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https://www.readbyqxmd.com/read/27918780/effect-of-a-proposed-trastuzumab-biosimilar-compared-with-trastuzumab-on-overall-response-rate-in-patients-with-erbb2-her2-positive-metastatic-breast-cancer-a-randomized-clinical-trial
#1
Hope S Rugo, Abhijit Barve, Cornelius F Waller, Miguel Hernandez-Bronchud, Jay Herson, Jinyu Yuan, Rajiv Sharma, Mark Baczkowski, Mudgal Kothekar, Subramanian Loganathan, Alexey Manikhas, Igor Bondarenko, Guzel Mukhametshina, Gia Nemsadze, Joseph D Parra, Maria Luisa T Abesamis-Tiambeng, Kakhaber Baramidze, Charuwan Akewanlop, Ihor Vynnychenko, Virote Sriuranpong, Gopichand Mamillapalli, Sirshendu Ray, Eduardo P Yanez Ruiz, Eduardo Pennella
Importance: Treatment with the anti-ERBB2 humanized monoclonal antibody trastuzumab and chemotherapy significantly improves outcome in patients with ERBB2 (HER2)-positive metastatic breast cancer; a clinically effective biosimilar may help increase access to this therapy. Objective: To compare the overall response rate and assess the safety of a proposed trastuzumab biosimilar plus a taxane or trastuzumab plus a taxane in patients without prior treatment for ERBB2-positive metastatic breast cancer...
December 1, 2016: JAMA: the Journal of the American Medical Association
https://www.readbyqxmd.com/read/27912236/prognostic-role-of-pten-gene-expression-in-breast-cancer-patients-from-north-east-iran
#2
Rahim Golmohammadi, Mohammad Hassan Rakhshani, Ali Reza Moslem, Akbar Pejhan
Background: PTEN protein is one of the most important tumour suppressor factors which is detectable by immunohistochemistry. The goal of the present study was to investigate the prognostic role of PTEN gene expression in breast cancer patients. Materials and Methods: This descriptive-analytical study was conducted on 100 breast cancer patients referred to Sabzevar hospitals in the north-east of Iran between 2010 and 2011, who were followed up to 2015. PTEN gene expression in tissue samples was determined using specific monoclonal antibodies and data were analyzed using Chi-square test and Fisher’s exact test...
January 9, 2016: Asian Pacific Journal of Cancer Prevention: APJCP
https://www.readbyqxmd.com/read/27899776/-new-classification-for-advanced-colorectal-cancer-using-cancerplex%C3%A2-genomic-tests
#3
Hitoshi Kameyama, Yoshifumi Shimada, Hiroshi Ichikawa, Masayuki Nagahashi, Jun Sakata, Takashi Kobayashi, Hitoshi Nogami, Satoshi Maruyama, Yasumasa Takii, Shujiro Okuda, Yiwei Ling, Hiroshi Izutsu, Keisuke Kodama, Mitsutaka Nakada, Toshifumi Wakai
Recently, targeted drugs have been developed for the treatment of colorectal cancer(CRC). Among targets, it is well known that KRAS mutations are associated with resistance to epidermal growth factor receptor(EGFR)monoclonal antibodies. However, response rates using anti-EGFR monotherapy for CRC were less than 20-30% in previous clinical studies. Thus, because the RAS/MAP2K/MAPK and PI3K/AKT pathways are associated with CRC resistance to chemotherapy, we analyzed gene mutations in Stage IV CRC patients using a genomic test(CancerPlex®)...
November 2016: Gan to Kagaku Ryoho. Cancer & Chemotherapy
https://www.readbyqxmd.com/read/27897268/germline-polymorphisms-as-biomarkers-of-tumor-response-in-colorectal-cancer-patients-treated-with-anti-egfr-monoclonal-antibodies-a-systematic-review-and-meta-analysis
#4
E K Morgen, H-J Lenz, D J Jonker, D Tu, G Milano, F Graziano, J Zalcberg, C S Karapetis, A Dobrovic, C J O'Callaghan, G Liu
Studies of germline polymorphisms as predictors of tumor response to anti-epidermal growth factor receptor (EGFR) monoclonal antibody agents in metastatic colorectal cancer have reported inconsistent results. We performed a systematic review of studies from 1990 to September 2015, followed by random-effects meta-analyses for polymorphisms examined in at least three studies. Of 87 studies, 40 passed the criteria for systematic review and 23 for meta-analysis. The polymorphisms suitable for meta-analysis were CCND1 (rs17852153), COX2 (rs20417), EGF (rs4444903), EGFR (rs712829, rs11543848, 3'UTR CA repeat), FCGR2A (rs1801274), FCGR3A (rs396991), IL8 (rs4073), KRAS (rs61764370) and VEGFA (rs3025039)...
