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Response evaluation of solid tumors

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https://www.readbyqxmd.com/read/28453692/safety-and-antitumor-activity-of-the-anti-pd-1-antibody-pembrolizumab-in-patients-with-recurrent-carcinoma-of-the-anal-canal
#1
P A Ott, S A Piha-Paul, P Munster, M J Pishvaian, E M J van Brummelen, R B Cohen, C Gomez-Roca, S Ejadi, M Stein, E Chan, M Simonelli, A Morosky, S Saraf, K Emancipator, M Koshiji, J Bennouna
Background: Safety and efficacy of pembrolizumab, a humanized programmed death 1 monoclonal antibody, was assessed in KEYNOTE-028, a multicohort, phase Ib trial for patients with programmed death ligand 1 (PD-L1)-positive advanced solid tumors. We report results for the cohort of patients with advanced anal carcinoma. Patients and methods: Patients with PD-L1-positive tumors (≥1%) received intravenous pembrolizumab 10 mg/kg once every 2 weeks for up to 2 years or until confirmed progression or unacceptable toxicity...
May 1, 2017: Annals of Oncology: Official Journal of the European Society for Medical Oncology
https://www.readbyqxmd.com/read/28449393/a-phase-1-study-of-the-c-met-inhibitor-tivantinib-arq197-in-children-with-relapsed-or-refractory-solid-tumors-a-children-s-oncology-group-study-phase-1-and-pilot-consortium-trial-advl1111
#2
James I Geller, John P Perentesis, Xiaowei Liu, Charles G Minard, Rachel A Kudgus, Joel M Reid, Elizabeth Fox, Susan M Blaney, Brenda J Weigel
BACKGROUND: The c-Met receptor tyrosine kinase is dysregulated in many pediatric cancers. Tivantinib is an oral small molecule that inhibits the c-Met receptor tyrosine kinase. A phase 1 and pharmacokinetic (PK) trial evaluating tivantinib was conducted in children with relapsed/refractory solid tumors. METHODS: Oral tivantinib capsules were administered twice daily with food, continuously in 28-day cycles. Dose levels 170, 200, and 240 mg/m(2) /dose were evaluated using a rolling-six design (Part A)...
April 27, 2017: Pediatric Blood & Cancer
https://www.readbyqxmd.com/read/28445951/pd-l1-expression-in-perihilar-and-intrahepatic-cholangiocarcinoma
#3
Jacqueline Fontugne, Jérémy Augustin, Anaïs Pujals, Philippe Compagnon, Benoit Rousseau, Alain Luciani, Christophe Tournigand, Daniel Cherqui, Daniel Azoulay, Jean-Michel Pawlotsky, Julien Calderaro
Cholangiocarcinoma is an aggressive biliary neoplasm lacking effective therapeutic agents. Immunotherapies targeting the PD-L1/PD-1 immune checkpoint have shown encouraging results in solid and hematologic cancers in clinical trials. Response to these immunomodulators is correlated with PD-L1 expression. Our goal was to characterize PD-L1 expression in intra-hepatic (iCCA) and perihilar (pCCA) cholangiocarcinomas, and to correlate our results with clinicopathological features, density of tumor-infiltrating lymphocytes (TILs) and PD-1 expression...
April 11, 2017: Oncotarget
https://www.readbyqxmd.com/read/28441447/tumor-response-assessment-by-mri-following-stereotactic-body-radiation-therapy-for-hepatocellular-carcinoma
#4
Guillaume Oldrini, Andres Huertas, Sophie Renard-Oldrini, Hélène Taste-George, Guillaume Vogin, Valérie Laurent, Julia Salleron, Philippe Henrot
BACKGROUND: To evaluate the MRI features of a tumor response, local control, and predictive factors of local control after stereotactic body radiation therapy (SBRT) for hepatocellular carcinoma (HCC). METHODS: Thirty-five consecutive patients with 48 HCCs who were treated by SBRT were included in this retrospective study. All patients provided written informed consent to be treated by SBRT, and prior to inclusion they authorized use of the treatment data for further studies...
