, duration of response, time to response, progression-free survival, overall survival, minimal residual disease, and pharmacokinetics/immunogenicity of DARA and JNJ-283. Enrollment of an additional 300 pts into Part 3 (Phase 3) will be considered if the primary efficacy endpoint is met and DARA plus JNJ-283 is deemed safe in Part 2. Clinical trial information: NCT03357952.
Predictors of survival in patients with gastrointestinal malignancies admitted to the intensive care unit.
Authors: Heidi Chwan Ko, Melissa Yan, Rohan Gupta, Juhee Song, Kayla Kebbel, Abhishek Maiti, Joseph L. Nates, Michael J. Overman
Journal: Journal of Clinical Oncology (2017)

e18050 Background: Cancer patients have a high use of healthcare utilization at the end of life which can frequently involve admissions to the intensive care unit (ICU). We sought to evaluate the predictors for outcome in gastrointestinal (GI) cancer patients admitted to the ICU for non-surgical conditions. Methods: The objective of this study was to determine the factors associated with ICU mortality, hospital mortality and overall survival (OS). A total of 200 patients with GI cancer admitted to the ICU at The University of Texas MD Anderson Cancer Center between November 2012 and February 2015 were retrospectively analyzed. Cancer characteristics, treatment characteristics, and Sequential Organ Failure Assessment (SOFA) scores defining severity based on 6 organ systems with scores ranging from 0 to 24 were analyzed for their effects on survival endpoints using multivariate logistic regression models and a multivariate Cox proportional hazards regression model. Results: The characteristics of the 200 patients were: 64.5% male, mean age of 60 years, median admission SOFA score of 6.0, and tumor types of primary intestinal (37.5%), hepatobiliary/pancreatic (36%), and gastroesophageal (GE) (24%). The ICU mortality was 26%, hospital mortality was 41%, and 6-month OS estimate was 25%. In multivariate analysis, ICU admission SOFA score &gt; 10 (odds ratio (OR) 17.1, p &lt; 0.0001), poorly differentiated tumor grade (OR 3.2, p = 0.02), and shorter duration of metastatic disease (OR 2.3, p = 0.07) were associated with increased odds of ICU mortality. These same variables were associated with increased odds of hospital mortality. In multivariate OS analysis, SOFA score 6-10 (hazard ratio (HR) 2.1, p = 0.0006) and SOFA score &gt; 10 (HR 4.4, p &lt; 0.0001), patients with GE primary (HR 2.2, p = 0.002) and patients with a poor outpatient performance status that precluded active chemotherapy (HR 2.2, p = 0.01) were associated with increased risk of death. Conclusions: The SOFA score was the most predictive factor for ICU mortality, hospital mortality, and OS for GI cancer patients admitted to the ICU. It should be utilized in all GI cancer patients upon ICU admission to improve both acute and longer-term prognostication.
Prognostic benefit of statin with or without metformin in elderly patients with advanced non-small cell lung cancer: A nationwide population-based outcome study.
Authors: Yun-Gyoo Lee, Ju Hyun Lee, Joung Soon Jang, Jee Hyun Kim
Journal: Journal of Clinical Oncology (2017)

e20661 Background: Taking statin or metformin potentially decreases chronic inflammation, which may reduce cancer mortality as well as incidence. We aimed to clarify the prognostic impact of either use of metformin or statin in elderly patients with advanced non-small cell lung cancer (NSCLC). Methods: Patients ≥ 70 years with advanced NSCLC incident from 2007 to 2012 were identified using reimbursement claims from Korea’s National Health Insurance Service Database, and exposure to metformin and/or statin documented. Median overall survival (OS) was assessed by using Kaplan-Meier methods. Cox proportional-hazards regression model was used to examine the use of metformin and/or statin on mortality. Propensity score matching method adjusted for confounding. Results: Excluding 976 patients treated by upfront EGFR tyrosine kinase inhibitor, 7298 patients receiving palliative chemotherapy were included: 949 (13.0%) had a history of statin use, 1010 (13.8%) used metformin, 255 (3.5%) used both, and 5594 (76.6%) used neither. Median OS of statin + / metformin +, statin + / metformin –, statin - / metformin +, and statin - / metformin – users was 14.5, 12.9, 11.4 and 9.9 months respectively. By multivariate analyses, metformin use was not statistically significantly associated with improved survival in statin non-user (HR 0.99; 95% CI 0.91-1.08; p= 0.819) and statin user (HR 0.99; 95% CI 0.85-1.16; p= 0.898) group. However, use of statin, regardless of metformin, was associated with improved OS (HR 0.80; 95% CI 0.74-0.86; p&lt; 0.001). In propensity-matched cohort, survival benefit was noted not by the use of metformin (HR 0.97; 95%CI 0.85-1.11; p= 0.661) but by the use of statin (HR 0.83; 95%CI 0.73-0.95; p= 0.007). Conclusions: Our findings did not suggest the survival benefit of metformin use in elderly patients with advanced NSCLC receiving palliative chemotherapy. Use of statin may provide a survival improvement in outcomes of elderly NSCLC.
Factors associated with non-adherence to lenalidomide in patients with multiple myeloma.
Authors: Siyang Leng, Suzanne Lentzsch, Yizhen Chen, Melissa Kate Accordino, Jason Dennis Wright, Alfred I. Neugut, Dawn L. Hershman
Journal: Journal of Clinical Oncology (2018)

