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Vonoprazan 10 mg or 20 mg *** 15 mg as maintenance therapy in Asian patients with healed erosive esophagitis:A randomized controlled trial

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Chinese Medical Journal 2024年第8期137卷 962-971页

作者： Yinglian Xiao Jiaming Qian Shutian Zhang Ning Dai Hoon Jai Chun Chengtang Chiu Chui Fung Chong Nobuo Funao Yuuichi Sakurai Jessica D.Eisner Li Xie Minhu Chen Department of Gastroenterology The First Affiliated HospitalSun Yat-sen UniversityGuangzhouGuangdong 510062China Department of Gastroenterology Peking Union Medical College HospitalPeking Union Medical CollegeChinese Academy of Medical SciencesBeijing 100006China Department of Gastroenterology Beijing Friendship HospitalCapital Medical UniversityBeijing 100050China Department of Gastroenterology Sir Run Run Shaw HospitalSchool of Medicine Zhejiang UniversityHangzhouZhejiang 310020China Department of Internal Medicine Korea University Anam HospitalKorea University College of Medicine73 Goryeodae-roSeongbuk-guSeoul 02841Republic of Korea Department of Gastroenterology&Hepatology Linkou Medical CenterChang Gung Memorial HospitalTaoyuanTaiwan 33353China College of Medicine Chang Gung UniversityTaoyuanTaiwan 33353China Takeda Development Center Asia Singapore 018981Singapore Takeda Pharmaceutical Company Chuo-kuOsaka 540-8645Japan Takeda Pharmaceuticals International Company CambridgeMA02142 USA China Medical Team Takeda ChinaBeijing 100027China Hoffmann-La Roche Basel4070 Switzerland Abbott Laboratories Lake ForestIL 60045USA

Background:Erosive esophagitis(EE)is a gastroesophageal reflux disease characterized by mucosal breaks in the *** pump inhibitors are widely used as maintenance therapy for EE,but many patients still *** this trial,we evaluated the noninferiority of vonoprazan *** as maintenance therapy in patients with healed ***:We performed a double-blind,double-dummy,multicenter,phase 3 clinical trial among non-Japanese Asian adults with endoscopically confirmed healed EE from April 2015 to February *** from China,South Korea,and Malaysia were randomized to vonoprazan 10 mg or 20 mg once daily or lansoprazole 15 mg once daily for 24 *** primary endpoint was endoscopically confirmed EE recurrence rate over 24 weeks with a noninferiority margin of 10%using a two-sided 95%confidence interval(CI).Treatment-emergent adverse events(TEAEs)were ***:Among 703 patients,EE recurrence was observed in 24/181(13.3%)and 21/171(12.3%)patients receiving vonoprazan 10 mg or 20 mg,respectively,and 47/184(25.5%)patients receiving lansoprazole(differences:-12.3%[95%CI,-20.3%to-4.3%]and-13.3%[95%CI,-21.3%to-5.3%],respectively),meeting the primary endpoint of noninferiority to lansoprazole in preventing EE recurrence at 24 *** of superiority(upper bound of 95%CImaintenance therapy was well-tolerated and noninferior to lansoprazole for preventing EE recurrence i

关键词： Erosive esophagitis Lansoprazole maintenance therapy Potassium-competitive acid blockers Vonoprazan

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Azacitidine maintenance therapy for blastic plasmacytoid dendritic cell neoplasm allograft: A case report

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World Journal of Clinical Cases 2024年第1期12卷 136-141页

作者： Li-Li Tao Hui-Ting Wen Zi-Yi Wang Juan Cheng Li Zhao Department of Hematology The First Clinical Medical CollegeLanzhou UniversityLanzhou 730000Gansu ProvinceChina Department of Hematology The First Hospital of Lanzhou UniversityLanzhou 730000Gansu ProvinceChina

