bluuebunny/crossref_metadata_2025_split huggingface dataset:
Correlation of Epstein-Barr virus-specific cytotoxic T lymphocyte precursors (EBV-CTLp) after tabelecleucel with response and survival in rituximab relapsing or refractory EBV+ post-transplant lymphoproliferative disease (PTLD).
Authors: Aftab Blake T. , Shen Rhine R. , Guzman-Becerra Norma , Sun Yan , Forozan Farahnaz , Prockop Susan , Doubrovina Ekaterina , O'Reilly Richard J. , Li Xiaoming , Hiremath Minoti , Gamelin Laurence , Navarro Willis H. 
Published: February 2020

38 Background: EBV+ PTLD is often a fatal disease. Tabelecleucel is an investigational off-the-shelf, allogeneic T-cell immunotherapy specific for EBV antigens. Functional in vivo expansion approximated by a limiting dilution analysis of EBV-CTLp has previously been correlated to clinical response. Methods: We conducted analyses of reported peak circulating EBV-CTLp levels following tabelecleucel administration in correlation to response and safety across two studies (N=42) in rituximab refractory or relapsing EBV+ PTLD following HCT or SOT. Results: Two cohorts were defined by the lowest EBV-CTLp quartile (n=11) and the combined upper 3 quartiles (n=31). Twenty-five of 31 subjects (80.6%) in upper quartiles exhibited a clinical response compared to 3 of 11 subjects (27.3%) in the lowest quartile. Eighteen of 20 complete responses and 7 of 8 partial responses demonstrated peak CTLp values in the upper quartiles of the population. Overall survival (OS) rate in subjects exhibiting CTLp values in the upper quartiles was 83.9% (95% CI: 65.5-92.9%) at 1 year and 66.1% (95% CI: 45.9-80.2%) at 2 years, compared to 18.2% (95% CI: 2.9-44.2%) in the lowest quartile over the same periods. OS is commensurate with a hazard ratio of 0.168 in favor of subjects with higher EBV-CTLp (95% CI: 0.067-0.425; Log-Rank Test p-value <0.001). Subjects demonstrating clinical responses experienced median CTLp values of 36.2 CTLp/ml (15.6-155 interquartile range), whereas non-responders exhibited significantly lower (p=0.001, based on Wilcoxon Rank Sum test) median CTLp of 0.07/ml (0.01-5.5 interquartile range). Tabelecleucel was well tolerated across both studies, with a safety profile in each group consistent with the underlying clinical condition of patients. Conclusions: These analyses illustrate the correlation of peak EBV-CTLp to clinical benefit in subjects receiving tabelecleucel. Significant correlation of EBV-CTLp with ORR and OS are consistent with potential use as a functional biomarker for the expansion of EBV-specific T-cells in the treatment of EBV+ PTLD in the rituximab refractory/relapsing setting. Clinical trial information: NCT01498484.
Impact of cachexia in advanced NSCLC patients treated with PD-1 inhibitor.
Authors: Jo Hitomi , Horinouchi Hidehito , Yagishita Shigehiro , Shinno Yuki , Okuma Yusuke , Yoshida Tatsuya , Goto Yasushi , Yamamoto Noboru , Ohe Yuichiro 
Published: February 2020

44 Background: Cancer cachexia is known to a multifactorial catabolic syndrome and is observed 15-40% in general cancer population with worse prognosis. A recent study suggested a shorter survival period in non-small cell lung cancer (NSCLC) patients with a higher pembrolizumab clearance associated with cachexia. We here conducted analyses for the clinical impact of cachexia in advanced NSCLC treated with pembrolizumab. Methods: We evaluated consecutive advanced NSCLC patients who received pembrolizumab between March 2017 and December 2018 at the National Cancer Center Hospital. Cachexia was defined as a body weight loss >5% over the past 6 months or >2% in patients with a BMI <20 kg/m2 at the start of treatment. Information on patient age, sex, performance status, histology, driver mutation status, smoking status, disease stage, treatment line, and PD-L1 tumor proportion score were recorded. The overall response rate (ORR), progression-free survival (PFS) and overall survival (OS) were investigated according to the presence of cachexia. Univariate and multivariate analyses were performed. Results: A total of 157 NSCLC patients received pembrolizumab during the study period. Of these, 134 patients with information for body weight were included in the final analysis. Patients with cachexia accounted for 35% (47 out of 134) of this cohort. The ORR was 38% among the patients with cachexia and 35% among those without cachexia. The median PFS was significantly shorter for the patients with cachexia than for the patients without cachexia (median PFS, 4.2 months vs. 7.1 months; hazard ratio, 1.63; 95% confidence interval, 1.06 – 2.53; P = 0.02). The median OS was significantly shorter for the patients with cachexia (median OS, 8.6 months vs. NR; hazard ratio, 1.83; 95% confidence interval, 1.03-3.25; P = 0.04). The presence of cachexia was independently associated with a shorter PFS in a multivariate analysis. Conclusions: The presence of cachexia was significantly associated with a shorter PFS and OS in our study cohort. Screening for cachexia may help to identify patients who are more likely to achieve a durable response.
Prognosis of patients developing immune-related adverse events with immune checkpoint inhibitors in melanoma influenced by the ability to resume therapy.
Authors: Song Jung Min , Behera Tapas Ranjan , Demski Kathryn , Yurco Ann , Patil Pradnya Dinkar , Funchain Pauline 
Published: February 2020

