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Effectiveness and safety of combined nimotuzumab and s-1 chemotherapy with concurrent radiotherapy for locally advanced esophageal cancer in malnourished and elderly patients:A prospective phase Ⅱ study

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Chinese Journal of Cancer Research 2024年第3期36卷 270-281页

作者： Guojie Feng Jiao Li Nuo Yu Ziyu Zheng Xiongtao Yang Lei Deng Tao Zhang Wenqing Wang Wenyang Liu Jianyang Wang Qinfu Feng Jima Lyu Zefen Xiao Zongmei Zhou Nan Bi Jianjun Qin Xin Wang Department of Radiation Oncology National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital Chinese Academy of Medical Sciences & Peking Union Medical College Department of Thoracic surgery National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital Chinese Academy of Medical Sciences & Peking Union Medical College

Objective: Definitive chemoradiotherapy(dCRT) is the standard treatment for unresectable locally advanced esophageal cancer. However, this treatment is associated with substantial toxicity, and most malnourished or elderly patients are unable to complete this therapy. Therefore, there is a need for a more suitable radiotherapy combination regimen for this population. This study was aimed to evaluate the efficacy and safety of a combination regimen comprising chemotherapy with nimotuzumab and s-1 and concurrent radiotherapy for patients with fragile locally advanced esophageal cancer with a high Nutritional Risk screening 2002(NRs-2002) score.Methods: Eligible patients with unresectable esophageal carcinoma who had an NRs-2002 score of 2 or higher were enrolled. They were treated with s-1 and nimotuzumab with concurrent radiotherapy, followed by surgery or definitive radiotherapy. The primary endpoint was the locoregional control(LRC) rate.Results: A total of 55 patients who met the study criteria were enrolled. After completion of treatment, surgery was performed in 15 patients and radiotherapy was continued in 40 patients. The median follow-up period was 33.3[95% confidence interval(95% CI), 31.4-35.1)] months. The LRC rate was 77.2%(95% CI, 66.6%-89.4%) at 1 year in the entire population. The overall survival(Os) rate and event-free survival(EFs) rate were 57.5% and 51.5% at 3 years, respectively. surgery was associated with better LRC [hazard ratio(HR)=0.16; 95% CI,0.04-0.70; P=0.015], Os(HR=0.19; 95% CI, 0.04-0.80; P=0.024), and EFs(HR=0.25; 95% CI, 0.08-0.75;P=0.013). Most adverse events were of grade 1 or 2, and no severe adverse events occurred.Conclusions: For malnourished or elderly patients with locally advanced esophageal cancer, radiotherapy combined with nimotuzumab and s-1 is effective and has a good safety profile.

关键词： Esophageal carcinoma squamous cell carcinoma nutritional risk score nimotuzumab s-1 definitive chemoradiotherapy

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Patients with Metastatic Colorectal Cancer after Failure of second-Line Treatment May Benefit from Low-Dose Apatinib and s-1 Combined with Jianpi Bushen Jiedu Decoction

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Chinese Journal of Integrative Medicine 2022年第10期28卷 924-929页

作者： CHEN Yue XU Yu-ying JIANG Hai-jun WANG Lei ZHAI Jia-wei ZHANG Tong YANG Yu-fei Graduate school Beijing University of Chinese MedicineBeijing(100029)China Department of Oncology Xiyuan HospitalChina Academy of Chinese Medical SciencesBeijing(100091)China Department of Oncology Central Hospital of Ankang CityAnkangShaanxi Province(725000)China

Objective: To evaluate the effect and safety of low-dose of apatinib and s-1 combined with Jianpi Bushen Jiedu Decoction(JBJD) in patients with metastatic colorectal cancer(mCRC) who have failed second or above lines treatment, in order to provide more treatment option for mCRC patients by integrated medicine. Methods: Thirteen patients were selected from a single-arm, open-label clinical study from April 2019 to september 2020. The patients were treated with low-dose apatinib(250 mg, once a day) and s-1(20 mg, twice a day) combined with JBJD for at least one cycle and were followed up to August 2021. The primary endpoint was disease progression-free survival(PFs). Disease control rate(DCR), objective response rate(ORR), and overall survival(Os) of patients were observed as the secondary endpoints. Adverse events were recorded as well. Results: The average age of the 13 patients was 56.5±13.0 years and 76.9% were male. The median PFs and median Os were 4.6 and 8.3 months, respectively. The ORR was 7.7%(1/13) while the DCR was 61.5%(8/13). The common adverse events were hypertension, proteinuria, elevated transaminase, and thrombocytopenia. One patient experienced thrombocytopenia of grade 3. Conclusions: Patients with mCRC after failure of the second or above lines of treatment may potentially benefit from the treatment of low-dose apatinib and s-1 combined with JBJD because of its similar effect as the standard dose of target therapy and relatively better safety.(Registration No. ChiCTR1900022673)

