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Cancer Chemotherapy and Pharmacology

Jing Li, Hengxiu Yan
We performed a meta-analysis to fully investigate the skin toxicities of anti-EGFR monoclonal antibody (EGFR-MoAbs) in cancer patients. The relevant studies of the randomized controlled trials (RCTs) in cancer patients treated with EGFR-MoAbs were retrieved and the systematic evaluation was conducted. EMBASE, MEDLINE, and PubMed were searched for articles published till November 2017. The relevant RCTs in cancer patients treated with EGFR-MoAbs were retrieved and the systematic evaluation was conducted. 65 RCTs and 25994 patients were included...
July 13, 2018: Cancer Chemotherapy and Pharmacology
Shravanti Bhowmik, Subhas Bhowmick, Kuntal Maiti, Amaresh Chakra, Pradeep Shahi, Deepak Jain, Thennati Rajamannar
PURPOSE: To compare the pharmacokinetic bioequivalence and safety of a generic pegylated liposomal doxorubicin formulation (SPIL DXR hydrochloride liposome injection) with that of the reference products, Caelyx or Doxil. METHODS: Two open-label, two-way reference crossover studies were conducted in patients with ovarian cancer. Cmax , AUC0 - t , and AUC0-∞ , Vd , and Cl for total, free, and encapsulated DXR were evaluated in 18 blood samples taken pre-dose (t = 0), at increasing time intervals over the following 14 days...
July 11, 2018: Cancer Chemotherapy and Pharmacology
Junji Furuse, Takayasu Kurata, Naohiro Okano, Yasuhito Fujisaka, Daisuke Naruge, Toshio Shimizu, Hiroshi Kitamura, Tsutomu Iwasa, Fumio Nagashima, Kazuhiko Nakagawa
PURPOSE: Patients with RAS-positive tumors respond poorly to chemotherapies and have a few treatment options. Salirasib is an oral RAS inhibitor that competitively blocks the membrane association of RAS proteins. The aim of this phase I multiple-ascending-dose clinical trial was to investigate the safety and pharmacokinetics of Salirasib in Japanese patients with relapsed/refractory solid tumors and to explore its efficacy. METHODS: Salirasib was started at a dose of 100-mg twice-daily and escalated to a maximum of 1000-mg twice-daily from days 1 to 21 of a 28-day regimen...
July 10, 2018: Cancer Chemotherapy and Pharmacology
Guofu Chen, Liming Sheng, Xianghui Du
OBJECTIVE: The aim of this study was to evaluate the efficacy and toxicities of liposome-paclitaxel and carboplatin concurrent with radiotherapy for locally advanced lung squamous cell carcinoma (LSCC). METHODS: The clinical data of 38 patients with locally advanced LSCC treated with liposome-paclitaxel based concurrent chemoradiotherapy were collected and reviewed. The overall response, toxicities, progression-free survival and overall survival were analyzed with SPSS software...
July 9, 2018: Cancer Chemotherapy and Pharmacology
Paul J Wood, Robyn Strong, Grant A McArthur, Michael Michael, Elizabeth Algar, Andrea Muscat, Lin Rigby, Melissa Ferguson, David M Ashley
PURPOSE: This was an open label, phase I (3 + 3 design), multi-centre study evaluating panobinostat in pediatric patients with refractory solid tumors. METHODS: Primary endpoints were to establish MTD, define and describe associated toxicities, including dose limiting toxicities (DLT) and to characterize its pharmacokinetics (PK). Secondary endpoints included assessing the anti-tumour activity of panobinostat, and its biologic activity, by measuring acetylation of histones in peripheral blood mononuclear cells...
July 9, 2018: Cancer Chemotherapy and Pharmacology
Yan Kang, Peiheng He, Hua Wang, Yibiao Ye, Xing Li, Peigen Xie, Bowen Wu
PURPOSE: Osteosarcoma is a common primary malignant bone tumour, and its cure rate has stagnated over the past 25-30 years. Brazilin, a purified natural product from sappan wood (Caesalpinia sappan L.), has been proved to possess potent anti-cancer effects. In this study, we investigated the anti-cancer effect of brazilin on human osteosarcoma and elucidated the underlying mechanisms. METHODS: We exposed MG-63 cells to different concentrations of brazilin (5, 10 and 20 µM) for 24 h...
July 9, 2018: Cancer Chemotherapy and Pharmacology
Jong Hwan Choi, Woo Jin Chung, Si Hyun Bae, Do Seon Song, Myeong Jun Song, Young Seok Kim, Hyung Joon Yim, Young Kul Jung, Sang Jun Suh, Jun Yong Park, Do Young Kim, Seung Up Kim, Sung Bum Cho
BACKGROUND/AIMS: Treatment responses of advanced hepatocellular carcinoma (HCC) with portal vein tumor thrombosis (PVTT) remain unacceptably low and treatment modalities are limited. We compared the efficacy and safety of sorafenib and hepatic arterial infusion chemotherapy (HAIC). METHODS: In this randomized, prospective, comparative study, data on 58 patients with advanced HCC with PVTT, with Child-Turcotte-Pugh (CTP) scores of 5-7, were collected from six university hospitals between January 2013 and October 2015...