2017: PloS One
https://www.readbyqxmd.com/read/28441372/assessing-response-of-high-grade-gliomas-to-immune-checkpoint-inhibitors
#5
Solmaz Sahebjam, Dexter G Stallworth, Sepideh Mokhtari, Nam D Tran, John A Arrington
BACKGROUND: Immunotherapeutic agents, especially checkpoint inhibitors, have emerged as the mainstay of therapy for several solid and hematological malignancies. These therapies are under investigation for the treatment of high-grade gliomas and brain metastases. METHODS: This article reviews the unique challenges encountered when evaluating changes on magnetic resonance imaging (MRI) of glioblastomas seen in response to immunotherapy and checkpoint inhibitors and how to effectively incorporate MRI findings into the response assessment of high-grade gliomas to these emerging therapies...
April 2017: Cancer Control: Journal of the Moffitt Cancer Center
https://www.readbyqxmd.com/read/28440955/phase-1-dose-escalation-study-of-mirvetuximab-soravtansine-imgn853-a-folate-receptor-%C3%AE-targeting-antibody-drug-conjugate-in-patients-with-solid-tumors
#6
Kathleen N Moore, Hossein Borghaei, David M O'Malley, Woondong Jeong, Shelly M Seward, Todd M Bauer, Raymond P Perez, Ursula A Matulonis, Kelli L Running, Xiaoyan Zhang, Jose F Ponte, Rodrigo Ruiz-Soto, Michael J Birrer
BACKGROUND: Mirvetuximab soravtansine (IMGN853) is an antibody-drug conjugate that selectively targets folate receptor α (FRα). In this phase 1 dose-escalation study, the authors investigated IMGN853 in patients with FRα-positive solid tumors. METHODS: Patients received IMGN853 on day 1 of a 21-day cycle (once every 3 weeks dosing), with cycles repeated until patients experienced dose-limiting toxicity or progression. Dose escalation commenced in single-patient cohorts for the first 4 planned dose levels and then followed a standard 3 + 3 scheme...
April 25, 2017: Cancer
https://www.readbyqxmd.com/read/28438067/gene-therapy-for-patients-with-advanced-solid-tumors-a-phase-i-study-using-gene-electrotransfer-to-muscle-with-the-integrin-inhibitor-plasmid-amep
#7
Iben Spanggaard, Karin Dahlstroem, Line Laessoee, Rasmus Hvass Hansen, Helle Hjorth Johannesen, Helle Westergren Hendel, Céline Bouquet, Pierre Attali, Julie Gehl
BACKGROUND: Gene electrotrotransfer describes the use of electric pulses to transfer DNA to cells. Particularly skeletal muscle has potential for systemic secretion of therapeutic proteins. Gene electrotransfer to muscle using the integrin inhibitor plasmid AMEP (Antiangiogenic MEtargidin Peptide) was investigated in a phase I dose escalation study. Primary objective was safety. MATERIAL AND METHODS: Patients with metastatic or locally advanced solid tumors, without further standard treatments available, were treated with once-only gene electrotransfer of plasmid AMEP to the femoral muscle...
April 25, 2017: Acta Oncologica
https://www.readbyqxmd.com/read/28434648/nivolumab-in-patients-with-advanced-hepatocellular-carcinoma-checkmate-040-an-open-label-non-comparative-phase-1-2-dose-escalation-and-expansion-trial
#8
Anthony B El-Khoueiry, Bruno Sangro, Thomas Yau, Todd S Crocenzi, Masatoshi Kudo, Chiun Hsu, Tae-You Kim, Su-Pin Choo, Jörg Trojan, Theodore H Welling, Tim Meyer, Yoon-Koo Kang, Winnie Yeo, Akhil Chopra, Jeffrey Anderson, Christine Dela Cruz, Lixin Lang, Jaclyn Neely, Hao Tang, Homa B Dastani, Ignacio Melero
BACKGROUND: For patients with advanced hepatocellular carcinoma, sorafenib is the only approved drug worldwide, and outcomes remain poor. We aimed to assess the safety and efficacy of nivolumab, a programmed cell death protein-1 (PD-1) immune checkpoint inhibitor, in patients with advanced hepatocellular carcinoma with or without chronic viral hepatitis. METHODS: We did a phase 1/2, open-label, non-comparative, dose escalation and expansion trial (CheckMate 040) of nivolumab in adults (≥18 years) with histologically confirmed advanced hepatocellular carcinoma with or without hepatitis C or B (HCV or HBV) infection...
