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| 1 | Non-small cell lung cancer in China显示文摘In China,lung cancer is a primary cancer type with high incidence and mortality.Risk factors for lung cancer include tobacco use,family history,radiation exposure,and the presence of chronic lung diseases.Most early-stage non-small cell lung cancer(NSCLC)patients miss the optimal timing for treatment due to the lack of clinical presentations.Population-based nationwide screening programs are of significant help in increasing the early detection and survival rates of NSCLC in China.The understanding of molecular carcinogenesis and the identification of oncogenic drivers dramatically facilitate the development of targeted therapy for NSCLC,thus prolonging survival in patients with positive drivers.In the exploration of immune escape mechanisms,programmed cell death protein 1(PD-1)/programmed death-ligand 1(PD-L1)inhibitor monotherapy and PD-1/PD-L1 inhibitor plus chemotherapy have become a standard of care for advanced NSCLC in China.In the Chinese Society of Clinical Oncology’s guidelines for NSCLC,maintenance immunotherapy is recommended for locally advanced NSCLC after chemoradiotherapy.Adjuvant immunotherapy and neoadjuvant chemoimmunotherapy will be approved for resectable NSCLC.In this review,we summarized recent advances in NSCLC in China in terms of epidemiology,biology,molecular pathology,pathogenesis,screening,diagnosis,targeted therapy,and immunotherapy。 | Peixin Chen Yunhuan Liu Yaokai Wen Caicun Zhou | 2022 | Cancer Communications2022，42，10： | 29 |
| 2 | The cutting-edge progress of immune-checkpoint blockade in lung cancer显示文摘Great advances in immune checkpoint blockade have resulted in a paradigm shift in patients with lung cancer.Immune-checkpoint inhibitor(ICI)treatment,either as monotherapy or combination therapy,has been established as the standard of care for patients with locally advanced/metastatic non-small cell lung cancer without EGFR/ALK alterations or extensive-stage small cell lung cancer.An increasing number of clinical trials are also ongoing to further investigate the role of ICIs in patients with early-stage lung cancer as neoadjuvant or adjuvant therapy.Although PD-L1 expression and tumor mutational burden have been widely studied for patient selection,both of these biomarkers are imperfect.Due to the complex cancer-immune interactions among tumor cells,the tumor microenvironment and host immunity,collaborative efforts are needed to establish a multidimensional immunogram to integrate complementary predictive biomarkers for personalized immunotherapy.Furthermore,as a result of the wide use of ICIs,managing acquired resistance to ICI treatment remains an inevitable challenge.A deeper understanding of the underlying biological mechanisms of acquired resistance to ICIs is helpful to overcome these obstacles.In this review,we describe the cutting-edge progress made in patients with lung cancer,the optimal duration of ICI treatment,ICIs in some special populations,the unique response patterns during ICI treatment,the emerging predictive biomarkers,and our understanding of primary and acquired resistance mechanisms to ICI treatment. | Fei Zhou Meng Qiao Caicun Zhou | 2021 | Cellular & Molecular Immunology2021，18，2： | 21 |
| 3 | Alterations of DNA damage response pathway:Biomarker and therapeutic strategy for cancer immunotherapy显示文摘Genomic instability remains an enabling feature of cancer and promotes malignant transformation.Alterations of DNA damage response(DDR)pathways allow genomic instability,generate neoantigens,upregulate the expression of programmed death ligand 1(PD-L1)and interact with signaling such as cyclic GMPe AMP synthase-stimulator of interferon genes(cGASe STING)signaling.Here,we review the basic knowledge of DDR pathways,mechanisms of genomic instability induced by DDR alterations,impacts of DDR alterations on immune system,and the potential applications of DDR alterations as biomarkers and therapeutic targets in cancer immunotherapy. | Minlin Jiang Keyi Jia Lei Wang Wei Li Bin Chen Yu Liu Hao Wang Sha Zhao Yayi He Caicun Zhou | 2021 | Acta Pharmaceutica Sinica B2021，11，10： | 12 |
