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regorafenib combined with programmed cell death-1 inhibitor against refractory colorectal cancer and the platelet-to-lymphocyte ratio’s prediction on effectiveness

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World Journal of Gastrointestinal Oncology 2022年第4期14卷 920-934页

作者： Yu-Jie Xu Peng Zhang Jin-Long Hu Hong Liang Yan-Yan Zhu Yao Cui Po Niu Min Xu Ming-Yue Liu Department of Oncology Henan Provincial People's HospitalPeople's Hospital of Zhengzhou UniversityZhengzhou 450003Henan ProvinceChina Department of Gastrointestinal Surgery Henan Provincial People's HospitalPeople's Hospital of Zhengzhou UniversityZhengzhou 450003Henan ProvinceChina Department of Hepatology The Third People's Hospital of ZhengzhouZhengzhou 450003Henan ProvinceChina

BACKGROUND The effectiveness of regorafenib plus programmed cell death-1(PD-1)inhibitor in treating microsatellite stable(MSS)metastatic colorectal cancer(mCRC)remains *** To investigate the benefits of regorafenib combined with PD-1 inhibitor in treating MSS mCRC and explore indicators predicting *** This retrospective study included a total of 30 patients with microsatellite stable metastatic colorectal cancer treated with regorafenib combined with programmed cell death-1 inhibitor at Henan Provincial People’s Hospital between December 2018 and December *** a 4-wk treatment cycle,regorafenib was performed for 3 continuous ***-1 inhibitor was intravenously injected starting on the first day of the oral intake of *** reviewed tumor response,progression-free survival(PFS),overall survival,and treatment-related adverse events(TRAEs)and evaluated association between platelet-tolymphocyte ratio(PLR)and outcomes in this retrospective *** Stable disease and progressive disease were found in 18(60.0%)and 12(40.0%)patients,*** disease control rate was 60.0%.The median follow-up time was 12.0 mo,and median PFS was 3.4 mo[95%confidence interval(CI):2.2-4.6 mo].Of the 12 patients with progressive disease,10(83.3%)had liver metastasis before starting the combined *** the 18 patients with SD,10(55.6%)did not have liver *** patient without liver metastases at baseline was found with a substantially prolonged PFS of 11.2 *** liver metastasis,the choice of programmed cell death-1 inhibitor other than nivolumab or pembrolizumab and previous exposure to regorafenib was’t associated with treatment *** median PFS in the low-PLR group was 4.2 mo(95%CI:3.5-4.9 mo),compared with 2.8 mo(95%CI:1.4-4.2 mo)in the high-PLR group(P=0.005).The major TRAEs included hand-foot syndrome(33.3%),hypertension(23.3%),malaise(20.0%),and gastrointestinal reaction(16.7%).The incidence of grade 3 TRAE

关键词： Colorectal neoplasms Microsatellite stable Programmed cell death-1 inhibitor Platelet-tolymphocyte ratio regorafenib Progression-free survival

Inhibitory effects of regorafenib, a multiple tyrosine kinase inhibitor, on corneal neovascularization

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International Journal of Ophthalmology(English edition) 2014年第2期7卷 220-225页

作者： Halil Ibrahim Onder Mesut Erdurmus Yasin Yücel Bucak Hüseyin Simavli Murat Oktay Ahmet Sahap Kukner Department of Ophthalmology Duzce University Medical Faculty Department of Ophthalmology Abant Izzet Baysal University Medical School Ophthalmology Clinic Izzet Baysal State Hospital Department of Pathology Duzce University Medical Faculty

AIM:To evaluate the inhibitory effects of regorafenib(BAY 73-4506),a multikinase inhibitor,on corneal neovascularization(NV).METHODS:Thirty adult male Sprague-Dawley rats weighing 250-300 g,were *** NV was induced by NaOH in the left eyes of each *** the establishment of alkali burn,the animals were randomized into five groups according to topical *** 1(n=6)received 0.9%NaCl,Group 2(n=6)received dimethyl sulfoxide,Group 3(n=6)received regorafenib 1 mg/mL,Group 4(n=6)received bevacizumab 5 mg/mL and Group 5(n=6)received 0.1%dexamethasone *** the 7d,the corneal surface covered with neovascular vessels was measured on photographs as the percentage of the cornea’s total area using computer-imaging *** corneas obtained from rats were semiquantitatively evaluated for caspase-3 and vascular endothelial growth factor by ***:A statistically significant difference in the percent area of corneal NV was found among the groups(P0.005).There was a statistically significant difference among the groups in apoptotic cell density(P=0.002).The staining intensity of vascular endothelial growth factor in the epithelial and endothelial layers of cornea was significantly different among the groups(Pregorafenib 1mg/mL is partly effective for preventing alkali-induced corneal NV in rats.

