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https://www.readbyqxmd.com/read/28213365/fda-approval-summary-tas-102
#1
Leigh Marcus, Steven J Lemery, Sachia Khasar, Emily Wearne, Whitney S Helms, Weishi Yuan, Kun He, Xianhua Cao, Jingyu Yu, Hong Zhao, Yaning Wang, Olen Stephens, Erika Englund, Rajiv Agarwal, Patricia Keegan, Richard Pazdur
FDA approved TAS-102 (Lonsurf, Taiho Oncology, Inc.) for the treatment of patients with metastatic colorectal cancer (mCRC) who have been previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF biological therapy, and if RAS wild-type, an anti-EGFR therapy. In an international, multicenter, double-blinded, placebo-controlled trial (TPU-TAS-102-301, herein referred to as RECOURSE), 800 patients with previously treated mCRC were randomly allocated (2:1) to receive either TAS-102 35mg/m2 orally twice daily after meals on Days 1-5 and 8-12 of each 28-day cycle (n=534) or matching placebo (n=266)...
February 17, 2017: Clinical Cancer Research: An Official Journal of the American Association for Cancer Research
https://www.readbyqxmd.com/read/28211162/efficacy-of-the-oral-mtorc1-inhibitor-everolimus-in-relapsed-or-refractory-indolent-lymphoma
#2
N Nora Bennani, Betsy R LaPlant, Stephen M Ansell, Thomas M Habermann, David J Inwards, Ivana N Micallef, Patrick B Johnston, Luis F Porrata, Joseph P Colgan, Svetomir N Markovic, Grzegorz S Nowakowski, William R Macon, Craig B Reeder, Joseph R Mikhael, Donald W Northfelt, Irene M Ghobrial, Thomas E Witzig
Relapsed indolent lymphoma often becomes refractory to standard chemoimmunotherapy and requires new therapeutic strategies. Targeting the PI3K/mTOR pathway in several types of lymphoma has shown preclinical and clinical efficacy providing the rationale to test this strategy in the treatment of relapsed/refractory indolent lymphomas. We investigated in a phase II open label clinical trial the efficacy and safety of single agent everolimus, an inhibitor of mTORC1, in patients with relapsed/refractory indolent lymphomas...
February 17, 2017: American Journal of Hematology
https://www.readbyqxmd.com/read/28210091/long-term-results-of-paclitaxel-plus-cisplatin-with-concurrent-radiotherapy-for-loco-regional-esophageal-squamous-cell-carcinoma
#3
Han-Ting Zhu, Da-Shan Ai, Hua-Rong Tang, Harun Badakhshi, Jian-Hong Fan, Jia-Ying Deng, Jun-Hua Zhang, Yun Chen, Zhen Zhang, Yi Xia, Xiao-Mao Guo, Guo-Liang Jiang, Kuai-Le Zhao
AIM: To evaluate the long-term effectiveness and late toxicities of paclitaxel (PTX) plus cisplatin (DDP) with concurrent radiotherapy for locally advanced esophageal squamous cancer. METHODS: Between 2008 and 2011, 76 patients were enrolled in a phase II study on the treatment of loco-regionally advanced esophageal cancer with radiotherapy (68.4 Gy/44 fractions or 61.2 Gy/34 fractions) combined with 4-cycle chemotherapy consisting of DDP (25 mg/m(2) per day for 3 d) and PTX (175 mg/m(2) for 3 h)...
January 21, 2017: World Journal of Gastroenterology: WJG
https://www.readbyqxmd.com/read/28209298/utidelone-plus-capecitabine-versus-capecitabine-alone-for-heavily-pretreated-metastatic-breast-cancer-refractory-to-anthracyclines-and-taxanes-a-multicentre-open-label-superiority-phase-3-randomised-controlled-trial
#4
Pin Zhang, Tao Sun, Qingyuan Zhang, Zhongyu Yuan, Zefei Jiang, Xiao Jia Wang, Shude Cui, Yuee Teng, Xi-Chun Hu, Junlan Yang, Hongming Pan, Zhongsheng Tong, Huiping Li, Qiang Yao, Yongsheng Wang, Yongmei Yin, Ping Sun, Hong Zheng, Jing Cheng, Jinsong Lu, Baochun Zhang, Cuizhi Geng, Jian Liu, Roujun Peng, Min Yan, Shaohua Zhang, Jian Huang, Li Tang, Rongguo Qiu, Binghe Xu
BACKGROUND: Utidelone, a genetically engineered epothilone analogue, has shown promise as a potential treatment for breast cancer in phase 1 and 2 trials. The aim of this phase 3 trial was to compare the efficacy and safety of utidelone plus capecitabine versus capecitabine alone in patients with metastatic breast cancer. METHODS: We did a multicentre, open-label, superiority, phase 3, randomised controlled trial in 26 hospitals in China. Eligible participants were female patients with metastatic breast cancer refractory to anthracycline and taxane chemotherapy regimens...