61 Background: Immune checkpoint inhibitors (ICPis) have improved survival in melanoma patients, however their use is associated with 5-60% patients experiencing severe immune related adverse events (irAEs). Severe irAEs may affect survival benefit imparted by ICPis. Objective: We aimed to analyze disease outcomes with resumption of immunotherapy as compared to non-resumption of immunotherapy in patients with severe irAEs (Grade 3/4 in CTCAE v5.0). Methods: Patients with melanoma being treated with ICPis who developed severe irAEs were discussed in an institutional irAE tumor board (TB). We analyzed all patients discussed in TB from September 2017 to September 2019 for cancer outcome of withholding versus resuming immunotherapy in the face of severe irAEs. Results: Out of 26 total patients with melanoma discussed in TB, 23 had severe irAE. Colitis was the most common irAE 9/23 (39.1%) followed by 2/23 (8.7%) of pneumonitis and hepatitis each. ICPi was resumed in 8 patients (resume group) (median age 53, range 42-67) and withheld in 15 patients (non-resume group) (median age 57, range 42-91). In the resume group all 8 patients (100%) are alive, of which 2/8 (25%) had disease progression (median follow up 106.5wk, range 35wk-131wk); whereas, in the non-resume group 9/15 (60%) progressed, of which 6/15 (40%) died (median follow up 91wk, range 3wk-197wk). Conclusions: Our data suggest that the ability to resume ICPi after an episode of severe irAE is associated with better prognosis in terms of disease progression and survival. Immunotherapy being the mainstay of the management in metastatic melanoma, inability to resume therapy is associated with worse prognosis. Timely management of irAEs should be prioritized in order to resume treatment.
Radiomics to predict response to pembrolizumab in patients with advanced rare cancers.
Authors: Colen Rivka R. , Ahmed Sara , Elshafeey Nabil , Karp Daniel D. , Pant Shubham , Subbiah Vivek , Piha-Paul Sarina Anne , Hong David S. , Yap Timothy A , Fu Siqing , Tsimberidou Apostolia Maria , Stephen Bettzy , Gong Jing , Rodon Ahnert Jordi , Naing Aung 
Published: February 2020

66 Background: To predict responders versus non-responders to Pembrolizumab, an anti PD-1 monoclonal antibody, in patients with advanced rare cancers. Methods: The study included 58 patients with advanced rare cancers (eg. squamous cell carcinoma of the skin, adrenocortical carcinoma, carcinoma of unknown primary, and paraganglioma) who were enrolled in a phase 2 trial of Pembrolizumab. Tumor response was evaluated using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. Patients were categorized into: 21 responders (stable disease, partial response, and complete response) and 37 non-Responders (progressive disease). Target lesion(s) obtain from standard-of-care, pre-treatment contrast enhanced CT scans were segmented using 3D slicer v4.8.1. A total of 610 features (10 histogram-based and 600 second-order texture features) were calculated from each extracted volume of interest (VOI). Radiomic features were obtained using a feature selection approach based on Least Absolute Shrinkage and Selection Operator (LASSO). Selected features were used to build a classification model, using XGboost, for prediction of tumor response to Pembrolizumab. To evaluate the robustness of the estimates, Leave-One-Out Cross-Validation (LOOCV) was performed. Results: A total of 10 radiomic features were selected; the XGboost-based classification robustly differentiated between responders vs non-responders (area under the curve, sensitivity and specificity were 99%, 100%, and 95%, respectively [p<0.0001]). Conclusions: Our radiomic derived features were able to identify imaging differences that can evaluate patients’ response to Pembrolizumab treatment.
A phase Ib study of troriluzole (BHV-4157) in combination with nivolumab.
Authors: Silk Ann W. , Saraiya Biren , Groisberg Roman , Chan Nancy , Spencer Kristen Renee , Girda Eugenia , Shih Weichung , Manne Veeraswamy , Palmeri Marisa , Berman Robert , Coric Vlad , Vieth Joshua , Chen Suzie , Mehnert Janice M. , Malhotra Jyoti 
Published: February 2020

