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SHR-A1811(antibody-drug conjugate)in advanced HER2-mutant non-small cell lung cancer:a multicenter,open-label,phase 1/2 study

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Signal Transduction and Targeted Therapy 2024年第8期9卷 3483-3492页

作者： Ziming Li Zhengbo Song Wei Hong Nong Yang Yongsheng Wang Hong Jian Zibin Liang Sheng Hu Min Peng Yan Yu Yan Wang Zicong Jiao Kaijing Zhao Ke Song You Li Wei Shi Shun Lu Shanghai Lung Cancer Center Shanghai Chest HospitalShanghai Jiaotong University School of MedicineShanghai 200030China Phase i Clinical Trial Ward Zhejiang Cancer HospitalHangzhou 310000China department of Thoracic oncology Zhejiang Cancer HospitalHangzhou 310000China department of Lung&Gastrointestinal oncology Hunan Cancer HospitalChangsha 410031China Thoracic oncology Ward/Cancer Center West China Hospital of Sichuan UniversityChengdu 610041China department of Thoracic oncology The Fifth Affiliated Hospital of Sun Yat-Sen UniversityZhuhai 51900China department of Medical oncology Hubei Cancer HospitalWuhan 43000China department of oncology Renmin Hospital of Wuhan UniversityWuhan 430200China department of Thoracic Medicine Harbin Medical University Cancer HospitalHarbin 150081China department of Medical oncology Cancer HospitalChinese Academy of Medical SciencesBeijing 100021China Geneplus-Beijing CoLtd.Beijing 102206China Jiangsu Hengrui Pharmaceuticals Co.Ltd.Shanghai 200120China

A dose-escalation and expansion,phase 1/2 study(***,NCT04818333)was conducted to assess the novel antibodydrug conjugate SHR-A1811 in pretreated HER2-altered advanced non-small cell lung cancer(NSCLC).Here,we report results from the phase 1 *** who had previously failed or were intolerant to platinum-based chemotherapy were enrolled and received SHR-A1811 intravenously at doses of 3.2 to 8.0 mg/kg every 3 *** escalation followed a Bayesian logistic regression model that included overdose control,with subsequent selection of tolerable levels for dose ***,63 patients were enrolled,including 43 receiving a recommended dose for expansion of 4.8 mg/*** patients had HER2-mutant ***-limiting toxicity occurred in one patient in the 8.0 mg/kg dose ***≥3 treatment-related adverse events occurred in 29(46.0%)*** patient in the 6.4 mg/kg cohort died due to interstitial lung *** of April 11,2023,the 4.8 mg/kg cohort showed an objective response rate of 41.9%(95%Cl 27.0-57.9),and a disease control rate of 95.3%(95%Cl 84.2-99.4).The median duration of response was 13.7 months,with 13 of 18 responses *** median progression-free survival was 8.4 months(95%Ci 7.1-15.0).SHR-A1811 demonstrated favourable safety and clinically meaningful efficacy in pretreated advanced HER2-mutantNSCLC.

关键词： SHR HER2 doses

Targeting RAF dimers in RAS mutant tumors:From biology to clinic

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Acta Pharmaceutica Sinica B 2024年第5期14卷 1895-1923页

作者： Huanhuan Yin Qiulin Tang Hongwei Xia Feng Bi Division of Abdominal Cancer Department of Medical OncologyCancer Center and Laboratory of Molecular Targeted Therapy in OncologyWest China HospitalSichuan UniversityChengdu 610041China

RAS mutations occur in approximately 30%of tumors worldwide and have a poor prognosis due to limited *** targeting of KRAS G12C has achieved significant success in recent years,but there is still a lack of efficient therapeutic approaches for tumors with non-G12C KRAS mutations.A highly promising approach is to target the MAPK pathway downstream of RAS,with a particular focus on RAF ***-generation RAF inhibitors have been authorized to treat BRAF mutant tumors for over a ***,their use in RAS-mutated tumors is not recommended due to the paradoxical ERK activation mainly caused by RAF *** address the issue of RAF dimerization,type ii RAF inhibitors have emerged as leading *** clinical studies have shown the initial effectiveness of these agents against RAS mutant ***,type ii RAF inhibitors in combination with MEK or ERK inhibitors have demonstrated impressive efficacy in RAS mutant *** review aims to clarify the importance of RAF dimerization in cellular signaling and resistance to treatment in tumors with RAS mutations,as well as recent progress in therapeutic approaches to address the problem of RAF dimerization in RAS mutant tumors.

