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https://www.readbyqxmd.com/read/27932229/regorafenib-for-patients-with-hepatocellular-carcinoma-who-progressed-on-sorafenib-treatment-resorce-a-randomised-double-blind-placebo-controlled-phase-3-trial
#1
Jordi Bruix, Shukui Qin, Philippe Merle, Alessandro Granito, Yi-Hsiang Huang, György Bodoky, Marc Pracht, Osamu Yokosuka, Olivier Rosmorduc, Valeriy Breder, René Gerolami, Gianluca Masi, Paul J Ross, Tianqiang Song, Jean-Pierre Bronowicki, Isabelle Ollivier-Hourmand, Masatoshi Kudo, Ann-Lii Cheng, Josep M Llovet, Richard S Finn, Marie-Aude LeBerre, Annette Baumhauer, Gerold Meinhardt, Guohong Han
BACKGROUND: There are no systemic treatments for patients with hepatocellular carcinoma (HCC) whose disease progresses during sorafenib treatment. We aimed to assess the efficacy and safety of regorafenib in patients with HCC who have progressed during sorafenib treatment. METHODS: In this randomised, double-blind, parallel-group, phase 3 trial done at 152 sites in 21 countries, adults with HCC who tolerated sorafenib (≥400 mg/day for ≥20 of last 28 days of treatment), progressed on sorafenib, and had Child-Pugh A liver function were enrolled...
December 5, 2016: Lancet
https://www.readbyqxmd.com/read/27916795/first-and-second-line-targeted-systemic-therapy-in-hepatocellular-carcinoma-an-update-on-patient-selection-and-response-evaluation
#2
REVIEW
Johann von Felden, Kornelius Schulze, Ines Gil-Ibanez, Tobias Werner, Henning Wege
Advanced hepatocellular carcinoma (HCC) with vascular invasion and/or extrahepatic spread and preserved liver function, according to stage C of the Barcelona Clinic Liver Cancer (BCLC) classification, has a dismal prognosis. The multi-targeted tyrosine-kinase receptor inhibitor (TKI) sorafenib is the only proven active substance in systemic HCC therapy for first-line treatment. In this review, we summarize current aspects in patient selection and management of side effects, and provide an update on response evaluation during first-line sorafenib therapy...
November 28, 2016: Diagnostics
https://www.readbyqxmd.com/read/27906677/the-implication-of-flt3-amplification-for-flt-targeted-therapeutics-in-solid-tumors
#3
Sung Hee Lim, Sun-Young Kim, Kyung Kim, Hyojin Jang, Soomin Ahn, Kyoung-Mee Kim, Nayoung K D Kim, Woongyang Park, Su Jin Lee, Seung Tae Kim, Se Hoon Park, Joon Oh Park, Young Suk Park, Se-Hoon Lee, Ho Yeong Lim, Keunchil Park, Won Ki Kang, Jeeyun Lee
We investigated the patients with solid cancers harboring Fms-like tyrosine kinase 3 (FLT3) amplification using targeted sequencing of tumor tissue specimen and FISH assay. Simultaneously, FLT3-amplified patient-derived cells (PDCs) were generated to evaluate the sensitivity to FLT3 inhibition. A patient with metastatic colon cancer who was previously treated with more than 3rd line cytotoxic chemotherapy was found to have FLT3 amplification and then received regorafenib showing partial response. In two PDC cell lines with FLT3 amplification, FLT3 mRNA expression was increased, however, the growth of tumor cells was not significantly inhibited by either regorafenib or sorafenib which is known to block the activity FLT3...