April 20, 2017: Lancet
https://www.readbyqxmd.com/read/28433601/volumetric-versus-unidimensional-measures-of-metastatic-colorectal-cancer-in-assessing-disease-response
#9
Meghan G Lubner, Nicholas Stabo, Sam J Lubner, Alejandro Munoz Del Rio, Chihwa Song, Perry J Pickhardt
INTRODUCTION: The purpose of this study was to compare unidimensional (1D/linear) and volumetric (3D) measures of metastatic colorectal cancer (mCRC) at computed tomography (CT) for predicting clinical outcome. PATIENTS AND METHODS: Analysis of CT images in 105 patients (mean age, 59 years; range, 25-81 years; 45 women, 60 men) receiving treatment for mCRC was performed. Both unidimensional and volumetric measures were obtained on index lesions at 3 time points (baseline/midpoint/post-therapy; mean interval, 4...
March 27, 2017: Clinical Colorectal Cancer
https://www.readbyqxmd.com/read/28432387/yttrium-90-radioembolization-for-unresectable-combined-hepatocellular-cholangiocarcinoma
#10
Lauren S Chan, Daniel Y Sze, George A Poultsides, John D Louie, Mohammed A Abdelrazek Mohammed, David S Wang
PURPOSE: Combined hepatocellular-cholangiocarcinoma (cHCC-CC) is a rare mixed cell type primary liver cancer with limited data to guide management. Transarterial radioembolization with yttrium-90 microspheres (RE) is an emerging treatment option for both hepatocellular carcinoma and intrahepatic cholangiocarcinoma. This study explored the safety and efficacy of RE for unresectable cHCC-CC. METHODS: Patients with histopathologically confirmed cHCC-CC treated with RE were retrospectively evaluated...
April 21, 2017: Cardiovascular and Interventional Radiology
https://www.readbyqxmd.com/read/28431263/epigenetic-therapy-and-chemosensitization-in-solid-malignancy
#11
REVIEW
Sean M Ronnekleiv-Kelly, Anup Sharma, Nita Ahuja
Epigenetic modifications result in dynamic shifts between transcriptionally active and suppressed states. The potentially reversible nature of epigenetic changes underlies the concept of epigenetic therapy, which serves to reprogram cancer cells as opposed to inducing cytotoxicity that occurs with standard chemotherapeutics. There are numerous enzymes involved in epigenetic changes and each can be potentially targetable. Although many investigations have evaluated the clinical potential of the various epigenetic therapies, currently only histone deacetylase inhibitors and DNA methyltransferase inhibitors are approved for use in specific hematologic malignancies...
April 8, 2017: Cancer Treatment Reviews
https://www.readbyqxmd.com/read/28430862/how-health-related-quality-of-life-assessment-should-be-used-in-advanced-colorectal-cancer-clinical-trials
#12
F Bonnetain, C Borg, R R Adams, J A Ajani, A Benson, H Bleiberg, B Chibaudel, E Diaz-Rubio, J Y Douillard, C S Fuchs, B J Giantonio, R Goldberg, V Heinemann, M Koopman, R Labianca, A K Larsen, T Maughan, E Mitchell, M Peeters, C J A Punt, H J Schmoll, C Tournigand, A de Gramont
Traditionally, the efficacy of cancer treatment in patients with advance or metastatic disease in clinical studies has been studied using overall survival (OS) and more recently tumor-based endpoints such as progression-free survival, measurements of response to treatment. However, these seem not to be the relevant clinical endpoints in current situation if such endpoints were no validated as surrogate of OS to demonstrate the clinical efficacy. Appropriate, meaningful, primary patient-oriented and patient-reported endpoints that adequately measure the effects of new therapeutic interventions are then crucial for the advancement of clinical research in metastatic colorectal cancer to complement the results of tumor-based endpoints...