关键词： metastatic colorectal cancer apatinib s-1 Jianpi Bushen Jiedu Decoction Chinese medicine progression-free survival clinical trial

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Comparison of involved-field intensity-modulated radiotherapy combined with s-1 vs radiotherapy alone for elderly patients with esophageal cancer

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World Journal of Clinical Cases 2022年第21期10卷 7365-7375页

作者： Li-Hua Liu Mao-Hui Yan Yu-Peng Di Zhi-Guang Fu Xiao-Dan Zhang Hong-Qi Li Department of Radiotherapy Heze Hospital of Traditional Chinese MedicineHeze 274000Shandong ProvinceChina Department of Radiotherapy Air Force Medical CenterChinese People’s Liberation ArmyBeijing 100142China

BACKGROUND It is estimated that about 30%of esophageal cancer(EC)patients are over 70 years old.Therefore,there is less evidence on the diagnosis and management of elderly EC patients.It is important to explore how elderly EC patients benefit from radical radiochemotherapy regimens,including the target area of radiotherapy(RT),radiation dose and fraction,and choice of chemotherapy drugs.AIM To compare the efficacy of involved-field intensity-modulated RT(IF-IMRT)combined with s-1 vs RT alone in the treatment of elderly EC patients in terms of safety,short-term response,and survival.METHODs Thirty-four EC patients aged>70 years were prospectively enrolled between December 2017 and December 2019.Based on the random number table,they were divided into an IF-IMRT+s-1 group and an IF-IMRT alone group,with 17 patients in each group.All patients were treated with IF-IMRT at a dose of 50.4-56 Gy in 28-30 fractions(1.8-2 Gy/fraction,5 fractions/wk).Oral s-1 was administered concomitantly in the IF-IMRT+s-1 group for 14 consecutive days,and a second cycle was started 7 d after drug withdrawal.After RT,4 cycles of s-1 treatment were offered as the consolidation chemotherapy.The safety,short-term response,and survival were observed after the treatment.REsULTs As of April 2022,these 34 patients had been followed up for 15.2-32.5 mo,with a median follow-up period of 24.5 mo.Complete efficacy indicators were obtained from all the patients.The objective response rate was 88.2%vs 76.5%,respectively,in the IF-IMRT+s-1 group and the RT alone group,where as the disease control rate was 100%vs 82.4%,respectively.The incidence of adverse events including grade 1-2 fatigue,granulocytopenia,thrombocytopenia,anemia,radiation esophagitis,radiation-induced skin injury,and radiation-induced lung injury was not significantly different between these two groups,so was the incidence of the grade 3 radiation esophagitis(0%vs 5.7%).The rate of progressive disease(PD)was 52.9%(n=9)in the IF-IMRT+s-1 group and 64.7%(n=11)in the RT alone group.The m

关键词： Elderly patients Esophageal cancer Involved-field radiation therapy s-1 Chemotherapy

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Efficacy and safety of gemcitabine plus s-1 vs. gemcitabine plus nab-paclitaxel in treatment-na?ve advanced pancreatic ductal adenocarcinoma

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Cancer Biology & Medicine 2023年第10期20卷 765-778页

作者： Zhou Zhu Hui Tang Jinrong Ying Yuejuan Cheng Xiang Wang Yingyi Wang Chunmei Bai Department of Medical Oncology Peking Union Medical College HospitalChinese Academy of Medical Sciences&Peking Union Medical CollegeBeijing 100730China 4+4 Medical Doctor Program Chinese Academy of Medical Sciences&Peking Union Medical CollegeBeijing 100730China