November 29, 2016: Oncotarget
https://www.readbyqxmd.com/read/27900102/comparison-of-cost-effectiveness-of-regorafenib-and-trifluridine-tipiracil-combination-tablet-for-treating-advanced-and-recurrent-colorectal-cancer
#4
Michio Kimura, Eiseki Usami, Mina Iwai, Makiko Go, Hitomi Teramachi, Tomoaki Yoshimura
Regorafenib and trifluridine/tipiracil combination tablet regimens are standard third-line or later treatments for advanced and recurrent colorectal cancer with no significant difference in efficacy. The present study aimed to compare the cost-effectiveness of using regorafenib vs. the trifluridine/tipiracil combination tablet. The expected cost was calculated based on data from patients with advanced and recurrent colorectal cancer who were treated with regorafenib or trifluridine/tipiracil combination tablet...
November 2016: Molecular and Clinical Oncology
https://www.readbyqxmd.com/read/27888325/total-lesion-glycolysis-tlg-as-an-imaging-biomarker-in-metastatic-colorectal-cancer-patients-treated-with-regorafenib
#5
Yoojoo Lim, Ji-In Bang, Sae-Won Han, Jin Chul Paeng, Kyung-Hun Lee, Jee Hyun Kim, Gyeong Hoon Kang, Seung-Yong Jeong, Kyu Joo Park, Tae-You Kim
PURPOSE: This study was performed to evaluate whether fluorine-18 fluorodeoxyglucose positron-emission tomography/computed tomography (FDG PET/CT) could predict treatment outcome of regorafenib in metastatic colorectal cancer (mCRC). METHODS: Previously treated refractory mCRC patients were enrolled into a prospective biomarker study of regorafenib. For this sub-study, the results of FDG PET/CT scans at baseline and after two cycles of treatment were analyzed. Various metabolic parameters obtained from PET images were analyzed in relation to treatment outcome...
November 25, 2016: European Journal of Nuclear Medicine and Molecular Imaging
https://www.readbyqxmd.com/read/27865140/overcoming-dynamic-molecular-heterogeneity-in-metastatic-colorectal-cancer-multikinase-inhibition-with-regorafenib-and-the-case-of-rechallenge-with-anti-egfr
#6
REVIEW
Andrea Sartore-Bianchi, Salvatore Siena, Giuseppe Tonini, Alberto Bardelli, Daniele Santini
In metastatic colorectal cancer (mCRC), fluorouracil-based combination therapy with oxaliplatin or irinotecan is the mainstay of first-line treatment. Patient survival has been significantly improved with the introduction of monoclonal antibodies against VEGF (bevacizumab), VEGFR2 (ramucirumab) or EGFR (cetuximab or panitumumab) in first- and second-line therapies. However, all patients treated with chemotherapy and targeted therapies will eventually relapse, and recently the emergence of alterations in EGFR, RAS, BRAF, ERB-B2, MET and possibly in other genes has been shown to jeopardize response to EGFR blockade...
October 29, 2016: Cancer Treatment Reviews
https://www.readbyqxmd.com/read/27864220/estimating-12-weeks-death-probability-in-patients-with-refractory-metastatic-colorectal-cancer-the-colon-life-nomogram
#7
F Pietrantonio, R Miceli, L Rimassa, S Lonardi, G Aprile, A Mennitto, F Marmorino, S Bozzarelli, L Antonuzzo, E Tamburini, F Morano, D Rossini, F Battaglin, M Baretti, R Berenato, V Formica, S Mosconi, F Petrelli, M Ghidini, F Loupakis, D Spada, S Cinieri, G Beretta, A Falcone, F de Braud, C Cremolini
BACKGROUND: Regorafenib and TAS-102 have recently demonstrated statistically significant survival gains in patients with refractory metastatic colorectal cancer (mCRC). Life expectancy ≥12 weeks was an inclusion criterion in registrative trials, and the identification of proper clinical selection tools for the daily use of these drugs in heavily pre-treated patients is needed to improve the cost-benefit ratio. We aimed at building a nomogram able to predict death probability within 12 weeks from the date of assessment of refractory mCRC...
