tbuckley/cabot-search huggingface dataset:
A cost-effectiveness analysis of DA-EPOCH-R versus R-CHOP for the treatment of diffuse large B-cell lymphoma.
Authors: Ashni Gokul, Maria Boyce, Deirdre O'Mahony, Brian Richard Bird
Journal: Journal of Clinical Oncology (2017)

e19018 Background: Clinical trials have indicated that dose adjusted etoposide, prednisolone, vincristine, cyclophosphamide, doxorubicin and rituximab (DA-EPOCH-R) may improve clinical outcomes when compared to standard rituximab, cyclophosphamide, doxorubicin, vincristine and prednisolone (R-CHOP) treatment in diffuse large B-cell lymphoma (DLBCL). The cost-effectiveness of the newer regimen, DA-EPOCH-R when compared to R-CHOP has not been assessed. Methods: Patients who received either DA-EPOCH-R or R-CHOP treatment at the Bon Secours Hospital from 2008-2016 for DLBCL were identified. The overall survival (OS), progression free survival (PFS) and event free survival (EFS) was determined for each treatment group using Kaplan-Meier survival estimation curves. Direct costs per treatment for each regimen were obtained from public hospital sources. Results: 71 patients were identified, 40 received DA-EPOCH-R, 31 received R-CHOP therapy. The DA-EPOCH-R group had a mean age at diagnosis of 62 years and a higher overall proportion under 70 years old (70%). The mean age for R-CHOP patients was 66 years and the patient age was largely equal for above and below 70 years at diagnosis. The majority of DA-EPOCH-R patients (77.5%) were stage III or higher at diagnosis compared to approximately half of R-CHOP patients (48.4%). Using a 6-year time horizon, there was no significant difference in Kaplan-Meier survival estimates between the two treatment groups for OS (p=0.58), PFS (p=0.48) or EFS (p=0.23). DA-EPOCH-R was found to be a more expensive treatment option in terms of total drug costs and hospital stay costs. Conclusions: DA-EPOCH-R was shown to have no significant difference in OS, PFS and EFS when compared to standard R-CHOP treatment overall in this population yet it is a significantly more expensive treatment option. The results of this study have not shown an economic or clinical advantage to the use of DA-EPOCH-R. It would be of interest to investigate this question in other high grade lymphomas.
Abstract 13391: Characteristics of Patients Undergoing Diagnostic Cardiac Catheterization Before Noncardiac Surgery; The National Cardiovascular Data Registry (NCDR)
Authors: Joshua Schulman-Marcus, Dmitriy N Feldman, Sunil V Rao, Abhiram Prasad, Lisa A McCoy, Kirk N Garratt, Luke K Kim, Robert M Minutello, Shing-Chiu Wong, Amit N Vora, Harsimran Singh, Daniel Wojdyla, Amr Mohsen, Geoffrey W Bergman, Rajesh V Swaminathan
Journal: Circulation (2015)

Background: While cardiac catheterization and/or revascularization before noncardiac surgery is not routinely indicated, many patients undergo these procedures as part of a preoperative evaluation. The angiographic findings and treatment patterns of these patients are unknown. Methods: Using the NCDR CathPCI registry, we performed a descriptive analysis of 194,444 patients at 1,046 sites reporting both diagnostic catheterization and PCI data who had a coronary angiogram prior to site-reported noncardiac surgery between 2009-2014. Patients with ACS, cardiogenic shock, cardiac arrest, or emergency catheterization were excluded. Demographics, pre-procedure noninvasive testing, angiographic findings, and treatment recommendations were summarized. Results: Of the included patients, 58.2% were male, the median age was 65 (IQR 57-73), and 83.6% were white. Most were overweight or obese (78.6%) and 40.6% had diabetes. A minority had prior MI (17.7%), PCI (18.9%), or CABG (12.1%). Most patients were asymptomatic (60.6%), although 57.8% had been on anti-anginal medications within 2 weeks of the procedure. Prior stress testing was reported in 65.2% and was positive in 86.4% of these patients; stress MPI was most commonly used (85.9% of noninvasive tests). Obstructive CAD (≥50% LM; ≥70% other) was present in 48.1%. After diagnostic angiography, revascularization with PCI or CABG was recommended in 23.8% of the overall cohort, 23.1% of asymptomatic patients, and in 48.3% of patients with obstructive CAD. Treatment recommendations varied by findings (Table). Conclusions: In this large contemporary US registry, a majority (60%) of patients undergoing diagnostic catheterization prior to noncardiac surgery are asymptomatic. Obstructive CAD by angiography is common, and revascularization is recommended in ~50% of these patients. These data highlight the complexity in decision making regarding the role of angiography and revascularization in this setting.
Rates of hepatitis b screening and prophylactic treatment before immunosuppressive therapy in hematological malignancies.
Authors: Ethan Tobias, Bernard Tawfik
Journal: Journal of Clinical Oncology (2018)