November 29, 2016: Pharmacogenomics Journal
https://www.readbyqxmd.com/read/27883347/-adalimumab-as-induction-therapy-for-crohn-s-disease-one-center-study
#5
Maciej Gonciarz, Aldona Mularczyk, Dawid Szkudłapski, Iwona Piątek, Marek Kopała
: Adalimumab is a subcutaneously administered recombinant fully human monoclonal antibody targeting tumor necrosis factor alpha. It has been approved for use in Poland to treat patients with Crohn's disease under the program of Polish National Health Found since 2010. AIM: The aim of this study was to evaluate the efficacy of adalimumab monotherapy for inducing clinical remission in patients with active Crohn's disease . The primary outcome assessment was the reduction in score to 150 or below on the Crohn's Disease Activity Index (CDAI) at 12 weeks and the secondary one was the reduction in ΔCDAI of at least 100 points...
November 25, 2016: Polski Merkuriusz Lekarski: Organ Polskiego Towarzystwa Lekarskiego
https://www.readbyqxmd.com/read/27879972/responses-of-metastatic-basal-cell-and-cutaneous-squamous-cell-carcinomas-to-anti-pd1-monoclonal-antibody-regn2810
#6
Gerald S Falchook, Rom Leidner, Elizabeth Stankevich, Brian Piening, Carlo Bifulco, Israel Lowy, Matthew G Fury
BACKGROUND: Basal cell carcinoma (BCC) and cutaneous squamous cell carcinoma (CSCC) share exposure to UV light as the dominant risk factor, and these tumors therefore harbor high mutation burdens. In other malignancies, high mutation burden has been associated with clinical benefit from therapy with antibodies directed against the Programmed Death 1 (PD-1) immune checkpoint receptor. Highly mutated tumors are more likely to express immunogenic tumor neoantigens that attract effector T cells, which can be unleashed by blockade of the PD-1 immune checkpoint...
2016: Journal for Immunotherapy of Cancer
https://www.readbyqxmd.com/read/27877050/development-of-proprotein-convertase-subtilisin-kexin-type-9-inhibitors-and-the-clinical-potential-of-monoclonal-antibodies-in-the-management-of-lipid-disorders
#7
REVIEW
Sanjiv Gupta
The aim of this manuscript is to review available data to evaluate the present status of proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors in the treatment of hypercholesterolemia. Relevant literature since 2003 is reviewed. The effectiveness of PCSK9 inhibitors in lowering low-density lipoprotein cholesterol and other atherogenic lipid fractions was studied in various Phase 2 and Phase 3 trials of Alirocumab, Evolocumab, and Bococizumab. The results of published long-term ODYSSEY and OSLER studies are summarized...
2016: Vascular Health and Risk Management
https://www.readbyqxmd.com/read/27873217/a-retrospective-evaluation-of-the-use-of-mass-spectrometry-in-fda-biologics-license-applications
#8
Sarah Rogstad, Anneliese Faustino, Ashley Ruth, David Keire, Michael Boyne, Jun Park
The characterization sections of biologics license applications (BLAs) approved by the United States Food and Drug Administration (FDA) between 2000 and 2015 were investigated to examine the extent of the use of mass spectrometry. Mass spectrometry was found to be integral to the characterization of these biotherapeutics. Of the 80 electronically submitted monoclonal antibody and protein biotherapeutic BLAs included in this study, 79 were found to use mass spectrometric workflows for protein or impurity characterization...
November 21, 2016: Journal of the American Society for Mass Spectrometry
https://www.readbyqxmd.com/read/27870103/role-of-immunotherapy-in-targeting-the-bone-marrow-microenvironment-in-multiple-myeloma-an-evolving-therapeutic-strategy
#9
Clement Chung
Multiple myeloma (referred to henceforth as myeloma) is a B-cell malignancy characterized by unregulated growth of plasma cells in the bone marrow. The treatment paradigm for myeloma underwent significant evolution in the last decade, with an improved understanding of the pathogenesis of the disease as well as the development of therapeutic agents that target not only the tumor cells but also their microenvironment. Despite these therapeutic advances, the prognosis of patients with relapsed or refractory myeloma remains poor...
November 21, 2016: Pharmacotherapy
https://www.readbyqxmd.com/read/27863374/magic-year-for-multiple-myeloma-therapeutics-key-takeaways-from-the-ash-2015-annual-meeting
#10
REVIEW
Kejie Zhang, Aakash Desai, Dongfeng Zeng, Tiejun Gong, Peihua Lu, Michael Wang
Despite the availability of various anticancer agents, Multiple Myeloma (MM) remains incurable in most cases, along with high relapse rate in the patients treated with these agents. The year 2015 saw major advancements in our battle against multiple myeloma. In 2015, the U.S. Food and Drug Administration (FDA) approved three new therapies for multiple myeloma, namely Ixazomib (an oral proteasome inhibitor), Daratumumab and Elotuzumab (monoclonal antibodies against CD38 and SLAMF7 respectively). The purpose of this review is to provide a detailed analysis of these aforementioned breakthrough therapies and two other newer agents, Filanesib (kinesis spindle inhibitor) and selinexor (SINE inhibitor), presented at the 2015 annual meeting of American Society of Hematology (ASH)...