February 10, 2017: Lancet Oncology
https://www.readbyqxmd.com/read/28208677/targeting-protein-kinase-ck2-evaluating-cx-4945-potential-for-gl261-glioblastoma-therapy-in-immunocompetent-mice
#5
Laura Ferrer-Font, Lucia Villamañan, Nuria Arias-Ramos, Jordi Vilardell, Maria Plana, Maria Ruzzene, Lorenzo A Pinna, Emilio Itarte, Carles Arús, Ana Paula Candiota
Glioblastoma (GBM) causes poor survival in patients even with aggressive treatment. Temozolomide (TMZ) is the standard chemotherapeutic choice for GBM treatment but resistance always ensues. Protein kinase CK2 (CK2) contributes to tumour development and proliferation in cancer, and it is overexpressed in human GBM. Accordingly, targeting CK2 in GBM may benefit patients. Our goal has been to evaluate whether CK2 inhibitors (iCK2s) could increase survival in an immunocompetent preclinical GBM model. Cultured GL261 cells were treated with different iCK2s including CX-4945, and target effects evaluated in vitro...
February 12, 2017: Pharmaceuticals
https://www.readbyqxmd.com/read/28204914/salvage-therapy-with-bendamustine-for-temozolomide-refractory-recurrent-anaplastic-gliomas-a-prospective-phase-ii-trial
#6
Marc C Chamberlain, Howard Colman, Bryan T Kim, Jeffrey Raizer
There is no standard therapy for recurrent anaplastic glioma (AG). Salvage therapies include alkylator-based chemotherapy, re-resection with or without carmustine implants, re-irradiation and bevacizumab. Bendamustine is a novel bifunctional alkylator with CNS penetration never previously evaluated in AG. Assess response and toxicity of bendamustine in recurrent AG in a phase II trial. Adults with radiation and temozolomide refractory recurrent AG were treated with bendamustine. A cycle of bendamustine was defined as two consecutive days of treatment (100 mg/m(2)/day) administered once every 4 weeks...
February 16, 2017: Journal of Neuro-oncology
https://www.readbyqxmd.com/read/28203300/a-modified-regimen-of-biweekly-gemcitabine-and-nab-paclitaxel-in-patients-with-metastatic-pancreatic-cancer-is-both-tolerable-and-effective-a-retrospective-analysis
#7
Daniel H Ahn, Kavya Krishna, Marlo Blazer, Joshua Reardon, Lai Wei, Christina Wu, Kristen K Ciombor, Anne M Noonan, Sameh Mikhail, Tanios Bekaii-Saab
BACKGROUND: Treatment with nab-paclitaxel with gemcitabine demonstrates a survival advantage when compared with single-agent gemcitabine. However, the combination is associated with significant toxicities, leading to a high rate of drug discontinuation. We implemented a modified regimen of gemcitabine and nab-paclitaxel (mGNabP) in an attempt to minimize toxicities while maintaining efficacy. METHODS: A total of 79 evaluable patients with metastatic pancreatic adenocarcinoma (mPC) treated with a modified regimen of gemcitabine (1000 mg/m(2)) and nab-paclitaxel (125 mg/m(2)) on days 1, 15 of every 28-day cycle were identified from our prospective database...
