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National guidelines for diagnosis and treatment of malignant lymphoma 2022 in China(English version)

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Chinese Journal of Cancer Research 2022年第5期34卷 425-446页

作者： National Health Commission of the People’s Republic of China Yuankai Shi National Health Commission of the People’s Republic of China

Contents 1.Overview 2.Diagnosis of lymphoma 2.1 Clinical manifestations 2.2 Physical examination 2.3 Laboratory examination 2.4 Imaging examination 2.4.1 CT 2.4.2 MRI 2.4.3 PET-CT 2.4.4 Ultrasound 2.4.5 Isotope bone scan 2.4.6 Endoscopy 2.5 Pathological examination 2.5.1 Morphology 2.5.2 IHC 2.5.3 Fluorescence in situ hybridization(FISH)2.5.4 Antigen receptor gene rearrangement of lymphocytes 2.5.5 Others。

关键词： diagnosis lymphoma Clinical

Cancer Pathogenesis and Therapy:A new journal,a new inspiration

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Cancer Pathogenesis and Therapy 2023年第1期1卷 1-2页

作者： Yuankai Shi David James Kerr Department of Medical Oncology National Cancer Center/National Clinical Research Center for Cancer/Cancer HospitalChinese Academy of Medical Sciences&Peking Union Medical CollegeBeijing Key Laboratory of Clinical Study on Anticancer Molecular Targeted DrugsBeijing 100021China Radcliffe Department of Medicine University of OxfordOxfordOX14DJUK

Dear readers:It is our great pleasure to introduce Cancer Pathogenesis and Therapy(CPT),a journal officially launched and supported by the Chinese Medical Association(CMA)and the only international English-language journal in the field of oncology published by the CMA.As the Editor-in-Chief appointed by the CMA,on behalf of the editorial team,we would like to extend a warm welcome to the readership of CPT.

关键词： Medical journal Oncology Publication

PhaseⅠdose-finding study of sorafenib with FOLFOX4 as firstline treatment in patients with unresectable locally advanced or metastatic gastric cancer

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Chinese Journal of Cancer Research 2015年第3期27卷 239-246页

作者： Yihebali Chi Jianliang Yang Sheng Yang Yongkun Sun Bo Jia Yuankai Shi Department of Medical Oncology Cancer HospitalChinese Academy of Medical Sciences & Peking Union Medical College National Center for Anticancer Drugs Clinical Study Beijing Key Laboratory of Clinical Study on Anticancer Molecular Targeted Drugs

Objective： To determine the maximum tolerated dose（MTD）, dose-limiting toxicity（DLT） and efficacy of sorafenib in combination with FOLFOX4（oxaliplatin/leucovorin（LV）/5-fluorouracil） as first-line treatment for advanced gastric cancer, we performed a phase I dose-finding study in nine evaluable patients with unresectable locally advanced or metastatic gastric cancer or gastroesophageal junction adenocarcinoma. Methods： According to modified Fibonacci method, the design of this study was to guide elevation of the sorafenib dosage to the next level（from 200 mg twice daily to 400 mg twice daily and then, if tolerated, 600 mg twice daily）. If the patient achieved complete response（CR）, partial response（PR） or stable disease（SD） after eight cycles of treatment, combination chemotherapy was scheduled to be discontinued and sorafenib monotherapy continued at the original dose until either disease progression or unacceptable toxicity. Results： In sorafenib 200 mg twice daily group, DLT was observed in 1 of 6 patients, and in 400 mg twice daily group, it was observed in 2 of 3 patients. Seven of 9（77.8%） evaluable patients achieved PR, with a median overall survival（OS） of 11.8 [95% confidence interval（CI）： 8.9-14.7] months. Common adverse effects include hand-foot syndrome, leukopenia, neutropenia, anorexia, and nausea.Conclusions： Twice-daily dosing of sorafenib 200 mg in combination with FOLFOX4 was proven effective and safe for the treatment of advanced gastric cancer, and could be an appropriate dosage for subsequent phase II clinical studies.