e20031 Background: Lenalidomide (LEN) improves outcomes in patients with multiple myeloma (MM) and is used in both frontline and refractory settings. We examined the association between medical and financial factors and nonadherence to LEN. Methods: We identified patients ≥ 18 years old with a diagnosis of MM (ICD-9 203.X, ICD-10 C90.X) in the Truven MarketScan Commercial Claims and Medicare Supplemental database from 2009-2016. Those with < 6 months enrollment, < 2 claims for LEN, or with incomplete prescription coverage were excluded. Adherence to LEN was defined as having a medication possession ratio (MPR) ≥ 80%. Discontinuation was defined as 60 days without LEN following the last day supplied. Univariate analyses and multivariable logistic regression were performed using the following covariates: age at first LEN claim, gender, region, employment status, insurance type, copay, coinsurance, deductible, anemia, renal disease, venous thromboembolism, dementia, depression, stem cell transplant, concurrent chemotherapy, hospitalizations, and emergency department (ED) visits. Results: Among 7,666 patients who met inclusion criteria, 5,178 received LEN as part of their initial treatment (Group 1), and 2,488 received LEN after other treatment (Group 2). Mean duration of LEN use was 6.9 ± 9.0 and 7.8 ± 9.8 months, respectively, and 25% of patients in both groups discontinued after 2 months. Of those who discontinued, 26.7% restarted. Nonadherence was 27% and 24.7% for Groups 1 and 2, respectively. In univariate analysis, in both groups, hospitalizations and ED visits were strongly associated with nonadherence (p < 0.001). In multivariable analysis of Group 1, patients with 1 hospitalization (OR 0.54, p < 0.001) and ≥ 2 (OR 0.47, p < 0.001) had lower adherence compared to patients with no hospitalizations. Copay amount was not associated with LEN adherence; however, having a deductible was associated with nonadherence (OR 0.78, p = 0.04). Similar results were seen in Group 2. Conclusions: Among patients with MM treated with LEN who have commercial insurance, nonadherence was related to both modifiable factors as well as disease related factors, such as hospitalizations.
TCT-45 Quality of Life Outcomes after Transcatheter Mitral Valve Repair in an Unselected Population. A Report from the STS/ACC TVT RegistryTM
Authors: Suzanne Arnold, Zhuokai Li, Sreekanth Vemulapalli, suzanne baron, Michael Mack, Andrzej Kosinski, Vinod Thourani, James B. Hermiller, David Cohen
Journal: Journal of the American College of Cardiology (2018)
Abstract 16357: Standardization of Care Transitions Including Early Cardiology Consultation in the Emergency Department is Associated With Reduced Risk for Readmission in Patients Hospitalized With Acute Decompensated Heart Failure
Authors: Corey E Tabit, Mitchell J Coplan, Charina F Alcain, Thomas Spiegel, James K Liao, Kirk T Spencer, Rupa M Sanghani
Journal: Circulation (2016)

Background: Hospitalization for Acute Decompensated Heart Failure (ADHF) carries a high rate of All-Cause Readmission (ACR). While isolated interventions may reduce HF-related readmission, methods ...
Libro Blu as a mobile app to improve cancer care.
Authors: Ilario Giovanni Rapposelli, Ornella Fusco, Panagiotis Deligiannis, Alessandro Pastorini, Mario Saverio Fiumanò, Elisabetta Menatti, Valentina Viaggi, Francesco Stiglich, Roberto Palazzolo, Andrea Maria Soccodato, Maurizio Volpi, Francesca Antoniazzi, Claudia Pedrotti, Fabio Malugani, Francesco De Filippi, Eros Libera, Cristina Songini, Emanuela Tavasci, Katia Dell'Agostino, Alessandro Stefano Bertolini
Journal: Journal of Clinical Oncology (2017)