关键词： RAS mutations RAF dimerization RAF inhibitors Cancer therapy Drug resistance

Predictive value of positive lymph node ratio in patients with locally advanced gastric remnant cancer

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World Journal of Gastrointestinal oncology 2024年第3期16卷 833-843页

作者： Meng Zhuo Lei Tian Ting Han Teng-Fei Liu Xiao-Lin Lin Xiu-Ying Xiao department of oncology Renji HospitalSchool of MedicineShanghai Jiao Tong UniversityShanghai 200127China department of oncology Hebei General HospitalShijiazhuang 050051Hebei ProvinceChina

BACKGROUND Traditional lymph node stage(N stage)has limitations in advanced gastric remnant cancer(GRC)patients;therefore,establishing a new predictive stage is *** To explore the predictive value of positive lymph node ratio(LNR)according to clinicopathological characteristics and prognosis of locally advanced *** Seventy-four patients who underwent radical gastrectomy and lymphadenectomy for locally advanced GRC were retrospectively *** relationship between LNR and clinicopathological characteristics was *** survival analysis was performed using Kaplan-Meier survival curves and Cox regression *** Number of metastatic LNs,tumor diameter,depth of tumor invasion,Borrmann type,serum tumor biomarkers,and tumor-node-metastasis(TNM)stage were correlated with LNR stage and N *** analysis revealed that the factors affecting survival included tumor diameter,anemia,serum tumor biomarkers,vascular or neural invasion,combined resection,LNR stage,N stage,and TNM stage(all Pian survival time for those with LNR0,LNR1,LNR2 and LNR3 stage were 61,31,23 and 17 mo,respectively,and the differences were significant(P=0.000).Anemia,tumor biomarkers and LNR stage were independent prognostic factors for survival in multivariable analysis(all PiON The new LNR stage is uniquely based on number of metastatic LNs,with significant prognostic value for locally advanced GRC,and could better differentiate overall survival,compared with N stage.

关键词： Gastric remnant cancer Positive lymph node ratio Clinicopathological characteristics Prognosis

Anti-EGFR antibody monotherapy for colorectal cancer with severe hyperbilirubinemia: A case report

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World Journal of Gastrointestinal oncology 2024年第2期16卷 557-562页

作者： Toshiaki Tsurui Yuya Hirasawa Yutaro Kubota Kiyoshi Yoshimura Takuya Tsunoda department of Medical oncology Showa UniversityTokyo 1428555Japan department of Clinical immuno oncology Clinical Research Institute of Clinical Pharmacology and TherapeuticsShowa UniversityTokyo 1578577Japan

BACKGROUND Hyperbilirubinemia with hepatic metastases is a common complication and a poor prognostic factor for colorectal cancer(CRC).Effective drainage is often im-possible before initiating systemic chemotherapy,owing to the liver’s diffuse metastatic ***,an appropriate chemotherapeutic approach for the treatment of hyperbilirubinemia is currently *** SUMMARY The patient,a man in his 50s,presented with progressive fatigue and severe *** tomography revealed multiple hepatic masses with thick-ened walls in the sigmoid colon,which was pathologically confirmed as a well-differentiated *** RAS or BRAF mutations were *** Eastern Cooperative oncology Group(ECOG)performance status(PS)score was *** drainage was impossible due to the absence of a dilated bile duct,and panitumumab monotherapy was promptly ***,the bilirubin level decreased and then normalized,and the patient’s PS improved to zero ECOG score after four cycles of therapy without significant adverse *** Anti-EGFR antibody monotherapy is a safe and effective treatment for RAS wild-type CRC and hepatic metastases with severe hyperbilirubinemia.