| 4 | Sintilimab versus docetaxel as second-line treatment in advanced or metastatic squamous non-small-cell lung cancer:an open-label,randomized controlled phase 3 trial(ORIENT-3)显示文摘Background:Treatment options for Chinese patients with locally advanced or metastatic squamous-cell non-small-cell lung cancer(sqNSCLC)after failure of first-line chemotherapy are limited.This study(ORIENT-3)aimed to evaluate the efficacy and safety of sintilimab versus docetaxel as second-line treatment in patients with locally advanced or metastatic sqNSCLC.Methods:ORIENT-3 was an open-label,multicenter,randomized controlled phase 3 trial that recruited patients with stage IIIB/IIIC/IV sqNSCLC after failure with first-line platinum-based chemotherapy.Patients were randomized in a 1:1 ratio to receive either 200 mg of sintilimab or 75 mg/m^(2) of docetaxel intravenously every 3 weeks,stratified by the Eastern Cooperative Oncology Group performance status.The primary endpoint was overall survival(OS)in the full analysis set(FAS).Secondary endpoints included progression-free survival(PFS),objective response rate(ORR),disease control rate(DCR),duration of response(DoR)and safety.Results:Between August 25,2017,and November 7,2018,290 patients were randomized.For FAS,10 patients fromthe docetaxel armwere excluded.Themedian OS was 11.79(n=145;95%confidence interval[CI],10.28-15.57)months with sintilimab versus 8.25(n=135;95%CI,6.47-9.82)months with docetaxel(hazard ratio[HR]:0.74;95%CI,0.56-0.96;P=0.025).Sintilimab treatment significantly prolonged PFS(median 4.30 vs.2.79 months;HR:0.52;95%CI,0.39-0.68;P<0.001)and showed higher ORR(25.50%vs.2.20%,P<0.001)and DCR(65.50%vs.37.80%,P<0.001)than the docetaxel arm.The median DoRwas 12.45(95%CI,4.86-25.33)months in the sintilimab arm and 4.14(95%CI,1.41-7.23)months in the docetaxel arm(P=0.045).Treatment-related adverse events of grade≥3were reported in 26(18.1%)patients in the sintilimab arm and 47(36.2%)patients in the docetaxel arm.Exploratory biomarker analysis showed potential predictive values of expression levels of two transcription factors,including OVOL2(HR:0.35;P<0.001)and CTCF(HR:3.50;P<0.001),for sintilimab treatment.Conclusions:Compared with docetaxel,sintilimab significantly improved the OS,PFS,and ORR of Chinese patients with previously treated locally advanced or metastatic sqNSCLC. | Yuankai Shi Lin Wu Xinmin Yu Puyuan Xing Yan Wang Jianying Zhou Airong Wang Jianhua Shi Yi Hu Ziping Wang Guangyu An Yong Fang Sanyuan Sun Caicun Zhou Changli Wang Feng Ye Xingya Li Junye Wang Mengzhao Wang Yunpeng Liu Yanqiu Zhao Ying Yuan Jifeng Feng Zhendong Chen Jindong Shi Tao Sun Gang Wu Yongqian Shu Qisen Guo Yi Zhang Yong Song Shucai Zhang Yuan Chen Wei Li Hongrui Niu Wenwei Hu Lijun Wang Jianan Huang Yang Zhang Ying Cheng Zhengdong Wu Bo Peng Jiya Sun Christoph Mancao Yanqi Wang Luyao Sun | 2022 | Cancer Communications2022，42，12： | 8 |
| 5 | Toripalimab plus chemotherapy as second-line treatment in previously EGFR-TKI treated patients with EGFR-mutant-advanced NSCLC:a multicenter phase-II trial显示文摘This multicenter phase-II trial aimed to investigate the efficacy,safety,and predictive biomarkers of toripalimab plus chemotherapy as second-line treatment in patients with EGFR-mutant-advanced NSCLC.Patients who failed from first-line EGFR-TKIs and did not harbor T790M mutation were enrolled.Toripalimab plus carboplatin and pemetrexed were administrated every three weeks for up to six cycles,followed by the maintenance of toripalimab and pemetrexed.The primary endpoint was objective-response rate(ORR).Integrated biomarker analysis of PD-L1 