e18190 Background: When ASCO published Top Five List to improve cancer care in 2012, we applied the same principles to build local guidelines, resulting in first edition of our “Libro Blu” (Blue Book), named after a similar tool previously adopted by the Swiss institution IOSI. In 2015 a reform of Lombardy public health, with the establishment of ASST-VAL, covering a huge area with 5 hospitals, brought a further need for harmonization of our work; moreover, the increasing appearance of high cost drugs and the simultaneous restrictions in public health budget required a more rational expense. Methods: After first edition in 2012, Libro Blu underwent periodic updates. In 2015 a major revision took place; besides up-to-date guidelines in the management of specific cancers, edited by Oncology, Hematology and Radiation Therapy specialists, attention was paid to supportive care, with consultants from many other fields. All recommendations in Libro Blu derive from Italian and international guidelines, adapted to our local reality after multidisciplinary discussion, and have been approved after a final joint review. Results: The implementation of Libro Blu resulted in a more consistent application of treatment protocols in ASST-VAL, ensuring all patients the same standard of care, and allowed to raise the level of both specific cancer treatment and supportive care. Furthermore, guidelines for a rational use of drugs allowed to reduce costs in our institution. After one year, 2015 edition of Libro Blu was submitted for review by a number of Italian oncologists from other institutions. Following this review, we used the updated version of Libro Blu to build, with unconditional support from Eli Lilly, a mobile app that will soon be available for download. Conclusions: Libro Blu established a common standard of care in a broad area and allowed a cost reduction that is particularly relevant at this moment, with cancer care facing the appearance of many high cost drugs along with a spending review that involves the Italian health system. The review from other Italian oncologists ensured the adherence of Libro Blu to national guidelines and to state-of-the-art clinical practice. Finally, the mobile app will make consultation easier and will allow to share this tool across all Italian institutions.
Allogeneic hematopoietic cell transplantation (AHCT) for hematological malignancies (HM) in United States: A comparison of hospitalization outcomes between young and elderly patients.
Authors: Guru Subramanian Guru Murthy, Paulette Mehta, Parameswaran Hari, Mehdi Hamadani
Journal: Journal of Clinical Oncology (2016)

7049 Background: AHCT is increasingly employed for the treatment of HM in elderly patients. However, it is unclear if the hospitalization outcomes of this procedure differ by patient’s age. Methods: Using Nationwide Inpatient Sample database, we analyzed the differences in hospitalization outcomes of elderly (age > 60 years) vs. young (age 20-60 years) patients who underwent AHCT for HM between the years 2006-2011. ICD-9 diagnosis and procedure codes were used to identify subjects. Patient’s length of stay (LOS), total charge (TOTCHG), complications and mortality were studied. Descriptive statistics, Chi-Square test, Mann-Whitney U test and multivariate logistic regression analyses were performed with p < 0.05 as significant. Results: A total of 4371 young and 1175 elderly patients who underwent AHCT were included. Baseline characteristics are summarized in table 1. Median LOS was 27 days in the young group vs. 25 days in elderly group (p < 0.01). Median TOTCHG was $ 267,321 in the young group vs. $ 240,269 in elderly group (p < 0.01). In-hospital mortality was 7.4% in the young group vs. 7.9% in elderly group (p = 0.53). Complications like septicemia (21% vs. 19.2% p = 0.16), respiratory failure (9% vs. 9.1%, p = 0.90), renal failure (14.5% vs. 15.4% p = 0.43), shock (3.6% vs. 3.7% p = 0.86) were comparable in both groups. On multivariate analysis, age > 60 was associated lower TOTCHG and LOS (OR 0.69, 95% CI 0.59-0.81, p < 0.01). Cord blood AHCT (OR 4.67, 95% CI 3.68-5.91, p < 0.01) and bone marrow AHCT (OR 1.59, 95% CI 1.39-1.84, p < 0.01) were associated with prolonged LOS and TOTCHG. Conclusions: Compared to younger patients, AHCT in elderly patients is associated similar medical complications and in-hospital mortality. Lower TOTCHG and LOS in elderly patients might be related to the practice of using lesser intensity conditioning regimen and better patient selection. Baseline characteristics. Young Elderly Median age (Range) 47 (20-60) 64 (61-78) Gender Male 2441 742 Female 1930 433 Race Whites 2844 899 Blacks 222 24 Others 568 81 Missing 737 171 Disease AML/MDS 2101 716 ALL 637 59 CML 275 38 CLL 207 102 Lymphoma 875 194 Myeloma 214 28 MPD 62 38
Clinical and neurophysiologic prospective study with time-event and long-term analysis of the chronic neurotoxicity associated with oxaliplatin in patients with colorectal cancer (CRC).
Authors: Javier Cassinello, Carolina Serrano, Melchor Alvarez De Mon
Journal: Journal of Clinical Oncology (2017)