关键词： corneal neovascularization regorafenib tyrosine kinase inhibitor

regorafenib-loaded poly(lactide-co-glycolide) microspheres designed to improve transarterial chemoembolization therapy for hepatocellular carcinoma

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Asian Journal of Pharmaceutical Sciences 2020年第6期15卷 739-751页

作者： Xiang Li Guangwei He Feng Su Zhaoxing Chu Leiming Xu Yazhong Zhang Jianping Zhou Yang Ding State Key Laboratory of Natural Medicines Department of PharmaceuticsChina Pharmaceutical UniversityNanjing 210009China Anhui Province Institutefor Food and Drug Control Hefei 230051China Hefei Industrial Pharmaceutical Institute Co Ltd Hefei 230051China

Transarterial chemoembolization(TACE)has been widely introduced to treat hepatocellular carcinoma(HCC)especially for unresectable patients for ***,TACE evokes an angiogenic response due to the secretion of vascular endothelial growth factor(VEGF),resulting in the formation of new blood vessels and eventually tumor ***,we aimed to develop regorafenib(REGO)-loaded poly(lactide-co-glycolide)(PLGA)microspheres that enabled localized and sustained drug delivery to limit proangiogenic responses following TACE in HCC ***-loaded PLGA microspheres were prepared using the emulsion-solvent evaporation/extraction method,in which DMF was selected as an organic phase ***,we optimized the proportion of DMF,which the optimal ratio to DCM was 1:9(v/v).After preparation,the microspheres provided high drug loading capacity of 28.6%,high loading efficiency of 91.5%,and the average particle size of 149μm for *** spectra and XRD were applied to confirming sufficient REGO *** in vitro release profiles demonstrated sustained drug release of microspheres for more than 30 d To confirm the role of REGO-loaded microspheres in TACE,the cell cytotoxic activity on HepG2 cells and anti-angiogenic effects in HUVECs Tube-formation assay were studied in combination with ***,the microspheres indicated the potential of antagonizing miriplatin resistance of HepG2 cells in *** preliminary studies exhibited that REGO could be sustainably released from microspheres for more than 30d after TACE in *** vivo anti-tumor efficacy was further determined in HepG2 xenograft tumor mouse model,demonstrating that REGO microspheres could improve the antitumor efficacy of miriplatin remarkably compared with miriplatin *** conclusion,the obtained REGO microspheres demonstrated promising therapeutic effects against HCC when combined with TACE.

关键词： regorafenib Microspheres Transarterial chemoembolization Hepatocellular carcinoma

Second-line therapy for advanced hepatocellular carcinoma with regorafenib or cabozantinib:Multicenter French clinical experience in real-life after matching

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World Journal of Gastrointestinal Oncology 2022年第8期14卷 1510-1527页

作者： Xavier Adhoute Marie De Matharel Laurent Mineur Guillaume Pénaranda Dann Ouizeman Clemence Toullec Albert Tran Paul Castellani Armelle Rollet Valérie Oules HervéPerrier Si Nafa Si Ahmed Marc Bourliere Rodolphe Anty Department of Gastroenterology and Hepatology Hôpital Saint-JosephMarseille 13000France Department of Gastroenterology and Hepatology Hôpital Universitaire de l’ArchetNice 06000France Department of Oncology Institut Sainte-CatherineAvignon 84000France Department of Biostatistics AlphaBio LaboratoryMarseille 13000France