关键词： Sorafenib gastric cancer FOLFOX4

Efficacy and safety of obinutuzumab for the first-line treatment of follicular lymphoma:a subgroup analysis of Chinese patients enrolled in the phase III GALLIUM study

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Chinese Medical Journal 2022年第4期135卷 433-440页

作者： Xiaonan Hong Yuqin Song Yuankai Shi Qingyuan Zhang Wei Guo Gang Wu Junmin Li Jifeng Feng Anastasiia Kinkolykh Andrea Knapp Tongyu Lin Department of Medical Oncology Fudan University Shanghai Cancer CenterShanghai 200032China Key Laboratory of Carcinogenesis and Translational Research(Ministry of Education) Peking University Cancer Hospital and InstituteBeijing 100142China National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital Chinese Academy of Medical Sciences and Peking Union Medical CollegeBeijing Key Laboratory of Clinical Study on Anticancer Molecular Targeted DrugsBeijing 100021China Department of Medical Oncology Harbin Medical University Cancer HospitalHarbin Medical UniversityHarbinHeilongjiang 150081China Department of Hematology The First Hospital of Jilin UniversityChangchunJilin 130015China Department of Medical Oncology Cancer CenterUnion HospitalTongji Medical CollegeHuazhong University of Science and TechnologyWuhanHubei 430023China Shanghai Institute of Hematology State Key Laboratory of Medical GenomicsNational Research Center for Translational Medicine at ShanghaiRuijin Hospital Affiliated to Shanghai Jiao Tong University School of MedicineShanghai 200025China Department of Medical Oncology Jiangsu Cancer HospitalNanjing Medical University Affiliated Cancer HospitalNanjingJiangsu 210009China Consultant to F.Hoffmann-La Roche Ltd BaselSwitzerlandvia GCE Solutions-an IQVIA businessSwitzerland Product Development Oncology F.Hoffmann-La Roche LtdBaselSwitzerland Department of Medical Oncology Sun Yat-Sen University Cancer CenterState Key Laboratory of Oncology in South Chinaand Collaborative Innovation Center for Cancer MedicineGuangzhouGuangdong 510075China

Backgrounds:GALLIUM is a global phase Ⅲ study that demonstrated significant improvements in progression-free survival(PFS)for obinutuzumab plus chemotherapy(G-chemo)vs.rituximab plus chemotherapy(R-chemo)in previously untreated patients with follicular lymphoma(FL).This study aimed to report the results of a subgroup of patients in China.Methods:Patients were randomized to G-chemo or R-chemo.Responders received maintenance therapy for 2 years or until disease progression.The primary endpoint was investigator(INV)-assessed PFS.Secondary endpoints included the overall response rate(ORR)and complete response rate(CRR)at the end of induction chemotherapy,overall survival(OS),and safety.Results:Overall,58 patients with FL were randomized to the G-chemo(n=25)and R-chemo arms(n=33).The INV-assessed PFS rate at 3 years was 81.8%in the G-chemo arm,vs.70.2%in the R-chemo arm(hazard ratio 0.35;95%confidence interval:0.09-1.34;P=0.1120).The INV-assessed CRRs(without positron emission tomography[PET])in these arms were 24.0%and 21.2%,respectively,whereas the ORRs were 80.0%and 90.9%,respectively.INV-assessed CRR-PET was 52.6%in the G-chemo,vs.60.9%in the R-chemo.Median OS was not reached in either arm.Grade 3 to 5 adverse events were more frequent in the R-chemo arm(97.0%vs.88.0%).Conclusions:The results of this subgroup analysis were consistent with those of the global population,and they suggest that G-chemo has a positive benefit-risk profile in patients from China with FL.Trial registration:ClinicalTrials.gov,No.NCT01332968.

关键词： Chinese Follicular lymphoma GALLIUM Obinutuzumab Rituximab

A phaseⅠtrial of an oral subtype-selective histone deacetylase inhibitor,chidamide,in combination with paclitaxel and carboplatin in patients with advanced non-small cell lung cancer

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Chinese Journal of Cancer Research 2016年第4期28卷 444-451页

作者： Xingsheng Hu Lin Wang Lin Lin Xiaohong Han Guifang Dou Zhiyun Meng Yuankai Shi Department of Medical Oncology Beijing Key Laboratory of Clinical Study on Anticancer Molecular Targeted DrugsNational Cancer Center/Cancer HospitalChinese Academy of Medical Sciences&Peking Union Medical CollegeBeijing 100021China Laboratory of Drug Metabolism and Pharmacokinetics Beijing Institute of Transfusion MedicineBeijing 100850China