关键词： Colorectal neoplasms Panitumumab Chemotherapy Hyperbilirubinemia Jaundice Case report

Concurrent chemoradiotherapyof different radiation doses and different irradiation fields for locally advanced thoracic esophageal squamous cell carcinoma:A randomized,multicenter,phase Ⅲ clinical trial

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Cancer Communications 2024年第10期44卷 1173-1188页

作者： Jian Zhang Minghao Li Kaixian Zhang Anping Zheng Guang Li Wei Huang Shaoshui Chen Xiangming Chen Xiaomin Li Yanxing Sheng Xinchen Sun Liping Liu Xiaowei Liu Jie Li Jun Wang Hong Ge Shucheng Ye Qingsong Pang Xianwen Zhang Shengbin Dai Richard Yu Wendong Gu Mingming Dai Gaowa Siqin Yunwei Han Xiaolin Ge Xin Yuan Yongjing Yang Haiwen Zhu Juan Pu Lihua Dong Xiangdong Sun Jundong Zhou Weidong Mao Fei Gao Haiqun Lin Heyi Gong Tao Zhou Zhenjiang Li Hongsheng Li Zhongtang Wang Baosheng Li department of oncology Central Hospital Affiliated to Shandong First Medical UniversityJinanShandongP.R.China department of Radiation oncology Shandong Cancer Hospital and InstituteShandong First Medical University and Shandong Academy of Medical SciencesJinanShandongP.R.China department of oncology Tengzhou Central People’s HospitalTengzhouShandongP.R.China department of Radiation oncology Anyang Tumor HospitalAnyangHenanP.R.China department of Radiation oncology the First Hospital of China Medical UniversityShenyangLiaoningP.R.China department of oncology Binzhou Medical University HospitalBinzhouShandongP.R.China department of oncology Taian CentralHospitalTaianShandongP.R.China department of Radiation oncology Shanxi Province Cancer HospitalTaiyuanShanxiP.R.China department of oncology Liaocheng People’s HospitalLiaochengShandongP.R.China department of Radiation oncology the First Affiliated Hospital of Nanjing Medical UniversityNanjingJiangsuP.R.China department of oncology Jining First People′s HospitalJiningShandongP.R.China department of oncology the Affiliated Hospital of Jining Medical UniversityJiningShandongP.R.China department of Radiation oncology the Fourth Hospital of Hebei Medical UniversityHebei Clinical Research Center for Radiation OncologyShijiazhuangHebeiP.R.China department of Radiation oncology the Affiliated Cancer Hospital of Zhengzhou UniversityZhengzhouHenanP.R.China department of Radiation oncology Tianjin Medical University Cancer Institute and HospitalNational Clinical Research Center for CancerKey Laboratory ofCancer Prevention and TherapyTianjin’s ClinicalResearch Center for CancerTianjinP.R.China department of oncology Subei People’s Hospital of Jiangsu ProvinceYangzhouJiangsuP.R.China department of oncology Taizhou People’s Hospital of Jiangsu ProvinceTaizhouZhejiangP.R.China department of Radiation oncology the Affiliated Hospital of Inner Mongolia Medical UniversityHohhotInner MongoliaP.R.China department of Radiation O

Background:Concurrent chemoradiotherapy(CCRT)is the standard treatment for locally advanced esophageal squamous cell carcinoma(ESCC).However,the optimal radiotherapy regimen,particularly in terms of total dose and planned range of irradiation field,remains *** phase iii clinical trial aimed to compare the survival benefits between different radiation doses and different target ***:This trial compared two aspects of radiation treatment,total dose and field,using a two-by-two factorial *** high-dose(HD)group received 59.4 Gy radiation,and the standard-dose(SD)group received 50.4 *** involved field irradiation(iFi)group and elective nodal irradiation(ENi)group adopted different irradiation *** participants were assigned to one of the four groups(HD+ENi,HD+iFi,SD+ENi and SD+iFi).The primary endpoint was overall survival(OS),and the secondary endpoints included progressionfree survival(PFS).The synergy indexwas used to measure the interaction effect between dose and ***:The interaction analysis did not reveal significant synergistic effects between the dose and irradiation *** comparison to the target field,patients in iFi or ENi showed similar OS(hazard ratio[HR]=0.99,95%Ci:0.80-1.23,p=0.930)and PFS(HR=1.02,95%Ci:0.82–1.25).TheHDtreatment did not show significantly prolonged OS compared with SD(HR=0.90,95%Ci:0.72–1.11,p=0.318),but it suggested improved PFS(25.2 months to 18.0 months).Among the four groups,the HD+iFi group presented the best survival,while the SD+iFi group had the worst *** significant difference in the occurrence of severe adverse events was found in dose or field ***:iFi demonstrated similar treatment efficacy to ENi in CCRT of *** HD demonstrated improved PFS,but did not significantly improve *** dose escalation based on iFi(HD+iFi)showed better therapeutic efficacy than the current recommendation(SD+ENi)and is worth further validation.

