Patients with cancer frequently use dietary supplementation and herbal therapies to control symptoms of disease and adverse effects of cancer therapy. Despite the widespread use of dietary supplementation and herbal therapies in oncology, robust scientific evidence in this area is lacking. Not only do these products need to be tested in large and well-designed observational or randomized studies, but their manufacturing process must be improved to achieve higher levels of standardization in product quality. Ginger is frequently used to counteract chemotherapy-induced nausea and vomiting (CINV), and some suggestions that it might be effective against CINV come from randomized and/or crossover clinical trials. However, several limitations in the methods of these studies limit their power and generalizability. The authors are conducting a randomized, double-blind study with a large sample size and homogeneous inclusion criteria in order to evaluate the efficacy of a well-standardized ginger extract in reducing nausea in patients with cancer. The widespread use of standardized herbal therapies and natural components among patients requires that scientific and rigorous research strategies are applied in this field to guide the physicians and the patients in safer use.

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Details of embryo-fetal development (EFD) studies were compiled from published FDA approval documents for 43 small molecule drugs (2014-2015) and 37 monoclonal antibodies (mAbs, 2002-2015). Anti-cancer agents were analyzed separately. Rats and rabbits were the species used for EFD studies on 93% of small molecule drugs. Overall, the rat and rabbit were equally sensitive to maternal and fetal toxicity (including teratogenicity). Dosages equivalent to more than 50-times the human exposure (or 10-times for mAbs) were frequently used, but were unnecessary for 90% of drugs. EFD studies were not required for several recently approved mAbs owing to pre-existing scientific knowledge. The cynomolgus monkey was used for developmental toxicity testing of 75% of mAbs, frequently using an ePPND study design. Studies in pregnant rodents using homologous murine antibodies supplemented or replaced monkey studies under some circumstances. Most anti-cancer small molecules and mAbs were tested for developmental toxicity in at least one species.
Copyright © 2016. Published by Elsevier Inc.

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To create a tool to predict probability of remission and low disease activity (LDA) in patients with RA being considered for anti-TNF treatment in clinical practice.
We analysed data from GO-MORE, an open-label, multinational, prospective study in biologic-naïve patients with active RA (DAS28-ESR ⩾3.2) despite DMARD therapy. Patients received 50 mg s.c. golimumab (GLM) once monthly for 6 months. In secondary analyses, regression models were used to determine the best set of baseline factors to predict remission (DAS28-ESR <2.6) at month 6 and LDA (DAS28-ESR ⩽3.2) at month 1.
In 3280 efficacy-evaluable patients, of 12 factors included in initial regression models predicting remission or LDA, six were retained in final multivariable models. Greater likelihood of LDA and remission was associated with being male; younger age; lower HAQ, ESR (or CRP) and tender joint count (or swollen joint count) scores; and absence of comorbidities. In models predicting 1-, 3- and 6-month LDA or remission, area under the receiver operating curve was 0.648-0.809 (R(2) = 0.0397-0.1078). The models also predicted 6-month HAQ and EuroQoL-5-dimension scores. A series of matrices were developed to easily show predicted rates of remission and LDA.
A matrix tool was developed to show predicted GLM treatment outcomes in patients with RA, based on a combination of six baseline characteristics. The tool could help provide practical guidance in selection of candidates for anti-TNF therapy.
© The Author 2016. Published by Oxford University Press on behalf of the British Society for Rheumatology.

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Cure rates for children and young adults with osteosarcoma have remained stagnant over the past three decades. Targeting glycoprotein non-metastatic b (GPNMB) with the antibody-drug conjugate glembatumumab vedotin has improved outcomes for patients with melanoma and breast cancer. The potential utility of targeting GPNMB in osteosarcoma was explored.
GPNMB protein expression was evaluated by immunohistochemistry in human osteosarcoma tumor samples and by enzyme-linked immunosorbent assay (ELISA) in osteosarcoma cell lines. mRNA expression was measured by quantitative PCR in primary osteosarcoma samples and cell lines. Surface GPNMB expression was evaluated by flow cytometry and correlated with in vitro and in vivo cytotoxicity of glembatumumab vedotin.
Sixty seven human osteosarcoma samples were evaluated by immunohistochemistry, including 12 samples from initial biopsy, 38 samples from definitive surgery, and 17 from the time of disease recurrence. GPNMB was expressed in 92.5% (62/67) of osteosarcoma samples. All primary osteosarcoma samples expressed high levels of GPNMB mRNA. Glembatumumab induced cytotoxic effects in 74% (14/19) of osteosarcoma cell lines, and GPNMB protein levels correlated with glembatumumab in vitro cytotoxicity (r = -0.46, P = 0.04). All osteosarcoma cell lines demonstrated surface GPNMB expression.
GPNMB is expressed in osteosarcoma and targeting GPNMB with the antibody-drug conjugate glembatumumab vedotin demonstrates osteosarcoma cytotoxic activity. Clinical trials are indicated to assess the efficacy of targeting GPNMB in patients with osteosarcoma.
© 2015 Wiley Periodicals, Inc.

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Type I Interferon (IFN) is a critical pathogenic factor during the progression of Lupus Nephritis (LN). Although microRNAs (miRNAs) have been shown to control IFN response in immune cells of LN, the role of miRNAs in resident renal cells remain unclear. Here, we investigated the role of miR-130b in IFN pathway in renal cells, and its therapeutic effect in LN.
Kidney tissues from patients and mouse model of LN were collected for detecting miR-130b levels. Primary renal mesangial cells (RMCs) were used to determine the role of miR-130b in IFN pathway. We overexpressed miR-130b by administrating miR-130b agomir in an IFNα-accelerated LN mouse model to test its therapeutic efficacy.
Downregulated miR-130b expression was observed in kidney tissues from patients and mouse model of LN. Further analysis showed that underexpression of miR-130b negatively correlated with abnormal activation of IFN response in LN patients. In vitro, overexpressing miR-130b suppressed the downstream of type I IFN pathway in RMCs by targeting interferon regulatory factor 1 (IRF1). The opposite effect was observed when inhibited internal miR-130b expression. The inverse correlation between IRF1 and miR-130b levels was detected in renal biopsies from LN patients. More importantly, in vivo administration of miR-130b agomir reduced IFNα-accelerated LN progression, including decreased proteinuria, lower levels of complexes deposition and lack of glomeruli lesion.
miR-130b is a novel negative regulator of type I IFN pathway in renal cells. Overexpression of miR-130b in vivo ameliorates IFNα-accelerated LN, providing potential novel strategies for LN therapeutic intervention. This article is protected by copyright. All rights reserved.
© 2016, American College of Rheumatology.

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