February 2017: Therapeutic Advances in Medical Oncology
https://www.readbyqxmd.com/read/28197645/subclinical-decrease-in-myocardial-function-in-asymptomatic-infants-of-diabetic-mothers-a-tissue-doppler-study
#8
Jenny E Zablah, Dorota Gruber, Guillaume Stoffels, Estefania G Cabezas, Denise A Hayes
Infants of diabetic mothers (IDMs) with hypertrophic cardiomyopathy are recognized to have impaired myocardial performance, but less is known about ventricular function in IDMs without hypertrophy. We hypothesized that in asymptomatic newborns with normal two-dimensional echocardiographic evaluations, pulsed wave tissue Doppler imaging (TDI) would suggest a subclinical decrease in the cardiac function of IDMs compared to infants of non-diabetics (nIDMs). This is a retrospective cohort study of asymptomatic neonates ≥36 weeks gestation, at 0-7 days of life, with normal standard echocardiograms...
February 14, 2017: Pediatric Cardiology
https://www.readbyqxmd.com/read/28196552/sows-with-high-milk-production-had-both-a-high-feed-intake-and-high-body-mobilization
#9
A V Strathe, T S Bruun, C F Hansen
Selection for increased litter size have generated hyper-prolific sows that nurses large litters, however limited knowledge is available regarding the connection between milk production, feed intake and body mobilization of these modern sows. The aim of the current study was to determine what characterized sows with high milk production and nursing large litters, differences between sows of different parities and effects of lactational performance on next reproductive cycle. In total 565 sows (parity 1 to 4) were studied from 7 days before farrowing until weaning...
February 15, 2017: Animal: An International Journal of Animal Bioscience
https://www.readbyqxmd.com/read/28196063/long-term-results-and-recurrence-patterns-from-scope-1-a-phase-ii-iii-randomised-trial-of-definitive-chemoradiotherapy-cetuximab-in-oesophageal-cancer
#10
T Crosby, C N Hurt, S Falk, S Gollins, J Staffurth, R Ray, J A Bridgewater, J I Geh, D Cunningham, J Blazeby, R Roy, T Maughan, G Griffiths, S Mukherjee
BACKGROUND: The SCOPE-1 study tested the role of adding cetuximab to conventional definitive chemoradiotherapy (dCRT), and demonstrated greater toxicity and worse survival outcomes. We present the long-term outcomes and patterns of recurrence. METHODS: SCOPE-1 was a phase II/III trial in which patients were randomised to cisplatin 60 mg m(-2) (day 1) and capecitabine 625 mg m(-2) bd (days 1-21) for four cycles +/- cetuximab 400 mg m(-2) day 1 then by 250 mg m(-2) weekly...
February 14, 2017: British Journal of Cancer
https://www.readbyqxmd.com/read/28195274/role-of-etching-mode-on-bonding-longevity-of-a-universal-adhesive-to-eroded-dentin
#11
Tamires Vercelino Forgerini, Jéssica Fogliato Ribeiro, Rachel de Oliveira Rocha, Fabio Zovico Maxnuck Soares, Tathiane Larissa Lenzi
PURPOSE: To assess the immediate and six-month microshear bond strength (μSBS) of a universal adhesive applied using different etching strategies on sound and eroded dentin. MATERIALS AND METHODS: Eighty bovine incisors were polished to obtain flat buccal dentin. Forty teeth were submitted to a pH-cycling model to simulate artificial erosion (3x/day cola drink for 7 days). Teeth from both dentin conditions (sound and eroded) were randomly assigned to four groups according to the adhesive and etching approach: a universal adhesive in self-etch and etch-and-rinse modes (Scotchbond Universal Adhesive), and as controls a twostep etch-and-rinse adhesive (Adper Single Bond Plus), and a two-step self-etch adhesive (Clearfil SE Bond)...
February 10, 2017: Journal of Adhesive Dentistry
https://www.readbyqxmd.com/read/28194058/l-probe-a-novel-non-anthracycline-combination-chemotherapy-regimen-for-aggressive-b-cell-non-hodgkin-lymphoma-in-elderly-patients
#12
Arjun Datt Law, Gaurav Prakash, Alka Khadwal, Ashim Das, Subhash Varma, Pankaj Malhotra
The management of aggressive B cell lymphomas in elderly patients is associated with poor tolerability of commonly used chemotherapeutic agents. The safety and tolerability of a novel combination chemotherapy regimen utilizing rituximab, lenalidomide, bendamustine, vincristine and prednisolone was assessed in a series of elderly patients with new onset or relapsed/refractory aggressive B cell lymphoma and inability to receive conventional chemotherapy due to poor performance status and/or significant comorbidities...