November 17, 2016: Annals of Oncology: Official Journal of the European Society for Medical Oncology
https://www.readbyqxmd.com/read/27864115/synergistic-antitumor-activity-of-regorafenib-and-lapatinib-in-preclinical-models-of-human-colorectal-cancer
#8
Wen-Ji Zhang, Yong Li, Meng-Ning Wei, Yao Chen, Jian-Ge Qiu, Qi-Wei Jiang, Yang Yang, Di-Wei Zheng, Wu-Ming Qin, Jia-Rong Huang, Kun Wang, Wen-Juan Zhang, Yi-Jun Wang, Dong-Hua Yang, Zhe-Sheng Chen, Zhi Shi
Regorafenib significantly prolongs overall survival in patients with metastatic colorectal cancer (mCRC), but the overall clinical efficacy of regorafenib remains quite limited. Combination chemotherapy is a potentially promising approach to enhance anticancer activity, overcome drug resistance, and improve disease-free and overall survival. The current study investigates the antitumor activity of regorafenib in combination with lapatinib in preclinical models of human CRC. Our results show improved antitumor efficacy when regorafenib is combined with lapatinib both in vitro and in vivo...
November 15, 2016: Cancer Letters
https://www.readbyqxmd.com/read/27849399/new-chemical-treatment-options-in-second-line-hepatocellular-carcinoma-what-to-do-when-sorafenib-fails
#9
Hyun Young Woo, So Young Yoo, Jeong Heo
There have been no therapies available for patients who experience disease progression after sorafenib treatment. Regorafenib inhibits multiple kinases involved in tumor proliferation and neoangiogenesis, which has produced a survival benefit in hepatocellular carcinoma (HCC) after sorafenib failure. Other active candidate agents are c-Met inhibitors and immune checkpoint inhibitors. Areas covered: This paper presents an updated summary of the preclinical and clinical experience with regorafenib, c-Met inhibitors (tivantinib, cabozantinib and tepotinib), and a checkpoint inhibitor (nivolumab, pembrolizumab) in HCC...
November 28, 2016: Expert Opinion on Pharmacotherapy
https://www.readbyqxmd.com/read/27842521/clinical-outcomes-of-patients-with-gastrointestinal-stromal-tumor-in-phase-i-clinical-trials
#10
Yoshiaki Nagatani, Kohei Shitara, Hideaki Bando, Yasutoshi Kuboki, Wataru Okamoto, Takashi Kojima, Takayuki Yoshino, Toshirou Nishida, Atushi Ohtsu, Toshihiko Doi
BACKGROUND: The prognosis of patients with gastrointestinal stromal tumor (GIST) after the failure of standard therapies is poor with supportive care alone. Guidelines recommend clinical trials, and patients with good performance status following standard therapies are often eligible for phase I clinical trials of investigational agents; however, there are no detailed reports on the clinical outcomes of GIST patients enrolled in these trials. METHODS: We retrospectively reviewed the clinical outcomes of 21 consecutive GIST patients who were enrolled in one or more phase I clinical trials at a single center between March 2009 and November 2014...
November 14, 2016: BMC Cancer
https://www.readbyqxmd.com/read/27836933/the-real-world-use-of-regorafenib-for-metastatic-colorectal-cancer-multicentre-analysis-of-treatment-pattern-and-outcomes-in-hong-kong
#11
Ka-On Lam, Kin-Chung Lee, Joanne Chiu, Victor Ho-Fun Lee, Roland Leung, T S Choy, Thomas Yau
PURPOSE OF THE STUDY: To evaluate the benefits and tolerability of regorafenib in the real-world setting, we performed a multicentre analysis in Hong Kong. STUDY DESIGN: Individual patient data were retrieved from three leading oncology centres in Hong Kong for analyses. All patients with metastatic colorectal cancer (mCRC) treated with regorafenib after failure of all standard systemic options were included. RESULTS: From July 2013 to December 2015, 45 consecutive patients treated with regorafenib for mCRC were analysed...