expression,tumor mutational burden(TMB),CD8+tumor-infiltrating lymphocyte(TIL)density,whole-exome,and transcriptome sequencing on tumor biopsies were also conducted.Forty patients were enrolled with an overall ORR of 50.0%and disease-control rate(DCR)of 87.5%.The median progression free survival(PFS)and overall survival were 7.0 and 23.5 months,respectively.The most common treatment-related adverse effects were leukopenia,neutropenia,anemia,ALT/AST elevation,and nausea.Biomarker analysis showed that none of PD-L1 expression,TMB level,and CD8+TIL density could serve as a predictive biomarker.Integrated analysis of whole-exome and transcriptome sequencing data revealed that patients with DSPP mutation had a decreased M2 macrophage infiltration and associated with longer PFS than those of wild type.Toripalimab plus chemotherapy showed a promising anti-tumor activity with acceptable safety profiles as the second-line setting in patients with EGFR-mutant NSCLC.DSPP mutation might serve as a potential biomarker for this combination.A phase-III trial to compare toripalimab versus placebo in combination with chemotherapy in this setting is ongoing(NCT03924050). | Tao Jiang Pingyang Wang Jie Zhang Yanqiu Zhao Jianying Zhou Yun Fan Yongqian Shu Xiaoqing Liu Helong Zhang Jianxing He Guanghui Gao Xiaoqian Mu Zhang Bao Yanjun Xu Renhua Guo Hong Wang Lin Deng Ningqiang Ma Yalei Zhang Hui Feng Sheng Yao Jiarui Wu Luonan Chen Caicun Zhou Shengxiang Ren | 2021 | Signal Transduction and Targeted Therapy2021，6，11： | 8 |
| 6 | Erlotinib versus chemotherapy as first-line treatment for patients with advanced EGFR mutation-positive non-small-cell lung cancer (OPTIMAL, CTONG-0802): a multicentre, open-label, randomised, phase 3 study显示文摘 | Caicun Zhou Yi-Long Wu Gongyan Chen Jifeng Feng Xiao-Qing Liu Changli Wang Shucai Zhang Jie Wang Songwen Zhou Shengxiang Ren Shun Lu Li Zhang Chengping Hu Chunhong Hu Yi Luo Lei Chen Ming Ye Jianan Huang Xiuyi Zhi Yiping Zhang Qingyu Xiu Jun Ma Li Zhang C | 2011 | Lancet Oncology2011，，8： | 7 |
| 7 | Uncommon EGFR mutations in a cohort of Chinese NSCLC patients and outcomes of first-line EGFR-TKIs and platinum-based chemotherapy显示文摘Objective: Data on the clinical activity of epidermal growth factor receptor(EGFR) tyrosine kinase inhibitors(TKIs) in patients with non-small-cell lung cancer(NSCLC) and uncommon EGFR mutations remain insufficient.This study aimed to investigate the effect of first-line EGFR-TKIs or platinum-based chemotherapy in NSCLC patients with uncommon EGFR mutations.Methods: We retrospectively enrolled 504 patients with EGFR-mutant NSCLC.The clinical characteristics and treatment outcomes were collected and compared between patients with common and uncommon EGFR-mutant NSCLC.Results: Seventy patients(13.9%) harboring uncommon EGFR mutations were included.Thirty of these patients received EGFR-TKIs and 40 received platinum-based chemotherapy as first-line therapy.The objective response rate(ORR) and median progression-free survival(m PFS) of patients treated with TKIs in the uncommon mutation group was significantly inferior to that in the common mutation group(ORR: 23.3% vs.51.8%,P=0.003; m PFS:7.1 vs.10.9 months,P<0.001).In the uncommon group,m PFS was similar between first-line EGFR-TKIs treatment and platinum-based chemotherapy(7.1 vs.6.1 months,P=0.893).In patients with EGFR G719 X or L861 Q mutations,the m PFS was longer in the first-line EGFR-TKIs treatment group than in the chemotherapy group,but the difference was not statistically significant(G719 X: 8.2 vs.5.8 months,P=0.061; L861 Q: 7.6 vs.4.1 months,P=0.872).Multivariate analyses identified adenocarcinoma(P=0.003) as the independent predictive factor for PFS in patients with uncommon EGFR mutations who were treated with first-line EGFR-TKIs.Conclusions: The current study demonstrated that the effect of first-line EGFR-TKIs was similar to that of platinum-based chemotherapy in patients with uncommon EGFR-mutant NSCLC.Adenocarcinoma was the independent predictive factor for PFS in uncommon EGFR-mutant NSCLC patients treated with first-line EGFRTKIs. | Jinpeng Shi Hui Yang Tao Jiang Xuefei Li Chao Zhao Limin Zhang Sha Zhao Xiaozhen Liu Yijun Jia Yan Wang Lei Xi Shijia Zhang Chunxia Su Shengxiang Ren Caicun Zhou | 2017 | Chinese Journal of Cancer Research2017，29，6： | 6 |
