bluuebunny/crossref_metadata_2025_split huggingface dataset:
Awareness, perceptions, and usage of whole person integrative oncology practices: Similarities and differences between breast cancer patients and oncologists.
Authors: Crudup Terri , Li Linna , Lawson Elizabeth , Dorr Jennifer Wright , Stout Rachel , Niknam Pedram Vazifeh , Jones Judi , Steen Robert , Lu Lynn L , Casner Susan , Wang Yi , Scott James , Zanine Shelby , Robertshaw Stacey , Broderick Gabriella , Palommella Vaishali , Harris Tye , Hanamirian Michael , Reddy Mula Shivani , Jonas Wayne 
Published: June 2021

e24123 Background: The use of Complementary and Lifestyle (C&L) approaches in conjunction with medical treatments is known as Integrative Oncology. While Integrative Oncology practices have been steadily rising in the past few decades, there are still awareness and education gaps that medical professionals can help address for their patients. Methods: Survey-based data collection and analysis was used to assess awareness, perceptions, and usage of Integrative Oncology. Patients were randomly sampled among breast cancer patients diagnosed within 2 years and included all stages (0-IV) and all US regions (NE, South, Midwest, West). Physicians were sampled from a panel of community and academic practices across the US, with the requirement they treat at least 10 breast cancer patients in a typical 3-month period and have been in practice for at least 6 years since residency or fellowship. Results: Survey invitations were sent to 1,901 patients and 2,758 Oncologists; 164 breast cancer patients and 115 Oncologists completed the surveys. Approximately two-thirds of Oncologists and patients agree that C&L approaches contribute to improved quality of life and well-being for patients (table row 1, 2). However, significantly more patients than Oncologists believe that Integrative Oncology also leads to better treatment outcome and survival (row 3). In addition, Oncologists are significantly more aware of C&L practices than are patients (row 4). When asked what percent of breast cancer patients they discuss C&L methods with, Oncologists report 55% average (CI: 50-60%). However, when asked how they became aware of C&L, only 28% of patients (CI: 21-35%) mention their Oncologist/cancer care team or the institution where they were treated (not in table). Ideally, patients desire information about C&L to come directly from Oncologists, but that is not the predominant model (row 5). Conclusions: Many breast cancer patients believe an Integrative approach will improve their treatment outcomes and prefer their providers to discuss this with them.[Table: see text]
ENVASARC: A pivotal trial of envafolimab, and envafolimab in combination with ipilimumab, in patients with advanced or metastatic undifferentiated pleomorphic sarcoma or myxofibrosarcoma who have progressed on prior chemotherapy.
Authors: D'Angelo Sandra P. , Robinson Steven Ian , Lam Joelle , Adams Bonne J. , Freddo James L. , Theuer Charles P. , Maki Robert G 
Published: June 2021

TPS11581 Background: Metastatic undifferentiated Pleomorphic Sarcoma (UPS) and the genetically related myxofibrosarcoma (MFS) are soft tissue sarcoma (STS) subtypes with poor prognoses. While responses to front line chemotherapy can approach 20%, efficacy remains limited in the 2nd line setting and beyond. Pazopanib, the only approved treatment in the refractory setting, has demonstrated an objective response rate (ORR) of 4%. Envafolimab is a single domain PD-L1 antibody administered rapidly by subcutaneous (SQ) injection that is being studied in two additional pivotal trials: microsatellite instability-high (MSI-H) cancer and biliary tract cancer. The activity of envafolimab appears to be similar to other PD-1 antibodies administered i.v. Envafolimab demonstrated a 32% objective response rate (ORR) in MSI-H colorectal cancer patients who failed three approved chemotherapeutics, similar to the ORR of 28% and 33% with nivolumab and pembrolizumab in these patient populations, respectively. The rationale for the ENVASARC trial is based on the previously reported activity of checkpoint inhibition in UPS/MFS. Single agent pembrolizumab demonstrated a 23% ORR, while the combination of nivolumab and ipilimumab demonstrated a 29% ORR in refractory UPS/MFS. Methods: ENVASARC (NCT 04480502) is a pivotal multicenter (at ̃25 U.S. centers) open-label, randomized, non-comparative, parallel cohort study of treatment with envafolimab 300 mg every 3 weeks by SQ injection (cohort A; n = 80) or envafolimab 300 mg every 3 weeks by SQ injection combined with ipilimumab 1 mg/kg every 3 weeks i.v. for four doses (cohort B; n = 80) in patients with locally advanced, unresectable or metastatic UPS/MFS who have progressed on one or two lines of prior therapy. The primary objective of each of parallel cohort is to demonstrate an ORR with a lower limit of the 95% confidence interval that excludes 5.0% in each cohort. If ≥ 9 responders are observed of the 80 patients enrolled in each cohort, then the lower bound of the 95% confidence interval will exclude 5.0%. Secondary endpoints include duration of response (DOR), PFS and OS. Key inclusion criteria: ≤ 2 prior lines of therapy (neoadjuvant and adjuvant therapy excluded), ECOG ≤ 1. Clinical trial information: NCT 04480502.