November 11, 2016: Postgraduate Medical Journal
https://www.readbyqxmd.com/read/27781196/regorafenib-as-second-line-systemic-therapy-may-change-the-treatment-strategy-and-management-paradigm-for-hepatocellular-carcinoma
#12
EDITORIAL
https://www.readbyqxmd.com/read/27780748/prophylactic-use-of-oral-dexamethasone-to-alleviate-fatigue-during-regorafenib-treatment-for-patients-with-metastatic-colorectal-cancer
#13
Shota Fukuoka, Kohei Shitara, Masaaki Noguchi, Akihito Kawazoe, Yasutoshi Kuboki, Hedeaki Bando, Wataru Okamoto, Takashi Kojima, Toshihiko Doi, Atsushi Ohtsu, Takayuki Yoshino
BACKGROUND: Fatigue is the most common toxicity of all grade toxicities with regorafenib, was the second most common toxicity in the CORRECT (regorafenib monotherapy for previously treated metastatic colorectal cancer) study, and is a major reason for early dose modification. The results from a recent randomized study suggested that dexamethasone (DEX) can improve cancer-related fatigue. PATIENTS AND METHODS: We retrospectively analyzed the effect of prophylactic use of an oral DEX on fatigue during regorafenib treatment in patients with metastatic colorectal cancer (mCRC)...
August 18, 2016: Clinical Colorectal Cancer
https://www.readbyqxmd.com/read/27780365/adherence-and-safety-of-regorafenib-for-patients-with-metastatic-colorectal-cancer-observational-real-life-study
#14
Salvatore Del Prete, Gregorio Cennamo, Luigi Leo, Liliana Montella, Bruno Vincenzi, Maria Biglietto, Francesca Andreozzi, Antonella Prudente, Patrizia Iodice, Clementina Savastano, Anna Nappi, Vincenzo Montesarchio, Raffaele Addeo
AIM: In this prospective multicenter real-life observational cohort study, we investigated the acceptance, adherence and safety of regorafenib, in the treatment of metastatic colorectal cancer patients. PATIENTS & METHODS: A total of 136 patients were recruited at six oncological hospital sites in southern Italy. The adherence to the treatment was measured with patient-completed medication diaries, physician interviews and pill counts. RESULTS: We found a statistically significant improvement of therapy adhesion by the acceptance questionnaire...
October 26, 2016: Future Oncology
https://www.readbyqxmd.com/read/27776286/inventory-of-oral-anticancer-agents-pharmaceutical-formulation-aspects-with-focus-on-the-solid-dispersion-technique
#15
E Sawicki, J H M Schellens, J H Beijnen, B Nuijen
Dissolution from the pharmaceutical formulation is a prerequisite for complete and consistent absorption of any orally administered drug, including anticancer agents (oncolytics). Poor dissolution of an oncolytic can result in low oral bioavailability, high variability in blood concentrations and with that suboptimal or even failing therapy. This review discusses pharmaceutical formulation aspects and absorption pharmacokinetics of currently licensed orally administered oncolytics. In nearly half of orally dosed oncolytics poor dissolution is likely to play a major role in low and unpredictable absorption...
September 20, 2016: Cancer Treatment Reviews
https://www.readbyqxmd.com/read/27753042/detection-and-quantification-of-kit-mutations-in-ctdna-by-plasma-safe-seqs
#16
Johannes Fredebohm, Daniel H Mehnert, Ann-Kathrin Löber, Frank Holtrup, Vanessa van Rahden, Philipp Angenendt, Frank Diehl
We have designed a highly sensitive assay based on the Safe-SeqS technology to detect de novo mutations in the KIT gene and tested its performance. This assay was applied to plasma samples of GIST patients before and after treatment with regorafenib (GRID III trial) and mutations at known and novel sites of potential secondary resistance were identified.