BACKGROUND Starting a second-line systemic treatment for hepatocellular carcinoma(HCC)is a common *** only therapeutic options in France are two broadspectrum tyrosine kinase inhibitors(TKIs),regorafenib(REG)and cabozantinib(CBZ),but no comparative real-life studies are *** To evaluate the progression-free survival(PFS)of patients treated with REG or CBZ,we investigated the disease control rate(DCR),overall survival(OS),and safety of both *** identify the variables associated with disease progression over *** A retrospective multicenter study was performed on the clinical data of patients attending one of three referral centers(Avignon,Marseille,and Nice)between January 2017 and March 2021 using propensity score *** and OS were assessed using the Kaplan-Meier *** analysis(MA)of progression risk factors over time was performed in matched-pair *** Fifty-eight patients 68(62-74)years old with HCC,Barcelona clinic liver cancer(BCLC)B/C(86%),Child-Pugh(CP)-A/B(24%)received REG for 3.4(1.4-10.5)mo as second-line *** patients 68(60-73)years,BCLC B/C(75%),CP-A/B(25%)received CBZ for 3.7(1.8-4.9)mo after first-line treatment with sorafenib[3(2-4)(CBZ)vs 4(2.9-11.8)mo(REG),P=0.0226].Twenty percent of patients received third-line *** matching,PFS and DCR were not significantly different after a median follow-up of 6.2(2.7-11.7)mo(REG)vs 5.2(4-7.2)mo(CBZ),P=*** was no difference in grade 3/4 toxicities,dose reductions,or *** OS of CP-A patients was 8.3(5.2-24.8)vs 4.9(1.6-11.7)mo(CP-B),P=*** MA of risk factors for progression over time identified C-reactive protein(CRP)>10 mg/L,neutrophil-to-lymphocyte ratio(NLR)>3,and aspartate aminotransferase(AST)>45 IU as predictive *** This multicenter indirect comparative study found no significant difference in PFS between REG and CBZ as second-line therapy for advanced *** levels of inflam

关键词： Hepatocellular carcinoma regorafenib Cabozantinib C-reactive protein Neutrophillymphocyte ratio

Efficacy comparison of fruquintinib,regorafenib monotherapy or plus programmed death-1 inhibitors for microsatellite stable metastatic colorectal cancer

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World Journal of Gastrointestinal Oncology 2024年第6期16卷 2449-2462页

作者： Tian-Qi An Hui Qiu Quan-Bo Zhou Hong Zong Shuang Hu Yu-Gui Lian Rui-Hua Zhao Department of Oncology The First Affiliated Hospital of Zhengzhou UniversityZhengzhou 450000Henan ProvinceChina Department of Hepato-Pancreato-Biliary Surgery Peking University Cancer Hospital and InstituteBeijing 100000China Department of Colorectal Surgery The First Affiliated Hospital of Zhengzhou UniversityZhengzhou 450000Henan ProvinceChina

BACKGROUND regorafenib(R)and fruquintinib(F)are the standard third-line regimens for colorectal cancer(CRC)according to the National Comprehensive Cancer Network guidelines,but both have limited *** phase 2 trials have indicated that R or F combined with immune checkpoint inhibitors can reverse immunosuppression and achieve promising efficacy for microsatellite stable or proficient mismatch repair(MSS/pMMR)*** to the lack of studies comparing the efficacy between F,R,F plus programmed death-1(PD-1)inhibitor,and R plus PD-1 inhibitors(RP),it is still unclear whether the combination therapy is more effective than *** To provide critical evidence for selecting the appropriate drugs for MSS/pMMR metastatic CRC(mCRC)patients in clinical *** A total of 2639 CRC patients were enrolled from January 2018 to September 2022 in our hospital,and 313 MSS/pMMR mCRC patients were finally *** A total of 313 eligible patients were divided into F(n=70),R(n=67),F plus PD-1 inhibitor(FP)(n=95)and RP(n=81)*** key clinical characteristics were well balanced among the *** median progression-free survival(PFS)of the F,R,FP,and RP groups was 3.5 months,3.6 months,4.9 months,and 3.0 months,*** median overall survival(OS)was 14.6 months,15.7 months,16.7 months,and 14.1 *** FP regimen had an improved disease control rate(DCR)(P=0.044)and 6-month PFS(P=0.014)and exhibited a better trend in PFS(P=0.057)compared with F,and it was also significantly better in PFS than RP(P=0.030).RP did not confer a significant survival benefit;instead,the R group had a trend toward greater benefit with OS(P=0.080)compared with *** significant differences were observed between the R and F groups in PFS or OS(P>0.05).CONCLUSION FP is superior to F in achieving 6-month PFS and DCR,while RP is not better than *** has an improved PFS and 6-month PFS compared with RP,but F and R had similar clinical ***,FP may be a

关键词： Colorectal cancer Fruquintinib regorafenib Programmed death-1 inhibitor Real-world