A phase 1 study to evaluate chimeric antigen receptor (CAR) T cells incorporating a chlorotoxin tumor-targeting domain for patients with MMP2+ Recurrent or progressive glioblastoma (NCT04214392).
Authors: Badie Behnam , Barish Michael E , Chaudhry Ammar , D'Apuzzo Massimo , Forman Stephen J. , Portnow Jana , Wang Shirong (Sean) , Ressler Julie A , Simpson Jennifer , Kilpatrick Julie , McNamara Paige , Wagner Jamie , Blanchard Suzette , Wang Dongrui , Brown Christine 
Published: June 2021

TPS2662 Background: Glioblastoma (GBM) is the most common and most aggressive primary brain tumor. Around 294,900 new cases are diagnosed globally with 241,000 deaths each year. The 5-year survival is only 5%. Median overall survival from first recurrence is only 5-8 months. There is no established standard of care for recurrent GBM. City of Hope (COH) has developed and optimized a CAR T cell therapy utilizing the chlorotoxin peptide (CLTX) as the CAR’s tumor recognition domain against GBM. CLTX-CAR T cells specifically and broadly target GBM through recognition of a receptor complex including membrane-bound matrix metalloprotease 2 (MMP-2). CLTX-CAR T cells do not exhibit off-tumor recognition of normal human or murine cells and tissues in preclinical models. In in vitro studies, COH evaluated patient-derived brain tumor (PBT) cell lines for CLTX binding and expression of IL13Rα2, HER2 and EGFR, three targets of CAR T cell trials for GBMs. Strong CLTX binding to tumor cells was observed in of the majority of primary GBM lines, independent of these other antigens. In preclinical studies using in vivo mouse models, a single intratumoral (ICT) injection of CLTX-CAR T cells (1×106 CAR+ T cells) exhibited robust anti-tumor activity against ffLuc+ PBT106 tumors orthotopically-engrafted in NSG mice. Overall, when compared to mice treated with mock-transduced Tn/mem (no CAR) T cells, the CLTX(EQ)28ζ/CD19t+ T cells reduced tumor burden and significantly increased survival. Taken together, these preclinical findings support the potential safety and efficacy of CLTX-CAR T cells, and provide the rationale for clinical testing of this therapy. As cellular heterogeneity intrinsic to GBM likely contributes to resistance to therapy and limited response rates, CLTX-CAR T cells may provide greater tumor eradication in a higher proportion of patients with GBM. Methods: This study is a phase 1, single center, safety and maximum tolerated dose (MTD) finding study of CLTX-CAR T cells for subjects with MMP2+ recurrent or progressive GBM. A safety lead-in of 3−6 participants receiving CLTX-CAR T cells by ICT delivery will be completed first. Subsequently, subjects would receive cells administered through both ICT and intraventricular (ICV catheters) (i.e. dual delivery) in two dose schedules. Subjects will be evaluated for safety and tolerability, and may continue to receive treatment until disease progression. Time to progression, overall survival, and disease response by Response Assessment in Neuro-Oncology (RANO) criteria, will be evaluated and descriptively compared to historical data. The study is actively enrolling patients. Clinical trial information: NCT04214392.