BACKGROUND Blastic plasmacytoid dendritic cell neoplasm(BPDCN)is a rare,highly invasive malignant *** is no universally accepted standard of care because of its rarity and the dearth of prospective *** is still challenging for some patients to achieve persistent clinical remission or cure,despite the success of allogeneic hematopoietic stem cell transplantation(allo-HSCT),indicating that there is still a significant recurrence *** report a case of prevention of BPDCN allograft recurrence by azacitidine maintenance therapy and review the relevant *** SUMMARY We report a 41-year-old man with BPDCN who was admitted to hospital due to skin sclerosis for>5 mo’*** was diagnosed by combined clinical assessment and laboratory *** diagnosis,the patients underwent induction consolidation chemotherapy to achieve the first complete remission,followed by bridging ***-transplantation,azacitidine(75 mg/m2 for 7 d)was administered as maintenance therapy,with repeat administration every 4–6 wk and appropriate extension of the chemotherapy *** 10 cycles,the patient has been disease free for 26 mo after *** assessments of bone marrow morphology,minimal residual disease,full donor chimerism,Epstein–Barr virus,and cytomegalovirus all yielded normal results with no abnormalities *** Azacitidine may be a safe and effective maintenance treatment for BPDCN following transplantation because there were no overt adverse events during the course of treatment.

关键词： Blastic plasmacytoid dendritic cell neoplasm Azacitidine Allogeneic hematopoietic stem cell transplantation maintenance therapy Case report

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maintenance therapy in advanced non-small cell lung cancer： a prime-time for change？

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Chinese Medical Journal 2013年第12期126卷 2390-2398页

作者： Oscar Siu Hong Chan Rebecca Mei WanYeung Anne Wing Mui Lee Department of Clinical Oncology Pamela Youde Nethersole Eastern Hospital Hong Kong China

Lung cancer is the leading cancer in terms of incidence and mortality in China and its incidence in China is predicted to increase in the next 20 years.1 The majority of the lung cancer patients are diagnosed with advanced stage disease,for which chemotherapy or targeted therapies are the mainstay palliative *** the identification of single-driver mutations,like the epidermal growth factor receptor （EGFR） mutation,platinum-based doublet was the standard first line treatment for advanced stage nonsmall cell lung cancer （NSCLC） patients with a good performance status （PS）.However,patient prognosis remains poor and the modest treatment efficacy seems to have reached a plateau despite newer generation of platinum doublets.2 The recommendation for the duration of first line platinum doublet treatment is 4-6 cycles.3 The paradigm was based on the fact that a protracted course of chemotherapy did not prolong survival but introduced cumulative toxicities.4,5 The use of maintenance therapy （MT）,defined by Grossi et al6 as the prolongation of chemotherapy with the administration of additional drugs at the end of a defined number of initial chemotherapy cycles after achieving maximum tumor response,was not considered as a standard option in the past.

关键词： non-small cell lung cancer chemotherapy maintenance therapy

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maintenance therapy for NSCLC: Consensus and Controversy

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Chinese Journal of Cancer Research 2011年第4期23卷 254-258页

作者： Shun Lu Yong‐feng Yu Shanghai Lung Cancer Center Chest Hospital Affiliated to Shanghai Jiao Tong University Shanghai 200030 China

Nowadays,advanced non-small cell lung cancer (NSCLC) is still an incurable ***,recent researches on maintenance therapy have led to considerable ***,pemetrexed and erlotinib have been approved for maintenance chemotherapy by both the *** and Drug Administration and European Medicines ***,there are not adequate data to support the maintenance therapy as the standard treatment for advanced NSCLC and there has been no conclusive predictor of who will get benefit from maintenance chemotherapy and what type of maintenance,continuation or switch,is *** article reviews the main studies on maintenance therapy of advanced NSCLC and discusses the results available to date.

关键词： Non-small cell lung cancer maintenance therapy Pemetrexed Erlotinib

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Single-agent maintenance therapy in non-small cell lung cancer： a systematic review and meta-analysis

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Chinese Medical Journal 2012年第17期125卷 3143-3149页

作者： YUAN Dong-mei WEI Shu-zhen LU Yan-ling ZHANG Yan MIAO Xiao-hui ZHAN Ping YU Li-ke SHI Yi SONG Yong Department of Respiratory Medicine Jinling Hospital Nanjing University School of Medicine Nanjing Jiangsu 210002 China Department of Respiratory Medicine Nanjing Chest Hospital Nanjing Jiangsu 210029 China