Case Report: Bilateral Pneumothoraces due to Targeted Tumor Therapy with regorafenib in a Young Woman with Metastatic Colorectal Cancer

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Case Reports in Clinical Medicine 2022年第5期11卷 139-145页

作者： Tobias Rachow Tim Sandhaus Thomas Ernst Helmut Schiffl Susanne M. Lang Klinik für Innere Medizin II Universit&auml tsklinikum Jena Jena Germany Klinik für Innere Medizin V Universit&auml tsklinikum Jena Jena Germany Klinik für Herz- und Thoraxchirurgie Universit&auml tsklinikum Jena Jena Germany Medizinische Klinik IV LMU München München Germany

Background: Colorectal cancer is one of the most common cancer types, frequently metastasizing into the lungs. Treatment options have been vastly improved over the last years. With the increasing use of targeted therapies, novel and rare adverse effects can be seen. Case Presentation: A 43-year-old woman presented in our oncology department with chest pain and dyspnea. The patient was diagnosed with colorectal cancer seven years earlier and had received chemoradiation, surgery, and multiple chemotherapies before she was started on regorafenib because of progressive pulmonary metastases. Computed tomography scans demonstrated cavitation of former nodular bilateral pulmonary metastases. After drainage and resolution of the right-sided pneumothorax, the patient returned eleven days later with recurrent symptoms caused by left-sided tension pneumothorax. Video-assisted thoracoscopy and bilateral pleurodeses were performed. Persistent air leaks with severe pain and pulmonary infiltrates led to the death of the patient. Conclusions: This case demonstrates the efficacy of oral antiangiogenetic therapy in advanced metastatic colorectal cancer. Nevertheless, it also depicts an important potential side effect by transforming multiple solid lung metastases into cavitations which led to recurrent pneumothoraces. Special attention should be paid to this phenomenon as treatment of these complications can be challenging.

关键词： regorafenib Pneumothorax Pulmonary Metastases Colorectal Cancer

Effects of sorafenib and regorafenib on the expression of hypoxia-inducible factors in hepatocellular carcinoma-transplanted nude mice

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Oncology and Translational Medicine 2022年第5期8卷 259-263页

作者： Ganxin Wang Bai Wei Qian Ma Shu Huang Qi Wu Division of Oncology Liyuan HospitalTongji Medical CollegeHuazhong University of Science and TechnologyWuhan 430077China Cancer Center Union HospitalTongji Medical CollegeHuazhong University of Science and TechnologyWuhan 430022China Department of Hepatology of Integrated Traditional Chinese and Western Medicine The Third People's Hospital of Hubei Province Affiliated to Jianghan UniversityWuhan 430056China

Objective The objective of this study was to investigate the inhibitory effects of sorafenib and regorafenib on the growth of hepatocellular carcinoma(HCC)using a subcutaneous transplantation tumor model in nude mice and exploring the effects of sorafenib and regorafenib on the expression of hypoxia-inducible factor(HIF)-1α,HIF-2α,and HIF-1βin HCC tissues collected from HCC-transplanted nude *** HepG2 cells were inoculated intradermally into nude *** mice were randomly assigned to either sorafenib treatment(100 mg/kg),regorafenib treatment(20 mg/kg),or solvent control group(dimethylsulfoxide)(n=8 per group)and received once-daily treatment for 14 *** tumor volumes were recorded every 3 days after the initiation of *** expression levels of HIF-1α,HIF-1β,HIF-2α,and SART1 in the HCC tissues were examined via quantitative real-time PCR(qRT-PCR)analysis and Western *** The tumors in the sorafenib and regorafenib treatment groups grew slower and smaller than did the tumors in the solvent control *** analysis and western blotting demonstrated that the mRNA and protein expressions of HIF-1αand HIF-1βwere *** expression of HIF-2αand SART1 was up-regulated in the sorafenib treatment group(Pregorafenib treatment group(Pregorafenib,which may induce the different effects of sorafenib on the expression of HIFs.

