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Targeted agents for second-line treatment of advanced hepatocellular carcinoma

World Journal of Gastrointestinal Oncology 2019年第10期11卷 788-803页

作者： Nicola Personeni Tiziana Pressiani Silvia Bozzarelli Lorenza Rimassa Medical Oncology and Hematology Unit Humanitas Cancer CenterHumanitas Clinical and Research CenterIRCCSRozzano 20089MilanItaly Department of Biomedical Sciences Humanitas UniversityPieve Emanuele 20090MilanItaly

Over the past ten years,sorafenib,a multikinase inhibitor,has been the standard of care for patients with unresectable hepatocellular carcinoma(HCC)and wellpreserved liver function.Recently,lenvatinib,a different multikinase inhibitor,was shown to be non-inferior to sorafenib,in terms of survival,while all other agents previously tested failed to prove non-inferiority(or superiority)when compared to sorafenib.Similarly,in the second-line setting,most investigational drugs failed to provide better survival outcomes than placebo.However,in the last 2 years three positive phase III trials have been published in this setting.The RESORCE trial,a phase III study evaluating regorafenib in HCC patients who experienced disease progression after first-line treatment with sorafenib,showed better outcomes with regorafenib compared to placebo.More recently,the phase III CELESTIAL trial demonstrated the superiority of cabozantinib,a multikinase inhibitor targeting vascular endothelial growth factor receptor,MET,and AXL,vs placebo in the second-and third-line setting in patients progressing on or intolerant to sorafenib.The survival benefits of a sustained anti-angiogenic inhibition were demonstrated also with ramucirumab in the phase III REACH-2 trial in patients previously treated with sorafenib and who had high baseline alpha-fetoprotein levels.Overall,the adverse events reported in these trials were in line with the known safety profiles of the tested agents.After nearly a decade of a certain degree of stagnation,we are now witnessing a period of novel therapeutic advances with multikinase inhibitors and monoclonal antibodies that will likely change the treatment scenario of HCC.

关键词： Hepatocellular carcinoma Advanced-metastatic second-line Third-line

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CMAB009 plus irinotecan versus irinotecan-only as second-line treatment after fluoropyrimidine and oxaliplatin failure in KRAS wild-type metastatic colorectal cancer patients:promising findings from a prospective,open-label,randomized,phase III trial

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Cancer Communications 2019年第1期39卷 258-270页

作者： Yuankai Shi Jin Li Jianming Xu Yan Sun Liwei Wang Ying Cheng Wei Liu Guoping Sun Yigui Chen Li Bai Yiping Zhang Xiaohui He Yi Luo Zhehai Wang Yunpeng Liu Qiang Yao Yuhong Li Shukui Qin Xiaohua Hu Feng Bi Rongsheng Zheng Xuenong Ouyang Department of Medical Oncology Beijing Key Laboratory of Clinical Study On Anticancer Molecular Targeted DrugsNational Cancer Center/National Clinical Research Center for Cancer/Cancer HospitalChinese Academy of Medical Sciences and Peking Union Medical CollegeBeijing 100021P.R.China Fudan University Shanghai Cancer Center Shanghai 200032P.R.China The Affiliated Hospital of Military Medical Sciences Beijing 100071P.R.China Shanghai General Hospital Shanghai 200080P.R.China Jilin Cancer Hospital Changchun 130012JilinP.R.China Tumor Hospital of Hebei Province Shijiazhuang 050011HebeiP.R.China The First Affiliated Hospital of Anhui Medical University Hefei 230022AnhuiP.R.China Fujian Provincial Cancer Hospital Fuzhou 350014FujianP.R.China Chinese People’s Liberation Army General Hospital Beijing 100853P.R.China Zhejiang Cancer Hospital Hangzhou 310022ZhejiangP.R.China Hunan Cancer Hospital Changsha 410013HunanP.R.China Shandong Cancer Hospital Jinan 250117ShandongP.R.China The First Hospital of China Medical University Shenyang 110001LiaoningP.R.China Tianjin People’s Hospital Tianjin 300121P.R.China Sun Yat-sen University Cancer Center State Key Laboratory of Oncology in South ChinaCollaborative Innovation Center of Cancer MedicineGuangzhou 510060GuangdongP.R.China Chinese People’s Liberation Army Bayi Hospital Nanjing 210002JiangsuP.R.China The Guangxi Zhuang Autonomous Region Tumor Hospital Nanning 530021GuangxiP.R.China West China Hospital Chengdu 610041SichuanP.R.China First Affiliated Hospital of Bengbu Medical College Bengbu 233004AnhuiP.R.China Fuzhou People’s Liberation Army General Hospital Fuzhou 350025FujianP.R.China

