tbuckley/cabot-search huggingface dataset:
Abstract 17894: Variation in Management of Single Ventricle Patients Undergoing Elective Cardiac Catheterization: a Report from the Congenital Cardiac Catheterization Project on Outcomes (C3PO)
Authors: Bryan H Goldstein, Laurie B Armsby, Sara M Trucco, Diego Porras, Joshua J Murphy, Susan R Foerster, Robert H Beekman, Lisa Bergersen
Journal: Circulation (2014)

Introduction: Variation in management surrounding cardiac catheterization (cath) in patients with single ventricle (SV) heart disease has not been rigorously described and is necessary to inform future quality improvement efforts and evidence-based guideline development. Objectives: To assess institutional variation in SV cath management. Methods: Patient and procedural characteristics related to elective SV cath were collected prospectively from 8 centers using a web-based multicenter registry (Congenital Cardiac Catheterization Project on Outcomes). Non-elective cases, those performed <30 days from cardiac surgery, <30 days of age, or in infants receiving prostaglandin therapy were excluded. Cases were stratified by stage of SV palliation (pre-bidirectional cavopulmonary anastomosis (pre-BCPA), pre-Fontan and post-Fontan) for analysis. Institutional variation was assessed. Results: Between 2/2007 and 6/2010, 1568 elective SV cath procedures met criteria for study inclusion, including 395 pre-BCPA, 611 p...
Physicians’ perspectives on multidisciplinary (MD) lung cancer care in a community-based hospital setting.
Authors: Satish Kedia, Kenneth Daniel Ward, Codruta Andy Collins, Siri Alicia Digney, Bianca Michelle Jackson, Fedoria Elaine Rugless Stewart, Nicholas Ryan Faris, Kristina S. Roark, Raymond U. Osarogiagbon
Journal: Journal of Clinical Oncology (2016)

6544 Background: The MD care model is recommended to improve the quality of lung cancer care, which is complex and involves multiple specialties. Physicians’ feedback on the management of lung cancer care is essential to improve the quality of care for lung cancer patients. Methods: We conducted focus groups with lung cancer specialists (pulmonologists, surgeons, medical oncologists, radiation oncologists, primary care physicians, hospitalists, and ER doctors) from both multidisciplinary and traditional clinical settings. Grounded Theory methodology guided the identification of recurrent themes that emerged from qualitative data analysis using Dedoose software. Results: 37 physicians participated in 9 focus groups. Almost all physicians agreed that the MD model could be beneficial for patients in terms of receiving high quality, efficient, and well-coordinated care. However, many felt that co-location was not an optimal use of their time and resources. Financial disincentives and time constraints were identified as major deterrents to full participation in a MD clinic. Several physicians were concerned that a MD clinic could compromise their referral base, and impact their own practice. Another perceived barrier was the challenge of integrating a MD care model into the existing health care system, which may not be positioned to provide co-located services efficiently. The team-based approach of MD care raised some uncertainty about who would be designated as the primary physician responsible for a patient’s care, and make final decisions about treatment. Suggested ways to improve implementation of the MD model included educating physicians about the availability of an MD clinic, establishing efficient processes for initial consultations, implementing technology for virtual participation, and using a nurse navigator with reliable closed-loop communication. Conclusions: Physicians generally agreed that the multidisciplinary model could improve lung cancer care, but they perceived significant personal, institutional, and system level barriers that need to be addressed in order to implement a MD system in a community healthcare setting succesfully.
Postradiation ctDNA status as a prognostic factor in locally advanced esophageal squamous cell carcinoma.
Authors: Ru Jia, Pansong Li, Chuanhua Zhao, Yan Wang, Rongrui Liu, Lianpeng Chang, Yanfang Guan, Xin Yi, Jian-Ming Xu
Journal: Journal of Clinical Oncology (2018)

