tbuckley/cabot-search huggingface dataset:
Ten year overview of germ cell tumours treated within the Anglian Germ Cell Cancer Collaborative Group (AGCCCG) (2005-2015): Outcomes and the impact of specialist multidisciplinary review on decision making.
Authors: Constantine Alifrangis, Wendy Ansell, Peter Wilson, Anju Sahdev, Dan Berney, Anne Warren, Danish Mazhar, Benjamin Thomas, Tristan Barrett, Sarah Maria Rudman, Susanna B. Alexander, Sara Stoneham, Jonathan Shamash
Journal: Journal of Clinical Oncology (2018)

e16538 Background: The AGCCCG is a well established UK network for the management of germ cell tumours covering a catchment area of over 7.4 million people and is hosted by St Bartholomew’s Hospital (SBH), London. Specialist review of radiology and pathology is undertaken and all management and outcomes logged on a central database. Poor risk and relapsed cases are managed centrally where there is expertise in dose intense and high dose chemotherapy. We sought to explore a recent cohort of outcomes of metastatic GCT and compare them to expected IGCCCG outcomes, and secondly to examine how the specialist review (SMDT) process changed pathology, radiology or clinical decision making. Methods: A retrospective review was undertaken of all patients discussed within the network from 2005 to 2015. Results: From 2005-2015 the network discussed 2867 cases of germ cell cancer and treated 846 cases of metastatic germ cell tumour (including 49 mediastinal). This included 583 patients with good risk disease with a 2 year PFS 91.6% and 3 year OS 95.2%. In 113 patients with intermediate risk disease the 2 year PFS was 71.2% with a 3 year OS of 78.0%. In 134 patients with poor risk the 2 year PFS was 55.7% and 3 year OS 66.5%. In the SMDT there were a total of 3206 cases reviewed by radiology centrally and 790 had central pathology review. The numbers of significant changes were 4.1 % and 18.0% respectively. There was a therapy change at the SMDT in 10% of cases. Conclusions: The survival of patients in the last 10 years in the AGCCCG compare favourably with those described by prognostic group in the IGCCCG classification, particularly notable for those presenting with poor risk metastatic disease. The specialist MDT is key to ensuring parity of clinical decision making for patients throughout the network and enables better outcomes to be achieved for patients presenting not just to specialist centres but to regional cancer centres.
Infusional gemcitabine + docetaxel/melphalan/carboplatin (GemDMC) ± bevacizumab (BEV) as an effective high-dose chemotherapy (HDC) regimen for refractory of poor-risk relapsed germ-cell tumors (GCT).
Authors: Yago Nieto, Shi-Ming Tu, Matthew T. Campbell, Roland Bassett, Nizar M. Tannir, John Francis Ward, Wayne Lewis Hofstetter, Roy B. Jones, Borje Andersson, Alison M Gulbis, Celina Ledesma, Melissa Timmons, Michelle Trapp, Richard E. Champlin, Lance C. Pagliaro
Journal: Journal of Clinical Oncology (2017)

4519 Background: Tandem HDC with carbo/etoposide (CE) is curative for a portion of relapsed GCT pts. However, outcomes of refractory or high-risk relapsed pts remain poor. We tested a new HDC regimen of GemDMC, based on DNA damage repair inhibition. We combined BEV with HDC given their potential synergy and the high vascularity of GCT metastases. Methods: Eligibility: Intermediate (int)/high-risk (Beyer Model), creatinine ≤1.8 mg/dL and adequate organ function. HDC included BEV (5 mg/kg) preceding GemDMC (HDC #1) and ifosfamide/CE (ICE) (HDC #2). Following accrual of 42 pts, we amended the trial omitting BEV. The trial was powered to distinguish a target 50% 2-yr RFS from an expected 25% in this population. Results: We enrolled 69 male pts in cohorts 1 (BEV, N=42) and 2 (no BEV, N=27) (Table). Pts were heavily pretreated and most had refractory tumors. Main AE: mucositis and renal (4 HDC-related deaths in cohort 1, 1 in cohort 2). Tumor markers normalized in 90% pts with active tumors at HDC. After HDC, 19 pts were in CR and 28 in PRm- (of these, 22 had residual lesions resected with no viable tumor found in 20/22, 2 xRT, 4 monitored). Median f/u = 39 (2-105) mo. The 2-yr RFS rates in cohorts 1 and 2 = 52% and 78%, respectively. Their respective 2-yr OS rates = 55% and 81%. Conclusions: Sequential HDC with GemDMC–ICE shows encouraging outcomes in heavily pretreated and refractory GCT, exceeding the anticipated results. Addition of BEV increases toxicity but not tumor control. Clinical trial information: NCT00936936. [Table: see text]
TCT-733 Comparision of Vascular Closure Device with Trans Femoral Approach versus Trans Radial Approach: An Updated Meta-analysis
Authors: None Sisir Siddamsetti, Udit Joshi, Sagar Ranka, Tauseef Akhtar, Senthil Balasubramanian, Srikanth Yandrapalli, Aviral Vij, Vamsi Kodumuri
Journal: Journal of the American College of Cardiology (2018)
Association of the high expressions of SOX2 and IGF-1R signaling molecules in thymic epithelial tumors with shorter overall survival.
Authors: Guk Jin Lee, Jin-Hyoung Kang, In Sook Woo, Ho Jung An, Heejung Lee
Journal: Journal of Clinical Oncology (2018)