March 2017: Indian Journal of Hematology & Blood Transfusion
https://www.readbyqxmd.com/read/28194052/once-weekly-1-6%C3%A2-mg-m-2-bortezomib-bcd-regimen-in-elderly-patients-with-newly-diagnosed-multiple-myeloma-who-are-unfit-for-standard-dose-chemotherapy
#13
Yong Tang, Ye-Hua Yu, Yi-Yun Yao, Li-Fang Zou, Hong-Ju Dou, Lei Wang, Qi Zhu
Bortezomib has shown anti-myeloma effects in combination with alkylating agents, but clinical benefits can be limited by neurotoxicity. There is less information on the efficacy and tolerability of once-weekly 1.6 mg/m(2) bortezomib combined with cyclophosphamide and dexamethasone (BCD) regimen in elderly patients with newly diagnosed multiple myeloma who are unfit for standard dose chemotherapy. Here, we report our experience of weekly 1.6 mg/m(2) intravenous bortezomib in this group of patients. Between March 2010 and February 2015, we treated 34 newly diagnosed elderly patients with the combination of bortezomib 1...
March 2017: Indian Journal of Hematology & Blood Transfusion
https://www.readbyqxmd.com/read/28192678/assaying-the-stability-and-inactivation-of-aav-serotype-1-vectors
#14
Douglas B Howard, Brandon K Harvey
Adeno-associated virus (AAV) vectors are a commonplace tool for gene delivery ranging from cell culture to human gene therapy. One feature that makes AAV a desirable vector is its stability, in regard to both the duration of transgene expression and retention of infectivity as a viral particle. This study examined the stability of AAV serotype 1 (AAV1) vectors under different conditions. First, transducibility after storage at 4°C decreased 20% over 7 weeks. Over 10 freeze-thaw cycles, the resulting transduction efficiency became variable at 60-120% of a single thaw...
February 2017: Human Gene Therapy Methods
https://www.readbyqxmd.com/read/28190334/regenerative-polysulfide-scavenging-layers-enabling-lithium-sulfur-batteries-with-high-energy-density-and-prolonged-cycling-life
#15
Fang Liu, Qiangfeng Xiao, Hao Bin Wu, Fei Sun, Xiaoyan Liu, Fan Li, Zaiyuan Le, L I Shen, Ge Wang, Mei Cai, Yunfeng Lu
Lithium-sulfur batteries, notable for high theoretical energy density, environmental benignity and low cost, hold great potentials for next-generation energy storage. Polysulfides, the intermediates generated during cycling, may shuttle between electrodes, compromising the energy density and cycling life. We report herein a class of regenerative polysulfide-scavenging layers (RSL), which effectively immobilize and regenerate polysulfides, especially for electrodes with high sulfur loadings (e.g. 6 mg cm-2)...
February 11, 2017: ACS Nano
https://www.readbyqxmd.com/read/28187089/clinical-outcome-of-neoadjuvant-radiochemotherapy-in-locally-advanced-cervical-cancer-results-of-an-open-prospective-multicenter-phase-2-study-of-the-north-eastern-german-society-of-gynecological-oncology
#16
Dominique Koensgen, Jalid Sehouli, Antje Belau, Martin Weiss, Matthias B Stope, Vivien Grokopf, Michael Eichbaum, Peter Ledwon, Werner Lichtenegger, Marek Zygmunt, Günter Köhler, Alexander Mustea
OBJECTIVE: The aim of this study was to determine the response rate, toxicity, operability, and surgical complication rate of neoadjuvant concomitant radiochemotherapy (cRCH) (ifosfamide + carboplatin) followed by radical hysterectomy plus external-beam radiotherapy with curative intention in locally advanced primary inoperable stages IIB and IIIB squamous cell cervical cancer. METHODS: Patients with cervical cancer from 8 departments were enrolled. Patients received 3 cycles of ifosfamide 1...
