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Response evaluation of solid tumors

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https://www.readbyqxmd.com/read/28087644/u-s-fda-approval-summary-nivolumab-for-treatment-of-unresectable-or-metastatic-melanoma-following-progression-on-ipilimumab
#1
Maitreyee Hazarika, Meredith K Chuk, Marc R Theoret, Sirisha Mushti, Kun He, Shawna L Weis, Alexander H Putman, Whitney S Helms, Xianhua Cao, Hongshan Li, Hong Zhao, Liang Zhao, Joel Welch, Laurie Graham, Meredith Libeg, Rajeshwari Sridhara, Patricia Keegan, Richard Pazdur
On December 22, 2014, the U. S. Food and Drug Administration (FDA) granted accelerated approval to nivolumab (OPDIVO®, Bristol-Myers Squibb) for the treatment of patients with unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation-positive, a BRAF inhibitor. Approval was based on a clinically meaningful, durable objective response rate (ORR) in a non-comparative analysis of 120 patients who received nivolumab 3 mg/kg intravenously every 2 weeks with at least 6 months follow-up in an ongoing, randomized, open-label, active-controlled clinical trial...
January 13, 2017: Clinical Cancer Research: An Official Journal of the American Association for Cancer Research
https://www.readbyqxmd.com/read/28081478/pulmonary-sarcomatoid-carcinoma-with-alk-rearrangement-frequency-clinical-pathologic-characteristics-and-response-to-alk-inhibitor
#2
Xinru Chen, Yu Zhang, Jiabin Lu, Chunwei Xu, Jianzhong Liang, Fang Wang, Wenyong Sun, Sangao Fang, Jingping Yuan, Huijuan Wang, Hui Wang, Xuewen Liu, Likun Chen
PURPOSE: The incidence of anaplastic lymphoma kinase (ALK) rearrangement in pulmonary sarcomatoid carcinoma (PSC) is controversial. In this study, we aimed to reveal the reliable frequency and the clinical-pathologic characteristics of pulmonary sarcomatoid carcinoma (PSC) with ALK rearrangement in Chinese population, and to provide insight into the translatability of anti-ALK treatment in this treatment-refractory disease. METHODS: Immunohistochemistry (IHC) using a Ventana anti-ALK (D5F3) rabbit monoclonal antibody was performed in 141 PSC specimens collected from multiple medical centers...
January 9, 2017: Translational Oncology
https://www.readbyqxmd.com/read/28081224/resveratrol-impairs-glioma-stem-cells-proliferation-and-motility-by-modulating-the-wnt-signaling-pathway
#3
Chiara Cilibrasi, Gabriele Riva, Gabriele Romano, Massimiliano Cadamuro, Riccardo Bazzoni, Valentina Butta, Laura Paoletta, Leda Dalprà, Mario Strazzabosco, Marialuisa Lavitrano, Roberto Giovannoni, Angela Bentivegna
Glioblastoma multiforme (GBM) is a grade IV astrocytoma and the most common form of malignant brain tumor in adults. GBM remains one of the most fatal and least successfully treated solid tumors: current therapies provide a median survival of 12-15 months after diagnosis, due to the high recurrence rate. Glioma Stem Cells (GSCs) are believed to be the real driving force of tumor initiation, progression and relapse. Therefore, better therapeutic strategies GSCs-targeted are needed. Resveratrol is a polyphenolic phytoalexin found in fruits and vegetables displaying pleiotropic health benefits...
2017: PloS One
https://www.readbyqxmd.com/read/28078806/prognostic-factors-of-hepatocellular-carcinoma-patients-with-portal-vein-tumor-thrombosis-treated-with-transcatheter-arterial-chemoembolization
#4
Hongyuan Liang, Peng Cui, Qiyong Guo, Xiaonan Mao, Feng Wen, Wei Sun, Ming Shan, Zaiming Lu
AIM: To investigate the factors that influence survival of hepatocellular carcinoma (HCC) patients with portal vein tumor thrombosis (PVTT) following transarterial chemoembolization (TACE). METHODS: Retrospectively enrolled HCC patients with PVTT (n = 57). Patients received TACE, and the local tumor response was evaluated by modified response evaluation criteria in solid tumor (mRECIST). Overall survival and disease progression were evaluated using Kaplan-Meier survival curves...