8578 Background: Thymic epithelial tumors (TET) are consisted of thymoma(TM) and thymic carcinoma(TC). They are rare heterogeneous tumors with a broad spectrum of clinical characteristics. Although the investigations for potential markers provided some insights into the molecular biology of TET, still there is no established target and biomarker. Methods: We performed the gene microarray related to Insulin-like growth factor-1 receptor (IGF-1R) pathway in the fresh tissues (6 TMs and 5 TCs), and validated the analyzed data of expression profile with quantitative measurement of IGF1, IGF2, IGF1R, INSR, SOX2, and OCT-4 mRNA transcripts using RT-PCR. With the tumor tissues collected from 140 TET patients, we constructed the tissue microarray and did immunohistochemistry (IHC) for IGF-1R signaling-related molecules including SOX2, IGF1R, IGF-1, and pAKT. Results: The mRNA expressions of SOX2 (216 folds) and IGF-1 (5.2 folds) were notably higher in fresh tumor tissue from TC patients than TM, but no significant differences of IGF-1R, Oct-4, and INSR were found between two tumors. Among 140 TET cases, 111 cases were TM, and 29 cases were TC. The expression level of SOX2 (HR 7.57, P= 0.001) and IGF-1 (HR = 9.43, P= 0.001) were significantly higher in TC than TM. With analyzing intermolecular correlation between each molecule, there was statistically significant implications between SOX2 and IGF-1, SOX2 and pAKT (P = 0.021, P = 0.026). In univariate analysis, LDH, clinical TNM staging, WHO classification, SOX2, IGF-1R, IGF-1, and pAKT expression were significantly correlated with overall survival (OS). By multivariate analysis using forward-selection procedure, not only clinical N staging and M staging, but also positive expression of SOX2 and IGF-1 (HR 4.48, P = 0.001) were strongly correlated with OS. Conclusions: Taken together, our study shows that there are great differences between SOX2 and IGF-1 expressions between thymoma and thymic carcinoma. In thymic epithelial tumors, the expression of SOX2 has a strong relation to IGF-1 expression and their higher expressions are significantly associated with shorter overall survival and more aggressive tumor behavior.
Trends of hospitalization for multiple myeloma patients: Insights from the national inpatient sample database.
Authors: Anusha Vakiti, Bhavisha Patel, Anil Jonnalagadda, Muhamad Alhaj Moustafa, Facundo Stingo, Prerna Mewawalla, Aarthi G. Shenoy
Journal: Journal of Clinical Oncology (2018)