Phase 1 first-in-human study of ABBV-184 monotherapy in adult patients with previously treated acute myeloid leukemia or non-small cell lung cancer.
Authors: Avigdor Abraham , Peterlin Pierre , Yuda Junichiro , Moskovitz Mor Tal , Gabrail Nashat Y. , Moshe Yakir , Quesnel Bruno , Henner William R , Reilly Edward B. , Huang Donghui , Kovalenko Maria , Parikh Apurvasena , Jaryno Stacy , Leibman Rachel S , Freise Kevin J , Saada-Bouzid Esma , Shimizu Toshio 
Published: June 2021

TPS2674 Background: Survivin, a member of the inhibitor of apoptosis protein family, is an attractive therapeutic target in cancer, due to its broad expression in solid tumors and hematologic malignancies but limited expression in normal tissues. Elevated survivin expression is associated with an increased invasive phenotype and worse clinical outcomes. ABBV-184 is a first-in-class T-cell receptor (TCR)/anti-cluster of differentiation 3 (CD3) bispecific molecule. It is composed of a soluble TCR that binds to a survivin-derived peptide bound to the class I MHC allele HLA-A2:01 expressed on tumor cells and to the CD3 receptor on T cells. Preclinical data have demonstrated that treatment with ABBV-184 results in T-cell activation, proliferation, and redirected cytotoxicity of HLA-A2:01–positive target cell lines. This first-in-human trial evaluates ABBV-184 monotherapy in patients with previously treated acute myeloid leukemia (AML) or non-small cell lung cancer (NSCLC). Methods: Patients (≥18 years, Eastern Cooperative Oncology Group performance status ≤2, HLA-A2:01 restricted genotype) with relapsed or refractory AML or NSCLC are currently enrolling in this phase 1 multicenter, open-label trial (NCT04272203), which includes parallel dose-escalation and dose-expansion phases for both diseases. Primary objectives are to determine the recommended phase 2 dose (RP2D) of ABBV-184 (dose escalation) and to assess its preliminary efficacy (dose expansion). Secondary objectives include safety, tolerability, pharmacokinetics (PK), and immunogenicity assessments (dose escalation and dose expansion) and duration of response (dose expansion). Patients will receive intravenous infusion of ABBV-184 once weekly. Dose escalation of ABBV-184 is guided by a Bayesian optimal interval design and the RP2D will be determined on the basis of clinical safety, PK, and pharmacodynamic data. For patients with AML, disease assessment is performed according to modified European LeukemiaNet-International Working Group criteria. For patients with NSCLC, response will be assessed using Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 and immune RECIST. Treatment can continue until disease progression or intolerable toxicity. Biomarker assessments will include longitudinal profiling of peripheral blood immune cells and cytokines, analysis of HLA-A2 and survivin levels on AML bone marrow blasts and NSCLC tumor biopsies, and retrospective correlations of biomarker data with antitumor activity. Enrollment initiated in Sep 2020, with 7 patients enrolled as of Jan 2021. Clinical trial information: NCT04272203.
BREAKWATER: Randomized phase 3 study of encorafenib (enco) + cetuximab (cetux) ± chemotherapy for first-line (1L) treatment (tx) of BRAF V600E-mutant (BRAFV600E) metastatic colorectal cancer (mCRC).
