The Skeptical Oncologist

By BISHAL GYAWALI, MD Why conduct post approval studies at all? Atezolizumab previously received accelerated approval in second-line metastatic or advanced urothelial cancer based on response rates from a single arm trial. The results of post approval confirmatory phase 3 are now published and demonstrate that atezolizumab did not improve survival versus chemotherapy (11.1 v 10.6 months, HR 0.87, p = 0.41). The concept of accelerated approval is to grant early and conditional approval and access to drugs in diseases of unmet need, and that the decision to fully approve or revoke be made based on results of confirmatory phase 3 trials. That means, if the confirmatory larger phase 3 trial shows that the assumed benefit with the drug didn’t exist, the approval be revoked. Naturally, the FDA has decided to revoke the approval. No, I am joking. The post approval studies don’t seem to matter at all. You can improve response rate in a single arm trial, gain an expedited approval and your approval will always remain. Previously, we also saw that a drug that was given accelerated approval based on response rates in a phase 2 received full approval after it failed to improve survival in a subsequent confirmatory phase 3.  Why bother conducting confirmatory studies at all? (Im)precision in precision oncology It goes without question that precision medicine requires precise measurement and validation of biomarkers. So it was very pleas...
Source: The Health Care Blog - Category: Consumer Health News Authors: Tags: Uncategorized Source Type: blogs

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ConclusionAccording to a literature review, some cases of multicentric IPNB have shown rapidly progressive recurrence and poor prognosis. We should consider multicentricity of IPNB even a few months after curative resection, and narrow examinations should also be considered.
Source: International Journal of Surgery Case Reports - Category: Surgery Source Type: research
Abstract Natural medicinal substances (NMS) have great inconsistency due to chemical variability, seriously limiting their development as therapeutics. Here, we chose toad venom with anti-tumor activities as a model and developed a pipeline of metabolomics-based screening and quality consistency control (MSQCC) as one potential solution to this long-standing problem. Our study firstly exemplified the power of the co-correlation screen of metabolomic and biological profiles of 180 fractions prepared from natural heterogeneous venom samples, to identify a series of bufadinolides as quality control markers for cancer...
Source: Analytica Chimica Acta - Category: Chemistry Authors: Tags: Anal Chim Acta Source Type: research
Source: BMJ Comments - Category: General Medicine Source Type: forums
Paeoniflorin inhibits IL-1β-induced MMP secretion via the NF-κB pathway in chondrocytes. Exp Ther Med. 2018 Aug;16(2):1513-1519 Authors: Hu PF, Sun FF, Jiang LF, Bao JP, Wu LD Abstract Paeoniflorin serves important cellular roles, exerting anti-cancer, anti-inflammatory and anti-pulmonary fibrosis effects and possesses immune-modulatory properties. However, the exact role of paeoniflorin in the pathogenesis of osteoarthritis (OA) remains unclear. The aim of the present study was to investigate the effects of paeoniflorin on articular surfaces in vitro. Rat chondrocytes were cultured in vitro...
Source: Experimental and Therapeutic Medicine - Category: General Medicine Tags: Exp Ther Med Source Type: research
Authors: Zhang M, Liu J, Li M, Zhang S, Lu Y, Liang Y, Zhao K, Li Y Abstract Glioblastoma multiforme (GBM) is a malignant tumor caused by complex pathological mechanisms, and is characterized by a high rate of cancer-related mortality and poor patient prognosis. Overgrowth of cancer cells, which results from the inhibition of cell apoptosis and/or the promotion of cell proliferation, leads to the progression of GBM. Therefore, studies into the regulatory mechanisms of cancer cell growth in GBM are required to identify potential therapeutic targets and improve treatment for GBM. In the present study, the role of ins...
Source: Experimental and Therapeutic Medicine - Category: General Medicine Tags: Exp Ther Med Source Type: research
Authors: Zhang X, Chen L Abstract Renal cell carcinoma (RCC) and chronic kidney disease (CKD) are associated with hypoxia, but the effects of hypoxia on the process of angiogenesis in the two diseases are dramatically different. Some of matrix metalloproteinases (MMPs), such as MMP2 and MMP9, may have a role because they represent the most prominent family of proteinases associated with angiogenesis. In the present study, the differential response of human renal cell cancer cells (786-0), human renal tubular epithelial cells (HK-2) and human microvascular endothelial cells (HMEC-1) to hypoxia with regards to the ex...
Source: Experimental and Therapeutic Medicine - Category: General Medicine Tags: Exp Ther Med Source Type: research
Authors: Lee SY, Lim S, Cho DH Abstract A 16-year-old female with Ewing sarcoma, a very rare disease with poor prognosis in women, was admitted to the hospital with abdominal pain. Diagnostic laparotomy revealed the Ewing sarcoma originating from the extramural uterus. Histological examination yielded positive test results for CD99, vimentin, S-100, eosin 5-maleimide and periodic acid-Shiff. EWS-FLI1 type 1 translocation was confirmed. Fibroblast growth factor receptor (FGFR) 4 (c.1162G> A) and HRas proto-oncogene (HRAS; c.182A> G) mutations were also detected. At eight months following complete remission, pe...
Source: Experimental and Therapeutic Medicine - Category: General Medicine Tags: Exp Ther Med Source Type: research
In conclusion, curcumin inhibited the proliferation of breast cancer cells and induced G2/M phase cell cycle arrest and apoptosis, which may be associated with the decrease of CDC25 and CDC2 and increase of P21 protein levels, as well as inhibition of the phosphorylation of Akt/mTOR and induction of the mitochondrial apoptotic pathway. The findings of the present study may provide a basis for the further study of curcumin in the treatment of breast cancer. PMID: 30116377 [PubMed]
Source: Experimental and Therapeutic Medicine - Category: General Medicine Tags: Exp Ther Med Source Type: research
Authors: Chira S, Raduly L, Braicu C, Jurj A, Cojocneanu-Petric R, Pop L, Pileczki V, Ionescu C, Berindan-Neagoe I Abstract Cancer, and particularly colon cancer, is associated with an increasing number of cases resistant to chemotherapy. One approach to overcome this, and to improve the prognosis and outcome of patients, is the use of adjuvant therapy alongside the standard chemotherapy regiment. In the present study, the effect of deuterium-depleted water (DDW) as a potential modulator of adjuvant therapy on DLD-1 colorectal cancer models was assessed. A number of functionality assays were performed, including MT...
Source: Experimental and Therapeutic Medicine - Category: General Medicine Tags: Exp Ther Med Source Type: research
Authors: Jia W, Yu T, An Q, Cao X, Pan H Abstract Plasma microRNA (miR)-423-5p is a potential biomarker for the detection of colon cancer. However, the expression and biological role of miR-423-5p in colon tumorigenesis remains unclear. In the current study, reverse transcription-quantitative polymerase chain reaction was used to determine miR-423-5p expression in malignant colon tissues and plasma from patients with colon cancer. Cell viability, colony formation and apoptosis assays, as well as western blotting, were performed to investigate the biological role and regulatory mechanisms of miR-423-5p in colon canc...
Source: Experimental and Therapeutic Medicine - Category: General Medicine Tags: Exp Ther Med Source Type: research
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