Objective： This phase I study was to evaluate safety, maximum tolerated dose, pharmacokinetics and preliminary antitumor activity of chidamide, a novel subtype-selective histone deacetylase （HDAC） inhibitor, in combination with paclitaxel and carboplatin in patients with advanced non-small cell lung cancer （NSCLC）. Methods： Ten patients received oral chidamide 20, 25, or 30 mg twice per week continuously with paclitaxel （175 mg/m2） and carboplatin [area under the curve （AUC） 5 mg/mL/min] administered in a 3-week cycle. Patients with response and stable disease after four cycles maintained chidamide monotherapy until disease progression or unacceptable toxicity. Blood samples were collected for pharmacoldnetic analysis after the first single oral of chidamide and first combination treatment in cycle 1 from all patients. Results： Two dose-limiting toxicities were recorded in the 30 mg cohort, including thrombocytopenia and prolonged neutropenia in the first cycle. Grade 3/4 neutropenia in any cycle was observed in all patients, but was not associated with significant complications. Other grade 3/4 hematologic toxicities included thrombocytopenia and leucopenia. No significant changes were observed in pharmacokinetic parameters for both chidamide and paclitaxel. One patient in the 20 mg cohort had confirmed partial response （PR）. Two out of 5 patients with brain metastases had intracranial complete remission after 4-cycle treatment. Conclusions： Chidamide combined with paclitaxel and carboplatin was generally tolerated without unanticipated toxicities or clinically relevant pharmacokinetic interactions. The recommended dose for chidamide in this combination was established at 20 mg, and a phase II trial is ongoing with this regimen in patients with advanced NSCLC.

关键词： Chidamide HDAC inhibitor phase I paclitaxel and carboplatin non-small cell lung cancer

Prognostic value of BCL2 and TP53 genetic alterations for diffuse large B-cell lymphoma patients treated with R-CHOP

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Cancer Biology & Medicine 2022年第6期19卷 893-909页

作者： Yan Qin Haizhu Chen Peng Liu Changgong Zhang Jianliang Yang Lin Gui Xiaohui He Liqiang Zhou Shengyu Zhou shiyu Jiang Hongxin Jiang Yuankai Shi Department of Medical Oncology National Cancer Center/National Clinical Research Center for Cancer/Cancer HospitalChinese Academy of Medical Sciences&Peking Union Medical CollegeBeijing Key Laboratory of Clinical Study on Anticancer Molecular Targeted DrugsBeijing 100021China Department of Medical Oncology Suzhou Municipal HospitalAffiliated Suzhou Hospital of Nanjing Medical UniversitySuzhou 215001China

Objective:Limited data about the prognostic significance of BCL2 mutations and BCL2 copy number variations in diffuse large B-cell lymphoma(DLBCL)are available.This study aimed to comprehensively describe BCL2 genetic alterations in DLBCL patients,and examine correlation of BCL2,TP53 and other genetic alterations with outcomes in patients treated with R-CHOP.Methods:Probe capture-based high-resolution sequencing was performed on 191 patients diagnosed with de novo DLBCL.MYC,BCL2,and BCL6 protein expressions were detected by immunohistochemistry.Results:The presence of BCL2 alterations significantly correlated with poor progression-free survival(PFS)(5-year PFS:13.7%vs.40.8%;P=0.003)and overall survival(OS)(5-year OS:34.0%vs.70.9%;P=0.036).Importantly,patients who harbored BCL2 gain/amplifications(BCL2GA/AMP)also had a remarkably inferior 5-year PFS(11.1%vs.38.3%;P<0.001)and OS(22.1%vs.69.6%;P=0.009).In contrast,neither BCL2 mutations nor BCL2 translocations were significantly prognostic for survival.Multivariable analyses showed that the presence of BCL2 alterations,especially BCL2GA/AMP,TP53 mutations,and International Prognostic Index(IPI)were significantly associated with inferior PFS and OS.Novel prognostic models for OS were constructed based on 3 risk factors,including BCL2 alterations(Model 1)or BCL2GA/AMP(Model 2),TP53 mutations,and IPI,to stratify patients into 4 risk groups with different survival outcomes.Conclusions:This study showed that DLBCL patients treated with R-CHOP,BCL2 alterations,especially BCL2GA/AMP and TP53 mutations were significantly associated with inferior outcomes,which were independent of the IPI.The novel prognostic models we proposed predicted outcomes for DLBCL patients treated with R-CHOP,but further validation of the prognostic models is still warranted.

