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H Jiang, L T Zhi, M Hou, J X Wang, D P Wu, X J Huang
Objective: To evaluate the efficacy and safety of generic imatinib (Genike, Chiatai Tianqing Pharmaceutical Group Co., Ltd.) and imatinib (Glevic, Novartis, Switzerland) in newly diagnosed patients with chronic myeloid leukemia in chronic phase (CML-CP) . Methods: A retrospective study of 323 CML-CP patients (205 in Glivec treatment group and 118 in Genike group) who were ≥ 18 years old receiving imatinib monotherapy over the period of June 2013 to March 2016 was done to compare the differences of cytogenetics, molecular curative effect, survival, and adverse reactions between the two groups...
July 14, 2017: Zhonghua Xue Ye Xue za Zhi, Zhonghua Xueyexue Zazhi
Gyan K Kayastha, Nora Ranjitkar, Radha Gurung, Raj Kumar Kc, Sanjit Karki, Roshan Shrestha, Piyush Rajbhandari, Raj K Thapa, Buddhi Poudyal, Paras Acharya, David J Roberts, Bruce Hayes, Mark Zimmerman, Buddha Basnyat
Philadelphia chromosome/BCR-ABL1 positive chronic myeloid leukaemia (CML) can be successfully treated with Glivec (Imatinib), which is available free of cost through the Glivec International Patient Assistance programme (GIPAP) to patients with proven CML without means to pay for the drug. We review the acquired mutations in the tyrosine kinase encoded by the BCR-ABL1 gene underlying Glivec failure or resistance in a cohort of 388 imatinib-treated CML patients (149 Female and 239 male) registered between February 2003 and June 2016 in Nepal...
June 2017: British Journal of Haematology
Gyan K Kayastha, Nora Ranjitkar, Radha Gurung, Raj K Kc, Sanjit Karki, Roshan Shrestha, Raj K Thapa, Piyush Rajbhandari, Buddhi Poudyal, Paras Acharya, David J Roberts, Bruce Hayes, Mark Zimmerman, Buddha Basnyat, Aaron Mansfield
The Glivec International Patient Assistance Programme makes Glivec (Imatinib mesylate) available to Philadelphia chromosome/BCR-ABL1 positive patients with chronic myeloid leukaemia (CML) in Lower and Middle Income Countries (LMIC). We have established a large cohort of 211 CML patients who are eligible for Imatinib, in Kathmandu, Nepal. Thirty-one patients were lost to follow-up. We report on 180 CML patients with a median age of 38 years (range 9-81). Of these 180 patients, 162 underwent cytogenetic testing and 110 were investigated by reverse transcription polymerase chain reaction...
June 2017: British Journal of Haematology
Erna Islamagic, Azra Hasic, Sabira Kurtovic, Emina Suljovic Hadzimesic, Lejla Mehinovic, Mirza Kozaric, Amina Kurtovic-Kozaric
INTRODUCTION: Generics of imatinib mesylate, the first tyrosine kinase inhibitor targeting the BCR-ABL1 fusion protein, have recently been approved in many countries as the alternative, low-cost forms for the treatment of patients with chronic myeloid leukemia (CML). The aim of this study was to evaluate the long-term clinical outcomes of patients with CML receiving first-line and second-line generic imatinib in Bosnia and Herzegovina. PATIENTS AND METHODS: This was a multicenter retrospective cohort study of patients (n = 41) treated with generic imatinib in Bosnia between September 1, 2013 and August 5, 2016...
February 16, 2017: Clinical Lymphoma, Myeloma & Leukemia
Guangying Sheng, Suning Chen, Ri Zhang, Miao Miao, Depei Wu, Seng Chuen Tan, Chao Liu, Tengbin Xiong
OBJECTIVES: Imatinib (Glivec) has been covered by critical disease insurance for treatment of chronic myeloid leukemia (CML) in Jiangsu province of China since 2013. Further, free molecular monitoring has been provided to patients at top clinical centers as part of a pilot study that has changed the local treatment pattern and outcomes of patients with CML. This study evaluates the impact of medical insurance coverage and the molecular monitoring frequency on outcomes of patients with CML treated at a central hospital in Jiangsu, China, according to patient-level data...
April 2017: Journal of Medical Economics
Guangying Sheng, Suning Chen, Chaohui Dong, Ri Zhang, Miao Miao, Depei Wu, Seng Chuen Tan, Chao Liu, Tengbin Xiong
OBJECTIVES: Imatinib (Glivec) and nilotinib (Tasigna) have been covered by critical disease insurance in Jiangsu province of China since 2013, which changed local treatment patterns and outcomes of patients with chronic myeloid leukemia (CML). This study evaluated the long-term cost-effectiveness of insurance coverage with imatinib as the first-line treatment for patients with CML in China from a societal perspective. METHODS: A decision-analytic model based on previously published and real-world evidence was applied to simulate and evaluate the lifetime clinical and economic outcomes associated with CML treatments before and after imatinib was covered by medical insurance...