79 Background: The Metabotropic Glutamate Receptor 1 (GRM1) is overexpressed in many solid tumors. It activates MAPK and PI3K/AKT pathways and promotes an immune-suppressive tumor microenvironment. In an immunocompetent melanoma mouse model, GRM1 blockade using riluzole or its pro-drug troriluzole (BHV-4157) and PD-1 blockade inhibit tumor growth in an additive manner. We conducted a phase Ib trial of troriluzole and the PD-1 antibody nivolumab. Methods: Patients with advanced or refractory solid tumors were treated with increasing doses of troriluzole. Troriluzole monotherapy was given for a 14-day lead-in period and then patients received troriluzole in combination with nivolumab 240 mg IV every 2 weeks. Results: We enrolled 14 patients with advanced solid tumors (melanoma=3, NSCLC=3, renal cell cancer=2, NSCLC=2, head and neck cancer=2). Eleven patients had prior therapy with anti-PD-(L)1. PK sampling demonstrated that the prodrug was cleaved efficiently without regard to food (Table). The most common TEAEs (all grades) occurring in >40% of patients were transaminitis, increased lipase and nausea. DLT occurred in 3 patients: 1) grade 3 anorexia, 2) grade 3 fatigue and, 3) atrial fibrillation. The MTD was determined to be troriluzole 140 mg QAM + 280 mg PO QHS. The response rate was 7 % (1/14); this occurred in a PD-L1 treated patient. The 6-month PFS rate was 21%. Correlative studies will be presented. Conclusions: The combination of troriluzole and nivolumab was safe and well-tolerated in this highly PD-1 refractory population. Clinical trial information: NCT03229278. [Table: see text]
Incidence and prediction of checkpoint inhibitor immune-related nephrotoxicity.
Authors: Sorah Jonathan D , Rose Tracy L. , Radhakrishna Roshni , Derebail Vimal , Milowsky Matthew I. 
Published: February 2020

91 Background: Immune checkpoint inhibitors (ICIs), through inhibition of self-tolerance, have the potential to cause immune-related adverse events that can affect any organ, including the kidneys. Our study aimed to better characterize the incidence of and predictive characteristics for immune-related nephrotoxicity. Methods: All patients at the University of North Carolina (UNC) who received ICIs between April 2014 and December 2018 for any malignancy were identified. Patients on dialysis or those who received concurrent platinum-based chemotherapy were excluded. Any patient who subsequently had a clinically significant acute kidney injury (AKI), defined as a doubling or more of baseline creatinine, was included for analysis. A retrospective chart review was performed to determine the cause of AKI. Any uncertain cases were reviewed by two nephrologists for expert consensus (R.R. and V.D.). Results: 1766 patients received an ICI during the study period. 123 (7%) patients had AKI within one year of the first ICI dose. 14 were due to immune-related nephrotoxicity (11% of patients with AKI and 0.8% of all ICI patients). Pre-existing autoimmune disease was more likely in patients with immune-related nephrotoxicity than in those with non-immune AKI (14% vs 3%, p = 0.04). Similarly, concurrent or prior other immune-related adverse events were more common in patients with immune-related AKI (57% vs 6%, p = 0.01). Patients with immune-related AKI were more likely to see a nephrologist (57% vs 23%, p = 0.007) and had a more profound increase in creatinine from baseline (median 2.6 vs 1.6, p = 0.02). Age, sex, urinalysis findings, and primary tumor type were not associated with increased risk. Conclusions: The true incidence of ICI related nephrotoxicity is difficult to ascertain due to the many confounders that contribute to AKI in this population. Severe immune-related nephrotoxicity is rare, but patients with preexisting autoimmune disease or history of immune-related adverse events are at increased risk.
Onset, duration, and clinical impact of immune-related adverse events in Hodgkin lymphoma.
Authors: Higgins Alexandra , Richter Michael D. , Patel Shruti , McCullough Kristen Beth , Habermann Thomas Matthew , Ansell Stephen M. , Thompson Carrie A. , Bennani Nabila Nora , Thanarajasingam Uma , Thanarajasingam Gita 
Published: February 2020