关键词： clinical trial concurrent chemoradiotherapy elective nodal radiation esophageal squamous cell carcinoma high dose radiation involved field radiation overall survival standard dose radiation

Penpulimab,an anti-PD-1 antibody,for heavily pretreated metastatic nasopharyngeal carcinoma:a single-arm phase ii study

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Signal Transduction and Targeted Therapy 2024年第7期9卷 3056-3062页

作者： Xiaozhong Chen Wei Wang Qingfeng Zou Xiaodong Zhu Qin Lin Yi Jiang Yan Sun Liangfang Shen Lin Wang Guorong Zou Xiaoyan Lin Shaojun Lin Minying Li Ying Wang Ruilian Xu Rui Ao Rensheng Wang Haifeng Lin Shuang Huang Tingting Xu Wenting Li Mengying Xia Yu Xia Zhongmin Wang Baiyong Li Jingao Li Chaosu Hu department of Radiation oncology Cancer Hospital of the University of ChineseAcademy of Sciences(Zhejiang Cancer Hospital)HangzhouChina Gastroenterology and Urology department ii Hunan Cancer Hospital/the Affiliated Cancer Hospital of Xiangya School of MedicineCentral South UniversityChangshaChina Clinical Research Center for Gastrointestinal Cancer in Hunan Province ChangshaChina department of Medical oncology Affiliated Cancer Hospital&Institute of Guangzhou Medical UniversityGuangzhouChina department of Radiation oncology Guangxi Medical University Affiliated Tumor Hospital&Key Laboratory of Early Prevention and Treatment for Regional High Frequency Tumor(Guangxi Medical University)Ministry of Education&Guangxi Key Laboratory of Early Prevention and Treatment for Regional High Frequency TumorGuangxi Medical UniversityNanningChina department of Radiation oncology Cancer CenterThe First Affiliated Hospital of Xiamen UniversityXiamenChina department of Medical oncology Cancer Hospital of Shantou University Medical CollegeShantouChina department of Radiation oncology Peking University Cancer Hospital&InstituteBeijingChina department of oncology Xiangya Hospital Central South UniversityChangshaChina department of Medical oncology Hainan General HospitalHainan Affiliated Hospital of Hainan Medical UniversityHaikouChina department of oncology The Affiliated Panyu Central Hospital of Guangzhou Medical UniversityGuangzhouChina department of Medical oncology Fujian Medical University Union HospitalFuzhouChina department of Radiation oncology Clinical Oncology School of Fujian Medical UniversityFujian Cancer HospitalFuzhouChina department of Radiation Therapy for Thoracic Tumors Zhongshan City People’s HospitalZhongshanChina Tumor Radiotherapy Center Chongqing University Cancer HospitalChongqing Cancer HospitalChongqing Cancer InstituteChongqingChina department of oncology Shenzhen People’s Hospital(The Second Clinical Medical CollegeJinan UniversityThe First Affiliated HospitalSo

Penpulimab is an anti-programmed cell death-1(PD-1)igG1 antibody with no Fc gamma receptor(FcγR)binding activity,and thus theoretically reduced immune-related adverse events(irAEs)while maintaining *** single-arm,phase ii trial conducted across 20 tertiary care centers in China enrolled adult patients with metastatic nasopharyngeal carcinoma(NPC)who had failed two or more lines of previous systemic *** received 200-mg penpulimab intravenously every 2 weeks(4 weeks per cycle)until disease progression or intolerable *** primary endpoint was objective response rate(ORR)per RECiST(version 1.1),as assessed by an independent radiological review *** secondary endpoints included progression-free survival(PFS)and overall survival(OS).One hundred thirty patients were enrolled and 125 were efficacy *** the data cutoff date(September 28,2022),1 patient achieved complete response and 34 patients attained partial *** ORR was 28.0%(95%Ci 20.3–36.7%).The response was durable,with 66.8%still in response at 9 ***-three patients(26.4%)were still on *** median PFS and OS were 3.6 months(95%Ci=1.9–7.3 months)and 22.8 months(95%Ci=17.1 months to not reached),***(7.6%)patients experienced grade 3 or higher *** has promising anti-tumor activities and acceptable toxicities in heavily pretreated metastatic NPC patients,supporting further clinical development as third-line treatment of metastatic NPC.