Background:The 5-fluorouracil/leucovorin plus oxaliplatin(FOLFOX)regimen is the standard first-line treatment for metastatic colorectal cancer(mCRC),however,the optimal second-line regimen for KRAS wild-type mCRC patients is still investigational.In this study,we aimed to determine the clinical efficacy and safety of CMAB009 plus irinotecan compared to irinotecan-only as a second-line regimen for treating KRAS wild-type mCRC patients.Methods:Patients with KRAS wild-type mCRC who had previously failed to respond to FOLFOX treatment were ran-domly assigned in a 2:1 ratio,to receive CMAB009 plus irinotecan or irinotecan-only.Patients receiving irinotecan-only were permitted to switch to CMAB009 therapy on disease progression and were grouped as the sequential-CMAB009 arm.The primary endpoints were overall response rate(ORR)and median progression-free survival(PFS).The second-ary endpoints were median overall survival(OS),disease control rate(DCR),clinical benefit rate(CBR),and duration of response(DOR).Results:The CMAB009 plus irinotecan arm demonstrated significantly improved ORR(33.2%vs.12.8%;Psecond-line regimen in com-par

关键词： CMAB009 Cetuximab Irinotecan second-line mCRC EGFR KRAS Immunogenicity Fluoropyrimidine Oxaliplatin failure

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Oral chemotherapy for second-line treatment in patients with gemcitabine-refractory advanced pancreatic cancer

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World Journal of Gastrointestinal Oncology 2019年第11期11卷 1021-1030页

作者： Se Jun Park Hyunho Kim Kabsoo Shin Myung Ah Lee Tae Ho Hong Division of Medical Oncology Department of Internal MedicineThe Catholic University of KoreaSeoul St.Mary’s HospitalSeoul 100744South Korea Department of General Surgery The Catholic University of KoreaSeoul St.Mary’s HospitalSeoul 100744South Korea

BACKGROUND There is no standard therapy for second-line treatment of gemcitabine-refractory pancreatic cancer patients with poor performance status.A combination of chemotherapy drugs 5-fluorouracil(5-FU),leucovorin,irinotecan,and oxaliplatin(FOLFIRINOX)or 5-fluorouracil/leucovorin plus nanoliposomal irinotecan can be considered as second-line treatment for such patients;however,due to toxicity,none of the regimens are recommended for patients with poor performance.Capecitabine or S-1 has relatively low toxicity and can be considered a treatment option for gemcitabine-refractory pancreatic cancer.AIM To investigate the efficacy and toxicity of oral chemotherapy as second-line treatment in patients with pancreatic cancer.METHODS Patients who had progressive disease after first-line gemcitabine-based chemotherapy were retrospectively analyzed between January 2011 and December 2018.They were treated with capecitabine or S-1 as the second-line treatment.Capecitabine was administered as a 2500 mg/m2 divided dose on days 1-14,followed by a 1-wk rest.S-1 was taken orally based on the patient’s body surface area for 28 d,followed by 2-wk of rest.Progression-free survival and overall survival were used to compare efficacy of capecitabine and S-1.RESULTS Of the 81 patients,41 were treated with capecitabine and 40 with S-1.The median time to treatment failure in both groups was 1.5 mo(P=0.425).The objective response rate was similar in the two groups:9.8%with capecitabine and 2.5%with S-1(P=0.359).Median progression-free survival was longer in the S-1 group than in the capecitabine group(S-12.7 mo,capecitabine 2.0 mo,P=0.003).There was no significant difference in the median overall survival between the capecitabine and S-1 groups(4.3 mo vs 5.0 mo,P=0.092).Grade 3 or 4 hand-foot syndrome was significantly more common in the capecitabine group than in the S-1 group(14.6%vs 0%,P=0.026).CONCLUSION Capecitabine or S-1 can be used as a second-line treatment for patients with advanced pancreatic cancer with poor performance statu