e16053 Background: Esophageal squamous cell carcinoma (ESCC) is one of the most malignant tumors with high mortality. Radiation therapy (RT) is currently one of the main treatments to ESCC. Circulating tumor DNA (ctDNA) in peripheral blood, containing tumor genetic alteration information, has been confirmed a potential noninvasive biomarker for various cancer types. Therefore, we investigated the clinical implications of ctDNA in ESCC patients receiving RT. Methods: Locally advanced ESCC patients who underwent radical RT from July 2013 to May 2016 were enrolled. Serial plasma samples were collected pre- and post-RT at every visit until recurrence or metastasis, and used for cell-free DNA (cfDNA) extraction. A customized panel of 180 genes was designed including ESCC common driver genes. Next-generation sequencing (NGS) was performed to identify somatic mutations and mutation spectrum pre- and post-RT was compared. Results: Sixty-seven baseline and postradiation plasma samples were collected from 24 ESCC patients. Fifty-eight non-silent single nucleotide variants (SNVs) occurred in 33 genes were identified and at least one mutation was detected from baseline sample of each patient. The most frequent mutant genes were TP53, NOTCH1, CCND1, CDKN2A, ERBB2 and NOTCH2. However, in 45.8% (11/24) patients, mutations were not detected (ctDNA mutation negative) post-treatment especially NOTCH1 was undetectable in all patients. There were no differences in both DFS and OS between patients with one mutation and more mutations at baseline (reflecting tumor burden). ctDNA mutation positive patients at first post-treatment timepoint had a trend of reduction in DFS (p = 0.068) and significantly decrease in OS (P = 0.005) than ctDNA mutation negative patients. Dynamic monitoring ctDNA could also be used as a biomarker for predicting efficacy of RT and detecting recurrence. Conclusions: ctDNA is detectable both before and after RT in locally advanced ESCC patients. ctDNA status at first postradiation timepoint could be an independent prognostic factor for locally advanced ESCC patients.
Phase I/II randomized trial of GM.CD40L vaccine plus/minus CCL21 in advanced lung adenocarcinoma: Final results.
Authors: Jhanelle Elaine Gray, Alberto Chiappori, Charles C. Williams, Tawee Tanvetyanon, Eric B. Haura, Ben C. Creelan, Rebecca D. Devane, Renee Smilee, David Noyes, Jongphil Kim, Scott Joseph Antonia
Journal: Journal of Clinical Oncology (2016)

9037 Background: Our GM.CD40L vaccine (an allogeneic tumor cell-based vaccine generated from human bystander cell line) recruits and activates dendritic cells, which then migrate to regional lymph nodes, where T-cell activation occurs, leading to systemic tumor cell killing. The CCL21 chemokine helps to recruit T cells and leads to enhanced T-cell responses. The GM.CD40L.CCL21 combination has demonstrated additive effects in NSCLC mouse models. Methods: We initiated a phase I/II randomized study with plans to evaluate GM.CD40L (Arm A; n = 32) vs. GM.CD40L.CCL21 (Arm B; n = 35) in patients with lung adenocarcinoma who had failed first-line therapy. Primary endpoints were safety/tolerability of Arm B in phase I and progression-free survival (PFS) in phase II; secondary endpoints included anti-tumor immune responses/T-cell responses by ELISpot assay on PBMC and tissue correlates. Intradermal vaccines were administered every 14 days for 3 doses and then monthly X3. A two-stage minimax design with a 10% type I and II error rate was used. Results: Between 4/2012 and 1/2016, in phase I, 3 patients were treated with GM.CD40L.CCL21 (no dose-limiting toxicities occurred), followed by enrollment of 37 patients in Arm A and 33 patients in Arm B. Including those in phase I, median age was 66/67 years; females: 47.5%/57.5%; PS1: 66%/66%, median prior regimens: 2.5/3 for Arm A vs. Arm B. Most common toxicities for Arm A vs. Arm B were injection site reaction (30%/46%) and fatigue (22%/20%). Median PFS/OS for Arm A vs. B was 2.4/9.3 vs. 3.1/9.4 months (p = 0.44/0.54). Of patients evaluable for efficacy per RECIST v1.1, 48% vs. 38% had stable disease and 52% vs. 62% had progressive disease for Arm A vs. Arm B, respectively. All 9 patients who remained on treatment after progression demonstrated confirmed progression on subsequent scans and treatment was stopped. Blood and tissue correlate studies are underway. Conclusions: GM.CD40L.CCL21 vaccine was well tolerated but did not clearly improve outcomes over the GM.CD40L vaccine. In a heavily pretreated, unselected NSCLC population, the median OS of GM.CD40L vaccine was similar to single-agent nivolumab. A clinical trial of anti-PD1 plus/minus GM.CD40L is planned. Clinical trial information: NCT01433172.
Minocycline to reduce cancer pain in patients with multiple myeloma: A phase II randomized trial.
Authors: Xin Shelley Wang, Charles S. Cleeland, Qiuling Shi, Seema Prasad, Raza H Bokhari, Robert Orlowski
Journal: Journal of Clinical Oncology (2017)