e18845 Background: Hepatitis B (HBV) can lead to clinical hepatitis, fulminant liver failure and cirrhosis in patients (pts) receiving immunosuppressive therapy (IST). The American Society of Clinical Oncology and other guidelines recommend screening cancer pts for chronic HBV if at high risk for infection or if anticipating highly IST such as stem cell transplant (SCT) or rituximab. It is recommended that patients who screen positive should be treated with antiviral prophylaxis (ppx) to decrease the risk of viral reactivation. In this study, we determine how these guidelines have impacted clinical practice. Methods: We performed a retrospective single center analysis of pts with hematologic malignancies who underwent intrathecal chemotherapy from 2010-2016. We collected data on HBV screening with either Hepatitis B surface antigen (HBsAg) or Hepatitis B core antibody (HBcAb) along with rates of antiviral prophylaxis and HBV reactivation. Results: In total, 170 pts were included of which 119 (70%) received HBV screening (114 tested for HBsAg, 84 tested for HBcAB). Eleven pts (9.2%) had a positive screening test within 1 year of chemotherapy and 8 (73%) of them were treated prophylactically. Two additional pts were found to be positive for HBcAb while on chemotherapy and neither received ppx. In total, 5 of 13 pts (38%) with positive tests for HBV did not receive ppx despite the fact that 4 of 5 (80%) were treated with either SCT or rituximab. There was one case of HBV reactivation which occurred in a patient who screened positive, was placed on ppx, but who developed an asymptomatic 2 log rise in HBV DNA and mild transaminitis 7 months into chemotherapy due to medication non-adherence. Viral ppx was resumed, HBV viral load decreased and the transaminitis resolved. Conclusions: In patient with hematological malignancies at a large academic medical center, there was significant variability in screening and prophylactic treatment of HBV. This can lead to poor patient outcomes which are avoidable and we are implementing a quality improvement project to streamline and improve this process.
Ex vivo expanded multi-antigen specific lymphocytes for the treatment of solid tumors.
Authors: Amy Houghtelin, C. Russell Cruz, Robert Ulrey, Barbara O'Brien, Maja Stanojevic, Shuroug Albihaini, Devin Saunders, Fahmida Hoq, Maria Fernanda Fortiz, Haili Lang, Patrick Hanley, Catherine Bollard, Holly Jane Meany
Journal: Journal of Clinical Oncology (2018)

3042 Background: Patients with solid tumors refractory to standard therapies have poor prognoses, and most salvage therapies are toxic and ineffective. Antigen-specific T cell therapies offer a promising alternative for targeted therapy with the ability to target multiple antigens in a single product. Hence, we hypothesize that patient-derived tumor-associated antigen-specific T cells (TAA-T) targeting WT1, PRAME, and survivin expressed by pediatric solid tumors can be safely administered to treat patients with relapsed/refractory disease. The objective of this phase I clinical trial is to determine the safety of administering TAA-T to these patients. The secondary objectives include determining disease response and tumor-specific immune reconstitution following infusion. Methods: T cells expanded from patient peripheral blood were stimulated weekly with antigen presenting cells pulsed with an overlapping peptide library spanning the TAAs WT1, PRAME, and survivin. Following release testing, patients were infused with TAA-T on a dose escalation study, ranging from 1 x 107/m2 (dose level 1) to 4 x 107/m2 (dose level 3). Clinical and immune studies were performed post-infusion to monitor for adverse effects and assess immune and disease responses. Results: We have generated TAA-T products from 14 patients (age range 6-54 years) with relapsed/refractory solid tumors (neuroblastoma, osteosarcoma, Wilms tumor, Ewing sarcoma, soft tissue sarcoma, rhabdomyosarcoma). 14 patients have received a median of 2 (range 1-8) infusions without product-related SAEs post-infusion. Epitope spreading was identified in 86% of responding patients. Preliminary outcome data (N = 10) show overall survival of 82% and event-free survival of 54% at 3 months. Conclusions: This unique immunotherapeutic has been well tolerated without causing life-threatening adverse events. Despite aggressive and multiply relapsed disease, 75% of patients have demonstrated evidence of disease control after TAA-T with epitope spreading identified in the majority of responding patients post-infusion. These clinical and laboratory data suggest that TAA-T may safely prolong survival in patients with relapsed/refractory solid tumors. Clinical trial information: NCT02789228.
Isolation and expansion of OCT4/Sox2 specific cytotoxic T lymphocytes in vitro.
Authors: Xueyan Zhang, Yuqing Lou, Xiaoxuan Zheng, Yanwei Zhang, Jianlin Xu, Ping Gu, Huiming Wang, Baohui Han
Journal: Journal of Clinical Oncology (2017)