关键词： metastatic nasopharyngeal supporting

Network meta-analysis of combination strategies in metastatic hormone-sensitive prostate cancer

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Asian Journal of Andrology 2024年第4期26卷 402-408页

作者： Shan-Shan Wang Xiao-Jie Bian Jun-Long Wu Bei-He Wang Sheng Zhang Ding-Wei Ye department of Urology Fudan University Shanghai Cancer CenterShanghai 200032China department of oncology Shanghai Medical CollegeFudan UniversityShanghai 200032China department of Medical oncology Fudan University Shanghai Cancer CenterShanghai 200032China.

This study compared different doublet and triplet therapies for efficacy and safety in metastatic hormone-sensitive prostate cancer(mHSPC).PubMed,EMBASE,and the Cochrane Library were comprehensively searched for eligible randomized controlled trials(RCTs)published from inception to October *** included abiraterone,apalutamide,enzalutamide,docetaxel,darolutamide,and androgen deprivation therapy(ADT),either as doublet or triplet *** outcomes examined were overall survival(OS),progression-free survival(PFS),castration-resistant prostate cancer(CRPC)-free survival,time to symptomatic skeletal event(SSE),and *** surface under the cumulative ranking curve(SUCRA)was determined to identify the preferred *** RCTs were *** combination of darolutamide,docetaxel,and ADT had the highest SUCRA of 84.3 for OS,followed by combined abiraterone,docetaxel,and ADT(SUCRA=71.6).The highest SUCRAs for PFS were observed for triplet therapies(abiraterone,docetaxel,and ADT[SUCRA=74.9],followed by enzalutamide,docetaxel,and ADT[SUCRA=74.3])and other androgen receptor axis-targeted therapy-based doublet therapies(SUCRAs:26.5–59.3).Darolutamide,docetaxel,and ADT had the highest SUCRAs,i.e.,80.8 and 84.0 regarding CRPC-free survival and time to SSE,*** Grade>3 adverse events(AEs),the SUCRAs of triplet therapies(SUCRAs:14.8–31.5)were similar to that of docetaxel and ADT(SUCRA=39.5).Three studies had a low risk of bias in all categories;the remaining studies had at least an unclear risk of bias in at least one *** therapy demonstrated potentially enhanced effectiveness than doublet therapy in mHSPC,with acceptable safety *** might be the optimal option for triplet therapy in combination with docetaxel and ADT.

关键词： androgen antagonist androgen receptor antagonist docetaxel meta-analysis prostatic neoplasm

Patient-Reported Outcomes of Postoperative NSCLC Patients with or without Staged Chinese Herb Medicine Therapy during Adjuvant Chemotherapy(NALLC 2): A Randomized, Double-Blind, Placebo-Controlled Trial

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Chinese Journal of integrative Medicine 2024年第11期30卷 963-973页

作者： ZHANG Yi-lu JiAO Li-jing GONG Ya-bin XU Jian-fang Ni Jian SHEN Xiao-yong ZHANG Jie ZHOU Di QiAN Cheng-xin WANG Qin YAO Jia-lin YANG Wen-xiao SU Ling-zi WANG Li-yu Li Jia-qi YAO Yi-qin ZHANG Yuan-hui WANG Yi-chao CHEN Zhi-wei XU Ling oncology department Yueyang Hospital of Integrated Traditional Chinese and Western Medicine Shanghai University of Traditional Chinese Medicine institute of Traditional Chinese Medicine oncology Shanghai University of Traditional Chinese Medicine oncology department Shanghai Pulmonary Hospital Shanghai Tongji University Thoracic Surgery department Huadong Hospital Shanghai Fudan University Thoracic Surgery department Shanghai Cancer Hospital Shanghai Fudan University oncology department Shanghai Chest Hospital Shanghai Jiao Tong University