10100 Background: Patients with multiple myeloma (MM) experience substantial pain that may be from disease and/or post autologous stem cell transplant condition, and exacerbated by maintenance therapy. Minocycline is a readily available, low-cost antibiotic with anti-inflammatory properties. We conducted a phase II randomized, double-blinded, placebo controlled clinical trial to investigate the effect of minocycline in reducing patient-reported symptoms during maintenance therapy. Methods: Adults with MM scheduled for maintenance therapy at a single-institution were consented and randomized to receive either minocycline (100 mg twice daily) or placebo over the first 3 cycles maintenance therapy. Feasibility, toxicity, and patient-reported outcome data were prospectively collected. The MD Anderson Symptom Inventory-MM (0–10 scale) was used to assess pain and other symptoms weekly during 3 months trial. The longitudinal analysis for pain was compared between the minocycline and control groups to examine minocycline’s efficacy. Results: From April 2013 to Aug 2016, 88 patients were enrolled and 69 (78%) were evaluable: 33 were randomized to minocycline and 36 to placebo. There were no grade 3+ study medication-related adverse events. The worst 5 symptoms on MDASI-core during the trial were fatigue, pain, numbness/tinging, drowsiness, and disturbed sleep, followed by two MM module item bone aches and muscle weakness. Demographic and disease characteristics were not significantly different between groups. Longitudinal modelling of revealed a significant reduction on pain in minocycline group than placebo group (time and treatment group interaction, estimate=-0.068, P=.003). The favorite pain reduction in minocycline group vs placebo arm was represented by a moderate effect size (Cohen’s d =0.48). Conclusions: Minocycline during maintenance therapy for MM was feasible, had a low toxicity profile, and yielded a statistically significant positive signal on pain reduction. These preliminary results are encouraging and warrant a Phase III trial to test its efficacy. Clinical trial information: NCT01793051.
Racial disparities in surgical management and survival in hispanic patients with potentially resectable esophageal cancer.
Authors: Dave Gupta, Yuan Liu, Renjian Jiang, Felix Fernandez, Seth Force, Allan Pickens, Conor Ernst Steuer, Mark William McDonald, Kristin Ann Higgins, Jonathan Jay Beitler, Suresh S. Ramalingam, Dong Moon Shin, Taofeek Kunle Owonikoko, Nabil F. Saba
Journal: Journal of Clinical Oncology (2018)

4027 Background: Practice patterns for potentially resectable disease are highly variable due to limited objective data to guide optimal management. Expanding on the well-known disparity in mortality among Black and White patients with esophageal cancer, we explored differences in epidemiology, tumor characteristics, surgical resection, and mortality for Hispanic and White patients with locoregional disease. Methods: Using the Surveillance, Epidemiology, and End Results (SEER) registry, we identified 6,250 cases of locoregional esophageal cancer (Stage I-III) occurring in Hispanic (n = 575) or White patients (n = 5675) between ages 18 and 65 (2003-2014). Cases were categorized by age, gender, education, tumor grade, histology, primary tumor site, and surgical status. Postdiagnosis survival was examined over time and compared by race and stratified by surgical status. Results: Hispanic patients with locoregional esophageal cancer are significantly less likely to receive surgery than White patients (46% vs 60%; p < 0.001), despite having comparable demographics (age, gender, income) and tumor characteristics (grade, histology, and primary site). There was a statistically significant difference in survival, with median OS of 22 months vs 29 months and long-term survival at 8 years of 24% vs 29% (p = 0.01) for Hispanics and Whites respectively. Patients who did not receive surgery had universally poor outcomes, with median OS of 15 vs 12 months and 8-year-survival of 15% vs 13% (p > 0.10). Patients treated with surgery had better overall survival with median OS of 40 vs 55 months and 8-year-survival of 35% vs 40% (p = 0.11), despite similar 1-year-survival of 83% vs 85%. Conclusions: Hispanic esophageal cancer patients experience higher mortality and use lower rates of potentially curative surgical management compared to White patients. These data support the need to better address patient barriers to surgical treatment and systemic biases present in medical care.
Impact of chemotherapy provided to patients late in life on resource utilization and cost of care.
Authors: Jennifer Webster, Jeff Scott, Kjel Andrew Johnson
Journal: Journal of Clinical Oncology (2018)