关键词： Pancreatic cancer Gemcitabine-refractory Capecitabine S-1 second-line treatment

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Efficacy and Safety of Generic Dasatinib as a second-line Treatment for Patients with Chronic Myeloid Leukemia:a Multicenter Retrospective Study in Hubei Province,China

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Current Medical Science 2018年第6期38卷 1005-1011页

作者： Li-feng CHEN Guo-lin YUAN Zhao-dong ZHONG Ping ZOU Deng-ju LI Yin BAO Hong-bo REN Li MENG Wei-ming LI Department of Hematology Union HospitalTongji Medical CollegeHuazhong University of Science and TechnologyWuhan 430022China Department of Hematology Xiangyang Central HospitalXiangyang 441000China Department of Hematology Tongji HospitalTongji Medical CollegeHuazhong University of Science and TechnologyWuhan 430030China Department of Hematology Xiangyang No.1 People's HospitalXiangyang 441000China Department of Hematology the First People's Hospital of JingzhouJingzhou 434000China

Dasatinib is a second-generation tyrosine kinase inhibitor (TKI)and it could be used as a second-line treatment for patients with chronic myeloid leukemia (CML).Yinishu,a generic dasatinib made in China,was approved by the China Food and Drug Administration in 2013 and it costs much less than the patented dasatinib SPRYCEL.The present study aimed to examine the efficacy and safety of Yinishu as a second-line treatment for CML by comparing the baseline clinical characteristics,rates of adverse events and efficacy between Yinishu and SPRYCEL groups. The results showed that there were no significant differences in the rates of optimal response between Yinishu and SPRYCEL for patients who started second-line treatment because of treatment failure.For patients who started second-line treatment because of intolerance of first-line treatment, their levels of BCR-ABL1/ABL1 on the international scale (BCR-ABL^IS)was maintained very low throughout the course of Yinishu treatment.Drug-related adverse events occurred with the same frequency in these two groups.It was confirmed that Yinishu was effective and safe as a second- line treatment for CML patients.Yinishu may be more suitable for patients who are economically unable to pay for the patented dasatinib SPRYCEL.

关键词： chronic myeloid leukemia generic dasatinib second-line treatment efficacy safety

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Efficacy of 14-d vs 7-d moxifloxacin-based triple regimens for second-line Helicobacter pylori eradication

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World Journal of Gastroenterology 2015年第18期21卷 5568-5574页

作者： Jae Jin Hwang Dong Ho Lee Ae-Ra Lee Hyuk Yoon Cheol Min Shin Young Soo Park Nayoung Kim Department of Internal Medicine Seoul National University Bundang Hospital Gyeonggi-do 463-707 South Korea