Authors: Kopetz Scott , Grothey Axel , Yaeger Rona , Ciardiello Fortunato , Desai Jayesh , Kim Tae Won , Maughan Tim , Van Cutsem Eric , Wasan Harpreet Singh , Yoshino Takayuki , Edwards Michelle L. , Golden Adele , Gollerkeri Ashwin , Tabernero Josep 
Published: June 2021

TPS3619 Background: Approximately 10% of patients (pts) with mCRC have BRAF mutations (mostly V600E). 1L tx options for BRAFV600E mCRC are limited to cytotoxic chemotherapy ± anti-VEGF or anti-EGFR, or immune checkpoint inhibitors in pts with MSI-H tumors. In Europe, Japan, and USA, the combination of BRAF inhibitor enco + EGFR inhibitor cetux is approved for tx of BRAFV600E mCRC after prior therapy. In BEACON CRC, enco + cetux resulted in a median overall survival (OS) of 9.3 months (95% confidence interval [CI]: 8.0–11.3) and an objective response rate (ORR) of 19.5% (95% CI: 14.5%–25.4%) in previously treated pts with BRAFV600E mCRC (median follow-up: 12.8 months); 57.4% of pts had grade 3/4 adverse events (AEs); 9% discontinued due to AEs. Given the poor prognosis of pts with BRAFV600E mCRC and based on the efficacy and tolerability of enco + cetux from BEACON CRC, BREAKWATER will evaluate efficacy and safety of enco + cetux ± chemotherapy in tx-naive pts with BRAFV600E mCRC. Methods: BREAKWATER is an open-label, global, multicenter, randomized, phase 3 study with a safety lead-in (SLI). Approximately 60 and 870 pts will be enrolled in the SLI and phase 3 parts of the study, respectively. Pts must have BRAFV600E mCRC (determined using tumor tissue or blood); ECOG performance status 0/1; and adequate bone marrow, hepatic, and renal function. Pts in the SLI must have evaluable disease (RECIST v1.1) and have received ≤ 1 prior tx regimen; those previously treated with a BRAF or EGFR inhibitor, or both oxaliplatin and irinotecan, will be excluded. Pts in the phase 3 study must have measurable disease and be tx naive for metastatic disease. Study tx and endpoints are shown in the table. Enrollment began on 6 January 2021. Clinical trial information: NCT04607421. [Table: see text]
EORTC 1707 VESTIGE: Adjuvant immunotherapy in patients with resected gastric cancer following preoperative chemotherapy with high risk for recurrence (ypN+ and/or R1)—An open-label randomized controlled phase II study.
Authors: Smyth Elizabeth Catherine , Peeters Ellen , Knoedler Maren Kristina , Giraut Anne , Wagner Anna Dorothea , Moehler Markus H. , van Grieken Nicole C.T. , Nilsson Magnus , Mauer Murielle E. , Lordick Florian 
Published: June 2021

TPS4156 Background: Gastroesophageal adenocarcinoma (GEA) patients with metastatic lymph nodes (ypN+) or a microscopically incomplete surgical resection (R1) following neoadjuvant chemotherapy are at high risk of disease recurrence. Current practice is to continue with the same perioperative chemotherapy used prior to surgery, despite these suboptimal outcomes. Adjuvant immunotherapy with nivolumab has shown efficacy in poor risk GEA patients following chemoradiotherapy and surgery in the CheckMate 577 trial, and nivolumab and ipilimumab have demonstrated activity in advanced GEA. We hypothesise that high risk (ypN+ and/or R1) post resection GEA patients who are treated with nivolumab and ipilimumab will have better disease free survival than patients who continue with standard post-operative chemotherapy. Methods: VESTIGE is an ongoing, international, open label randomized phase II study designed to evaluate the efficacy of adjuvant nivolumab plus ipilimumab versus standard post-operative chemotherapy in high risk (ypN+ and/or R1) post resection GEA patients. Eligible patients (n=240) will be randomised 1:1 to receive post-operative adjuvant chemotherapy (identical regimen as pre-operatively) or nivolumab 3mg/kg IV q2w plus ipilimumab 1mg/kg IV q6w x 1 year. Key inclusion criteria include ypN+ and/or R1 status following neoadjuvant chemotherapy plus surgery and an adequate pre-specified surgical resection. The primary endpoint of the study is disease free survival, with secondary endpoints of overall survival, safety, toxicity and quality of life. Since start of recruitment in August 2019, the trial has recruited 85 of 240 patients at 18 sites in the Czech Republic, France, Germany, Israel, Italy, Norway, Poland, Spain, and United Kingdom. The VESTIGE translational research programme includes collection of pre-treatment biopsies, post-chemotherapy resection specimens and serial liquid biopsy on treatment to explore biomarkers predictive of immune checkpoint blockade efficacy. Clinical trial information: NCT03443856.