e22014 Background: Previous studies have consistently shown that chemotherapy is administered to a third of patients in the last month of life and to a fifth of patients in the final 14 days of life. The recent societal focus on providing appropriate palliative and end-of-life care suggests a reduction in the administration of late in life chemotherapy should be occurring. This study measured the proportion of patients who received chemotherapy in the last month or 14 days of life and the differences in resource utilization and total cost of care between patients who did and did not receive chemotherapy late in life. Methods: We evaluated 85,554 Medicare Oncology Care Model patients treated in the community care setting. Patients were included in the study if they had been diagnosed with cancer, had received at least one dose of chemotherapy between July 1, 2016 and December 31, 2016, and subsequently died within six months. Of this subset, patients were evaluated for chemotherapy administration in the final month or 14 days of life, admission to and number of days in hospice, admission to a hospital or intensive care unit (ICU) in the final month life, and total Medicare reimbursement for the six-month period initiated by chemotherapy. Results: 5,446 patients met the inclusion criteria and 1,677 (30.8%) and 983 (18.0%) received chemotherapy in the last month and 14 days of their life, respectively, with last 14 day chemotherapy administration similar between men and women (18.6% v 17.4%, p = ns). Patients not receiving chemotherapy in the last 14 days of life were more likely to be admitted to hospice (71.2% v 45.5%, p < .05), averaged more days in hospice (13.9 v 3.8 days, p < .05), and were less likely to be hospitalized (54.4% v 67.2%, p < .05) or to be admitted to an ICU (28.9% v 38.1%, p < .05). In addition, patients without chemotherapy in the last month life had lower total cost of care for the six-month periods initiated by chemotherapy ($23,039 v $25,123, p < .05). Conclusions: The proportion of patients receiving chemotherapy late in life has not changed over time. Resource utilization and overall cost of care is higher in these patients.
Endobronchial ultrasound-guided transbronchial needle aspiration versus cervical mediastinoscopy in lung cancer diagnosis and mediastinal staging: A retrospective comparison study.
Authors: Rong Zhang, Yuxiang Ma, Guoliang Xu, Xiaoyan Gao, Guangyu Luo, Qingguang Lin, Yunpeng Yang, Xin Wang, Li Zhang
Journal: Journal of Clinical Oncology (2017)

e20066 Background: Invasive mediastinal lymph node staging is essential for resectable lung cancers. This retrospective study compares the diagnosis yield of endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) and cervical mediastinoscopy (CMS). Methods: Consecutive patients were analyzed from Jan 2009 to March 2016. Only pathologically confirmed results were accepted, and systematic mediastinal lymphadenectomy (SML) were used as the standard. The disease diagnosis and N stagingaccuracywere compared in this study. Results: 103 EBUS-TBNA patients and 232 CMS patients were included, 1014 mediastinal lymph nodes were biopsied in lung cancer patients. In per case analysis, there was no significant differences between EBUS-TBNA and CMS in disease diagnosis accuracy (89.4% vs. 81.2%, P = 0.097), and no significant difference in N staging accuracy (75.0% vs. 78.3%, P = 0.629). However, EBUS-TBNA had significantly higher disease diagnosis sensitivity than CMS (82.4% vs. 47.6%, P &lt; 0.001). In lymph nodes diagnosis comparison (station #2, #4 and #7), both EBUS-TBNA and CMS showed very high accuracy, sensitivity, and specificity (94.7% vs. 99.6%, 88.6% vs. 94.8%, 97.2% vs. 100%), however CMS were slightly better. Positive lymph nodes had longer major and minor axes than negative nodes, and the positive rateswere as high as 59.2% in lymph nodes with a minor axis measuring ≥21mm. More complications and injuries were found in patients receiving CMS. Conclusions: For clinically suspected lung cancers, both EBUS-TBNA and CMS are favorable options for invasive mediastinal staging. EBUS-TBNA may be preferred for its higher disease diagnosis sensitivity and fewer complications.
Phase II study of maintenance pembrolizumab (pembro) in extensive stage small cell lung cancer (ES-SCLC) patients (pts).
Authors: Shirish M. Gadgeel, Jaclyn Ventimiglia, Gregory Peter Kalemkerian, Mary J. Fidler, Wei Chen, Ammar Sukari, Balazs Halmos, Julie Boerner, Antoinette J. Wozniak, Cathy Galasso, Nathan A. Pennell
Journal: Journal of Clinical Oncology (2017)