April 2017: Journal of Medical Economics
H X Shi, Y Z Qin, Y Y Lai, X J Huang, Q Jiang
Objective: To compare the efficacy and safety between Chinese generic imatinib (Xinwei(®), Jiansu Hansoh Pharmaceutical Group Co., Ltd.) versus branded imatinib (Glivec(®), Novartis) in patients with newly-diagnosed chronic myeloid leukemia in chronic phase (CML-CP). Methods: Patients with newly diagnosed CML-CP were enrolled and assigned to receive either Xinwei or Glivec at an initial dose of 400 mg/d according to patients' financial capability. The efficacy and adverse effects were evaluated. Results: From January 2014 to September 2015, 145 eligible patients were assigned to Xinwei (n=89) or Glivec (n=56) group...
December 1, 2016: Zhonghua Nei Ke za Zhi [Chinese Journal of Internal Medicine]
L Yu, H B Wang, X J Huang, Q Jiang
OBJECTIVE: To explore the impact of Glivec related side effects on daily life in Chinese patients with chronic myeloid leukemia (CML) in the chronic phase (CP). METHODS: From May to November in 2014, anonymous questionnaires were distributed to adult CML patients who were receiving tyrosine kinase inhibitors (TKI) treatment in China. The impact of TKI related side effects on daily life were assessed by the score of 1 (no impact) to 5 (high impact) from patient self- report...
July 2016: Zhonghua Xue Ye Xue za Zhi, Zhonghua Xueyexue Zazhi
Mark Lawler, Declan French, Raymond Henderson, Ajay Aggarwal, Richard Sullivan
In his last two State of the Union addresses, President Barack Obama has focused on the need to deliver innovative solutions to improve human health, through the Precision Medicine Initiative in 2015 and the recently announced Cancer Moonshot in 2016. Precision cancer care has delivered clear patient benefit, but even for high-impact medicines such as imatinib mesylate (Glivec) in chronic myeloid leukaemia, the excitement at the success of this practice-changing clinical intervention has been somewhat tempered by the escalating price of this 'poster child' for precision cancer medicine (PCM)...
2016: Public Health Genomics
Konstantins Logviss, Dainis Krievins, Santa Purvina
BACKGROUND: Number of orphan medicinal products on the market and number of rare disease patients, taking these usually expensive products, are increasing. As a result, budget impact of orphan drugs is growing. This factor, along with the cost-effectiveness of orphan drugs, is often considered in the reimbursement decisions, directly affecting accessibility of rare disease therapies. The current study aims to assess the budget impact of orphan drugs in Latvia. METHODS: Our study covered a 5-year period, from 2010 to 2014...
2016: Orphanet Journal of Rare Diseases
Wu Luo, Li Song, Xi-Lei Chen, Xiang-Feng Zeng, Jian-Zhang Wu, Cai-Rong Zhu, Tao Huang, Xiang-Peng Tan, Xiao-Mian Lin, Qi Yang, Ji-Zhong Wang, Xiao-Kun Li, Xiao-Ping Wu
Multidrug resistance protein-1 (MDR1) has been proven to be associated with the development of chemoresistance to imatinib (Glivec, STI571) which displays high efficacy in treatment of BCR-ABL-positive chronic myelogenous leukemia (CML). However, the possible mechanisms of MDR1 modulation in the process of the resistance development remain to be defined. Herein, galectin-1 was identified as a candidate modulator of MDR1 by proteomic analysis of a model system of leukemia cell lines with a gradual increase of MDR1 expression and drug resistance...
May 3, 2016: Oncotarget
Laurence Zitvogel, Sylvie Rusakiewicz, Bertrand Routy, Maha Ayyoub, Guido Kroemer
Around 15 years ago, imatinib mesylate (Gleevec(®) or Glivec(®), Novartis, Switzerland) became the very first 'targeted' anticancer drug to be clinically approved. This drug constitutes the quintessential example of a successful precision medicine that has truly changed the fate of patients with Philadelphia-chromosome-positive chronic myeloid leukaemia (CML) and gastrointestinal stromal tumours by targeting the oncogenic drivers of these diseases, BCR-ABL1 and KIT and/or PDGFR, mutations in which lead to gain of function of tyrosine kinase activities...
July 2016: Nature Reviews. Clinical Oncology
László G Boros, Dominic P D'Agostino, Howard E Katz, Justine P Roth, Emmanuelle J Meuillet, Gábor Somlyai
The naturally occurring isotope of hydrogen ((1)H), deuterium ((2)H), could have an important biological role. Deuterium depleted water delays tumor progression in mice, dogs, cats and humans. Hydratase enzymes of the tricarboxylic acid (TCA) cycle control cell growth and deplete deuterium from redox cofactors, fatty acids and DNA, which undergo hydride ion and hydrogen atom transfer reactions. A model is proposed that emphasizes the terminal complex of mitochondrial electron transport chain reducing molecular oxygen to deuterium depleted water (DDW); this affects gluconeogenesis as well as fatty acid oxidation...