March 2017: International Journal of Gynecological Cancer
https://www.readbyqxmd.com/read/28186961/combination-epigenetic-therapy-in-metastatic-colorectal-cancer-mcrc-with-subcutaneous-5-azacitidine-and-entinostat-a-phase-2-consortium-stand-up-2-cancer-study
#17
Nilofer S Azad, Anthony El-Khoueiry, Jun Yin, Ann L Oberg, Patrick Flynn, Douglas Adkins, Anup Sharma, Daniel J Weisenberger, Thomas Brown, Prakriti Medvari, Peter A Jones, Hariharan Easwaran, Ihab Kamel, Nathan Bahary, George Kim, Joel Picus, Henry C Pitot, Charles Erlichman, Ross Donehower, Hui Shen, Peter W Laird, Richard Piekarz, Stephen Baylin, Nita Ahuja
PURPOSE: Therapy with demethylating agent 5-azacitidine and histone deacetylase inhibitor entinostat shows synergistic re-expression of tumor-suppressor genes and growth inhibition in colorectal (CRC) cell lines and in vivo studies. EXPERIMENTAL DESIGN: We conducted a phase II, multi-institutional study of the combination in metastatic CRC patients. Subcutaneous azacitidine was administered at 75 mg/m2 days 1-5 and 8-10 and entinostat was given 7 mg orally on days 3 and 10...
February 5, 2017: Oncotarget
https://www.readbyqxmd.com/read/28185792/randomized-phase-iii-study-of-docetaxel-plus-cisplatin-versus-pemetrexed-plus-cisplatin-as-first-line-treatment-of-nonsquamous-non-small-cell-lung-cancer-a-trail-trial
#18
Cheol-Kyu Park, In-Jae Oh, Kyu-Sik Kim, Yoo-Duk Choi, Tae-Won Jang, Youn-Seup Kim, Kwan-Ho Lee, Kyeong-Cheol Shin, Chi Young Jung, Sei-Hoon Yang, Jeong-Seon Ryu, Seung-Hun Jang, Seung-Soo Yoo, Suk-Joong Yong, Kye Young Lee, Kwang-Ho In, Min-Ki Lee, Young-Chul Kim
INTRODUCTION: To date, no prospective phase III trials have directly compared the efficacy of pemetrexed plus cisplatin (Pem-Cis) with docetaxel plus cisplatin (Doc-Cis) in patients with nonsquamous non-small-cell lung cancer. MATERIALS AND METHODS: A total of 148 chemotherapy-naive patients lacking driver mutations were randomized into 21-day regimens of cisplatin 70 mg/m(2) with either docetaxel 60 mg/m(2) (n = 71) or pemetrexed 500 mg/m(2) (n = 77) for ≤ 4 cycles...
January 11, 2017: Clinical Lung Cancer
https://www.readbyqxmd.com/read/28184331/verticillin-a-inhibits-leiomyosarcoma-and-malignant-peripheral-nerve-sheath-tumor-growth-via-induction-of-apoptosis
#19
A Zewdu, G Lopez, D Braggio, C Kenny, D Constantino, H K Bid, K Batte, O H Iwenofu, N H Oberlies, C J Pearce, A M Strohecker, D Lev, R E Pollock
OBJECTIVE: The heterogeneity of soft tissue sarcoma (STS) represents a major challenge for the development of effective therapeutics. Comprised of over 50 different histology subtypes of various etiologies, STS subsets are further characterized as either karyotypically simple or complex. Due to the number of genetic anomalies associated with genetically complex STS, development of therapies demonstrating potency against this STS cluster is especially challenging and yet greatly needed...
November 2016: Clinical & Experimental Pharmacology
https://www.readbyqxmd.com/read/28184234/exploring-diurnal-variation-using-piecewise-linear-splines-an-example-using-blood-pressure
#20
Jamie M Madden, Xia Li, Patricia M Kearney, Kate Tilling, Anthony P Fitzgerald
BACKGROUND: There are many examples of physiological processes that follow a circadian cycle and researchers are interested in alternative methods to illustrate and quantify this diurnal variation. Circadian blood pressure (BP) deserves additional attention given uncertainty relating to the prognostic significance of BP variability in relation to cardiovascular disease. However, the majority of studies exploring variability in ambulatory blood pressure monitoring (ABPM) collapse the data into single readings ignoring the temporal nature of the data...
2017: Emerging Themes in Epidemiology
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