e15150 Background: The sensitive, symmetric, chronic neurotoxicity is a frequent dose-dependent and dose-limiting secondary effect of oxaliplatin (COXALIN). Time-event and long-term studies about COXALIN and its progression after the end of treatment ( coasting) are lacking. Methods: A prospective, translational, clinical and neurophysiologic study was performed in patients (p) with CRC treated with oxaliplatin. We analyzed COXALIN during and after treatment (at the time of initial, maximum coasting, improvement and maximum improvement). We followed p every 3 months the first year and every 6 months thereafter. The NCI-CTC V3.0 sensitive and modified TNSc (without motor and autonomic skills) clinical scales and Quantitave Sensitive Test and ENG were used. Results: 41 chemo naive p with CRC were included, 22 men, median age 60 y (IA:55-73).Oxaliplatin was administrated as adjuvant treatment in 36p. FOLFOX combination was used in 40p. The median cumulative doses was 825,25 mg/m2 (IA: 697-963). The median follow-up was 21,5m (11-27). 38 p developed COXALIN at median 5,5 m (IA: 4,4-6,6) and maximum coasting at median 8,5 m (IA: 7,6-9,5); in multivariant analysis, cumulative dose at 3 months (p = 0,039; OR 2,5; p = 0,027; HR 0,5) was predictive factor and female gender (p = 0,017; OR 0,11) was protective factor. Fine fiber neuropathy was detected in 47,4% p. All p improved at median 8,7m (IA: 7,1-10,2) since COXALIN, reaching the maximum improvement at 13,4 m (IA:16,0-20,4); on multivariate analysis, the COXALIN intensity was the predictive factor (p = 0,03; HR 0,42). 76,6%p showed residual COXALIN (73,9% p subclinical/mild, 17,4% p moderated and 8,7% p severe). A high correlation was found between clinical scales and neurophysiologic studies along the study (p &lt; 0,0001). Sensitive NCI-CTC scale was more sensible than modified TNSc to evaluate COXALIN intensity in our study. Conclusions: We confirm coasting in COXALIN which prolongs 6 months after treatment. About 80% p showed residual COXALIN in the long-term but it was subclinical or mild in most cases. Sensitive NCI-CTC 3.0 scale is a simple and reliable method for the follow-up of COXALIN.
The natural history and clinical/molecular characterization of primary Gleason pattern 5 (G5) prostate cancer (PCa) treated with radical prostatectomy (RP).
Authors: Jong Chul Park, Tamara L. Lotan, Amanda L. Blackford, Michael Anthony Carducci, Samuel R. Denmeade, Mario A. Eisenberger
Journal: Journal of Clinical Oncology (2016)

e16576 Background: Patients (pts) with primary G5 PCa have aggressive disease with high rates of recurrence and development of distant metastasis. This study was designed to further define clinical and molecular features of primary G5 PCa to provide information regarding response and outcomes and identify potential targets for new treatments. Methods: We performed a retrospective analysis of pts diagnosed with primary G5 PCa (5+5=10 or 5+4=9) at RP between 2005 and 2015 at a single institution. Baseline clinical/pathologic annotations were assessed and a panel of molecular biomarkers in the tissue are performed. Results: Total of 80 pts diagnosed with primary G5 PCa are analyzed (median follow-up of 33 months (mos)). Mean age was 62 and median initial PSA was 7.4 ng/ml. Clinical stage: 72 (90%) cT1/2, 8 (10%) cT3/4, 1 (1%) cN1. Pathologic stage: 11 (14%) pT2, 69 (86%) pT3/4, 17 (21%) pN1. 44 pts (55%) had the initial biopsy primary Gleason score upgraded at RP. 72 (90%) had clinically organ confined disease (OCD) but only 11 (14%) had pathologically OCD at RP. 30 pts (37%) failed to achieve undetectable PSA after RP, 20 (25%) had subsequent PSA recurrence, and 25 (31%) developed distant metastasis. Key outcomes are shown on table. Median time to PSA recurrence was 11 mos with estimated 3-yr recurrence free survival of 36%. 16 pts have died at the time of analysis. The estimated 5-yr survival rate was 62%. Tissue molecular studies are ongoing and includes PTEN, ERG, p53 and Rb status and genomic analysis. Conclusions: Pts with primary G5 PCa most commonly have non-OCD, recurrence after RP (biochemical and regional/distant metastasis), rapid progression to castration resistance, and short overall survival suggesting that aggressive multimodality treatment is necessary. Ongoing molecular characterization and next generation sequencing may provide important diagnostic and biological information for optimal treatment planning. Outcomes of primary G5 PCa. Total Clinical Pathologic Biochemical failure Distant metastasis Castration resistance T3/4 cN+ T3/4 pN+ Number 80 8 (10%) 1 (1%) 69 (86%) 17 (21%) 50 (63%) 25 (31%) 20/31 (65%) Median time 33 mos 11 mos 11 mos