e20015 Background: The prevalence of multiple myeloma (MM) in the US has increased from 50,484 cases in 2002 to 118,539 cases in 2014 per the SEER database. Overall survival has improved with the advent of novel therapies. Complications from the disease can lead to hospitalization however, limited data is available about the nationwide changes in MM related hospitalizations. The main objective of our study was to analyze patient demographics, outcomes, and comorbid conditions associated with MM hospitalizations. Methods: Nationwide inpatient sample (NIS) database was used to identify MM admissions from 2002 (prior to novel therapies) to 2014 (during novel therapies) using ICD-9-CM code 203.0x as the principal discharge diagnosis. All analyses were performed using SPSS Version 20. Results: A total of 1,157,994 hospital admissions were identified. The number of hospitalizations increased from 76,414 in 2002 to 99,505 in 2014 (23.2% increase, p < 0.0001), particularly in the age group of 65 to 75 years. Males had a higher incremental increase compared to females. African Americans and Hispanics had an increased trend while Caucasians had a decreased trend in the percentage of hospitalizations. In-hospital mortality decreased from 7.9% in 2002 to 5.3% in 2014 (p < 0.0001). Mean length of hospital stay remained unchanged at 7.5 days but the mean cost of hospitalization increased from $11,898 in 2002 to $17,606 in 2014 (32% increase, p < 0.0001). The most frequent coexisting comorbidities were hypertension (51.2%), fluid and electrolyte disorders (35.3%), anemia (34.5%) and renal failure (25.6%). Conclusions: To our knowledge, this is the first study analyzing hospitalization trends in MM patients. Overall in-hospital mortality decreased but the number of hospitalizations and mean cost increased. Although the prevalence has increased by more than two folds from 2002 to 2014, hospitalization rates have increased only by 23.2%. This observed discordance is likely due to better disease control achieved by novel treatments, improvement in outpatient treatment capacity and better supportive care. The racial disparity in trends of hospitalization is unexplained and further studies are needed.
Oncocontraception in cancer care.
Authors: Erika K. Radeke, Lindsay Zimmerman, Rebecca Bridge, Megan Adam, Ashlesha Patel
Journal: Journal of Clinical Oncology (2017)

e18018 Background: Focus on fertility preservation has overshadowed other aspects of reproductive health including sexuality and contraception in cancer care. Regardless of future childbearing interest, the first 18-months post-diagnosis of cancer are considered suboptimal for childbearing. We have coined the term, oncocontraception, for the application of contraception in cancer care. To address this need at our institution, we used the novel Family Planning Quotient/Reproductive Life Index (FPQ/RepLI) which allows providers to better understand patients’ reproductive health goals and counsel them towards appropriate family planning services. These tools aid providers in implementing clinical care to prevent pregnancy during this critical time. They are routinely utilized at Stroger Hospital in the Family Planning Clinic for women within the reproductive age, between the ages of 18 and 55. Methods: FPQ and RepLI were adapted for use with oncology patients. They were used to visually depict and quantify a woman’s reproductive life plan and assist health care providers in speaking to a woman regarding family planning as it pertains to and aligns with her cancer treatment. Results: During our study period, 36 reproductive aged women were seen in our family planning clinic after a cancer diagnosis. Our study population was comprised of mostly Hispanic/Latino women (58.3.0%) and 50.0% were between the ages of 31-40. The majority of the study group had breast cancer (77.8%) and were being treated with chemotherapy (52.8%). Among the study population, 80.6% received a form of contraception (44.8% short-term, 55.2% long-term). Conclusions: We established a link between the Oncology and Family Planning Clinics to incorporate contraceptive counseling as an essential piece of comprehensive cancer care. Approximately 45% of the women newly diagnosed with cancer are in the reproductive age range. With improvements in treatments and prognosis, quality of life factors are of increasing importance for these women. With this essential clinical relationship, patient counseling and provider-patient communication regarding contraceptive care in the context of cancer diagnosis will continue to grow and improve.
Self-reported quality-of-life (QoL) impairment and productivity loss in patients with polycythemia vera (PV) enrolled in the REVEAL study.
Authors: Michael Richard Grunwald, Ralph V. Boccia, Alison Moliterno, Brady Stein, Stephen T. Oh, Ahmad Bilal Naim, Joseph A. Cordaro, Wei Peng, Hao Sun, Shreekant Parasuraman, Ruben A. Mesa
Journal: Journal of Clinical Oncology (2016)