Objective:Gemcitabine plus nab-paclitaxel(GnP)is the standard first-line therapy for advanced pancreatic ductal adenocarcinoma(PDAC).s-1,an oral fluoropyrimidine derivative,as compared with gemcitabine,is non-inferior in terms of overall survival(Os)and is associated with lower hematologic toxicity.Accordingly,s-1 is a convenient oral alternative treatment for advanced PDAC.This study was aimed at comparing the efficacy and safety of gemcitabine plus s-1(Gs)vs.GnP as first-line chemotherapy for advanced PDAC.Methods:Patients with advanced PDAC who received first-line Gs or GnP at the Peking Union Medical College Hospital between March 2011 and November 2022 were evaluated.Results:A total of 300 patients were assessed,of whom 84 received Gs and 216 received GnP.The chemotherapy completion rate was higher with Gs than GnP(50.0%vs.30.3%,P=0.0028).The objective response rate(ORR)was slightly higher(14.3%vs.9.7%,P=0.35),and the median Os was significantly longer(17.9 months vs.13.3 months,P=0.0078),in the Gs group than the GnP group.However,the median progression-free survival(PFs)did not significantly differ between groups.Leukopenia risk was significantly lower in the Gs group than the GnP group(14.9%vs.28.1%,P=0.049).Conclusions:As first-line chemotherapy for advanced PDAC,the Gs regimen led to a significantly longer Os than the GnP regimen.The PFs,ORR,and incidence of severe adverse events were comparable between the Gs and GnP groups.

关键词： Advanced pancreatic cancer first-line chemotherapy gemcitabine s-1 nab-paclitaxel

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Efficacy and safety of s-1 based adjuvant chemoradiotherapy for resected pancreatic ductal adenocarcinoma with high-risk pathological feature: a prospective, single-arm, interventional study

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Journal of Pancreatology 2022年第1期5卷 18-26页

作者： Lili Wu Yaolin Xu Zhaochong Zeng Yixing Chen Yuhong Zhou Dansong Wang Jing sun Minzhi Lv shisuo Du Wenhui Lou Department of Radiotherapy Zhongshan Hospital Fudan UniversityShanghaiChina Department of General surgery Zhongshan Hospital Fudan UniversityShanghaiChina Department of Medical Oncology Zhongshan Hospital Fudan UniversityShanghaiChina Department of Biostatistics Zhongshan Hospital Fudan UniversityShanghaiChina

Objective: It remains unclear whether adjuvant chemoradiotherapy (CRT) improves survival outcome of pancreatic ductal adenocarcinoma (PDAC) patients after surgery. This study aimed to investigate the efficacy and safety of tegafur/gimeracil/oteracil (s-1)-based adjuvant concurrent chemoradiotherapy in resected PDAC patients with defined high-risk pathological features.Methods: We conducted a single-arm, prospective, and interventional study at Zhongshan Hospital Fudan University from December 2012 to December 2019 and the last follow-up was conducted in December 2021. This study was approved by the Ethics Committee of Zhongshan Hospital Fudan University on December 27, 2012 (approval No. B2012-139). Resected PDAC patients with high-risk pathological features, including positive resection margin, pathological T3-4N1-2M0 disease, peripancreatic fat invasion, microvascular invasion, and perineural invasion, were recruited. Primary endpoint was overall survival and secondary endpoints were disease-free survival, treatment toxicity, and 2-, 5-year survival rates.Results: A total of 54 patients were recruited. Mean age was 63.6 years old (±7.2). The distribution of T and N stages were 24.1% for T1, 46.3% for T2, 27.8% for T3, 1.9% for T4, 33.3% for N1, and 11.1% for N2. seven patients had R1 resection. The median overall survival and disease-free survival were 27.1 and 13.7 months, respectively, while no fatal adverse events were recorded. subgroup analyses showed differences in survival outcomes among patients with microvascular invasion, different N stages, and preoperative CA 19-9 levels. Further, a Cox proportional hazard model demonstrated associations of lymph node metastases, CA 19-9 level, and microvascular invasion with overall survival and disease-free survival.Conclusion: s-1 -based adjuvant CRT showed promising efficacy and manageable toxicity in resected PDAC patients with highrisk pathological features.

关键词： Adjuvant chemoradiotherapy Pancreatic cancer Pathology s-1 surgery

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Eight-year survival after advanced gastric cancer treated with s-1 followed by surgery

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World Journal of Gastroenterology 2010年第22期16卷 2824-2827页

作者： susumu Hijioka Keisho Chin Yasuyuki seto Noriko Yamamoto Kiyohiko Hatake Department of Medical Oncology Cancer Institute Hospital of JFCR Department of surgery Cancer Institute Hospital of JFCR Department of Pathology Cancer Institute Hospital of JFCR

We report a case of advanced gastric cancer, with cervical, axillary, and abdominal paraaortic lymph node metastases, that was successfully treated with chemotherapy and surgery. The disease was initially considered unresectable, and the patient was treated with orally administered s-1. Chemotherapy was effective, and all lymph node metastases disappeared after 6 courses. After 27 mo of chemotherapy, the patient underwent curative surgery, with subtotal gastrectomy and lymph node dissection. Histopathological examination revealed many viable poorly differentiated adenocarcinoma cells in the stomach, but no cancer cells in the lymph nodes. The patient is alive, without recurrence, 8 years later. This, therefore, is a case report of an 8-year survivor of advanced gastric cancer with distant lymph node metastasis.

