目的:探讨阿帕替尼用于二线及二线以上治疗失败的晚期胃癌患者的临床疗效分析及预后因素研究.方法:研究对象为2014-10/2015-08曾接受过二线及二线以上治疗失败的60例晚期胃癌患者,均经病理确诊.给予阿帕替尼口服850m g/d,直至疾病进展,...目的:探讨阿帕替尼用于二线及二线以上治疗失败的晚期胃癌患者的临床疗效分析及预后因素研究.方法:研究对象为2014-10/2015-08曾接受过二线及二线以上治疗失败的60例晚期胃癌患者,均经病理确诊.给予阿帕替尼口服850m g/d,直至疾病进展,观察临床疗效及不良反应发生情况.应用Kaplan-Meier法进行生存分析.结果:根据实体瘤的疗效评定标准(Response Evaluation Criteria in Solid Tumors,RECIST)全部可评价疗效.其中完全缓解(complete response,CR)占0%(0/60),部分缓解(partial response,PR)占3.33%(2/60),疾病稳定(stable disease,SD)占38.33%(23/60),疾病进展(progressive disease,PD)占58.33%(35/60).客观缓解率(CR+PR)为3.33%,疾病控制率(CR+PR+SD)为38.33%(23/60).中位无进展生存期为3.76 mo.甲胎蛋白(a-f e t o p r o t e i n,A F P)阳性胃癌患者的疾病控制以及生存受益优于AFP阴性患者.高血压、骨髓抑制是影响阿帕替尼治疗的最主要的不良反应.结论:阿帕替尼治疗二线及二线以上治疗失败的晚期胃癌仍有较好的疾病控制及生存获益,不良反应可控制,值得临床上广泛应用.展开更多
Background:Effective therapeutic options are limited for patients with advanced esophageal squamous cell carcinoma(ESCC).The incorporation of an immune checkpoint inhibitor and a molecular anti-angiogenic agent into t...Background:Effective therapeutic options are limited for patients with advanced esophageal squamous cell carcinoma(ESCC).The incorporation of an immune checkpoint inhibitor and a molecular anti-angiogenic agent into the commonly adopted chemotherapy may produce synergistic effects.Therefore,we aimed to investigate the efficacy and safety of camrelizumab plus apatinib combined with chemotherapy as the first-line treatment of advanced ESCC.Methods:In this single-arm prospective phase II trial,patients with unresectable locally advanced or recurrent/metastatic ESCC received camrelizumab 200 mg,liposomal paclitaxel 150 mg/m2,and nedaplatin 50 mg/m2 on day 1,and apatinib 250 mg on days 1-14.The treatments were repeated every 14 days for up to 9 cycles,followed by maintenance therapy with camrelizumab and apatinib.The primary endpoint was objective response rate(ORR)according to the Response Evaluation Criteria in Solid Tumors(version 1.1).Secondary endpoints included disease control rate(DCR),progression-free survival(PFS),overall survival(OS),and safety.Results:We enrolled 30 patients between August 7,2018 and February 23,2019.The median follow-up was 24.98 months(95%confidence interval[CI]:23.05-26.16 months).The centrally assessed ORR was 80.0%(95%CI:61.4%-92.3%),with a median duration of response of 9.77 months(range:1.54 to 24.82+months).The DCR reached 96.7%(95%CI:82.8%-99.9%).The median PFS was 6.85 months(95%CI:4.46-14.20 months),and the median OS was 19.43 months(95%CI:9.93 months–not reached).The most common grade 3-4 treatmentrelated adverse events(AEs)were leukopenia(83.3%),neutropenia(60.0%),and increased aspartate aminotransferase level(26.7%).Treatment-related serious AEs included febrile neutropenia,leukopenia,and anorexia in one patient(3.3%),and single cases of increased blood bilirubin level(3.3%)and toxic epidermal necrolysis(3.3%).No treatment-related deaths occurred.Conclusions:Camrelizumab plus apatinib combined with liposomal paclitaxel and nedaplatin as first-line treatment demonstrated feas展开更多
文摘目的:探讨阿帕替尼用于二线及二线以上治疗失败的晚期胃癌患者的临床疗效分析及预后因素研究.方法:研究对象为2014-10/2015-08曾接受过二线及二线以上治疗失败的60例晚期胃癌患者,均经病理确诊.给予阿帕替尼口服850m g/d,直至疾病进展,观察临床疗效及不良反应发生情况.应用Kaplan-Meier法进行生存分析.结果:根据实体瘤的疗效评定标准(Response Evaluation Criteria in Solid Tumors,RECIST)全部可评价疗效.其中完全缓解(complete response,CR)占0%(0/60),部分缓解(partial response,PR)占3.33%(2/60),疾病稳定(stable disease,SD)占38.33%(23/60),疾病进展(progressive disease,PD)占58.33%(35/60).客观缓解率(CR+PR)为3.33%,疾病控制率(CR+PR+SD)为38.33%(23/60).中位无进展生存期为3.76 mo.甲胎蛋白(a-f e t o p r o t e i n,A F P)阳性胃癌患者的疾病控制以及生存受益优于AFP阴性患者.高血压、骨髓抑制是影响阿帕替尼治疗的最主要的不良反应.结论:阿帕替尼治疗二线及二线以上治疗失败的晚期胃癌仍有较好的疾病控制及生存获益,不良反应可控制,值得临床上广泛应用.
基金This study was supported by the Chinese Society of Clinical Oncology(CSCO)-Hengrui Oncology Research Fund(No.Y-HR2018-364)。
文摘Background:Effective therapeutic options are limited for patients with advanced esophageal squamous cell carcinoma(ESCC).The incorporation of an immune checkpoint inhibitor and a molecular anti-angiogenic agent into the commonly adopted chemotherapy may produce synergistic effects.Therefore,we aimed to investigate the efficacy and safety of camrelizumab plus apatinib combined with chemotherapy as the first-line treatment of advanced ESCC.Methods:In this single-arm prospective phase II trial,patients with unresectable locally advanced or recurrent/metastatic ESCC received camrelizumab 200 mg,liposomal paclitaxel 150 mg/m2,and nedaplatin 50 mg/m2 on day 1,and apatinib 250 mg on days 1-14.The treatments were repeated every 14 days for up to 9 cycles,followed by maintenance therapy with camrelizumab and apatinib.The primary endpoint was objective response rate(ORR)according to the Response Evaluation Criteria in Solid Tumors(version 1.1).Secondary endpoints included disease control rate(DCR),progression-free survival(PFS),overall survival(OS),and safety.Results:We enrolled 30 patients between August 7,2018 and February 23,2019.The median follow-up was 24.98 months(95%confidence interval[CI]:23.05-26.16 months).The centrally assessed ORR was 80.0%(95%CI:61.4%-92.3%),with a median duration of response of 9.77 months(range:1.54 to 24.82+months).The DCR reached 96.7%(95%CI:82.8%-99.9%).The median PFS was 6.85 months(95%CI:4.46-14.20 months),and the median OS was 19.43 months(95%CI:9.93 months–not reached).The most common grade 3-4 treatmentrelated adverse events(AEs)were leukopenia(83.3%),neutropenia(60.0%),and increased aspartate aminotransferase level(26.7%).Treatment-related serious AEs included febrile neutropenia,leukopenia,and anorexia in one patient(3.3%),and single cases of increased blood bilirubin level(3.3%)and toxic epidermal necrolysis(3.3%).No treatment-related deaths occurred.Conclusions:Camrelizumab plus apatinib combined with liposomal paclitaxel and nedaplatin as first-line treatment demonstrated feas