e18561 Background: Pts with PV can have profound symptom burdens that impair QoL. Historical treatments have not demonstrated QoL improvement. The REVEAL study describes disease burden, PV management, and patient-reported outcomes (PROs) for US pts with PV. This updated and expanded analysis presents PROs for currently enrolled pts (data cutoff, 13 Nov 2015). Methods: REVEAL is a prospective, observational study enrolling adults ( ≥ 18 years [y]) with PV. PROs are collected at enrollment and every 3 mo via the 10-item Myeloproliferative Neoplasm Symptom Assessment Form (MPN-SAF; score 0 [absent] to 10 [worst]); total symptom score (TSS; 0–100); 30-item EORTC Cancer QoL Questionnaire–Core 30 (EORTC QLQ-C30; score 0–100 in 3 categories, higher score = better QoL, higher level of functioning, and worse symptom severity); and the Work Productivity & Activity Impairment Specific Health Problem questionnaire (WPAI-SHP; score 0% [minimal/no impairment] to 100% [maximal impairment/productivity loss]). Results: 1687 pts were enrolled: 54% men, 89.5% white, median age 67 y. 1552 pts completed questionnaires at enrollment. MPN-SAF moderate to severe (score ≥ 4) symptoms were reported for 72.8% of pts. Mean (SD) symptom scores were highest for fatigue 3.5 (2.7), night sweats 1.8 (2.7), early satiety 2.6 (2.7), inactivity 2.6 (2.8), itching 2.4 (3.0), and concentration problems 2.1 (2.6); mean (SD) MPN-SAF TSS was 19.1 (15.7). Mean (SD) global health status/QoL reported on the EORTC QLQ-C30 was 73.2 (23.4); functional subscales were as follows: cognitive 80.7 (24.2); emotional 80.9 (23.8); physical 83.5 (19.8); role 85.0 (25.2); and social 85.7 (24.3). Of 575 pts employed at enrollment, mean (SD) PV-related WPAI-SHP scores were absenteeism 3.0% (11.9%); presenteeism 12.2% (20.8%); work productivity loss (absenteeism and presenteeism) 13.6% (22.5%); and activity impairment 19.6% (26.6%). Conclusions: Patients enrolled in REVEAL have high symptom burdens leading to notable physical and emotional QoL impairment and considerable work productivity loss due to PV. Longitudinal PRO assessments in REVEAL can help examine QoL changes over time and should be used in routine clinical practice. Clinical trial information: NCT02252159.
Tumour response and survival of treatment-naïve head and neck cancer patients treated with nimotuzumab: A systematic review and meta-analysis.
Authors: Sundaram Subramanian, Naresh Somani, Shyam Ji Rawat, Sridharan Nithya, Ashwani Marwah, Sameer Chaudhari
Journal: Journal of Clinical Oncology (2018)

e18083 Background: Several trials have studied the efficacy of Nimotuzumab in head and neck cancer. However, they are limited by small sample size and varying results. The purpose of this meta-analysis was to assess the efficacy of nimotuzumab in the treatment of previously untreated, unresectable locally advanced head and neck cancer (HNC) patients. Methods: A systematic literature search was performed in the databases of PubMed, Cochran Library and Google scholar from January 2000 to January 2018. Trials involving nimotuzumab in previously untreated, unresectable locally advanced head and neck cancer patients were included. Trials of oral cavity, oropharynx, hypopharynx and larynx were included while trials of other tumour locations such as nasopharynx were excluded. Trials were further divided in two groups according to the concomitant treatment given: Nimotuzumab with chemoradiotherapy (CCRT) or radiotherapy (RT). Meta-Analysis was performed to estimate effect size on complete response (CR), overall response rate (ORR) and overall survival (OS) using Meta Analyst statistical software with both DerSimonian-Laird and Fixed effect Meta analytical models. Heterogeneity was tested using Cochran Q heterogeneity test and if exist tackled by random effect model. Results: Thirteen trials with a total of 584 patients (Median sample size = 39, IQR = 23 - 57) which met the inclusion criteria were considered in this meta-analysis. In patients treated with nimotuzumab and CCRT; CR, ORR and 5-year survival rate were 61.90% (95% CI: 53.7 - 69.4), 83.7% (95% CI: 71.8 – 91.2), 55.7% (95% CI: 47.0 – 64.0), respectively. In patients treated with nimotuzumab and RT; CR and ORR were 67.6% (95% CI: 57.7 – 76.2), 78.8% (95% CI: 59.6 – 90.3), respectively. Conclusions: In the management of treatment-naïve head and neck cancer patients, addition of nimotuzumab has shown to be efficacious in terms of tumour response as well as long term survival. Comparing these outcomes with conventional treatment will draw conclusive inference.
Phase 2, open-label study of CUDC-907 with and without rituximab in patients with relapsed/refractory MYC-altered diffuse large B-cell lymphoma.
Authors: Daniel Jeffrey Landsburg, Kevin Kelly, Jaye Viner, Jing Wang, Lucy Gong, Myles Steven Clancy, Anna W Ma, Yasuhiro Oki
Journal: Journal of Clinical Oncology (2016)