January 12, 2017: Asia-Pacific Journal of Clinical Oncology
https://www.readbyqxmd.com/read/28078434/a-retrospective-open-label-uncontrolled-study-of-epoetin-zeta-on-the-treatment-of-chemotherapy-induced-anemia-in-solid-tumors
#5
Constantinos E Alifieris, Kyriakos Orfanakos, Aristina Papanota, George P Stathopoulos, Nikolaos Sitaras, Dimitrios T Trafalis
PURPOSE: This is a single-center uncontrolled retrospective study to evaluate the efficacy and safety of the biosimilar epoetin zeta after approval in chemotherapy-induced anemia (CIA). METHODS: Patients screened were >18 years old suffering from solid malignancies and CIA with Hg ≤10 or <11 g/dl if symptomatic anemia. Patients had measurable disease by TNM and Eastern Cooperative Oncology Group (ECOG). Patients were treated for at least 12 weeks and the primary endpoint was to determine the incidence of blood transfusions, and secondarily, the overall safety and efficacy defined as ≥1 g/dl rise in Hb concentration or ≥40,000 cells/μl rise in reticulocyte count...
January 11, 2017: Journal of Cancer Research and Clinical Oncology
https://www.readbyqxmd.com/read/28078116/pretreatment-tumor-volume-as-a-prognostic-factor-in-metastatic-colorectal-cancer-treated-with-selective-internal-radiation-to-the-liver-using-yttrium-90-resin-microspheres
#6
Neha Bhooshan, Navesh K Sharma, Shahed Badiyan, Adeel Kaiser, Fred M Moeslein, Young Kwok, Pradip P Amin, Svetlana Kudryasheva, Michael D Chuong
BACKGROUND: Yttrium-90 ((90)Y)-resin microspheres can prolong intrahepatic disease control and improve overall survival (OS) in patients with metastatic colorectal cancer (CRC). Prognostic factors for improved outcomes in patients undergoing selective internal radiation therapy (SIRT) have been studied, but the relationship between pre-SIRT liver tumor volume and outcomes has not well described. METHODS: We retrospectively reviewed the records of patients with metastatic CRC who were treated at our institution with (90)Y-resin microspheres...
December 2016: Journal of Gastrointestinal Oncology
https://www.readbyqxmd.com/read/28078110/radioembolization-with-90-y-glass-microspheres-for-the-treatment-of-unresectable-metastatic-liver-disease-from-chemotherapy-refractory-gastrointestinal-cancers-final-report-of-a-prospective-pilot-study
#7
Nicholas Fidelman, Robert K Kerlan, Randall A Hawkins, Miguel Pampaloni, Andrew G Taylor, Maureen P Kohi, K Pallav Kolli, Chloe E Atreya, Emily K Bergsland, R Kate Kelley, Andrew H Ko, W Michael Korn, Katherine Van Loon, Ryan M McWhirter, Jennifer Luan, Curt Johanson, Alan P Venook
BACKGROUND: This prospective pilot single-institution study was undertaken to document the feasibility, safety, and efficacy of radioembolization of liver-dominant metastatic gastrointestinal cancer using (90)Y glass microspheres. METHODS: Between June 2010 and October 2013, 42 adult patients (26 men, 16 women; median age 60 years) with metastatic chemotherapy-refractory unresectable colorectal (n=21), neuroendocrine (n=11), intrahepatic bile duct (n=7), pancreas (n=2), and esophageal (n=1) carcinomas underwent 60 lobar or segmental administrations of (90)Y glass microspheres...
December 2016: Journal of Gastrointestinal Oncology
https://www.readbyqxmd.com/read/28074302/enable-exportable-notation-and-bookmark-list-engine-an-interface-to-manage-tumor-measurement-data-from-pacs-to-cancer-databases
#8
Nikhil Goyal, Andrea B Apolo, Eliana D Berman, Mohammad Hadi Bagheri, Jason E Levine, John W Glod, Rosandra N Kaplan, Laura B Machado, Les R Folio
Oncologists evaluate therapeutic response in cancer trials based on tumor quantification following selected "target" lesions over time. At our cancer center, a majority of oncologists use Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 quantifying tumor progression based on lesion measurements on imaging. Currently, our oncologists handwrite tumor measurements, followed by multiple manual data transfers; however, our Picture Archiving Communication System (PACS) (Carestream Health, Rochester, NY) has the ability to export tumor measurements, making it possible to manage tumor metadata digitally...