关键词： s-1 Lymph node metastasis Gastric cancer Gastrectomy

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s-1 induced secondary acute erythroid leukemia with a chromosome inv(12)(p13;q13)

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World Journal of Gastroenterology 2011年第41期17卷 4632-4634页

作者： Kensuke Matsumoto Akira Kitanaka Makiko Uemura Fusako Waki Tetsuya Fukumoto Hiroaki Ohnishi Yoshitsugu Kubota Toshihiko Ishida First Department of Internal Medicine Faculty of MedicineKagawa Univesity Hematology Faculty of MedicineKagawa Univesity Department of Transfusion Medicine Kagawa University

Adjuvant chemotherapy by s-1 following gastrectomy is considered standard treatment in Japan.Analysis of follow-up data have proved the effi cacy of s-1 admin-istration,and that hematological adverse events were relatively rare.Pyrimidine anti-metabolites,including s-1,have shown relatively lower risks for secondary hematological malignancies in comparison to alkylat-ing agents and topoisomerase-Ⅱ inhibitors.We here report a case of therapy-related leukemia after s-1 administration.A patient who had received s-1as the sole adjuvant chemotherapy was diagnosed with acute erythroid leukemia.To the best of our knowledge,our patient represents the fi rst report of s-1 induced acute leukemia.

关键词：急性白血病红白血病 s-1 染色体继发性诱导恶性血液病拓扑异构酶

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Therapeutic effects of combined oxaliplatin and s-1 in older patients with advanced gastric cardiac adenocarcinoma

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World Journal of Gastroenterology 2011年第47期17卷 5221-5226页

作者： she-Gan Gao Rui-Nuo Jia Xiao-shan Feng Xuan-Hu Xie Tan-You shan Li-Xian Pan Na-sha song Yu-Feng Wang Kai-Li Ding Li-Dong Wang Department of Oncology First-Affiliated HospitalCancer Institute Henan University of Science and TechnologyLuoyang 471003 Henan Province China Henan Key Laboratory for Esophageal Can-cer Laboratory for Cancer Research Basic Medical CollegeZhengzhou University Zhengzhou 450052 Henan ProvinceChina

AIM:To evaluate the effects and safety of combination chemotherapy with oxaliplatin (L-OHP) and s-1 (sOX regimen) in older patients with advanced gastric cardiac adenocarcinoma (GCA). METHODs: seventy patients with advanced GCA were classified according to age into an older group (≥ 75 years) and a control group (s). The sOX regimen was administered to the two groups as follows: s-1 (40 mg/m2 po bid) on days 1 to 14 followed by a 7-d off period, plus L-OHP (65 mg/m2 iv) for 2 h on days 1 and 8 of a 21-d cycle. This regimen was repeat-ed for four to six cycles. Response and swallow statuses were evaluated after two cycles (6 wk). Effects and toxicity were evaluated four weeks after chemotherapy was completed. REsULTs: The response rate was 65.6% (21/32) in the older group and 68.4% (26/38) in the control group (χ2 = 0.062 and P = 0.804). Improvement in swallowing was 78.1% (25/32) in the older group and 76.3% (29/38) in the control group (χ2 = 0.032 and P = 0.857). Effi cacy was 68.8% (22/32) in the older group and 65.8% (25/38) in the control group (χ2 = 0.069 and P = 0.793). Toxicities were reversible and similar in both groups (P > 0.05). CONCLUsION: The sOX regimen is an effective, safe and well-tolerated regimen for older patients with advanced GCA.