2016: Advances in Experimental Medicine and Biology
https://www.readbyqxmd.com/read/27752061/protein-tyrosine-phosphatase-1b-targets-pitx1-p120rasgap-thus-showing-therapeutic-potential-in-colorectal-carcinoma
#17
Hao-Wei Teng, Man-Hsin Hung, Li-Ju Chen, Mao-Ju Chang, Feng-Shu Hsieh, Ming-Hsien Tsai, Jui-Wen Huang, Chih-Lung Lin, Hsiang-Wen Tseng, Zong-Keng Kuo, Jeng-Kai Jiang, Shung-Haur Yang, Chung-Wai Shiau, Kuen-Feng Chen
Protein tyrosine phosphatase 1B (PTP1B) is known to promote the pathogenesis of diabetes and obesity by negatively regulating insulin and leptin pathways, but its role associated with colon carcinogenesis is still under debate. In this study, we demonstrated the oncogenic role of PTP1B in promoting colon carcinogenesis and predicting worse clinical outcomes in CRC patients. By co-immunoprecipitation, we showed that PITX1 was a novel substrate of PTP1B. Through direct dephosphorylation at Y160, Y175 and Y179, PTP1B destabilized PITX1, which resulted in downregulation of the PITX1/p120RasGAP axis...
October 18, 2016: Scientific Reports
https://www.readbyqxmd.com/read/27751848/regorafenib-efficacy-in-multiple-refractory-sarcoma-types
#18
John H Healey
No abstract text is available yet for this article.
October 14, 2016: Lancet Oncology
https://www.readbyqxmd.com/read/27751846/safety-and-efficacy-of-regorafenib-in-patients-with-advanced-soft-tissue-sarcoma-regosarc-a-randomised-double-blind-placebo-controlled-phase-2-trial
#19
Olivier Mir, Thomas Brodowicz, Antoine Italiano, Jennifer Wallet, Jean-Yves Blay, François Bertucci, Christine Chevreau, Sophie Piperno-Neumann, Emmanuelle Bompas, Sébastien Salas, Christophe Perrin, Corinne Delcambre, Bernadette Liegl-Atzwanger, Maud Toulmonde, Sarah Dumont, Isabelle Ray-Coquard, Stéphanie Clisant, Sophie Taieb, Cécile Guillemet, Maria Rios, Olivier Collard, Laurence Bozec, Didier Cupissol, Esma Saada-Bouzid, Christine Lemaignan, Wolfgang Eisterer, Nicolas Isambert, Loïc Chaigneau, Axel Le Cesne, Nicolas Penel
BACKGROUND: Regorafenib is a multikinase inhibitor with proven activity in refractory gastrointestinal stromal tumours and chemotherapy-refractory advanced colorectal cancers. We assessed this agent's efficacy and safety in patients with metastatic soft tissue sarcomas previously treated with anthracycline. METHODS: In this randomised, double-blind, phase 2 trial undertaken in France and Austria, we enrolled patients aged 18 years and older with advanced soft tissue sarcomas who had received previous doxorubicin or other anthracycline treatment...
October 14, 2016: Lancet Oncology
https://www.readbyqxmd.com/read/27750243/recent-trends-in-the-management-of-hepatocellular-carcinoma-with-special-emphasis-on-treatment-with-regorafenib-and-immune-checkpoint-inhibitors
#20
Masatoshi Kudo
Hepatocellular carcinoma (HCC) is the fifth most common cancer and the third leading cause of cancer deaths worldwide. Sonazoid-enhanced ultrasound and gadolinium ethoxybenzyl diethylenetriamine pentaacetic acid-enhanced MRI are the most important imaging modalities in diagnosing HCC. There are 2 non-contradictory HCC treatment algorithms in Japan. Hepatic arterial infusion chemotherapy plays an important role in the treatment of advanced HCC with main or branch portal vein invasion. Regorafenib, as a second-line systemic treatment, prolongs survival in patients with intermediate and advanced HCC who progressed on sorafenib...
2016: Digestive Diseases
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