July 7, 2018: Cancer Chemotherapy and Pharmacology
Bodine P S I Belderbos, Ronald de Wit, Caly Chien, Anna Mitselos, Peter Hellemans, James Jiao, Margaret K Yu, Gerhardt Attard, Iurie Bulat, W Jeffrey Edenfield, Fred Saad
PURPOSE: Phase Ib study evaluating the effect of apalutamide, at therapeutic exposure, on ventricular repolarization by applying time-matched pharmacokinetics and electrocardiography (ECG) in patients with castration-resistant prostate cancer. Safety of daily apalutamide was also assessed. METHODS: Patients received 240 mg oral apalutamide daily. Time-matched ECGs were collected via continuous 12-lead Holter recording before apalutamide (Day - 1) and on Days 1 and 57 (Cycle 3 Day 1)...
July 5, 2018: Cancer Chemotherapy and Pharmacology
L van Andel, H Rosing, M M Tibben, L Lucas, R Lubomirov, P Avilés, A Francesch, S Fudio, A Gebretensae, M J X Hillebrand, J H M Schellens, J H Beijnen
PURPOSE: Plitidepsin absorption, distribution, metabolism and excretion characteristics were investigated in a mass balance study, in which six patients received a 3-h intravenous infusion containing 7 mg 14 C-plitidepsin with a maximum radioactivity of 100 µCi. METHODS: Blood samples were drawn and excreta were collected until less than 1% of the administered radioactivity was excreted per matrix for two consecutive days. Samples were pooled within-patients and between-patients and samples were screened for metabolites...
July 4, 2018: Cancer Chemotherapy and Pharmacology
James J Harding, Richard K Do, Imane El Dika, Ellen Hollywood, Khrystyna Uhlitskykh, Emily Valentino, Peter Wan, Casey Hamilton, Xiaoxing Feng, Amanda Johnston, John Bomalaski, Chien-Feng Li, Eileen M O'Reilly, Ghassan K Abou-Alfa
PURPOSE: Arginine depletion interferes with pyrimidine metabolism as well as DNA damage repair pathways. Preclinical data indicates that pairing pegylated arginine deiminase (ADI-PEG 20) with fluoropyrimidines or platinum enhances cytotoxicity in vitro and in vivo in arginine auxotrophs. METHODS: This is a single-center, open-label, phase 1 trial of ADI-PEG 20 and modified FOLFOX6 (mFOLFOX6) in treatment-refractory hepatocellular carcinoma (HCC) and other advanced gastrointestinal tumors...
July 3, 2018: Cancer Chemotherapy and Pharmacology
Cody J Peer, Oliver M Hall, Tristan M Sissung, Richard Piekarz, Sanjeeve Balasubramaniam, Susan E Bates, William D Figg
PURPOSE: Belinostat is a second-generation histone deacetylase inhibitor (HDI) predominantly metabolized by UGT1A1-mediated glucuronidation. Two common polymorphisms (UGT1A1*28 and UGT1A1*60) were previously associated with impaired drug clearance and thrombocytopenia risk, likely from increased drug exposure. This latter phenomenon has been observed with other HDIs such as abexinostat, panobinostat, romidepsin, and vorinostat. It was the intention of this brief report to expand a population pharmacokinetic (PPK) model to include a pharmacodynamic (PD) model describing the change in platelet levels in patients with cancer administered belinostat as a 48-h continuous intravenous infusion, along with cisplatin and etoposide...
June 27, 2018: Cancer Chemotherapy and Pharmacology
John P Fruehauf, Monica El-Masry, Katherine Osann, Basmina Parmakhtiar, Maki Yamamoto, James G Jakowatz
PURPOSE: This phase II study evaluated the safety and clinical activity of pazopanib, a potent and mutlitargeted tyrosine kinase inhibitor (TKI) of vascular endothelial growth factor receptors (VEGFRs)-1, -2 and -3, platelet-derived growth factor receptor (PDGFR)-α and β, and cKit, in combination with metronomic paclitaxel in patients with metastatic melanoma. EXPERIMENTAL DESIGN: Sixty chemotherapy-naive patients received pazopanib at a starting dose of 800 mg daily in combination with metronomic dosing of paclitaxel 80 mg/m2 weekly thrice every 4 weeks...
June 25, 2018: Cancer Chemotherapy and Pharmacology
Kyoichi Kaira
No abstract text is available yet for this article.
June 25, 2018: Cancer Chemotherapy and Pharmacology
Sreenivasulu Palugulla, Panneer Devaraju, Smita Kayal, Sunil K Narayan, Jayanthi Mathaiyan
PURPOSE: Digestive tract cancer patients treated with oxaliplatin are often associated with the development of peripheral neuropathy. The aim of the present study is to identify the influence of single-nucleotide polymorphisms (SNPs) in genes involved in oxaliplatin metabolism, cell cycle control, detoxification or excretion pathways with the development of oxaliplatin-induced acute peripheral neuropathy (acute OXAIPN) and its severity among digestive tract cancer patients treated with oxaliplatin-based chemotherapy...