AIM: To evaluate the efficacy of the 14-d moxifloxacinbased triple therapy for the second-line eradication of Helicobacter pylori(H. pylori) infection.METHODS: Between 2011 and 2013, we conducted a retrospective review of the medical records of 160 patients who had experienced failure of their first-line proton pump inhibitor-based eradication therapy and subsequently received the moxifloxacin-based triple therapy as a second-line eradication treatment regimen. The patients who were treated with the moxifloxacinbased triple therapy(oral 20 mg rabeprazole b.i.d., 1000 mg amoxicillin b.i.d., and 400 mg moxifloxacin q.d.) for 7 d were assigned to the RAM-7 group(n = 79) while those who took them for 14 days were assigned to RAM-14 group(n = 81). The eradication rates for both groups were determined by intentionto-treat(ITT) and per-protocol(PP) analyses. ITT analysis compared the treatment groups as originally allocated while the PP analysis including only those patients who had completed the treatment as originally allocated. Successful eradication therapy for H. pylori infection was defined as the documentation of a negative 13C-urea breath test 4 wk after the end of the eradication treatment.RESULTS: The overall ITT eradication rate was 76.2%(122/160). The final ITT eradication rates were 70.8%(56/79; 95%CI: 63.3%-77.1%) in the RAM-7 group and 81.4%(66/81; 95%CI: 74.6%-88.3%) in the RAM-14 group(P = 0.034). The overall PP eradication rate was 84.1%(122/145), and the final PP eradication rates were 77.7%(56/72; 95%CI: 70.2%-85.3%) in the RAM-7 group and 90.4%(66/73; 95%CI: 82.8%-98.1%) in the RAM-14 group(P = 0.017). The H. pylori-eradication rates in the RAM-14 group were significantly higher compared with that of the RAM-7 group according to both the ITT(P = 0.034) and the PP analyses(P = 0.017). Both groups exhibited good treatment compliance(RAM-7/RAM-14 group: 100%/100%). The adverse event rates were19.4%(14/72)and 20.5%(15/73)in the RAM-7 and RAM-14 groups,respectively(P=0.441).Adverse events occurred in 14

关键词： Helicobacter pylori Treatment failure second-line treatment Moxifloxacin Eradication rate

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Tacrolimus and mycophenolate mofetil as second-line treatment in autoimmune hepatitis:Is the evidence of sufficient quality to develop recommendations?

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World Journal of Gastroenterology 2020年第38期26卷 5896-5910页

作者： Mohammadreza Abdollahi Neda Khalilian Ekrami Morteza Ghojazadeh H Marike Boezen Mohammadhossein Somi Behrooz Z Alizadeh Department of Epidemiology University of GroningenGroningen 9700 RBNetherlands Research Center for Evidence Based Medicine Tabriz University of Medical SciencesTabriz ***Iran Liver and Gastrointestinal Diseases Research Center Tabriz University of Medical SciencesTabriz ***Iran

BACKGROUND The standard management of autoimmune hepatitis(AIH)is based on corticosteroids,alone or in combination with azathioprine.second-line treatments are needed for patients who have refractory disease.However,high-quality data on the alternative management of AIH are scarce.AIM To evaluate the efficacy and safety of tacrolimus and mycophenolate mofetil(MMF)and the quality of evidence by using the Grading of Recommendations Assessment,Development and Evaluation approach(GRADE).METHODS A systematic review and meta-analysis of the available data were performed.We calculated pooled event rates for three outcome measures:Biochemical remission,adverse events,and mortality,with their corresponding 95%confidence intervals(CI).RESULTS The pooled biochemical remission rate was 68.9%(95%CI:60.4-76.2)for tacrolimus,and 59.6%(95%CI:54.8-64.2)for MMF,and rates of adverse events were 25.5%(95%CI:12.4-45.3)for tacrolimus and 24.1%(95%CI:15.4-35.7)for MMF.The pooled mortality rate was estimated at 11.5%(95%CI:7.1-18.1)for tacrolimus and 9.01%(95%CI:6.2-12.8)for MMF.Pooled biochemical remission rates for tacrolimus and MMF in patients with intolerance to standard therapy were 56.6%(CI:43.4-56.6)vs 73.5%(CI:58.1-84.7),and among non-responders were 59.1%(CI:48.7-68.8)vs 40.8%(CI:32.3-50.0),respectively.Moreover,the overall quality assessments using GRADE proved to be very low for all our outcomes in both treatment groups.CONCLUSION Tacrolimus and MMF are in practice considered effective for patients with AIH who are non-responders or intolerant to first-line treatment,but we found no high-quality evidence to support this statement.

