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10.1530/ERC-15-0002 http://scihub22266oqcxt.onion/10.1530/ERC-15-0002 C4566955!4566955 !25900182     free     free     free Warning: file_get_contents(https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pubmed&id=25900182 &cmd=llinks): Failed to open stream: HTTP request failed! 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Phase I study of the anti-IGF1R antibody cixutumumab with everolimus and octreotide in advanced well-differentiated neuroendocrine tumors |pdf=|usr=}}{{25900182 }} gab.com Text Phase I study of the anti-IGF1R antibody cixutumumab with everolimus and octreotide in advanced well-differentiated neuroendocrine tumors JO: Endocr Relat Cancer http://www.kidney.de/pget.php?&tw=1&pmid=25900182 #FOAvip Preclinical data suggest multiple roles for the IGF1 receptor (IGF1R) in neuroendocrine tumors (NETs), including mediating resistance to mammalian target of rapamycin (mTOR) inhibitors. Everolimus, an oral mTOR inhibitor, and octreotide long-acting repeatable (LAR) are approved for subgroups of well-differentiated NET. The primary objective of the present study was to establish the safety and recommended phase II dose (RP2D) of cixutumumab, a monoclonal antibody (MAB) against IGF1R, with everolimus and octreotide LAR. Patients with well-differentiated NET were treated with 10? mg everolimus p.o. daily, 20? mg octreotide LAR i.m. every 21 days, and escalating doses of cixutumumab. An expansion cohort was enrolled at RP2D. Correlative studies included the evaluation of mTOR pathway inhibition in paired tumor biopsies and the effects of this combination on metabolism via indirect calorimetry. Nineteen patients with progressive disease were enrolled, including nine to the expansion portion. Two patients had dose-limiting toxicities of grade 3 mucositis at 15? mg/kg cixutumumab. Long-term tolerance at RP2D was problematic, and the most common ?grade 3 adverse event was fatigue. One patient with metastatic insulinoma had a confirmed partial response, whereas 17 had stable disease. The median progression-free survival was 43.6 weeks, and the median overall survival was 25.5 months. The RP2D of this combination per the predefined study protocol of 10? mg/kg cixutumumab i.v., 20? mg octreotide LAR i.m. every 21 days plus 10 ?mg everolimus p.o. daily is associated with non-dose-limiting toxicities that limit long-term tolerance. Although a signal of activity was noted in the present study, this will need to be reconciled with limited tolerance of the combination and data from larger studies of anti-IGF1R MABs in NET that have been disappointing. Twit Text FOAVip Phase I study of the anti-IGF1R antibody cixutumumab with everolimus and octreotide in advanced well-differentiated neuroendocrine tumors ????Endocr Relat Cancer http://www.kidney.de/pget.php?&tw=1&pmid=25900182 #FOAvip Twit Text # Free Paper on # # # # # LINK http://www.kidney.de/pget.php?&tw=1&pmid=25900182 #FOAvip English Wikipedia <ref>{{Cite pmid|25900182 }}</ref> Phase I study of the anti-IGF1R antibody cixutumumab with everolimus and octreotide in advanced well-differentiated neuroendocrine tumors #MMPMID25900182 Dasari A ; Phan A ; Gupta S ; Rashid A ; Yeung SC ; Hess K ; Chen H ; Tarco E ; Chen H ; Wei C ; Anh-Do K ; Halperin D ; Meric-Bernstam F ; Yao J Endocr Relat Cancer 2015[Jun]; 22 (3 ): 431-41 PMID25900182 show ga Preclinical data suggest multiple roles for the IGF1 receptor (IGF1R) in neuroendocrine tumors (NETs), including mediating resistance to mammalian target of rapamycin (mTOR) inhibitors. Everolimus, an oral mTOR inhibitor, and octreotide long-acting repeatable (LAR) are approved for subgroups of well-differentiated NET. The primary objective of the present study was to establish the safety and recommended phase II dose (RP2D) of cixutumumab, a monoclonal antibody (MAB) against IGF1R, with everolimus and octreotide LAR. Patients with well-differentiated NET were treated with 10? mg everolimus p.o. daily, 20? mg octreotide LAR i.m. every 21 days, and escalating doses of cixutumumab. An expansion cohort was enrolled at RP2D. Correlative studies included the evaluation of mTOR pathway inhibition in paired tumor biopsies and the effects of this combination on metabolism via indirect calorimetry. Nineteen patients with progressive disease were enrolled, including nine to the expansion portion. Two patients had dose-limiting toxicities of grade 3 mucositis at 15? mg/kg cixutumumab. Long-term tolerance at RP2D was problematic, and the most common ?grade 3 adverse event was fatigue. One patient with metastatic insulinoma had a confirmed partial response, whereas 17 had stable disease. The median progression-free survival was 43.6 weeks, and the median overall survival was 25.5 months. The RP2D of this combination per the predefined study protocol of 10? mg/kg cixutumumab i.v., 20? mg octreotide LAR i.m. every 21 days plus 10 ?mg everolimus p.o. daily is associated with non-dose-limiting toxicities that limit long-term tolerance. Although a signal of activity was noted in the present study, this will need to be reconciled with limited tolerance of the combination and data from larger studies of anti-IGF1R MABs in NET that have been disappointing. |Aged [MESH] |Antibodies, Monoclonal, Humanized [MESH] |Antibodies, Monoclonal/administration & dosage/adverse effects [MESH] |Antineoplastic Combined Chemotherapy Protocols/adverse effects/*therapeutic use [MESH] |Dose-Response Relationship, Drug [MESH] |Everolimus/administration & dosage/adverse effects [MESH] |Female [MESH] |Humans [MESH] |Male [MESH] |Middle Aged [MESH] |Neuroendocrine Tumors/*drug therapy/pathology [MESH]Phase I study of the anti-IGF1R antibody cixutumumab with everolimus a(epmc).pdf DeepDyve Pubget Overpricing