e14578 Background: The main reason for tumor MDR (multidrug resistance ,MDR) is the presence of CSC(cancer stem cells,CSC). In the CSC of lung cancer, OCT4 and Sox2 are closely related to the tumor MDR. Therefore, in the current study, we introduced a method for the generation of OCT4+/Sox2+ CSC specific CTL(cytotoxic T lymphocytes,CTL) through co-culture with CD154+ feeder layer cells. Methods: Lenti/CD154 was constructed. The NIH3T3 cells were incubated with Lenti/CD154 (10 3 vp per cell) for 24 h at 37 °C and 5% CO 2 . Then the NIH3T3 cells were subsequently maintained in fresh complete DMEM medium. Lenti/GFP was used as a control. On the 6 th day post infection, the infection rate was determined by flow cytometry after incubation with CD154-PE antibody. The feeder layer cells were co-cultured with CD40B cells and the biomarkers of CD40B cells were determined by flow cytometry. The CTL were treated with OCT4 plus Sox2 antigen and then the biomarkers of CTL were examined by flow cytometry and IL-2 and IFNγ were determined by ELISA. Results: The rate of CD154+ NIH3T3 cells was 99.7%, which was higher than that of uninfected-cells (14.8%). After co-culture with CD154+ NIH3T3 cells, the rates of CD40B expressing CD80, CD86 and HLA-A were significantly increased. OCT4 plus Sox2 treatment further increased the CD3, CD4 and CD8 expression and elevated the secretion of IL-2 and IFNγ. After co-culture of CTL with MDR PC9-drived cancer stem cells (CSC) and parental PC9 cells at different ratio, CTL significantly killed the tumor cells compared with control. Conclusions: The generation and expansion of OCT/Sox2 specific CTL is a feasible method for the treatment of lung cancer.
CTLA-4 and PD-1 inhibition in metastatic uveal melanoma: A single center experience.
Authors: Vidhya Karivedu, Abouelmagd Makramalla, Zelia Correa, Nagla Abdel Karim
Journal: Journal of Clinical Oncology (2018)

e21548 Background: Metastatic uveal melanoma (MUM) is associated with poor prognosis with a median overall survival (OS) of 4-15 months. Patients with MUM have low response rates to traditional treatment options and are routinely excluded from clinical trials. Here, we report our experience of 8 patients with MUM who received immunotherapy at University of Cincinnati Medical Center (UCMC). Methods: As a part of our retrospective study in ocular melanoma, we identified eight patients with MUM from UCMC treated with ipilimumab and nivolumab combination followed by nivolumab maintenance between 2015-2017. Radiographic response was assessed by RECIST and immune-related response criteria (irRC). Immune related side effects and survival were also evaluated. Results: Median age at initiation of CTLA-4 and PD1 inhibition was 68 years (range 55-77), six patients were male. Six patients had been treated with ipilimumab 1mg/kg and nivolumab 3mg/kg combination every 3 weeks for four cycles followed by nivolumab 240 mg every 2 weeks maintenance. Two patients received only one dose of combination followed by maintenance nivolumab due to adverse effects. 7 of the 8 patients had liver metastases and received liver directed locoregional therapy; transarterial chemoembolization (TACE) or immunoembolization. Median time on CTLA-4 and PD1-1 initiation was 18 months (range, 5-23). Median OS from the start of immunotherapy was 21 months (range, 7-25). Three patients had partial response, three had stable disease, two had progression of disease. Three patients had autoimmune colitis as adverse events and one patient had grade II rash and arthralgia with combination therapy as expected with published experiences with combination. Conclusions: In this single center experience, improvement in median OS was shown with CTLA-4 and PD-1 inhibition as well as liver directed locoregional therapy. Combination therapies may be worth exploring in the treatment of MUM.
TCT-199 Comparison of Ridaforolimus-Eluting and Zotarolimus-Eluting Coronary Stents in Patients with Long Lesions: 1-Year Outcomes from the Randomized BIONICS Trial
Authors: David Kandzari, Pieter Smits, Ori Ben-Yehuda, Maayan Konigstein, Gidon Perlman, M. Ozgu Ozan, Mengdan Liu, Martin Leon, Gregg Stone
Journal: Journal of the American College of Cardiology (2018)
TCT-615 Percutaneous Coronary Intervention for Patients with Ischemic Cardiomyopathy Is Associated with Low Mortality and Improves Ejection Fraction: A Meta-Analysis of 3,844 Patients
Authors: Ameera Ahmed, Richard Cheng, Abhimanyu Uberoi, Raj Makkar, Babak Azarbal
Journal: Journal of the American College of Cardiology (2018)
Real-world utilization patterns of PI and IMiD combination therapy as treatment for relapse multiple myeloma.
Authors: Eric M. Maiese, Terra Slaton, Brian Macomson, Chris M. Kozma
Journal: Journal of Clinical Oncology (2016)