关键词：胃的心脏的腺癌 Oxaliplatin s-1 治疗效果

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A phase Ⅱ trial of oxaliplatin plus s-1 as a first-line chemotherapy for patients with advanced gastric cancer

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中华医学杂志(英文版) 2013年第18期126卷 3470-3474页

作者： YANG Lin sONG Yan ZHOU Ai-ping QIN Qiong CHI Yihebali HUANG Jing WANG Jin-wan Department of Medical Oncology Cancer Hospital and InstituteChinese Academy of Medical Sciences

Background Palliative chemotherapy has been shown to have a survival benefit for patients with recurrent or metastatic gastric cancer.We conducted a Phase II trial to determine the efficacy and safety of s-1 plus oxaliplatin（sOX regimen）as first-line chemotherapy for patients with unresectable locally advanced or metastatic gastric cancer.Methods Eligible patients had measurable lesions and no previous history of chemotherapy（except adjuvant chemotherapy）.Oxaliplatin was administered intravenously at a dose of 130 mg/m;on day 1.s-1 was administered orally in doses of 80,100,or 120 mg/d according to body surface areas of1.25 m;,1.25-1.5 m;,or>1.5 m;respectively;the total dose was divided into two daily doses on days 1-14.Treatments were repeated every 3 weeks until disease progression or intolerable toxicity occurred.Results Forty-three patients were enrolled in the study.All were assessable for efficacy and adverse events.The objective response and disease control rates were 55.8%and 76.7%respectively.The median follow-up time was 16.5 months.The median progression-free survival time was 7 months（95%CI,5.8-8.2 months）and the median overall survival time was16.5 months（95%CI,9.7-23.3 months）.The one-year survival rate was 54.2%.Major adverse reactions were grade 3/4neutropenia（9.3%）and thrombocytopenia（20.9%）.Conclusion The sOX regimen with oxaliplatin at a dose of 130 mg/m;was found to be effective and safe as a first-line chemotherapy in Chinese patients with advanced gastric cancer.

关键词： stomach neoplasms drug therapy oxaliplatin s-1

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Adjuvant chemotherapy with s-1 plus oxaliplatin improves survival of patients with gastric cancer after D2 gastrectomy: A multicenter propensity score-matched study

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World Journal of Clinical Cases 2018年第10期6卷 373-383页

作者： Deng-Feng Ren Fang-Chao Zheng Jun-Hui Zhao Guo-shuang shen Raees Ahmad shui-sheng Zhang Yu Zhang Jie Kan Li Dong Zi-Yi Wang Fu-Xing Zhao Jiu-Da Zhao Department of Medical Oncology Affiliated Hospital of Qinghai University Affiliated Cancer Hospital of Qinghai University Department of Medical Oncology Shouguang Hospital of Traditional Chinese Medicine Department of surgical Oncology Affiliated Hospital of Qinghai University Affiliated Cancer Hospital of Qinghai University Department of Pancreatic and Gastric surgery National Cancer Center/Cancer Hospital Chinese Academy of Medical Sciences and Peking Union Medical College Department of Medical Oncology Qinghai Red Cross Hospital Department of Medical Oncology People's Hospital of Qinghai Province Institutes of Biomedical sciences Shanxi University

AIM To investigate the safety and efficacy of s-1 plus oxaliplatin(sOX) as an adjuvant chemotherapy regimen in gastric cancer(GC) after D2 dissection.METHODs GC Patients who underwent D2 gastrectomy from september 2009 to December 2011 in four Chinese institutions were enrolled. Patients with stage ⅠB-ⅢC GC, who received adjuvant sOX treatment were matched by propensity scores with those who underwent surgery alone and those who conducted capecitabine plus oxaliplatin(XELOX) regimen. Disease-free survival(DFs) and overall survival(Os) were compared among the groups. In addition, adverse events in sOX patients were analyzed.Of 1944 GC patients who underwent D2 dissection, 867 were included for analysis. One hundred and seventeen patients treated with sOX were matched to 234 patients who conducted surgery alone. Fifty-seven patients treated with sOX were matched to 57 patients who received XELOX. The estimated five-year DFs was 57.5% in the adjuvant sOX group which was higher than that(44.6%) in the surgery alone group(P = 0.001); and the estimated five-year Os was 68.3% which was higher than that(45.8%) of surgery alone group(P 1). survival benefit was also revealed in stage III and > 60 years old subgroups(P 1 and P = 0.015, respectively). Compared with XELOX regimen, sOX showed no significant difference in DFs(P = 0.340) and Os(P = 0.361). The most common ≥ 3 grade adverse events of sOX regimen were neutropenia(22.6%), leukopenia(8.9%) and thrombocytopenia(5.6%).CONCLUsION Compared with surgery alone, sOX regimen significantly improves the long-term survival and has acceptable toxicity in patients with stage ⅠB-ⅢC GC after D2 dissection. It may be a novel adjuvant chemotherapy regimen in GC patients.

关键词： Gastric cancer D2 gastrectomy Adjuvant chemotherapy s-1 Oxaliplatin Capecitabine

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