Background Can single-agent maintenance therapy be considered as an ideal strategy for non-small cell lung cancer （NSCLC） treatment to achieve prolonged survival and tolerated toxicity？ A systematic review and meta-analysis was performed to etuc（date this issue. Methods The electronic databases were searched for RCTs comparing single-agent maintenance therapy with placebo, best support care or observation. The required data for estimation of response, survival and toxicity were extracted from the publications and the combined data were calculated. Results Eleven RCTs involving 3686 patients were identified. We found a statistically significant higher probability of tumor response for patients with maintenance therapy versus control patients （OR： 2.80, 95% CI： 2.15-3.64）. Patients receiving maintenance therapy had significantly longer progression-free survival （PFS）（HR： 0.67, 95% CI： 0.62-0.71） and overall survival （OS）（HR： 0.84, 95% CI： 0.78-0.90）. However, maintenance therapy was associated with more severe toxicities （OR： 6.45, 95% CI： 4.61-9.01）. Conclusion In patients with advanced NSCLC, the use of single-agent maintenance therapy is associated with higher response rate and significantly prolongs PFS and OS despite of the risk of additional toxicity.

关键词： non-small cell lung cancer maintenance therapy molecular targeted therapy systematic review meta-analysis

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Capecitabine maintenance therapy after First-Line Chemotherapy in Patients with Metastatic Colorectal Cancer

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Chinese Journal of Cancer Research 2010年第3期22卷 181-185页

作者： Yan Li Jing Li Ming Lu Xi-cheng Wang Lin Shen Key Laboratory of Carcinogenesis and Translational Research(Ministry of Education) Department of GI OncologyPeking University School of OncologyBeijing Cancer Hospital&InstituteBeijing 100142China

Objective:To evaluate the efficacy and toxicity of capecitabine maintenance therapy in metastatic colorectal cancer(mCRC) ***:From June 2001 to November 2006,after they had achieved clinical response from first-line chemotherapy,patients with mCRC in our hospital received two different treatment ***-three patients in maintenance group were treated with capecitabine 1000 mg/m2 po bid d1-14,***-two patients in non-maintenance group did not receive any further ***:Patients in maintenance group and non-maintenance group both received FOLFOX,FOLFIRI and XELOX as first-line *** median chemotherapy cycles the two groups received were the same(6 vs 6).The response rates of first-line chemotherapy were 33.3% in maintenance group and 32.7% in non-maintenance *** in maintenance group received 3-9 cycles of capecitabine therapy(median cycle 4).29/33(87.9%) patients in maintenance group and 47/52(90.4%) in non-maintenance group received following second-line chemotherapy,and no patients underwent targeted *** median survival time and TTP were 40.4 months(95%CI:24.2-56.6) and 9.0 months(95%CI:6.7-11.3) in maintenance group,as compared with 21.5 months(95%CI:14.9-28.0,P=0.015) and 6.5 months(95%CI:4.4-8.5,P=0.007) in non-maintenance *** severe adverse event was observed in the capecitabine maintenance ***:mCRC patients could benefit from capecitabine maintenance therapy by prolonging survival time and TTP.

关键词： maintenance therapy Metastatic colorectal cancer Capecitabine

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The role of capecitabine as maintenance therapy in de novo metastatic nasopharyngeal carcinoma:A propensity score matching study

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Cancer Communications 2020年第1期40卷 32-42页

作者： Xue-Song Sun Sai-Lan Liu Yu-Jing Liang Qiu-Yan Chen Xiao-Yun Li Lin-Quan Tang Hai-Qiang Mai Department of Nasopharyngeal Carcinoma State Key Laboratory of Oncology in South ChinaCollaborative Innovation Center for Cancer MedicineGuangdong Key Laboratory of Nasopharyngeal Carcinoma Diagnosis and TherapySun Yat-sen University Cancer CenterGuangzhouGuangdong 510060P.R.China