关键词： sorafenib regorafenib liver cancer hypoxia-inducible factor hypoxia-associated factor

索拉非尼和regorafenib的合成索拉非尼类似物作为PET显像剂的合成

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索拉非尼和Regorafenib的合成索拉非尼类似物作为PET显像剂的合成

作者：刘亚方天津大学

学位级别：硕士

索拉非尼和regorafenib都是由德国拜耳和美国Onyx公司共同研发的两个多激酶抑制剂类抗癌药物。索拉非尼主要用于治疗晚期肾细胞癌和晚期肝细胞癌，regorafenib主要用于治疗转移性结直肠癌和不能手术切除或转移性胃肠道间质瘤。本文研究... 详细信息

索拉非尼和regorafenib都是由德国拜耳和美国Onyx公司共同研发的两个多激酶抑制剂类抗癌药物。索拉非尼主要用于治疗晚期肾细胞癌和晚期肝细胞癌，regorafenib主要用于治疗转移性结直肠癌和不能手术切除或转移性胃肠道间质瘤。本文研究目的在于找到一种成本低廉、操作简单，收率较高并且适用于工业化生产索拉非尼和regorafenib的合成方法。从两个药物相似的结构及已有的报道的合成路线来看，两者的合成方法相似。本文采用两种合成路线分别来制备索拉非尼和regorafenib，对每条路线中每一步反应进行详细研究，并通过实验操作确定每一步反应中适合的反应条件，最终确定了制备索拉非尼和regorafenib的最适合的合成方法。确定的合成工艺为：起始原料2-吡啶甲酸经氯化、甲醇解、酰胺化、亲核取代反应得到关键中间体，最后与4-氯-3-三氟甲基苯异氰酸酯缩合得到索拉非尼或regorafenib。正电子发射断层显像（PET）技术是一种用于检测生物体放射性核物质分布的非创伤性的高分辨率影像技术，近年来已广泛用于肿瘤、心血管疾病和脑部疾病三大疾病的鉴别诊断与疗效监测。抗肿瘤药物索拉非尼可以用于治疗晚期肾细胞癌和晚期肝细胞癌，而且临床上证实索拉非尼还对恶性黑色素瘤、非小细胞癌等疾病也有很好的疗效。本文研究的主要内容是设计出一种氟-18标记的索拉非尼类似物（16）用于诊断并预防肿瘤。研究工作是合成该目标化合物（16）的前体17和标准对照品27。合成方法为以2-吡啶甲酸为原料，经氯化、酰胺化之后与对氨基苯酚发生亲核取代得到中间体19，19与4-氯-3-三氟甲基苯异氰酸酯反应得到化合物23。最后化合物23与1,2-双（甲苯磺酰氧基）乙烷（24）反应得到前体17，或者与1-（4-甲基苯磺酰氧基）-2-氟乙烷（29）反应得到对照品27。

关键词：抗肿瘤药物索拉非尼 regorafenib PET 18F-标记合成

regorafenib联合PD⁃1抑制剂在晚期微卫星稳定型结直肠癌中的疗效和安全性

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中国癌症防治杂志 2022年第5期14卷 521-528页

作者：罗茜茜陈佳梅石薇陈永顺武汉大学人民医院肿瘤中心武汉430060

目的评估瑞戈非尼(regorafenib)联合PD-1抑制剂三线及以上治疗晚期微卫星稳定(microsatellite stable,MSS)型结直肠癌(colorectal cancer,CRC)的疗效和安全性。方法选择2019年1月至2022年3月在武汉大学人民医院肿瘤中心接受regorafenib联合PD-1抑制剂或regorafenib单药三线及以上治疗的22例晚期MSS型CRC患者为研究对象,其中联合治疗组10例,regorafenib单药组12例。比较两组的无疾病进展生存期(progression-free survival,PFS)、总生存期(overall survival,OS)、客观缓解率(objective response rate,ORR)、疾病控制率(disease control rate,DCR)及不良反应发生情况。结果Kaplan-Meier生存分析显示,联合治疗组和单药组中位OS差异无统计学意义(6.10个月vs 6.13个月,P=0.827);但联合治疗组的中位PFS优于单药组(4.00个月vs 1.63个月,P=0.025)。相比单药组,联合治疗组在DCR(70.0%vs 25.0%,P=0.084)表现出优势,但差异无统计学意义。两组均未出现4级及以上不良反应,联合治疗组和单药组不良反应总发生率(100.0%vs 91.7%)以及≥3级不良反应发生率(30.0%vs 25.0%)比较差异均无统计学意义(均P>0.05)。结论相比于regorafenib单药治疗,regorafenib联合PD-1抑制剂作为晚期MSS型CRC三线及以上治疗方案可能在PFS方面带来获益,值得进一步开展临床试验研究。

关键词：结直肠癌 regorafenib PD-1抑制剂微卫星稳定型疗效安全性