| 8 | PD-L1 expression and its effect on clinical outcomes of EGFRmutant NSCLC patients treated with EGFR-TKIs显示文摘Objective:Epidermal growth factor receptor(EGFR)activation was reported to upregulate programmed death-ligand 1(PD-L1)expression in lung cancer cells and subsequently contribute to immune escape,indicating its critical role in EGFR-driven lung tumors.This study characterized PD-L1 expression in patients with surgically resected EGFR-mutant non-small cell lung cancer(NSCLC).The effect of PD-L1 expression on clinical outcomes was also investigated in advanced EGFR-mutant NSCLC treated with EGFR-tyrosine kinase inhibitors(TKIs).Methods:In total,73 patients with surgically resected NSCLC and EGFR mutations were identified.PD-L1 expression and CD8+tumor-infiltrating lymphocyte(TIL)density were assessed by immunohistochemistry.A literature review of publications that assessed the predictive and prognostic value of PD-L1 expression in advanced EGFR-mutant NSCLC patients treated with EGFR-TKIs was performed.Results:Nineteen(26.0%)patients were positive for PD-L1 expression,which was significantly associated with concomitant KRAS mutation(P=0.020)and marginally associated with higher CD8+TILs density(P=0.056).Positive PD-L1 expression was associated with markedly inferior overall survival(OS)in multivariate analysis(P=0.032).The combination of PD-L1 and CD8+TILs expression could be used to stratify the population into three groups with distinct prognoses.A meta-analysis of six publications showed that positive PD-L1 expression was not associated with OS[hazard ratio(HR)=0.90;95%confidence interval(CI),0.42–1.38]or progression-free survival(HR=1.03;95 CI,0.73–1.33)in advanced EGFR-mutant NSCLC patients receiving EGFR-TKIs.Conclusions:PD-L1 expression tended to correlate with CD8+TIL expression,concomitant KRAS mutation,and poor survival in surgically resected EGFR-mutant NSCLC.PD-L1 expression was neither the predictive nor the prognostic factor in advanced EGFR-mutant NSCLC patients treated with EGFR-TKIs. | Yuchen Bai Xiaoxia Chen Likun Hou Jun Qian Tao Jiang Caicun Zhou Maciej Ciebiada | 2018 | Cancer Biology & Medicine2018，15，4： | 5 |
| 9 | Afatinib versus cisplatin plus gemcitabine for first-line treatment of Asian patients with advanced non-small-cell lung cancer harbouring EGFR mutations (LUX-Lung 6): an open-label, randomised phase 3 trial显示文摘 | Yi-Long Wu Caicun Zhou Cheng-Ping Hu Jifeng Feng Shun Lu Yunchao Huang Wei Li Mei Hou Jian Hua Shi Kye Young Lee Chong-Rui Xu Dan Massey Miyoung Kim Yang Shi Sarayut L Geater | 2014 | Lancet Oncology2014，，2： | 3 |
| 10 | Advances in the management of acquired resistance to EGFR-TKI in non-small cell lung cancer显示文摘Drugs that specifically target the tyrosine kinase domain of epidermal growth factor receptor(EGFR), such as erlotinib or gefitinib, have exhibited striking efficacy in non-small cell lung cancer(NSCLC) patients harboring activating EGFR mutations. However, acquired resistance inevitably develops and remains a serious barrier for the successful management of patients with this disease. Multiple mechanisms are reportedly involved in the process of acquired resistance, which provide new insights into the management of EGFRtyrosine kinase inhibitor(EGFR-TKI) resistance. Here, we provide an overview of the emerging treatment approaches for patients with EGFR-TKI resistance. | Fei Zhou Caicun Zhou | 2015 | The Chinese-German Journal of Clinical Oncology2015，14，1： | 2 |