关键词： BCL2 TP53 genetic alterations diffuse large B-cell lymphoma prognosis

Efficacy and safety of utidelone for the treatment of patients with locally advanced or metastatic non-small-cell lung cancer who have failed standard second-line treatment:A phase 2 clinical trial(BG01-1801)

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Cancer Pathogenesis and Therapy 2024年第2期2卷 103-111页

作者： Yuankai Shi Gongyan Chen Yanqiu Zhao Jing Zhao Lin Lin Department of Medical Oncology National Cancer Center/National Clinical Research Center for Cancer/Cancer HospitalChinese Academy of Medical Sciences&Peking Union Medical CollegeBeijing Key Laboratory of Clinical Study On Anticancer Molecular Targeted DrugsBeijing 100021China Department of Respiration Harbin Medical University Cancer HospitalHarbinHeilongjiang 150040China Respiratory Department of Internal Medicine Henan Provincial Cancer HospitalZhengzhouHenan 450003China Department of Pulmonary and Critcal Care Medicine Peking Union Medical College HospitaChinese Academy of Medical Sciences&Peking Union Medical College Beijing100021China

Background:Chemotherapy remains the standard-of-care for many patients with locally advanced or metastatic non-small-cell lung cancer(NSCLC),but acquired resistance presents challenges.The aim of this open-label,multicenter phase 2 clinical trial was to determine the efficacy and safety of utidelone,a novel genetically engineered epothilone analog and microtubule-stabilizing agent,as a third-or later-line treatment for locally advanced ormetastatic NSCLC.Methods:Patients who had failed standard second-line treatment(including platinum-containing chemotherapy or targeted therapy)received utidelone(40 mg/m?via intravenous injection daily,day 1-5)every 21 days.The primary endpoint was the objective response rate(ORR).Secondary endpoints were the duration of response(DoR),progression-free survival(PFS),overall survival(OS),and safety.Results:From March 12,2019 to January 18,2021,26 pretreated patients with locally advanced or metastatic NSCLC(100%of patients had received prior platinum and 65.4%patients had received prior taxane treatment)were enrolled(80.8%of patients had adenocarcinoma).At baseline,nine(34.6%)patients had received secondline treatment,10(38.5%)patients had received third-line treatment,and seven(26.9%)patients had received fourth-or later-line treatment.By the data cut-off date of August 10,2021,the median follow-up was 7.49 months(range,1.4-26.7 months).The ORR was 15.4%(95%confidence interval[CI],4.4%-34.9%)in the intention-totreat(ITT)cohort(N=26)and 19.0%(95%CI,5.4%-41.9%)in the per-protocol(PP)cohort(N=21).The disease control rate was 69.2%(95%CI,48.2%-85.7%)and 81.0%(95%CI,58.1%-94.6%)in the ITT and PP cohorts,respectively.The median DoR was 4.1 months(95%CI,3.1-5.1 months)in the ITT cohort.The median PFS was 4.37 months(95%CI,2.50-5.29 months)in the ITT cohort and 4.37 months(95%CI,2.50-9.76 months)in the PP cohort.The median OS was not reached,and the 12-month OS rate was 69%(95%CI,45.1%-84.1%).Grade 3/4 treatment-emergent adverse events occurred in 38.5%of patients,and the most common was

关键词： Utidelone Locally advanced or metastatic non-small-cell lung cancer Efficacy Platinum-and taxane-refractory

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肺癌脑转移中国治疗指南(2021年版)

中华肿瘤杂志 2021年第3期43卷 269-281页

作者：无石远凯中国医师协会肿瘤医师分会中国医疗保健国际交流促进会肿瘤内科分会国家癌症中心国家肿瘤临床医学研究中心中国医学科学院北京协和医学院肿瘤医院内科抗肿瘤分子靶向药物临床研究北京市重点实验室100021