Camrelizumab combined with ablation and chemotherapy for pancreatic cancer with liver metastases: A single-arm, phase II, prospective clinical study.
Authors: Li Zhiwei , Li Qingwei , Ma Zhigang , Ma Yue , Su Dan , Lou Changjie , Wang Guangyu , Liu Chao , Zhang Yanqiao 
Published: June 2021

TPS4169 Background: Pancreatic cancer represents one of the most aggressive tumors and the majority of patients receive a diagnosis of metastatic disease, mainly in the liver, leading to poor prognosis and survival. Currently, chemotherapy has been the treatment of choice for fit patients with pancreatic cancer liver metastases (PCLM), reaching a median survival of about 5 to 7 months. In addition, local ablation of the metastatic tumors, by increasing neoantigen exposure and transforming the immune microenvironment to reduce the progression of liver metastases, might increase the survival benefit of patients. Camrelizumab, an anti-PD-1 monoclonal antibody, has obtained preliminary results in metastatic pancreatic cancer. Therefore, this study aims to explore the effectiveness and safety of camrelizumab combined with ablation and chemotherapy in the treatment of PCLM. Methods: In this single-arm, prospective, phase II study, 34 patients with histological or cytological diagnosis of PCLM, ECOG performance score of 0-1, no prior chemotherapy or the interval of adjuvant chemotherapy ≥6 months, plan to be enrolled. The enrolled patients first received ablation surgery of liver metastases, then chemotherapy (the standard regimen for advanced pancreatic cancer, determined by the investigator) combined with camrelizumab (200 mg, iv, q3w) is administered 1 week after ablation. If the patient has multiple metastatic tumors, the ablation needs to be performed in stages. The treatment regimens will continue until the disease progression, unacceptable toxicity or withdrawal of consent. The primary endpoint is 6-month progress-free survival (6-month PFS) rate (per RECIST v1.1 by researcher). Secondary endpoints are objective response rate, disease control rate, progression-free survival, overall survival and safety. On the basis of a threshold 6-month PFS rate of 25%, targeting an expected 6-month PFS rate of 44% and assuming 18 months follow-up, 80% power and a one-sided α = 0.05, this design requires 34 evaluable patients to be accrued over 2 years. Clinical trial information: NCT04420130.
A phase II, open-label pilot study evaluating the safety and activity of liposomal irinotecan (Nal-IRI) in combination with 5-FU and oxaliplatin (NALIRIFOX) in preoperative treatment of pancreatic adenocarcinoma (NEO-Nal-IRI study) (NCT03483038).
Authors: Rogers Sherise C. , Ramnaraign Brian Hemendra , Hitchcock Kathryn , Hughes Steven J. , Lee Ji-Hyun , Fan Z. Hugh , Allegra Carmen Joseph , Trevino Jose , El-Far Ahmad , Turk Anita Ahmed , Russell Karen Bullock , DeRemer David L. , George Thomas J. 