February 2016: Medical Hypotheses
Jelena Gacic, Emina Vorkapic, Renate Slind Olsen, Daniel Söderberg, Therese Gustafsson, Robert Geffers, Karin Skoglund, Andreas Matussek, Dick Wågsäter
BACKGROUND: Imatinib mesylate (Glivec®, formerly STI-571) is a selective tyrosine kinase inhibitor used for the treatment of chronic myeloid leukemia and gastrointestinal stromal tumors. However, there are reports suggesting that imatinib could be atheroprotective by lowering plasma low-density lipoprotein (LDL). AIM: To investigate the potential inhibitory effect of imatinib on cholesterol uptake in human macrophages as well as its effect on matrix metalloproteinase (MMP) activity...
February 2016: Pharmacological Reports: PR
Philippe Saiag, Jean-Jacques Grob, Celeste Lebbe, Josep Malvehy, Veronique del Marmol, Hubert Pehamberger, Ketty Peris, Alexander Stratigos, Mark Middelton, Lars Basholt, Alessandro Testori, Claus Garbe
Dermatofibrosarcoma protuberans (DFSP) is a skin fibroblastic tumour that is locally aggressive, with a tendency for local recurrence, but rarely metastasizes. A unique collaboration of multi-disciplinary experts from the European Dermatology Forum (EDF), the European Association of Dermato-Oncology (EADO) and the European Organization of Research and Treatment of Cancer (EORTC) was formed to make recommendations on DFSP diagnosis and treatment, based on systematic literature reviews and the experts' experience...
November 2015: European Journal of Cancer
Masako Yokoo, Yasushi Kubota, Yoko Tabe, Shinya Kimura
Long-term treatment with imatinib mesylate (IM) allows patients with chronic myeloid leukemia (CML) to live a near-normal lifespan. However, the fact that tyrosine kinase inhibitors, including IM, are extremely expensive is a major cause of poor adherence, resulting in disease relapse or drug resistance. Therefore, physicians are encouraged to prescribe generic drugs to reduce the financial burden of medical expenses. In Japan, only generic drugs that have a basic chemical structure and pharmacokinetic data that are the same as those of the original drug are approved...
2015: Biological & Pharmaceutical Bulletin
Ahmet Emre Eskazan, Teoman Soysal
As the first tyrosine kinase inhibitor (TKI), imatinib (Gleevec or Glivec, Novartis Pharmaceuticals) was introduced, the treatment of chronic myeloid leukemia (CML) has changed radically, and the TKIs are now the mainstay of CML treatment. The substantially high treatment cost has unfortunately been a major issue, which puts a strain on health-care budgets even in developed countries. So reimbursement policies encourage generic drug (i.e. generic imatinib) use to lower the expenses, and it is true that generics would lead to considerable cost savings, but they also give rise to questions associated with their efficacy, safety and quality...
April 2016: Journal of Oncology Pharmacy Practice
Kelvin Harvey Kramp, Mohab Galal Omer, Patrick Schoffski, Andre d'Hoore
Gastrointestinal stromal tumours (GISTs) are generally rare but are known to be the most common mesenchymal tumours of the gastrointestinal tract. We present a case of a patient who presented with persistent obstructive gastrointestinal and urological symptoms, a sense of incomplete evacuation and bleeding per rectum. A colonoscopy was performed and a biopsy was taken of a submucosal mass in the distal rectum that revealed a GIST with positive KIT immunostaining. A positron emission tomography (PET)/CT scan showed a large metabolically active distal rectal tumour of 8 cm with macroscopic invasion of surrounding structures...
January 8, 2015: BMJ Case Reports
Svenja Beckmann, Thavy Long, Christina Scheld, Rudolf Geyer, Conor R Caffrey, Christoph G Grevelding
In the search for new drugs and drug targets to treat the flatworm disease schistosomiasis, protein kinases (PKs) have come under particular scrutiny because of their essential roles in developmental and physiological processes in schistosome parasites. In this context the application of the anti-cancer Abl tyrosine kinase (TK) inhibitor Imatinib (Gleevec/Glivec; STI-571) to adult Schistosoma mansoni in vitro has indicated negative effects on diverse physiological processes including survival. Motivated by these in vitro findings, we performed in vivo experiments in rodent models of S...
December 2014: International Journal for Parasitology, Drugs and Drug Resistance
Selcen Celik, Dilara Akcora, Tulin Ozkan, Nuray Varol, Sena Aydos, Asuman Sunguroglu
Death-associated protein kinase-1 (DAPK1) is a pro-apoptotic gene that induces cellular apoptosis in response to internal and external apoptotic stimulants. The silencing of DAPK1 can result in uncontrolled cell proliferation, indicating that it may have a role in tumor suppression. DAPK1 activity can be inhibited by the cytosine methylation that occurs in its promoter region. These methylation changes in the promoter region of DAPK1 have been reported in a range of solid and hematological malignancies. In the present study, DAPK1 methylation was investigated in chronic myeloid leukemia patients (n=43) using bisulfite conversion followed by methylation-specific polymerase chain reaction...
January 2015: Oncology Letters
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