8052 Background: Multiple myeloma (MM) combination therapy has been shown to convey greater efficacy compared to monotherapy (+/- steroids) in earlier lines of therapy. However, data describing real-world use of combination therapy is limited. This analysis describes treatment patterns and characteristics of MM patients who received proteasome inhibitor (PI) and/or immunomodulatory (IMiD) therapy for first MM relapse (2ndline of therapy (LOT)). Methods: A US claims database (Truven Health MarketScan) was used to identify adult patients with ≥ 2 MM diagnoses (ICD-9 203.0x) between Jan 1, 2005-Dec 31, 2014 (end of study) with; 1) MM treatment between Jan 1, 2007-Jun 30, 2014 and within 90 days of an MM diagnosis code (date of first MM treatment set as index date); 2) continuous medical insurance 24 months pre and ≥ 6 months postindex); and 3) 2nd LOT included a PI or IMID. Patients were excluded if they had 1) MM treatment preindex; 2) non-MM chemo; 3) stem cell transplant, pregnancy or HIV diagnoses. An algorithm was used to identify LOTs based on treatment gaps and changes in therapy. Patients were assigned to study groups based on 2ndLOT treatment: 1) PI-based (no IMiD); 2) IMiD-based (no PI); 3) PI+IMiD-based. Chi-square tests were used to test for differences in categorical variables and a general linear model for continuous variables. Results: Of the 1,471 patients included; 38.4% had PI-based, 45.8% IMiD-based, 15.8% PI+IMiD-based treatment for 2nd LOT. Patients with PI+IMiD were younger (66.8 yrs) vs. PI (70.4 yrs; p < 0.0001) and IMiD (70.4 yrs; p < 0.0001). Patients with PI+IMiD were more likely to have commercial health insurance (38.2%) vs. PI (25.1%; p = 0.0002) and IMiD (25.4%; p = 0.0002). The mean length of 1st LOT was shortest for PI+IMiD group (183 days) vs. PI and IMiD groups (269 days; p < 0.0001 and 335 days; p < 0.0001, respectively). The mean length of 2ndLOT was shortest for PI+IMiD group (263 days) vs. PI (322 days; p = 0.03) and IMiD groups (412 days; (p < 0.0001). Conclusions: Patients with PI+IMiD for 2nd LOT tended be younger, have commercial insurance, and shorter 1st and 2nd LOTs. Real-world use of PI+IMiD combination therapy for treatment of first MM relapse may occur in patients with faster disease progression.
AB1440-HPR Yoga-therapy for rheumatoid arthritis: rapid improvement in proms
Authors: V Sadana, T. Cartwright, M. Cahill, K. Anie, C.B. Colaço
Journal: Annals of the Rheumatic Diseases (2018)