Background:Capecitabine was previously used as a second-line or salvage therapy for metastatic nasopharyngeal carcinoma(NPC)and has shown satisfactory curative effect as maintenance therapy in other metastatic *** study aimed to explore the role of capecitabine as maintenance therapy in de novo metastatic NPC patients with different plasma Epstein-Barr virus(EBV)DNA levels before ***:We selected de novo metastatic NPC patients treated with locoregional radiotherapy(LRRT)for this retrospective *** propensity score matching(PSM)was applied to balance potential confounders between patients who underwent capecitabine maintenance therapy and those who did not with a ratio of 1:*** survival(OS)was the primary *** association between capecitabine maintenance therapy and survival was assessed using the log-rank test and a Cox proportional hazard ***:Among all patients eligible for this study,64 received capecitabine maintenance therapy after *** PSM,192 patients were identified in the nonmaintenance *** the matched cohort,patients treated with capecitabine achieved a higher 3-year OS rate compared with patients in the non-maintenance group(68.5%vs.61.8%,P=0.037).Multivariate analysis demonstrated that capecitabine maintenance therapy was an independent prognostic *** subgroup analysis,3-year OS rate was comparable between the maintenance and non-maintenance groups in patients with high pretreatment EBV DNA levels(˃30,000 copies/mL)(54.8%vs.45.8%,P=0.835),whereas patients with low pretreatment EBV DNA levels(≤30,000 copies/mL)could benefit from capecitabine maintenance therapy in OS(90.0%vs.68.1%,P=0.003).Conclusion:Capecitabine maintenance therapy may be superior to non-maintenance therapy in prolonging OS for de novo metastatic NPC patients with pretreatment EBV DNA≤30,000 copies/*** in patients with high pretreatment EBV DNA levels(˃30,000 copies/mL)(54.8%vs.45.8%,P=0.835),whereas patients with

关键词： capecitabine de novo Epstein-Barr virus locoregional maintenance therapy nasopharyngeal carcinoma propensity score matching radiotherapy survival

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Real-world cost-effectiveness associated with infliximab maintenance therapy for moderate to severe Crohn's disease in China

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World Journal of Gastroenterology 2020年第41期26卷 6455-6474页

作者： Ji-Hao Shi Liang Luo Xiao-Li Chen Yi-Peng Pan Zhou Zhang Hao Fang Ying Chen Wen-Dong Chen Qian Cao Department of Gastroenterology Sir Run Run Shaw HospitalCollege of MedicineZhejiang UniversityHangzhou 310016Zhejiang ProvinceChina Department of Project Changsha Normin Health Technology LtdChangsha 410013Hunan ProvinceChina Department of HEOR Normin Health Consulting LtdToronto L5R 0E9OntarioCanada Inflammatory Bowel Disease Center Sir Run Run Shaw HospitalHangzhou 310016Zhejiang ProvinceChina

BACKGROUND Infliximab was the first approved biologic treatment for moderate to severe Crohn's disease(MS-CD) in China. However, the cost-effectiveness of infliximab maintenance therapy(IMT) for MS-CD relative to conventional maintenance therapy remained *** To assess the cost-effectiveness of IMT for MS-CD in Chinese patients from the perspective of Chinese public insurance *** A cohort of MS-CD patients managed in a Chinese tertiary care hospital was created to compare IMT with conventional maintenance therapy(CMT) for clinical outcomes and direct medical costs over a 1-year observation time using conventional regression analyses. A decision-analytic model with the generated evidence was constructed to assess the cost-effectiveness of IMT relative to CMT using reimbursed medical *** Based on the included 389 patients, IMT was associated with significantly higher disease remission chance [odds ratio: 4.060, P = 0.003], lower risk of developing new complications(odds ratio: 0.527, P = 0.010), higher utility value for quality of life(coefficient 0.822, P = 0.008), and lower total hospital costs related to disease management(coefficient-0.378, P = 0.008) than CMT. Base-case cost-effectiveness analysis estimated that IMT could cost Chinese health insurance payers $55260 to gain one quality-adjusted life year(QALY). The cost-effectiveness of IMT was mainly driven by the estimate of quality of life, treatment efficacy of maintenance therapy, mortality risk associated with active disease, and unit price of infliximab. The probability that IMT was cost-effective at a willingness-to-pay threshold of three times gross domestic product [2018 Chinese gross domestic product per capita(GDPPC)] was 86.4%.CONCLUSION IMT significantly improved real-world health outcomes and cost the Chinese public health insurance payers less than one GDPPC to gain one QALY in Chinese MS-CD patients.