肺癌患者脑转移发生率高、预后差、自然生存时间短。近年来,随着外科手术、放射治疗和内科治疗水平的不断提高,肺癌脑转移患者的治疗选择越来越多,生存时间得以延长。为了及时反映国内外肺癌脑转移治疗的新进展,进一步提高肺癌脑转移患... 详细信息

肺癌患者脑转移发生率高、预后差、自然生存时间短。近年来,随着外科手术、放射治疗和内科治疗水平的不断提高,肺癌脑转移患者的治疗选择越来越多,生存时间得以延长。为了及时反映国内外肺癌脑转移治疗的新进展,进一步提高肺癌脑转移患者的规范化治疗水平,中国医师协会肿瘤医师分会和中国医疗保健国际交流促进会肿瘤内科分会组织专家编写了《肺癌脑转移中国治疗指南(2021年版)》,以供临床医师参考。

关键词：肺肿瘤脑转移治疗规范

Chidamide combined with cyclophosphamide,doxorubicin,vincristine and prednisone in previously untreated patients with peripheral T-cell lymphoma

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Chinese Journal of Cancer Research 2021年第5期33卷 616-626页

作者： Lin Gui Junning Cao Dongmei Ji Huilai Zhang Qian Fan Jun Zhu Yuqin Song shiyu Jiang Zhiqiang Ning Jia Yu Yuankai Shi Department of Medical Oncology National Cancer Center/National Clinical Research Center for Cancer/Cancer HospitalChinese Academy of Medical Sciences&Peking Union Medical CollegeBeijing Key Laboratory of Clinical Study on Anticancer Molecular Targeted DrugsBeijing 100021China Department of Medical Oncology Fudan University Shanghai Cancer CenterShanghai Medical CollegeFudan UniversityShanghai 200032China Department of Lymphoma Sino-US Center for Lymphoma and Leukemia ResearchTianjin Medical University Cancer Institute and HospitalNational Clinical Research Center of CancerKey Laboratory of Cancer Prevention and TherapyTianjin’s Clinical Research Center for CancerTianjin 300060China Key Laboratory of Carcinogenesis and Translational Research(Ministry of Education/Beijing) Department of LymphomaPeking University Cancer Hospital&InstituteBeijing 100142China Shenzhen Chipscreen Biosciences Co.LTD.Shenzhen 518057China

Objective:Chidamide is an oral histone deacetylase subtype-selective inhibitor approved for relapsed or refractory peripheral T-cell lymphoma(PTCL).This phase 1 b study evaluated the safety,pharmacokinetics,and preliminary efficacy of chidamide in combination with cyclophosphamide,doxorubicin,vincristine and prednisone(CHOP)for treatment-na?ve PTCL patients.Methods:This study was an open-label,multicenter trial composed of dose escalation and dose expansion.Patients received CHOP for six 21-d cycles and chidamide on d 1,4,8 and 11 in each cycle.Four dose levels of chidamide(20,25,30 and 35 mg)were evaluated.The primary objective was to evaluate the safety and tolerability of the combination regimen.Results:A total of 30 patients were evaluated in this study:15 in the dose-escalation part and 15 in the doseexpansion part.In the dose-escalation study,three patients were enrolled in the 35 mg chidamide cohort.One had dose-limiting toxicity with grade 3 vascular access complications,and one had grade 2 neutropenia with a sustained temperature>38°C.Dose escalation was stopped at this chidamide dose level.The most common(≥10%)grade 3 or 4 adverse events(AEs)were leukopenia(90.0%),neutropenia(83.3%),vomiting(13.3%),thrombocytopenia(10.0%)and febrile neutropenia(10.0%).No significant changes in chidamide pharmacokinetic properties were observed before and after combination treatment.The objective response rate for the 28 patients evaluable for preliminary efficacy was 89.3%(25/28),with 16(57.1%)achieving complete response or unconfirmed complete response.The estimated median progression-free survival was 14.0 months.In summary,we chose chidamide 30 mg as the recommended dose for phase 2.Conclusions:The addition of chidamide to standard CHOP chemotherapy was tolerable with promising preliminary efficacy in previously untreated PTCL patients,which supports further clinical studies with this combination regimen for the frontline treatment of PTCL.

关键词： Chidamide CHOP PTCL frontline treatment