June 23, 2018: Cancer Chemotherapy and Pharmacology
Amita Patnaik, Michael Gordon, Frank Tsai, Kyri Papadopoulous, Drew Rasco, S Muralidhar Beeram, Siqing Fu, Filip Janku, Scott M Hynes, Sushma R Gundala, Melinda D Willard, Wei Zhang, Aimee Bence Lin, David Hong
PURPOSE: The phase I study characterized the safety, pharmacokinetics, anti-tumor activity, and recommended phase II dose/schedule of LY3164530 in patients with advanced or metastatic cancer. METHODS: Patients received LY3164530 on days 1 and 15 (Schedule 1: 300, 600, 1000, and 1250 mg) or Days 1, 8, 15, and 22 (Schedule 2: 500 and 600 mg) of each 28 days cycle. Dose escalation used a modified toxicity probability interval model. RESULTS: Dose escalation defined a maximum tolerated dose (MTD) of 1000 mg on Schedule 1 and 500 mg on Schedule 2...
June 20, 2018: Cancer Chemotherapy and Pharmacology
Fabienne Thomas, Gareth J Veal, Souleiman El Balkhi, Thierry Lafont, Nicolas Picard, Laurence Brugières, Etienne Chatelut, Christophe Piguet
PURPOSE: Chemotherapy dosing in neonates represents a major clinical challenge because of a lack of clinical pharmacology information in this patient population. In this study, we investigate the use of cisplatin dose adaptation based on therapeutic drug monitoring in a 2-week-old neonate with localized hepatoblastoma. METHODS: Cisplatin concentrations were determined in plasma and ultrafiltrate samples collected on each of six cycles of a monotherapy regimen, beginning with a dose of 1...
June 19, 2018: Cancer Chemotherapy and Pharmacology
Chao Xu, Patanjali Ravva, Jun Steve Dang, Johann Laurent, Céline Adessi, Christine McIntyre, Georgina Meneses-Lorente, François Mercier
PURPOSE: To inform lumretuzumab and pertuzumab dose modifications in order to decrease the incidence, severity, and duration of the diarrhea events in metastatic breast cancer patients treated with a combination therapy of lumretuzumab (anti-HER3) in combination with pertuzumab (anti-HER2) and paclitaxel using quantitative clinical pharmacology modeling approaches. METHODS: The safety and pharmacokinetic (PK) data from three clinical trials (lumretuzumab monotherapy n = 47, pertuzumab monotherapy n = 78, and the combination therapy of lumretuzumab, pertuzumab and paclitaxel n = 35) were pooled together to develop a continuous-time discrete states Markov model describing the dynamics of the diarrhea events...
June 18, 2018: Cancer Chemotherapy and Pharmacology
Mohammad Mahmoudian, Sara Salatin, Ahmad Yari Khosroushahi
Lipoproteins (LPs) are a set of naturally occurring bio-nanoparticles consisting of Apo-LPs, phospholipids, a highly hydrophobic core of cholesteryl esters and triglycerides that participate mainly in the targeted transport of cholesteryl esters and other hydrophobic molecules through the bloodstream. They also are able to recognize specific receptors on normal and abnormal cells. Therefore, LPs represent a relevant tool for targeted delivery of cancer diagnostics and therapeutics due to their native biocompatibility, biodegradability, nano-scale size and receptor-mediated uptake...
June 18, 2018: Cancer Chemotherapy and Pharmacology
Xiao-Fang Guo, Sai-Sai Li, Xiao-Fei Zhu, Qiao-Hua Dou, Duan Liu
PURPOSE: Paclitaxel-based chemoradiotherapy was proven to be efficacious in treating patients with advanced esophageal cancer. However, the toxicity and the development of resistance limited its anticancer efficiency. The present study was to evaluate the antitumor effects of lapatinib, a dual tyrosine inhibitor of both epidermal growth factor receptor (EGFR) and human epidermal growth factor receptor 2 (HER2), combined with paclitaxel on the esophageal squamous cancer. METHODS: MTT assays were used to evaluate the effects of the combination of lapatinib and paclitaxel on the growth of esophageal squamous cancer cell lines (KYSE150, KYSE450, KYSE510 and TE-7)...
June 16, 2018: Cancer Chemotherapy and Pharmacology
Inderjeet Singh, Akash Patel, Ronak Patel, Vinu Jose
PURPOSE: This study compared pharmacokinetics, pharmacodynamics, safety and immunogenicity profiles of INTP5 (a potential pegfilgrastim biosimilar) with that of Neulasta® . METHODS: In this randomised, assessor-blind, crossover study, 344 healthy subjects received single subcutaneous dose of both INTP5 and Neulasta at 3 mg/0.3 ml (n = 172) or 6 mg/0.6 ml (n = 172) dose. The primary endpoints were AUC0-t , AUC0-∞ and Cmax of pegfilgrastim; and AUEC0-t and Emax of absolute neutrophil count (ANC)...
June 15, 2018: Cancer Chemotherapy and Pharmacology
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