TPS7579 Background: The prognosis for patients (pts) with relapsed and/or refractory (RR) MYC-altered DLBCL is dismal as they are often ineligible for or progress following autologous stem cell transplantation (ASCT) and respond poorly to subsequent therapies. Pharmacologic inhibition of HDAC and PI3K pathway activities has been shown to suppress MYC-driven oncogenic activities and represents a therapeutic option for these pts. In cultured MYC-dependent DLBCL cell lines, treatment with CUDC-907, an oral inhibitor of class I and II HDAC and class I PI3K enzymes, results in a rapid and dramatic decrease in MYC protein levels at single-digit nM concentrations. In a Phase 1 study, pts with RR DLBCL treated with CUDC-907 achieved objective responses, including complete responses (CRs), in a subset of pts with MYC-altered disease. The ongoing Phase 2 study is designed to demonstrate efficacy of CUDC-907 in treating pts with MYC-altered RR DLBCL. Methods: Up to 120 pts with RR DLBCL who have MYC-altered disease, per local or central testing, will be enrolled to receive either CUDC-907 alone or in combination with rituximab. Within each treatment cohort (n = ~60), data will be analyzed based on MYC status as determined by central testing: MYC translocation and/or gene copy number gain by FISH, and/or ≥ 40% of cells scored as MYC protein expression positive by IHC, or MYC negative in all 3 assays in case of discordance between local and central testing. Other key eligibility criteria include: Age ≥ 18 years, ECOG score ≤ 2, ≥ 2 prior lines of therapy, and ineligible for/failed prior ASCT. All pts will take 60 mg of CUDC-907 orally once a day on a 5 days on/2 days off schedule in 21-day cycles. Pts assigned to the combination arm will also receive rituximab 375 mg/m2 IV on Day 1 of each cycle for the first 6 cycles. Response will be evaluated every other cycle per Cheson criteria by central review and survival assessments will occur every 12 weeks. The primary endpoint is ORR; secondary endpoints include DOR, PFS, median and 6-month PFS, and OS. Other disease associated biomarkers, including BCL-2 and BCL-6, will also be evaluated. Clinical trial information: NCT01742988.
TCT-300 Feasibility and Clinical Impact of Esophagogastrodudenoscopy within 7 Days in Patients Receiving Coronary Stent due to ST-segment elevation myocardial infarction
Authors: Sang Min Park, Minsu Kim, Woong Chol Kang, Chungwon Ko, Kyung-Soon Hong
Journal: Journal of the American College of Cardiology (2018)
Leading the way: The National Cancer Institute’s (NCI) single IRB for multi-site research.
Authors: Holly A. Massett, Jacqueline Goldberg, Sharon Hampp, Margaret M. Mooney, Brian Campbell, Suma Narasimhaswamy, Grace Mishkin, Ravi Rajaram, Laura Covington, Michael Montello, Andrea Denicoff, Martha Kruhm, Jeffrey S. Abrams
Journal: Journal of Clinical Oncology (2017)

e18259 Background: NCI instituted a Central IRB (CIRB) with voluntary participation in 2001 for its late-phase trials and demonstrated that efficiency could be improved and costs reduced (Wagner et al JCO, 2010; 28). As a forerunner to the new NIH policy for single IRBs for all NIH multi-site trials (Hudson et al. JAMA Oct 4, 2010), NCI implemented a new CIRB model in 2014 where the CIRB was the IRB of record. We report adoption data of the new model within NCI’s National Clinical Trials Network (NCTN) and lessons learned from the rollout. Methods: We reviewed: Annual CIRB participant data from 2013-2016; site/accrual data for late phase trials activated between 2013-2016 (N = 64) via CIRB or local IRBs; and data from CIRB reports to identify acceptance and lessons learned. We compared time required for CIRB protocol reviews via the new model to baseline measures in the literature. Results: Of the 2,300 U.S. NCTN sites, the percentage of participation went from 47% in 2013, to 74% (2014), 79% (2015), and 81% (2016). For activated trials, a median of 43% of sites used their local IRB in 2013, dropping to 18% in 2014, 5% in 2015, and only 1% in 2016; i.e., 99% of sites opening trials in 2016 did so using the CIRB. Annual accrual to NCTN trials remained steady through the CIRB adoption; CIRB sites represented a median of 56% of total accrual in 2013 increasing to 87% in 2016. Help-desk and survey data indicate increased acceptance and a reduction of concerns over the 3 years. Previous analyses prior to 2013 reported a median of 70-123 days required from protocol application receipt to final CIRB approval; the new model reports a median of 41 days in 2016. Conclusions: NCI has demonstrated that a single IRB for multi-site trials is not only viable but valuable. Its new CIRB model rollout over 3 years has resulted in a doubling of site adoption, high utilization rates, further efficiencies, and overall acceptance, with no noticeable effect on overall NCTN accrual. Our experiences provide important lessons learned and insights into the successful implementation of a single IRB at a national level, and support the feasibility of NIH’s recently finalized policy requiring all sites to use a single IRB for multi-site research.