January 10, 2017: Journal of Digital Imaging: the Official Journal of the Society for Computer Applications in Radiology
https://www.readbyqxmd.com/read/28071636/epidemiology-of-male-seminomatous-and-nonseminomatous-germ-cell-tumors-and-response-to-first-line-chemotherapy-from-a-tertiary-cancer-center-in-india
#9
A Joshi, S Zanwar, N Shetty, V Patil, V Noronha, G Bakshi, G Prakash, S Menon, K Prabhash
INTRODUCTION: Unlike the developed countries, there is a lack of good epidemiologic data for testicular germ cell tumors (GCTs) in India with majority presenting in advanced stage. This study aims to elaborate on the epidemiology of testicular GCTs and response to standard first-line chemotherapy (CT). METHODS: GCTs treated at our center from January 2013 to June 2014 were retrospectively analyzed. Patients underwent orchidectomy either outside or at our hospital...
April 2016: Indian Journal of Cancer
https://www.readbyqxmd.com/read/28070718/first-in-human-trial-of-an-anti-5t4-antibody-monomethylauristatin-conjugate-pf-06263507-in-patients-with-advanced-solid-tumors
#10
Geoffrey I Shapiro, Ulka N Vaishampayan, Patricia LoRusso, Jeremy Barton, Steven Hua, Steven D Reich, Ronald Shazer, Carrie T Taylor, Dawei Xuan, Hossein Borghaei
Background The antibody-drug conjugate PF-06263507 targets the cell-surface, tumor-associated antigen 5T4 and consists of a humanized IgG1 conjugated to the microtubule-disrupting agent monomethylauristatin-F by a non-cleavable maleimidocaproyl linker. In this first-in-human, dose-finding trial (NCT01891669), we evaluated safety, pharmacokinetics, and preliminary antitumor activity of PF-06263507 in pretreated patients with advanced solid tumors, unselected for 5T4 expression. starting at 0.05 mg/kg, with 25, 56, and 95% dose increments, depending on observed dose-limiting toxicities (DLTs), applying a modified continual reassessment method...
January 9, 2017: Investigational New Drugs
https://www.readbyqxmd.com/read/28068151/prognostic-impact-of-pretreatment-neutrophil-to-lymphocyte-ratio-in-castration-resistant-prostate-cancer-patients-treated-with-first-line-docetaxel
#11
Consuelo Buttigliero, Chiara Pisano, Marcello Tucci, Francesca Vignani, Valentina Bertaglia, Davide Iaconis, Pamela Guglielmini, Gianmauro Numico, Giorgio V Scagliotti, Massimo Di Maio
BACKGROUND: The neutrophil-to-lymphocyte ratio (NLR), a measure of systemic inflammatory response, has been associated with poor outcome in several solid tumors, including prostate cancer. We retrospectively investigated the prognostic role of pretreatment NLR in metastatic castration-resistant prostate cancer (mCRPC) patients treated with first-line docetaxel. METHODS: All CRPC patients treated with first-line docetaxel at two Italian institutions, with available data about baseline neutrophil and lymphocyte values, were included in this retrospective analysis...
January 9, 2017: Acta Oncologica
https://www.readbyqxmd.com/read/28066978/mrecist-to-predict-survival-in-advanced-hcc-analysis-of-two-randomised-phase-ii-trials-comparing-nintedanib-versus-sorafenib
#12
Tim Meyer, Daniel H Palmer, Ann-Lii Cheng, Julia Hocke, Arsène-Bienvenu Loembé, Chia-Jui Yen
BACKGROUND & AIMS: Response Evaluation Criteria in Solid Tumors (RECIST) has been shown to be a poor surrogate for survival benefit with targeted therapy in advanced hepatocellular carcinoma (HCC). METHODS: We investigated whether response evaluated using modified RECIST (mRECIST) predicted overall survival (OS) using data from two Phase II clinical trials. Analyses were conducted on pooled data from 188 patients with advanced HCC treated with nintedanib or sorafenib, of whom 180 were evaluable for response...