关键词： Autoimmune hepatitis Efficacy Grading of Recommendations Assessment,Development and Evaluation approach Systematic review Meta-analysis second-line

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Effectiveness of second-line anti-HER2 treatment in HER2-positive metastatic breast cancer patients previously treated with trastuzumab:A real-world study

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Chinese Journal of Cancer Research 2020年第3期32卷 361-369页

作者： Wei Zhao Li Bian Tao Wang Shaohua Zhang Jianbin Li Fengrui Xu Zefei Jiang Department of Breast Oncology Academy of Military Medical SciencesBeijing 100850China Department of Breast Oncology the Fifth Medical Center of Chinese PLA General HospitalBeijing 100071China PLA Rocket Force Characteristic Medical Center Beijing 100088China

Objective:Several studies have demonstrated different benefits for patients whose disease progressed despite previous trastuzumab treatment.Due to limited real-world data,we evaluate the effectiveness of anti-human epidermal growth factor receptor 2(HER2)therapy(lapatinib or trastuzumab)plus chemotherapy or chemotherapy alone in patients who were previously treated with trastuzumab-containing regimens and investigate factors associated with effectiveness.And we further show the effectiveness of the two anti-HER2 therapy groups.Methods:A total of 342 HER2-positive metastatic breast cancer(MBC)patients whose disease progressed during prior anti-HER2(trastuzumab)and standard chemotherapy therapy from Department of Breast Oncology,the Fifth Medical Center of Chinese PLA General Hospital,from August 2010 to December 2016 were included.Seventy-eight patients received standard chemotherapy only,148 patients continued to receive trastuzumab and switched to other chemotherapy drugs,and 116 patients received tyrosine-kinase inhibitors(TKIs;lapatinib)and chemotherapy.The main outcome measures were progression-free survival(PFS),overall response rate(ORR),and clinical benefit rate(CBR).Subgroup analyses were conducted to identify patient characteristics associated with the greatest clinical benefit.Results:After a median follow-up of 26.2(range,2.0-56.0)months,PFS significantly improved with anti-HER2 therapy compared with chemotherapy alone:median 6.0 months with lapatinib[95%confidence interval(95%CI),4.53-7.47],4.5 months with trastuzumab(95%CI,3.99-5.01)vs.3.0 months with chemotherapy alone(95%CI,2.42-3.58);stratified hazard ratio(HR)=0.70,95%CI,0.60-0.81;P<0.0001.The ORR values were 33.6%,25.0%and 12.8%,respectively,the CBR values were 60.3%,48.6%and 26.9%,respectively.The effectiveness of lapatinib group and trastuzumab group were further analyzed.In multivariate analysis,lapatinib group was associated with a longer PFS,after controlling other potential confounders(HR=0.68,95%CI,0.52-0.90;P=0.006).Conclusions:The combi

关键词： Metastatic breast cancer trastuzumab failure second-line real-world study

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Fourteen- vs seven-day bismuth-based quadruple therapy for second-line Helicobacter pylori eradication

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World Journal of Gastroenterology 2015年第26期21卷 8132-8139页

作者： Jae Jin Hwang Dong Ho Lee Ae-Ra Lee Hyuk Yoon Cheol Min Shin Young Soo Park Nayoung Kim Department of Internal Medicine Seoul National University Bundang Hospital