95 Background: The incidence of immune-related adverse events (irAEs) in patients (pts) with Hodgkin lymphoma (HL) treated with PD-1 antibodies (ICI) is reported at 28 - 36%. However, clinically relevant information on irAE onset, duration, or impact on ability to continue therapy in HL is lacking. Additionally, these incidence rates reflect CTCAE definition and grading, and not ASCO Clinical Practice Guidelines irAE-specific criteria (Brahmer et al, JCO 2018). The objectives of this study were to evaluate the rate and severity of irAEs in HL pts using ASCO criteria, to characterize irAE time profile and to assess their impact on continued therapy. Methods: HL pts who received a PD-1 inhibitor for the treatment of HL at Mayo Clinic Rochester between January 1, 2011 and March 1, 2018 were identified. We conducted a detailed, longitudinal retrospective chart review with definition and grading of irAEs in accordance with ASCO guidelines. Results: Fifty-one pts were identified (35% women, median age at ICI initiation 35 years [range: 19-87]). Median duration of follow up from ICI start was 30 months (range: 1-70). Thirty-one pts (61%) had any irAE. Most common irAEs were inflammatory/bullous dermatoses (23.5%/5.9% any grade/grade3-4; median onset/duration of 81/57 days[d]), followed by thyroiditis (22%/0%; 86/84 d), colitis (14%/8%; 82/106 d), pneumonitis (14%/10%; 241/182 d), and hepatitis (14%/4%; 71/35 d). Fifteen pts (29%) required treatment with steroids. Among the total cohort, ICI was held for an irAE 28 times (50% of 56 total irAEs). Median treatment cycles held was 2.5 and ICI was permanently discontinued due to irAE in 18%. The most common irAE leading to treatment discontinuation was pneumonitis, followed by neuritis (5.9%/3.9%; 179/374 d), colitis, and rash. Conclusions: The rate of irAEs of 61% in this cohort as defined by ASCO consensus criteria was higher than reported in trials. Most irAEs were characterized by delayed onset of several months and prolonged duration, particularly pneumonitis and neuritis. Treatment discontinuation due to irAEs was infrequent overall. Further studies are needed to determine whether the development or duration of irAEs is predictive of treatment outcomes in HL.
Revolutionary Positions
Authors: Chase Michelle , Cosse Isabella 
Published: February 2020

AbstractThis essay opens new perspectives on the Cuban Revolution by considering its global impact through the lens of gender and sexuality. This framework provides important new insights into the rise of the New Left and the anticommunist Right by centering ideas of gender, sexuality, and the family. Locating the Cuban Revolution alongside other contemporary struggles against racism and imperialism, the essay argues that gender and sexuality were crucial terrains of struggle that demonstrate the complexity of the Cold War in the Global South. Moreover, this point of view challenges long-standing perceptions of revolutionary Cuba as “isolated” by showing how the island precipitated and was embedded in transnational networks and flows of people and ideas, including solidarity campaigns, military missions, and forms of cultural diplomacy.
Angela Davis in Cuba as Symbol and Subject
Authors: Seidman Sarah J. 
Published: February 2020

Abstract
This essay examines how gender facilitated the encounters between Angela Y. Davis and the Cuban Revolution in the late 1960s and 1970s. Davis’s multifaceted identity as a black woman and communist shaped both her representation and reception in Cuba. Cubans supported Davis by participating in the global campaign for her freedom and welcoming her to the island several times, often with delegations from the Communist Party, beginning in 1969. The Cuban state propagated an iconography of Davis that cast her as a global signifier for both repression and international solidarity. Furthermore, at a transitional moment when Cuban leadership advocated institutionalization of the revolution, the Federation of Cuban Women provided highly visible opportunities for Davis to speak and be seen not afforded to men in the black liberation movement. Davis’s time in Cuba proved transformative and foundational in shaping her view of global liberation.
Tactical Negrificación and White Femininity
Authors: Bayard de Volo Lorraine 
Published: February 2020