关键词： Infliximab Crohn's disease maintenance therapy Cost-effectiveness Outcomes Direct medical costs

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Efficacy and safety of S-1 maintenance therapy in advanced nonsmall- cell lung cancer patients

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World Journal of Clinical Cases 2020年第21期8卷 5172-5179页

作者： Xiao-Wei Cheng Wen-Hua Leng Chun-Ling Mu Department of Respiratory and Critical Care Medicine Panzhihua Central HospitalPanzhihua 617067Sichuan ProvinceChina Department of Ultrasound Panzhihua Central HospitalPanzhihua 617067Sichuan ProvinceChina

BACKGROUND Previous reports have demonstrated that S-1 has remarkable effects in the maintenance treatment of advanced non-small-cell lung cancer(NSCLC),and has less toxic and side effects than conventional *** To investigate the efficacy and safety of S-1 maintenance therapy in patients with advanced *** Ninety-four patients with NSCLC admitted to our hospital from September 2015 to April 2018 were included in the study and divided into the S-1 group(47 cases)and the gemcitabine group(47 cases)by random digital table *** S-1 group was treated with S-1,while the gemcitabine group received gemcitabine *** clinical efficacy and quality of life of the patients after treatment in the two groups were *** There was no significant difference in the total effectiveness rate between the two groups(P=0.519).The quality-of-life scores indicated that there was no significant difference between the two groups in terms of four dimensions of the GQOLI-74 questionnaire(P=0.518,0.094,0.338,0.418).The incidence of nausea and vomiting,granulocytopenia and diarrhea in the S-1 group was significantly lower than that in the gemcitabine group(P=0.001,0.001 and 0.001,respectively).There was no significant difference in the incidence of thrombocytopenia(P=0.366),the progression-free survival(P=0.064),and the survival between the two groups(P=0.050).CONCLUSION S-1 maintenance therapy shows a significant therapeutic effect in patients with advanced *** has the same clinical efficacy as gemcitabine,but with less toxic and side effects than conventional drugs.

关键词： Advanced non-small cell lung cancer maintenance therapy S-1 Gemcitabine Efficacy Toxic and side effects

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A Phase Ⅱ Trial of Gefitinib as maintenance therapy after First-Line Chemotherapy for Advanced Non-Small Cell Lung Cancer in China

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Chinese Journal of Cancer Research 2010年第1期22卷 1-9页

作者： Lu Yang Zhi-jie Wang Tong-tong An Hua Bai Jun Zhao Jian-chun Duan Ping-ping Li Mei-na Wu Hong Sun Li Liang Jie Wang The Key Laboratory of Carcinogenesis and Translational Research （Ministry of EducationDepartment of Thoracic Medical Oncology Department of Traditional Chinese Medicine Combined West Medical Oncology Peking University School of Oncology Beijing Cancer Hospital ＆ Institute Beijing 100142 China Department of Oncology the Third Hospital of Peking University Beijing 100083 China

Objective： To investigate the efficacy and safety of gefitinib as maintenance therapy for advanced non-small cell lung cancer （NSCLC） patients who obtained disease control （DC） after first-line chemotherapy in Chinese population. Methods： Chinese patients with advanced NSCLC treated with standard chemotherapy and obtained DC were assigned to receive gefitinib as maintenance treatment. The primary end point was overall survival time （OS）, the second end point was disease control rate （DCR） and progression-free survival time （PFS）. DCR included complete response （CR） plus partial response （PR） and plus stable disease （SD）. The impact of epidermal growth factor receptor （EGFR） mutation status on the treatment as exploratory point was also evaluated by denaturing high-performance liquid chromatography （DHPLC）. Results： Among 75 enrolled patients, the overall response rate was 37% and the DCR （CR ＋ PR ＋SD） was 66%. The median PFS and OS were 17.13 months and 26.13 months respectively, with 1- and 2-year survival rates 89.3% and 34.7%. Patients harboring somatic EGFR mutations obtained a prolonged median PFS and OS compared with EGFR wide type （25.1 vs. 13.0 months, P=0.019 and 33.37 vs. 25.57 months, P=0.014, respectively）. In COX regression model, only EGFR mutation status was the independently factor influencing both PFS and OS （P=0.029 and 0.017, respectively）, however, rash status was the predictor in terms of PFS （P=0.027）. Conclusion： Gefitinib produced encouraging survival when delivered as maintenance therapy in Chinese patients obtaining DC after first-line chemotherapy, especially for patients carrying somatic EGFR mutations. EGFR mutation is an independently predictive factor of survival.

关键词： Gefitinib maintenance therapy Non-small cell lung cancer

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