| 11 | Erlotinib versus chemotherapy as first-line treatment for patients with advanced EGFR mutation-positive non-small-cell lung cancer (OPTIMAL, CTONG-0802): a multicentre, open-label, randomised, phase 3 study显示文摘 | Caicun Zhou Yi-Long Wu Gongyan Chen Jifeng Feng Xiao-Qing Liu Changli Wang Shucai Zhang Jie Wang Songwen Zhou Shengxiang Ren Shun Lu Li Zhang Chengping Hu Chunhong Hu Yi Luo Lei Chen Ming Ye Jianan Huang Xiuyi Zhi Yiping Zhang Qingyu Xiu Jun Ma Li Zhang C | 2011 | Lancet Oncology2011，，8： | 1 |
| 12 | Erlotinib versus chemo- therapy as first-line treatment for patients with advanced EGFR mutation-positive non-small-cell lung cancer(OPTIMAL,CTONG-0802): a multicentre,open-label,randomised,phase 3 study显示文摘 | Caicun Z Yi-Long W Gongyan C | 2011 | Lancet Oncology2011，12，8： | 1 |
| 13 | Afatinib versus cispl- atin plus gemcitabine for first-line treatment of Asian patients with advanced non-small-cell lung cancer harbouring EGFR mutations (LUX-Lung 6): an open-label,randomised phase 3 trial显示文摘 | Yi-Long W Caicun Z Cheng-Ping H | 2014 | Lancet Oncology2014，15，2： | 1 |
| 14 | Erlotinib versus chemotherapy as first-line treatment for patients with advanced EGFR mutation-positive non-small-cell lung cancer (OPTIMAL, CTONG-0802): a multicentre, open-label, randomised, phase 3 study显示文摘 | Caicun Zhou Yi-Long Wu Gongyan Chen Jifeng Feng Xiao-Qing Liu Changli Wang Shucai Zhang Jie Wang Songwen Zhou Shengxiang Ren Shun Lu Li Zhang Chengping Hu Chunhong Hu Yi Luo Lei Chen Ming Ye Jianan Huang Xiuyi Zhi Yiping Zhang Qingyu Xiu Jun Ma Li Zhang C | 2011 | Lancet Oncology2011，，8： | 1 |
| 15 | Erlotinib versus chemotherapy as first-line treatment for patients with advanced egfr mutation-positive non-small-cell lung cancer( optimal, Ctong-0802 ) : a muhicentre, Open-label, Randomised, Phase 3 study显示文摘 | Caicun zhou Yi-long Wu Gongyan chen | 2011 | Lancet Oncology2011，12，8： | 1 |
| 16 | Erlotinib versus chemotherapy as first-line treatment for patients with advanced EGFR mutation-positive non-small-cell lung cancer (OPTIMAL, CTONG-0802): a multicentre, open-label, randomised, phase 3 study 显示文摘 | Zhou Caicun Wu Yi-long Chen G | 2011 | Lancet Oncol2011，12，8： | 1 |
| 17 | Association between polymorphisms of DNA repair genes and survival of advanced NSCLC patients treated with platinum-based chemotherapy显示文摘 | Shengxiang Ren Songwen Zhou Fengyin Wu Ling Zhang Xuefei Li Jie Zhang Jianfang Xu Meijun Lv Jie Zhang Caicun Zhou | 2011 | Lung Cancer2011，，1： | 1 |
| 18 | Intercalated combination of chemotherapy and erlotinib for patients with advanced stage non-small-cell lung cancer (FASTACT-2): a randomised, double-blind trial显示文摘 | Yi-Long Wu Jin Soo Lee Sumitra Thongprasert Chong-Jen Yu Li Zhang Guia Ladrera Vichien Srimuninnimit Virote Sriuranpong Jennifer Sandoval-Tan Yunzhong Zhu Meilin Liao Caicun Zhou Hongming Pan Victor Lee Yuh-Min Chen Yan Sun Benjamin Margono Fatima Fuerte | 2013 | Lancet Oncology2013，，8： | 1 |
| 19 | Afatinib versus cisplatin plus gemcitabine for first-line treatment of Asian patients with advanced non-small-cell lung cancer harbouring EGFR mutations (LUX-Lung 6): an open-label, randomised phase 3 trial显示文摘 | Yi-Long Wu Caicun Zhou Cheng-Ping Hu Jifeng Feng Shun Lu Yunchao Huang Wei Li Mei Hou Jian Hua Shi Kye Young Lee Chong-Rui Xu Dan Massey Miyoung Kim Yang Shi Sarayut L Geater | 2014 | Lancet Oncology2014，，2： | 1 |
| 20 | Intercalated combination of chemotherapy and erlotinib for patients with advanced stage non-small-cell lung cancer (FASTACT-2): a randomised, double-blind trial显示文摘 | Yi-Long Wu Jin Soo Lee Sumitra Thongprasert Chong-Jen Yu Li Zhang Guia Ladrera Vichien Srimuninnimit Virote Sriuranpong Jennifer Sandoval-Tan Yunzhong Zhu Meilin Liao Caicun Zhou Hongming Pan Victor Lee Yuh-Min Chen Yan Sun Benjamin Margono Fatima Fuerte | 2013 | Lancet Oncology2013，，8： | 1 |
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