January 9, 2017: Liver International: Official Journal of the International Association for the Study of the Liver
https://www.readbyqxmd.com/read/28066805/evaluation-of-soft-tissue-sarcoma-response-to-preoperative-chemoradiotherapy-using-dynamic-contrast-enhanced-magnetic-resonance-imaging
#13
Wei Huang, Brooke R Beckett, Alina Tudorica, Janelle M Meyer, Aneela Afzal, Yiyi Chen, Atiya Mansoor, James B Hayden, Yee-Cheen Doung, Arthur Y Hung, Megan L Holtorf, Torrie J Aston, Christopher W Ryan
This study aims to assess the utility of quantitative dynamic contrast-enhanced (DCE) magnetic resonance imaging (MRI) parameters in comparison with imaging tumor size for early prediction and evaluation of soft tissue sarcoma response to preoperative chemoradiotherapy. In total, 20 patients with intermediate- to high-grade soft tissue sarcomas received either a phase I trial regimen of sorafenib + chemoradiotherapy (n = 8) or chemoradiotherapy only (n = 12), and underwent DCE-MRI at baseline, after 2 weeks of treatment with sorafenib or after the first chemotherapy cycle, and after therapy completion...
December 2016: Tomography: a Journal for Imaging Research
https://www.readbyqxmd.com/read/28063788/response-to-chemotherapy-and-prognosis-in-metastatic-colorectal-cancer-with-dna-deficient-mismatch-repair
#14
Alexandra Khichfy Alex, Sheila Siqueira, Renata Coudry, Juliana Santos, Michel Alves, Paulo M Hoff, Rachel P Riechelmann
BACKGROUND: DNA deficient mismatch repair (dMMR) genes are associated with microsatellite instability and good prognosis in early-stage colorectal cancer (CRC). However dMMR is rare in metastatic CRC (mCRC) and little is known about its influence on treatment response rate (RR). The primary objective of this study was to compare the RR of patients with mCRC according to dMMR status. METHODS: This was a retrospective study that compared the RR by Response Evaluation Criteria In Solid Tumors 1...
November 26, 2016: Clinical Colorectal Cancer
https://www.readbyqxmd.com/read/28054329/a-first-in-human-phase-1-study-of-epirubicin-conjugated-polymer-micelles-k-912-nc-6300-in-patients-with-advanced-or-recurrent-solid-tumors
#15
Hirofumi Mukai, Takahiro Kogawa, Nobuaki Matsubara, Yoichi Naito, Masaoki Sasaki, Ako Hosono
Background K-912 also known as NC-6300 is a novel epirubicin pro-drug conjugate developed using micellar nanoparticle technology. We conducted a first-in-human, Phase 1, open-label, non-randomized dose escalation study to evaluate the safety, tolerability, efficacy, and pharmacokinetics of K-912 administered as monotherapy in patients with advanced or recurrent solid tumors. Methods Patients aged 41 to 72 years with histologically or cytologically confirmed advanced or recurrent malignant solid tumors either refractory to standard therapy or had no other viable treatment options were enrolled...
January 4, 2017: Investigational New Drugs
https://www.readbyqxmd.com/read/28053943/novel-oncolytic-viral-therapies-in-patients-with-thoracic-malignancies
#16
REVIEW
Zeeshan Ahmad, Robert A Kratzke
Oncolytic virotherapy is the use of replication-competent viruses to treat malignancies. The potential of oncolytic virotherapy as an approach to cancer therapy is based on historical evidence that certain viral infections can cause spontaneous remission of both hematologic and solid tumor malignancies. Oncolytic virotherapy may eliminate cancer cells through either direct oncolysis of infected tumor cells or indirect immune-mediated oncolysis of uninfected tumor cells. Recent advances in oncolytic virotherapy include the development of a wide variety of genetically attenuated RNA viruses with precise cellular tropism and the identification of cell-surface receptors that facilitate viral transfer to the tissue of interest...