Published: June 2021

TPS4170 Background: Neoadjuvant treatment for potentially curable pancreatic cancer (PDAC) is increasing in acceptability, but a standard regimen has yet to be established. Multiple studies have demonstrated feasibility and effectiveness of the FOLFIRINOX (5-fluorouracil, leucovorin, oxaliplatin and irinotecan) regimen in the perioperative setting. However, FOLFIRINOX often requires dose modifications, delays and growth factor support due to excessive toxicity which can complicate care delivery when given neoadjuvantly. Liposomal irinotecan injection (Nal-IRI) is FDA approved with a well-tolerated safety profile in relapsed, refractory metastatic PDAC. The current study aims to substitute Nal-IRI for traditional irinotecan in the standard FOLFIRINOX regimen (NALIRIFOX) and to demonstrate safe and effective neoadjuvant delivery. Methods: This phase 2, open-label, multicenter single-arm study focuses on patients (pts) with operable PDAC without metastatic disease. Other key eligibility criteria include age ≥18 years, resectability confirmed by multiD GI tumor board (resectable vs. borderline), adequate cardiac, renal, hepatic function and ECOG performance status of 0 to 1. Pts receive NALIRIFOX regimen as per the table every 2 weeks for four months followed by disease reassessment. Pts who remain surgical candidates will undergo surgical resection within 4 to 8 weeks following last dose of therapy. The primary endpoint is to assess safety and feasibility of regimen in perioperative setting. Secondary endpoints include R0 resection rate, clinical, biochemical and radiological response rate and patient-reported quality of life during treatment as measured by the NCI validated FACT-G scale. Enrollment continues to a maximum of 28 evaluable pts to demonstrate a reduction in historical 30 day postoperative complication rate. NCT03483038. NALIRIFOX regimen components given intravenously (IV) every 14 days. Clinical trial information: NCT03483038. [Table: see text]
AUREA study: Atezolizumab (Atezo) combined with split-dose gemcitabine plus cisplatin (s-GC) in locally advanced or metastatic urothelial cancer (LA/mUC): A SOGUG study.
Authors: Gomez De Liano Lista Alfonso , Anguera Georgia , Esteban Emilio , Fernandez Calvo Ovidio , García-Carbonero Iciar , Garcia del Muro Xavier , González Maeso Iria , Lorente-Estelles David , Martínez Ortega Esther , Pinto Alvaro , Puente Javier , de Velasco Guillermo 
Published: June 2021

TPS4589 Background: First-line cisplatin-based chemotherapy (70 mg/m2) is the standard of care for LA/mUC patients (pts). However, about 50% will be ineligible for Cisplatin according to Galsky´s criteria. Moreover, a significant proportion of cisplatin-fit pts will receive carboplatin based on physician criteria. s-GC represents a feasible alternative in such situations, and could improve response rate compared to carboplatin regimens. Atezo is a programmed death-ligand 1 (PD-L1) inhibitor that is approved as first line treatment for cisplatin-ineligible LA/mUC pts with PD-L1 expression ≥5% (Ventana SP142). We present the study design of a phase II single arm trial of Atezo +s-GC in previously untreated pts with LA/mUC (NCT04602078). Methods: This single arm, open-label, multicenter study evaluates the efficacy and safety of Atezo +s-GC in previously untreated pts with LA/mUC. 66 pts will be enrolled and receive s-GC x 6 cycles (Cisplatin 35mg/m2 + Gemcitabine 1000mg/m2 on days 1 and 8 Q3W) and Atezo (1200 mg IV Q3W), followed by Atezo (1200 mg IV Q3W) until disease progression, toxicity or absence of clinical benefit. Eligibility criteria include histologically confirmed unresectable LA/mUC, measurable disease per RECIST 1.1 and adequate organ and marrow. Pts must be unfit for full cisplatin dose based on: age > 70 years, PS ECOG 0-2, creatinine Clearance >30 and <60 mL/min per Cockroft-Gault formula or by 24-hour urine collection. Other reasons for cisplatin ineligibility as considered by investigator, including those uncovered by Galsky´s criteria, will be allowed, prior discussion with PI. Exclusion criteria include prior systemic therapy for LA/mUC (adjuvant/neoadjuvant allowed if finished > 12 months prior to inclusion), prior autoimmune disease and uncontrolled significant illnesses. The primary endpoint is ORR per RECIST 1.1 assessed by investigator; the secondary endpoints are DoR, OS, PFS and safety. Biomarker analysis, including PD-L1 expression and microbiome relationship, will be an exploratory objective. The first two patients were enrolled in February 2021. Clinical trial information: NCT04602078.