April 18, 2017: Annals of Oncology: Official Journal of the European Society for Medical Oncology
https://www.readbyqxmd.com/read/28426123/cabozantinib-in-hepatocellular-carcinoma-results-of-a-phase-2-placebo-controlled-randomized-discontinuation-study
#13
R K Kelley, C Verslype, A L Cohn, T-S Yang, W-C Su, H Burris, F Braiteh, N Vogelzang, A Spira, P Foster, Y Lee, E Van Cutsem
Background: Cabozantinib, an orally bioavailable inhibitor of tyrosine kinases including MET, AXL, and VEGF receptors, was assessed in patients with hepatocellular carcinoma (HCC) as part of a phase 2 randomized discontinuation trial with nine tumor-type cohorts. Patients and methods: Eligible patients had Child-Pugh A liver function and ≤1 prior systemic anticancer regimen, completed ≥4 weeks before study entry. The cabozantinib starting dose was 100 mg daily...
March 1, 2017: Annals of Oncology: Official Journal of the European Society for Medical Oncology
https://www.readbyqxmd.com/read/28424962/phase-i-dose-escalation-study-of-milciclib-in-combination-with-gemcitabine-in-patients-with-refractory-solid-tumors
#14
Sandrine Aspeslagh, Kunwar Shailubhai, Rastilav Bahleda, Anas Gazzah, Andréa Varga, Antoine Hollebecque, Christophe Massard, Anna Spreafico, Michele Reni, Jean-Charles Soria
BACKGROUND: This phase I trial evaluated the safety and tolerability of milciclib, an inhibitor of multiple cyclin-dependent kinases and tropomycin receptor kinase A, in combination with gemcitabine in patients with refractory solid tumors. DESIGN: Sixteen patients were enrolled and treated with milciclib at three dose levels (45 mg/m(2)/day, n = 3; 60 mg/m(2)/day, n = 3; and 80 mg/m(2)/day, n = 10) with a fixed dose of gemcitabine (1000 mg/m(2)/day). Milciclib was administered orally once daily for 7 days on/7 days off in a 4-week cycle, and gemcitabine was administered intravenously on days 1, 8 and 15 in a 4-week cycle...
April 19, 2017: Cancer Chemotherapy and Pharmacology
https://www.readbyqxmd.com/read/28422858/350-560%C3%A2-%C3%AE-m-gelatin-sponge-particles-combined-with-transcatheter-arterial-chemoembolization-for-the-treatment-of-elderly-hepatocellular-carcinoma-the-safety-and-efficacy
#15
Guang Sheng Zhao, Chuang Li, Ying Liu, Zhi Zhong Ren, Xiao Lin Yuan, Jun Zhou, Yue Wei Zhang, Ming Zhang
To retrospectively analyze the safety and efficacy of 350-560 μm gelatin sponge particles combined with single-chemotherapy drug transcatheter arterial chemoembolization (Gs-TACE) for the treatment of elderly hepatocellular carcinoma without surgical resection.Thirty elderly hepatocellular carcinoma patients without surgical resection, who received Gs-TACE in our hospital, were selected. Slowly injected gelatin sponge particles (350-560 μm)+ 10 mg lobaplatin injection into the regional embolization tumor target vessel...
April 2017: Medicine (Baltimore)
https://www.readbyqxmd.com/read/28421163/phase-i-trial-of-triapine-cisplatin-paclitaxel-chemotherapy-for-advanced-stage-or-metastatic-solid-tumor-cancers
#16
Charles A Kunos, Edward Chu, Della Makower, Andreas Kaubisch, Mario Sznol, Susan Percy Ivy
Ribonucleotide reductase (RNR) is an enzyme involved in the de novo synthesis of deoxyribonucleotides, which are critical for DNA replication and DNA repair. Triapine is a small-molecule RNR inhibitor. A phase I trial studied the safety of triapine in combination with cisplatin-paclitaxel in patients with advanced stage or metastatic solid tumor cancers in an effort to capitalize on disrupted DNA damage repair. A total of 13 patients with various previously treated cancers were given a 96-h continuous intravenous (i...
