苹果酸舒尼替尼二线治疗国人晚期胃肠间质瘤的临床观察

摘要

目的 探讨苹果酸舒尼替尼二线治疗甲磺酸伊马替尼治疗失败的国内胃肠间质瘤(GIST)患者的疗效和安全性,并初步分析后续治疗对生存的影响.方法 回顾性分析2008年11月至2009年12月应用舒尼替尼二线治疗伊马替尼失败的24例GIST患者资料,口服舒尼替尼50mg/日,连续4周,停药2周,6周为1周期.按照RECIST 1.1版进行疗效评价,根据NCI CTC 3.0版进行毒性评价.结果 24例患者共接受治疗232个周期,平均9.7个周期(2～29个周期).获PR 6例,SD 12例,PD 6例,有效率为25％,疾病控制率为75％.舒尼替尼二线治疗进展后有8例接受后续治疗.中位随访时间为378天(190～1554天),中位无进展生存时间(PFS)为336天(95％ CI:223.2 ～448.8天),中位总生存时间(0S)为655天(95％CI:359.7～950.3天).其中未接受后续治疗组的中位OS为392天(95％ CI:190.1 ～593.9天),接受后续治疗组的中位OS为1303天(95％ CI:661.2 ～ 1544.8天),两组差异有统计学意义(P =0.000).毒副反应多为1～2级,未发生治疗相关性死亡.结论 舒尼替尼二线治疗伊马替尼失败的国内GIST患者有效,不良反应轻微,安全可控；对于二线治疗失败的患者采取后续治疗可能有生存获益.%Objective To retrospectively explore the efficacy and safety of sunitinib as second-line therapy for Chinese patients with recurrent or metastatic gastrointestinal stromal tumor (GIST) and analyze primarily the impact of further treatment on survival.Methods Twenty-four patients who failured to imatinib were treated with sunitinib 50mg daily(4-week-on,2-week-off) as secondline from November 2008 to December 2009.Response rate was evaluated according to RECIST version 1.1 criteria and toxicity according to NCI CTC version 3.0 criteria.Results All 24 patients received 232 cycles of sunitinib (mean 9.7,range 2-29) and 8 patients received continues therapy after progression.Response rate(RR) was 25％ and DCR was 75％,including 6 PR,12 SD and 6 PD.Mean following-up duration was 378days(190-1554),meanwhile 17 patients died during the period.Median PFS and OS of all cases were 336 days (95％ CI:223.2-448.8) and 655 days(95％ CI:359.7-950.3),respectively.Median OS of non-continues treatment group and continues group were 392days and 1303 days (P =0.000).Common toxicities in most patients were grade Ⅰ-Ⅱ,with no treatment-related death.Conclusion Response rate of sunitinib as second-line therapy on patients with recurrent or metastatic GIST failured to imatinib was similar to published data and survival was prolonged markedly.Common toxicities in most patients were grade Ⅰ-Ⅱ.To GIST patients who progressed to sunitinib,continued therapy maybe benefit on survival and worthy of further study.