8504 Background: The median progression free survival (PFS) and overall survival (OS) following initial chemotherapy in ES-SCLC pts are 2 and 7 months, respectively (Ready N, J Clin Oncol 2015). We evaluated the benefits of maintenance pembro in ES-SCLC pts who had response/stable disease after 4-6 cycles of platinum/etoposide. Methods: Pts were required to begin pembro within 8 weeks of completion of chemotherapy, with restaging scans no more than 3 weeks prior to start of pembro. Prophylactic cranial radiation was permitted. Pts were treated with pembro 200 mg I.V. every 3 weeks for a maximum of 2 years. Disease assessment was done every 2 cycles for the first 6 cycles and then as per investigator discretion. Primary end point of the study was PFS. PFS according to immune related response criteria (irPFS) and OS were also assessed. Tumor tissue was analyzed for PD-L1 expression by the DAKO 22C3 antibody. Any level of expression was considered as positive for PDL1. Blood for circulating tumor cells (CTCs) was collected prior to first, second and third cycle of pembro. Results: Of the 45 pts enrolled, 55% were males and 22% had brain metastases. Median age was 66 years. The median time from end of chemotherapy to start of pembro was 5 weeks. Median number of pembro cycles was 4 (1-20 cycles). 35 pts had measurable disease at study entry. The disease control rate with pembro was 42% (1 CR, 3 PR, 15 SD). At a median follow up of 6 months, the median PFS was 1.4 months (90% CI-1.3-4.0) and the irPFS was 4.7 months (90% CI- 1.8-6.7). The median OS was 9.2 months (90% CI-6.1-15.2). 11 pts are still on therapy (3-20 cycles). The median CTC prior to pembro was 1 (0-256, n=37 pts). Each unit increase in baseline CTC correlated with worse PFS (p = 0.052; adjusted for brain mets, age and sex). PDL1 could be assessed in 35 pts and was positive in 1 pt. Most common adverse events were fatigue, nausea, cough and dyspnea. One pt developed atrio-ventricular conduction block and 1 pt type 1 diabetes. Conclusions: Maintenance pembro did not improve PFS in these patients but favorable OS suggests that some SCLC patients can benefit from maintenance pembro. Biomarkers to identify patients most likely to benefit from pembro need to be defined. Clinical trial information: NCT02359019.
Overall survival (OS) achieved with gemcitabine (G) or gemcitabine-abraxane (GA) in patients (pts) with advanced pancreatic ductal adenocarcinoma (PDAC) who received first line modified FOLFIRINOX (m-FFX) palliative chemotherapy.
Authors: Kyaw Lwin Aung, Sean Creighton, Adriana Fraser, Anna Dodd, Shari Moura, Hamzeh Albaba, Grainne M. O'Kane, David W. Hedley, Neesha C. Dhani, Jennifer J. Knox
Journal: Journal of Clinical Oncology (2017)

e15715 Background: The standard second line treatment in advanced PDAC pts after m-FFX first line palliative chemotherapy is not clearly defined. G is the standard 2 nd line treatment in Canada and GA can only be prescribed for pts with a private fund or private drug plan that covers the cost of Abraxane. More data is needed to establish OS achieved with 2 nd line G or GA. Methods: The OS of PDAC pts treated with G or GA after m-FFX palliative chemotherapy given between 01-Dec-2011 and 30-Nov-2015 at the Princess Margaret Cancer Centre (PM), Toronto, Canada were retrospectively reviewed. OS was calculated from date of commencement of 2 nd line treatment until death or date of last oncology follow up. Results: Over the 4-year study period, 132 pts were treated with 1 st line palliative m-FFX at PM. Of them, at disease progression, 78 (59%) pts received a 2 nd line therapy (50 G, 17 GA, 9 clinical trials, and 2 other). The results including demographics, treatment details and survival outcomes of patients treated with G and GA are summarized in the Table 1. Conclusions: Our results do not support single agent G after m-FFX 1 st line palliative chemotherapy as median duration of treatment was too short and OS observed with G in this setting is very much limited. The median duration of treatment on GA and OS achieved with GA seem superior but sample size was too small to make a conclusion. [Table: see text]