AIM: To compare the efficacy of 14- and 7-d bismuthbased quadruple therapies as second-line eradication treatment for Helicobacter pylori(H.pylori) infection.METHODS: Between 2004 and 2014,the medical records of 790 patients who had experienced failure of first-line proton pump inhibitor(PPI)-based eradication therapy and were then treated with bismuth-based quadruple therapy were retrospectively reviewed.Those who received bismuth-based quadruple therapy [PPI,bismuth,metronidazole,and tetracycline(PBMT)] for either 7 d or 14 d were assigned to a PBMT-7 group(n = 543) or a PBMT-14 group(n = 247),respectively.The eradication rates for both groups were determined by intention-to-treat(ITT) and per-protocol(PP) analyses.ITT analysis compared the treatment groups as originally allocated while the PP analysis including only those patients who had completed the treatment as originally allocated.Successful eradication therapy for H.pylori infection was defined as a negative 13C-urea breath test 4 wk after the end of eradication treatment.RESULTS: The overall ITT eradication rate was 69.1%(546/790).Final ITT eradication rates were 67.4%(366/543; 95%CI: 63.1%-71.7%) in the PBMT-7 group and 72.8%(180/247; 95%CI: 67.4%-78.2%) in the PBMT-14 group(P = 0.028).The overall PP eradication rate was 80.0%(546/682),and the final PP eradication rates were 78.2%(366/468; 95%CI: 72.1%-84.0%) in the PBMT-7 group and 84.1%(180/214; 95%CI: 76.8%-90.8%) in the PBMT-14 group(P = 0.009).The H.pylori eradication rates in the PBMT-14 group weresignificantly higher than in the PBMT-7 group according to both ITT(P = 0.028) and PP analysis(P = 0.009).Compliance was similar in both groups(PBMT-7 group: 97.9%; PBMT-14 group: 96.4%).Adverse event rates were 10.7%(51/478) and 17.1%(38/222) in the PBMT-7 and PBMT-14 groups,respectively(P = 0.487).CONCLUSION: The 14-d bismuth-based quadruple therapy is a significantly more effective second-line eradication treatment for H.pylori infection than the 7-d alternative.

关键词： Helicobacter pylori Treatment failure second-line treatment Bismuth Eradication rate

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second-line treatment of metastatic gastric cancer:Current options and future directions

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World Journal of Gastroenterology 2015年第41期21卷 11621-11635页

作者： Dheepak Kanagavel Mikhail Fedyanin Alexey Tryakin Sergei Tjulandin Department of Clinical Pharmacology andChemotherapy N. N. Blokhin Russian Cancer Research Center

Gastric cancer remains one among the leading causes of cancer-related deaths, regardless of its decreasing incidence and newly available treatment options. Most patients present at an advanced stage and are treated with upfront systemic chemotherapy. Those patients receiving first-line therapy may initially respond to treatment, but many of them relapse over time. In such condition, second-line treatment for disease progression remains the only available option. Although there exists no standard approach in the second-line setting, several phase Ⅲ trials have shown modest survival benefit in patients receiving irinotecan, taxane and ramucirumab over the best supportive care or active agents. This review analyzes the currently available treatment regimens and future directions of research in the second-line setting for metastatic gastric cancer with the best available evidence. Additionally, the prognostic factors that influence patient survival in those receiving second-line therapy are discussed.

关键词： Metastatic gastric cancer second-line chemotherapy

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Metastatic gastric cancer treatment: second line and beyond

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World Journal of Gastroenterology 2016年第11期22卷 3069-3077页

作者： Marwan Ghosn Samer Tabchi Hampig Raphael Kourie Mustapha Tehfe Hematology-Oncology Department Faculty of MedicineSaint Joseph University Department of Medical Oncology Centre Hospitalier de l'Université de Montréal

Advanced gastric cancer(a GC), not amenable to curative surgery, is still a burdensome illness tormenting afflicted patients and their healthcare providers. Whereas combination chemotherapy has been shown to improve survival and tumor related symptoms in the frontline setting, second-line therapy(SLT) is subject to much debate in the scientific community, mainly because of the debilitating effects of GC, which would impede the administration of cytotoxic therapy. Recent data has provided sufficient evidence for the safe use of SLT in patients with an adequate performance status. Taxanes, Irinotecan and even some Fluoropyrimidine analogs were found to provide a survival advantage in this subset of patients. Most importantly, quality of life measures were also improved through the use of adequate therapy. Even more pertinent were the findings involving antiangiogenic agents, which would add measurable improvements without significantly jeopardizing the patients' well-being. Further lines of therapy are cause for much more debate nowadays, but specific targeted agents have shown considerable promise in this context. We herein review noteworthy published data involving the use of additional lines of the therapy after failure of standard frontline therapies in patients with a GC.

关键词： Advanced gastric cancer Treatment second-line Cytotoxic Targeted therapy

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