<h3>Background</h3> Rheumatoid Arthritis (RA) is associated with mood disorders and poor quality of life (QOL) Chorus et al., 2003 Yoga therapy (Y-T) has been used in several Long Term Conditions. Khalsa et al, 2016. <h3>Objectives</h3> This study investigated: a) impact of a 16 week Y-T intervention on functional outcomes and QOL in 10 adult-onset RA patients, b) acceptability and experiences of the intervention. <h3>Methods</h3> Ten adult RA patients (Ages: 29–71 Y; RA duration: 1–15 years) consented to 10 individual Y-T sessions (weekly ×4; biweekly ×6) with a yoga therapist in a standard consulting room. The intervention was tailored to the needs and abilities of each patient and included: breath-centred physical yoga postures, breathing and visualisation techniques, mantras and meditation, and Lifestyle/behavioural strategies. All participants completed measures to assess changes in health pre- and post-intervention (EQ-5D and HADS) and took part in a semi-structured interview in a mixed methods design. Thematic analysis was applied to interview data. <h3>Results</h3> 98/100 sessions were attended by participants. Qualitative findings indicated that considerable value was placed on the therapeutic function of the consultation, of being listened to and receiving advice on concerns. Therapeutic mechanisms appeared to reflect tailored physical practices alongside psychosocial techniques which promoted psychological wellbeing and increased perceptions of control and self-efficacy. Several reported reductions in their medication and broader benefits such as improved sleep, mood and energy. All but one participant reported positive changes to their RA symptoms, including pain reduction, greater mobility and joint flexibility. <h3>Conclusions</h3> This novel pilot YT intervention was positively received by patients with RA, with high levels of adherence to both the course of treatments and the tailored home practice. The results suggest that yoga therapy has potential as an adjunct therapy to improve RA symptoms, increase self-care behaviours and address negative mood. Whilst promising, a larger multi-centre study is required to evaluate the therapeutic and cost-effectiveness of Y-T. <h3>References</h3> [1] Chorus AM, Miedema HS, Boonen A, Van Der Linden S. (2003). Quality of life and work in patients with rheumatoid arthritis and ankylosing spondylitis of working age. Ann Rheum Dis. 62(12):1178–1184. [2] Khalsa, SB, Cohen, L, McCall, T &amp; Telles, S (2016) (Eds). <i>The Principles and Practice of Yoga in Health Care</i>. Handspring Publishing. <h3>Acknowledgements</h3> LNWH Trust Fund, CMH Rheumatology Patient Support Group,University of Westminster Department of Health Psychology. <h3>Disclosure of Interest</h3> V. Sadana Grant/research support from: Study Charity Grant NWLHT, T. Cartwright: None declared, M. Cahill: None declared, K. Anie: None declared, C. B. Colaço: None declared
Health-related quality of life (HRQoL) of pembrolizumab (pembro) vs standard of care (SOC) for recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC) in KEYNOTE-040.
Authors: Ezra E.W. Cohen, Denis Soulieres, Christophe Le Tourneau, Jose Dinis, Lisa F. Licitra, Myung-Ju Ahn, Ainara Soria, Jean-Pascal H. Machiels, Nicolas Mach, Ranee Mehra, Barbara Burtness, Misoo C. Ellison, Jonathan D. Cheng, Diana Romana Chirovsky, Ramona F. Swaby, Kevin J. Harrington
Journal: Journal of Clinical Oncology (2018)

6013 Background: In KEYNOTE-040 (NCT02252042) (N = 495), pembro 200 mg Q3W for 24 mo yielded a clinically meaningful improvement in overall survival over SOC choice of methotrexate (Mtx), docetaxel (Dtx), or cetuximab (Ctx) in patients (pts) with R/M HNSCC, with fewer grade 3-5 drug-related adverse events. We present results of prespecified exploratory HRQoL analyses. Methods: The EORTC QLQ-C30, EORTC QLQ-H&N35, and EQ-5D were administered electronically at baseline; wks 3, 6, 9; then every 6 wk up to 1 y or end of treatment; and at 30-day safety follow-up visit. HRQoL was analyzed in pts who received ≥1 dose of study drug and had ≥1 HRQoL assessment. Mean change from baseline to wk 15 was compared using a constrained longitudinal data analysis model. Time to deterioration (TTD) (defined as ≥10-point decline from baseline) was estimated by Kaplan-Meier method and Cox regression model. Results: The HRQoL population included 469 pts (241 pembro; 228 SOC). HRQoL compliance at wk 15 was 75.3% for pembro and 74.6% for SOC. From baseline to wk 15, global health status (GHS)/QoL scores were stable for pembro (least-squares [LS] mean, 0.39; 95% CI, –3.00, 3.78) but worsened for SOC (LS mean –5.86; 95% CI, –9.6 8, –2.04); difference in LS mean between arms was 6.25 points (95% CI, 1.32, 11.18; nominal 2-sided P= 0.013). Subgroup analyses by SOC choice identified a greater difference in LS mean for GHS/QoL scores with pembro vs Dtx (10.23; 95% CI, 3.15, 17.30) compared with pembro vs Mtx (6.21; 95% CI, –4.57, 16.99) or Ctx (–1.44; 95% CI, –11.43, 8.56). Median TTD in GHS/QoL with pembro vs SOC was 4.8 and 2.8 mo (HR, 0.79; 95% CI, 0.59, 1.05; nominal 1-sided P= 0.048). Pts in the pembro arm generally had stable functioning and symptom scores at wk 15; no notable between-group differences were seen. Conclusions: Over 15 wks, pembro-treated pts had stable GHS/QoL; those receiving SOC generally showed a decline. This effect was more marked for Dtx-treated pts. Additional HRQoL analyses by SOC choice will further assess trends. Along with previously presented efficacy and safety results, these data support the clinically meaningful benefit of pembro in R/M HNSCC. Clinical trial information: NCT02252042.