2017: Oncolytic Virotherapy
https://www.readbyqxmd.com/read/28053022/phase-1-study-of-ont-380-a-her2-inhibitor-in-patients-with-her2-advanced-solid-tumors-with-an-expansion-cohort-in-her2-metastatic-breast-cancer-mbc
#17
Stacy Moulder-Thompson, Virginia F Borges, Tara D Baetz, Tessa Mcspadden, Gina Fernetich, Rashmi K Murthy, Renae Chavira, Kari Guthrie, Emma Barrett, Stephen Chia
PURPOSE: ONT-380 (ARRY-380) is a potent and selective oral HER2 inhibitor. This Phase 1 study determined the maximum tolerated dose (MTD), pharmacokinetics (PK) and antitumor activity of ONT-380 in HER2 positive advanced solid tumors, with an expansion cohort of patients with HER2-positive MBC. EXPERIMENTAL DESIGN: ONT-380 was administered twice daily (BID) in continuous 28-day cycles. After a modified 3+3 dose escalation design determined the MTD, the expansion cohort was enrolled...
January 4, 2017: Clinical Cancer Research: An Official Journal of the American Association for Cancer Research
https://www.readbyqxmd.com/read/28053021/first-in-human-phase-1-study-of-the-oral-inhibitor-of-indoleamine-2-3-dioxygenase-1-epacadostat-incb024360-in-patients-with-advanced-solid-malignancies
#18
Gregory L Beatty, Peter J O'Dwyer, Jason Clark, Jack G Shi, Kevin J Bowman, Peggy Scherle, Robert C Newton, Richard Schaub, Janet Maleski, Lance Leopold, Thomas F Gajewski
PURPOSE: Indoleamine 2,3-dioxygenase-1 (IDO1) catalyzes the degradation of tryptophan to N-formyl-kynurenine. Overexpressed in many solid malignancies, IDO1 can promote tumor escape from host immunosurveillance. This first-in-human phase 1 study investigated the maximum tolerated dose, safety, pharmacokinetics, pharmacodynamics, and antitumor activity of epacadostat (INCB024360), a potent and selective inhibitor of IDO1. PATIENTS AND METHODS: Fifty-two patients with advanced solid malignancies were treated with epacadostat (50 mg once daily or 50, 100, 300, 400, 500, 600, or 700 mg twice daily [BID]) in a dose-escalation 3 + 3 design and evaluated in 28-day cycles...
January 4, 2017: Clinical Cancer Research: An Official Journal of the American Association for Cancer Research
https://www.readbyqxmd.com/read/28050790/first-in-human-study-of-the-antibody-dr5-agonist-ds-8273a-in-patients-with-advanced-solid-tumors
#19
Andres Forero, Johanna C Bendell, Prasanna Kumar, Linda Janisch, Michael Rosen, Qiang Wang, Catherine Copigneaux, Madhuri Desai, Giorgio Senaldi, Michael L Maitland
Background DR5 is a transmembrane receptor that transduces extracellular ligand-binding to activate apoptosis signaling cascades. This phase 1 study evaluated the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics of a new monoclonal antibody potent DR5 agonist, DS-8273a, in subjects with advanced solid tumors. Methods The study comprised dose escalation and dose expansion cohorts. The dose escalation cohorts intended to determine the safety and to identify the maximum tolerated dose (MTD) or maximum administered dose (MAD) and to characterize the pharmacokinetics and pharmacodynamics by a conventional 3 + 3 design (starting at 2 mg/kg and escalating through 8, 16 and 24 mg/kg once every 3 weeks)...
January 3, 2017: Investigational New Drugs
https://www.readbyqxmd.com/read/28050234/how-to-assess-the-efficacy-or-failure-of-targeted-therapy-deciding-when-to-stop-sorafenib-in-hepatocellular-carcinoma
#20
REVIEW
Jean-Luc Raoul, Xavier Adhoute, Marine Gilabert, Julien Edeline
Sorafenib is thus far the only systemic treatment for hepatocellular carcinoma (HCC) based on the results of two randomized controlled trials performed in Western and in Eastern countries, despite a poor response rate (from 2% to 3.3%) following conventional evaluation criteria. It is now recognized that the criteria (European Association of the Study of the Liver criteria, modified response evaluation criteria in solid tumors) based on contrast enhanced techniques (computed tomography scan, magnetic resonance imaging) aimed to assess the evolution of the viable part of the tumor (hypervascularized on arterial phase) are of major interest to determine the efficacy of sorafenib and of most antiangiogenic drugs in patients with HCC...
December 18, 2016: World Journal of Hepatology
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