Abstract
At the ideological heart of the Cuban Revolution is the commitment to liberation from oppressive systems at home and abroad. From early on, as it supported anti-imperialist struggles, revolutionary Cuba also officially condemned racism and sexism. However, the state’s attention to racism and sexism has fluctuated—it has been full-throated at times, silent at others. This essay examines gender and race in Cuba’s international liberatory efforts while also considering the human costs of armed internationalism. Focusing on Cuba’s Angola mission (1975–91), it finds that the state approached gender and racial liberation separately and tactically, as means to military, political, and diplomatic ends. Through negrificación (blackening) of national identity, Cuba highlighted race to internationally legitimize its Angola mission. Women were a minor and primarily domestic theme, yet military women’s femininity was racialized, as idealized feminine combatants were typically represented as white, light-skinned women despite a diverse racial composition.
Insurgent Intimacies
Authors: Schields Chelsea 
Published: February 2020

Abstract
This article examines the intertwined arguments for sexual revolution and decolonization in the Dutch Atlantic in the 1960s and 1970s. In this period, Antillean activists in the Netherlands and the Netherlands Antilles celebrated aspects of the Cuban Revolution and the US Black Power movement for their purported ability to regenerate romantic love. Activists contended that socialism and antiracist activism could forge new bonds of erotic equality to explode the ongoing effects of colonialism, slavery, and the regimes of sexual violence that maintained both. Considering the centrality of sexual politics to Antillean radical imaginaries, this article argues that Antilleans viewed sexual liberation as a primary rather than ancillary component of self-determination. Illuminating the Atlantic currents that informed Antillean arguments for insurgent forms of intimacy—from revolutionary Cuba to black struggle in the United States—this article reconceives of both the substance and geography of the sexual revolution.
“Chilean! Is This How You Want to See Your Daughter?”
Authors: Casals Marcelo 
Published: February 2020

Abstract
This article studies the impact that the Cuban Revolution had on conservative political actors in Chile during the 1964 presidential campaign. At that time, Cuba served as a dystopian example for anticommunist forces through the direct identification between the Cuban experience and the Chilean Left. They utilized a “language of family” to give meaning to their rejection of any possible establishment of socialism in Chile. In this sense, an eventual electoral victory of the Marxist Left was seen as an attack—as in Cuba—on the stability of the family, traditional gender roles, and even parental control of their daughters’ sexuality. These representations were widely distributed through an anticommunist propaganda campaign known as the “campaign of terror,” which forged transnational networks among local actors, the CIA, and conservative Brazilian women. This triple articulation of anticommunism, Cuba, and gender became a potent discourse in the Chilean electoral campaign.
Rewriting Gender in the New Revolutionary Song
Authors: Chomsky Aviva 
Published: February 2020

AbstractThis essay examines the meanings of gender in the music of Cuba’s Nueva Trova, an important expression of what came to be known as the Nueva Canción (New Song) that flourished throughout Latin America between the 1960s and the 1980s. The continent-wide movement sought to challenge the commercialization of the airwaves by raising profound, revolutionary, and deeply Latin American themes while revaluing traditional instruments and styles. Music played an important role in articulating a rejection of capitalist and colonial values, a turn to popular and indigenous roots, a commitment to continent-wide revolution, and a vision of a better world. Through festivals, gatherings, and conferences, mass concerts and radio, international travel, and, under dictatorship, clandestinely circulated cassette tapes, the Nueva Canción exemplified a generation’s search for multiple meanings of liberation. In participating in radical critiques of Latin America’s social order, the Nueva Canción rewrote gender norms embedded in society and its music. Revolutionary singer-songwriters explored the meanings of human emancipation in ways that challenged traditional gender roles and ideologies. Political, personal, and love songs upended gender stereotypes to offer new, revolutionary meanings to romantic love. Songwriters linked the Cuban Revolution to other Latin American revolutionary processes and imagined how the new society would liberate the human spirit and human potential. Socially committed art reflected, explored, and contributed to imagining the new world, and reimagining gender played a role in the process and in its music.
Historicizing Sexuality in the Cuban Revolution
Authors: Lambe Jennifer L. 
Published: February 2020

AbstractWhat should be the place of the Cuban Republic in histories of sexuality under the revolution? This essay argues that scholarly accounts of gender and sexuality in post-1959 Cuba want for a fuller engagement with their pre-1959 context. In particular, it seeks to open up a conversation about questions and topics in the history of sexuality that might straddle the 1959 divide, as well as the historiographical (and political) consequences of writing across it.