November 11, 2016: Oncotarget
https://www.readbyqxmd.com/read/27821382/a-prospective-multicenter-randomized-phase-ii-study-to-evaluate-the-efficacy-and-safety-of-eculizumab-in-patients-with-guillain-barr%C3%A3-syndrome-gbs-protocol-of-japanese-eculizumab-trial-for-gbs-jet-gbs
#11
Nobuko Yamaguchi, Sonoko Misawa, Yasunori Sato, Kengo Nagashima, Kanako Katayama, Yukari Sekiguchi, Yuta Iwai, Hiroshi Amino, Tomoki Suichi, Takanori Yokota, Yoichiro Nishida, Nobuo Kohara, Koichi Hirata, Kazutoshi Nishiyama, Ichiro Yabe, Ken-Ichi Kaida, Norihiro Suzuki, Hiroyuki Nodera, Shoji Tsuji, Haruki Koike, Jun-Ichi Kira, Hideki Hanaoka, Susumu Kusunoki, Satoshi Kuwabara
BACKGROUND: Guillain-Barré syndrome (GBS) is an immune-mediated neuropathy that causes acute flaccid paralysis. Immunoglobulin and plasma exchange are established treatments for GBS; however, a substantial number of patients, particularly those with severe disease, have poor recovery and residual deficits. Recent studies suggest that complement activation plays a pivotal role in GBS-associated axonal degeneration, and eculizumab is a humanized monoclonal antibody that specifically binds to complement component 5 and potently inhibits complement activation...
November 7, 2016: JMIR Research Protocols
https://www.readbyqxmd.com/read/27807766/monoclonal-antibody-and-fusion-protein-biosimilars-across-therapeutic-areas-a-systematic-review-of-published-evidence
#12
REVIEW
Ira Jacobs, Danielle Petersel, Lesley G Shane, Chee-Keng Ng, Carol Kirchhoff, Gregory Finch, Sadiq Lula
BACKGROUND: Despite regulatory efforts to formalize guidance policies on biosimilars, there remains a need to educate healthcare stakeholders on the acknowledged definition of biosimilarity and the data that underpin it. OBJECTIVES: The objectives of the study were to systematically collate published data for monoclonal antibodies and fusion protein biosimilars indicated for cancer, chronic inflammatory diseases, and other indications, and to explore differences in the type and weight (quantity and quality) of available evidence...
November 2, 2016: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
https://www.readbyqxmd.com/read/27806428/daratumumab-elotuzumab-and-the-development-of-therapeutic-monoclonal-antibodies-in-multiple-myeloma
#13
Jacob P Laubach, Claudia E Paba Prada, Paul G Richardson, Dan L Longo
There has been substantial progress in clinical outcomes for patients with multiple myeloma. This encouraging trend derives in large part from the increasing number of effective therapeutic options and the ability as a result of this to achieve higher quality responses to treatment. The approval of both daratumumab and of elotuzumab in combination with lenalidomide and dexamethasone in late 2015 was a notable achievement in the field, as daratumumab and elotuzumab represent the first monoclonal antibodies available for use in multiple myeloma...
November 2, 2016: Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/27797438/putting-t-cells-to-work-outsourcing-neoantigen-detection-in-head-and-neck-cancer
#14
Roy Xiao, Carter Van Waes, Nicole C Schmitt
The recent genomic characterization of head and neck squamous cell carcinomas by The Cancer Genome Atlas demonstrated the high frequency of mutations affecting these cancers (Cancer Genome Atlas Network, 2015). This high rate of genomic alterations allows head and neck cancers to be highly immunogenic, thus promoting responses to immune therapies (Allen et al, 2015; Ferris, 2015). For instance, inhibitors of immune checkpoints like the anti-PD-1 monoclonal antibodies nivolumab and pembrolizumab have demonstrated promising results in head and neck cancer (Ferris et al, 2016; Chow et al, 2016), both recently receiving FDA approval in the setting of recurrent or metastatic disease...
October 31, 2016: Oral Diseases
https://www.readbyqxmd.com/read/27732819/a-randomized-controlled-trial-of-zmapp-for-ebola-virus-infection
#15
(no author information available yet)
Background Data from studies in nonhuman primates suggest that the triple monoclonal antibody cocktail ZMapp is a promising immune-based treatment for Ebola virus disease (EVD). Methods Beginning in March 2015, we conducted a randomized, controlled trial of ZMapp plus the current standard of care as compared with the current standard of care alone in patients with EVD that was diagnosed in West Africa by polymerase-chain-reaction (PCR) assay. Eligible patients of any age were randomly assigned in a 1:1 ratio to receive either the current standard of care or the current standard of care plus three intravenous infusions of ZMapp (50 mg per kilogram of body weight, administered every third day)...