Objective:To investigate whether the combination of chemotherapy with staged Chinese herbal medicine(CHM) therapy could enhance health-related quality of life(QoL) in non-small-cell lung cancer(NSCLC)patients and prolong the time before deterioration of lung cancer symptoms,in comparison to chemotherapy ***:A prospective,double-blind,randomized,controlled trial was conducted from December 14,2017 to August 28,2020.A total of 180 patients with stage ⅠB-ⅢA NSCLC from 5 hospitals in Shanghai were randomly divided into chemotherapy combined with CHM(chemo+CHM) group(120 cases) or chemotherapy combined with placebo(chemo+placebo) group(60 cases) using stratified blocking *** European Organization for Research and Treatment of Cancer(EORTC) Quality-of-Life-Core 30 Scale(QLQ-C30) was used to evaluate the patient-reported outcomes(PROs) during postoperative adjuvant chemotherapy in patients with early-stage *** events(AEs) were assessed in the safety ***:Out of the total 180 patients,173 patients(116in the chemo+CHM group and 57 in the chemo+placebo group) were included in the PRO *** initial mean QLQ-C30 Global Health Status(GHS)/QoL scores at baseline were 57.16±1.64 and 57.67±2.25 for the two respective groups(P>0.05).Compared with baseline,the chemo+CHM group had an improvement in QLQ-C30GHS/QoL score at week 18 [least squares mean(LSM) change 17.83,95% confidence interval(Ci) 14.29 to 21.38].Conversely,the chemo+placebo group had a decrease in the score(LSM change-13.67,95% Ci-22.70 to-4.63).A significant between-group difference in the LSM GHS/QoL score was observed,amounting to 31.63 points(95% Ci25.61 to 37.64,Pimilar trends were observed in physical functioning,fatigue and appetite *** week 18,patients in the chemo+CHM group had a higher proportion of improvement or stabilization in GHS/QoL functional and symptom scores compared to chemo+placebo group(Pian time to deterioration

关键词： Chinese herbal medicine adjuvant chemotherapy health-related quality of life non-small-cell lung cancer patient-reported outcome

Designing macrophage membrane-engineered ruthenium/selenium nanoparticles to block bone metastasis of breast cancer

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Nano Research 2024年第8期17卷 7504-7512页

作者： Meijin Yang Zhiying Tang Xiaoying Li Yanzi Yu Lizhen He Tianfeng Chen College of Chemistry and Materials Science Department of Oncology of The First Affiliated HospitalJinan UniversityGuangzhou 510632China

Bone metastasis along with osteolysis is a common complication of advanced breast cancer,which directly destroys bone function and becomes one of the major causes of cancer-related *** is crucial to develop a new strategy to achieve effective cancer therapy and inhibition of osteolytic bone *** ruthenium(Ru)complexes exhibit therapeutic potential in cancer ***,the clinical applications of Ru complexes were limited by poor bioavailability,lacking targeting,nonspecific ***,in this study,engineering of cell membrane biomimetic modification was used to construct a highly biocompatible nanoplatform with carrying Ru metal complex of RuPOP and Se nanoparticles(SeNPs).Strikingly,the obtained RPSR nanoparticles can efficiently inhibit the proliferation,invasion and migration of breast cancer cells(MDA-MB-231 cells)in *** importantly,RPSR nanoparticles can induce cycle arrest,apoptosis by generating excessive intracellular(reactive oxygen species,ROS)to disrupt the normal redox balance and induce DNA damage in tumor ***,RPSR nanoparticles can also reshape bone microenvironment by regulating selenoproteins to inhibit osteoclasts and avoid osteolytic bone metastasis induced by tumor *** together,this study not only provides an effective cell membrane biomimetic strategy to enhance the shortcomings of metal complexes,but also demonstrates potential clinical significance for the combined treatment of anti-cancer and bone metastasis inhibition.

关键词： cell membrane nanoparticles biomimetic modification ruthenium complexes selenium nanoparticles tumor bone metastasis