2017: Frontiers in Oncology
https://www.readbyqxmd.com/read/28418819/cancer-genomics-and-important-oncologic-mutations-a-contemporary-guide-for-body-imagers
#17
REVIEW
Veronica L Cox, Priya Bhosale, Gauri R Varadhachary, Nicolaus Wagner-Bartak, Isabella C Glitza, Kathryn A Gold, Johnique T Atkins, Pamela T Soliman, David S Hong, Aliya Qayyum
The field of cancer genomics is rapidly evolving and has led to the development of new therapies. Knowledge of commonly involved cellular pathways and genetic mutations is now essential for radiologists reading oncology cases. Radiogenomics is an emerging area of research that seeks to correlate imaging features with cancer genotypes. Such knowledge may extend the utility of multiparametric imaging to yield information regarding cancer prognosis and likelihood of therapeutic response. To date, only a handful of radiogenomics studies have been performed to evaluate solid tumors of the body, and there is much to explore...
May 2017: Radiology
https://www.readbyqxmd.com/read/28417284/a-phase-i-dose-escalation-study-of-the-safety-and-pharmacokinetics-of-a-tablet-formulation-of-voxtalisib-a-phosphoinositide-3-kinase-inhibitor-in-patients-with-solid-tumors
#18
Janice M Mehnert, Gerald Edelman, Mark Stein, Heather Camisa, Joanne Lager, Jean-François Dedieu, Anne-Frédérique Ghuysen, Jyoti Sharma, Li Liu, Patricia M LoRusso
Background Voxtalisib, a PI3K/mTOR inhibitor, has shown antitumor activity in capsule formulation in patients with solid tumors. This Phase I study assessed safety and pharmacokinetics of voxtalisib administered as immediate-release tablets in patients with solid tumors (NCT01596270). Methods A "3 + 3" dose escalation design was used. Adverse events (AEs), pharmacokinetics (PK), food effect and tumor response were evaluated. Results Thirty-two patients received voxtalisib doses ranging from 50 mg to 70 mg once daily (QD) and 17 patients received voxtalisib doses ranging from 30 mg to 50 mg twice daily (BID), for two 28-day cycles...
April 17, 2017: Investigational New Drugs
https://www.readbyqxmd.com/read/28416953/response-evaluation-of-chemotherapy-for-lung-cancer
#19
REVIEW
Ki-Eun Hwang, Hak-Ryul Kim
Assessing response to therapy allows for prospective end point evaluation in clinical trials and serves as a guide to clinicians for making decisions. Recent prospective and randomized trials suggest the development of imaging techniques and introduction of new anti-cancer drugs. However, the revision of methods, or proposal of new methods to evaluate chemotherapeutic response, is not enough. This paper discusses the characteristics of the Response Evaluation Criteria In Solid Tumor (RECIST) version 1.1 suggested in 2009 and used widely by experts...
April 2017: Tuberculosis and Respiratory Diseases
https://www.readbyqxmd.com/read/28415807/efficacy-and-safety-of-apatinib-in-stage-iv-sarcomas-experience-of-a-major-sarcoma-center-in-china
#20
Feng Li, Zhichao Liao, Jun Zhao, Gang Zhao, Xubin Li, Xiaoling Du, Yun Yang, Jilong Yang
PURPOSE: This study was conducted to review the efficacy and safety of Apatinib in stage IV sarcoma patients who failed previous chemotherapy. MATERIALS AND METHODS: The clinical information on 16 patients with stage IV sarcomas who failed in prior chemotherapy and subsequently received Apatinib treatment was collected. Apatinib was given 500mg/daily and 4 weeks as a cycle. All patients had at least one measurable extracranial tumor according to Response Evaluation Criteria In Solid Tumors 1...
March 16, 2017: Oncotarget
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