October 13, 2016: New England Journal of Medicine
https://www.readbyqxmd.com/read/27730538/budget-impact-analysis-of-biosimilar-trastuzumab-for-the-treatment-of-breast-cancer-in-croatia
#16
August Cesarec, Robert Likić
BACKGROUND AND OBJECTIVE: Breast cancer is the most common cancer in women and has considerable impact on healthcare budgets and patients' quality of life. Trastuzumab (Herceptin(®)) is a monoclonal antibody directed against the human epidermal growth factor receptor (HER2) for the treatment of breast cancer. Several trastuzumab biosimilars are currently in development. In 2015, trastuzumab was the drug with the highest financial consumption among all drugs in Croatia. This model estimates the 1-year budget impact of the introduction of biosimilar trastuzumab in Croatia...
October 11, 2016: Applied Health Economics and Health Policy
https://www.readbyqxmd.com/read/27696389/improvements-in-hepatitis-b-virus-screening-before-rituximab-therapy-a-community-based-safety-net-hospital-experience
#17
Kevin Junus, Maria Aguilar, Priya Patel, David Irwin, Stephen Yee, Benny Liu, Taft Bhuket, Robert J Wong
BACKGROUND: Individuals with chronic hepatitis B virus infection (HBV) or previously resolved HBV are at increased risk of HBV exacerbation or reactivation when they receive treatment with anti-CD20 monoclonal antibodies (against B-lymphocyte antigen cluster of differentiation 20 [CD20], an activated-glycosylated phosphoprotein) like rituximab (RTX). The objective of the current study was to evaluate the rates of appropriate HBV screening before patients started receiving RTX, at the initiation of HBV treatment, and during HBV flares among an underserved safety-net population...
October 3, 2016: Cancer
https://www.readbyqxmd.com/read/27693088/immune-checkpoint-inhibitors-for-nonsmall-cell-lung-cancer-treatment
#18
Yuh-Min Chen
Immune checkpoint inhibition with blocking antibodies that target cytotoxic T-lymphocyte antigen-4 (CTLA-4) and the programmed cell death protein 1 (PD-1) pathway [PD-1/programmed death-ligand 1 (PD-L1)] have demonstrated promise in a variety of malignancies. While ipilimumab has been approved as a CTLA-4 blocking antibody by the US Food and Drug Administration for the treatment of advanced melanoma, it is still not approved for lung cancer treatment. In contrast, nivolumab and pembrolizumab, both PD-1 blocking antibodies, have been approved for second-line treatment of nonsmall cell lung cancer in 2015 because of their high potency and long-lasting effects in some patient subgroups...
September 29, 2016: Journal of the Chinese Medical Association: JCMA
https://www.readbyqxmd.com/read/27688901/correlation-between-blood-magnesium-and-calcium-concentration-in-patients-treated-with-an-anti-egfr-antibody
#19
Toshiyasu Tsujii, Takafumi Ogaki, Kaori Nakae, Kiyotaka Imai, Daisuke Kise, Shoji Tada, Hiroki Ueda, Masahiro Moriyama
BACKGROUND: Hypomagnesemia is one of the characteristic side effects of the human anti-epidermal growth factor receptor (EGFR) monoclonal antibodies, cetuximab and panitumumab. The major mechanism of anti-EGFR antibody-related hypomagnesemia is suppression of EGFR-mediated urinary Mg(2+) reabsorption in both the renal tubule the intestinal tract. Since Mg(2+) is known to affect blood Ca(2+) levels through regulation of parathyroid hormone (PTH) secretion, we investigated the correlation between Ca(2+) and Mg(2+) concentration in blood...
2016: Journal of Pharmaceutical Health Care and Sciences
https://www.readbyqxmd.com/read/27668357/efficacy-and-safety-of-rituximab-therapy-in-neuromyelitis-optica-spectrum-disorders-a-systematic-review-and-meta-analysis
#20
Valentina Damato, Amelia Evoli, Raffaele Iorio
Importance: Neuromyelitis optica spectrum disorders (NMOSDs) are autoimmune astrocytopathies characterized by predominant involvement of the optic nerves and spinal cord. In most patients, an IgG autoantibody binding to astrocytic aquaporin 4, the principal water channel of the central nervous system, is detected. Rituximab, a chimeric monoclonal antibody specific for the CD20 B-lymphocyte surface antigen, has been increasingly adopted as a first-line off-label treatment for patients with NMOSDs...
September 26, 2016: JAMA Neurology
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