伊马替尼一线治疗国人晚期胃肠间质瘤获益人群特征分析:多中心8年随访数据

Analyses of clinical features for responders on imatinib mesylate to Chinese patients with advanced gastrointestinal stromal tumor as first-line treatment: multi-center,eight years followed-up outcome

目的本项多中心回顾性研究旨在分析国人晚期胃肠间质瘤（GIST）伊马替尼一线治疗获益人群的临床病理学特征,为伊马替尼的长期使用提供依据。方法收集国内4家综合性三级甲等医院2007年10月31日之前生存期8年以上的国人晚期GIST伊马替尼治疗获益患者（包括CR、PR和SD）的临床病理学资料,采用Kaplan-Meier法（Log-rank检验）进行单因素的生存统计,应用Cox风险比例模型（Enter法）进行多因素的生存分析。结果至随访截止日期,符合生存分析的患者共92例,已死亡患者25例（27.2%）。全组患者的中位疾病进展生存期（TTP）为97.0个月（95%CI：86.2~107.8个月）;中位总生存期（OS）为115.0个月（95%CI：105.3~124.7个月）;1、3、5、8、10年无进展生存率分别为94.6%、86.9%、74.8%、49.0%和24.4%;1、3、5、8、10年生存率分别为96.7%、91.3%、85.8%、76.5%和67.0%。Cox多因素分析显示,女性、年龄≤60岁、肿瘤长径≤10 cm和Exon 11突变是TTP获益的预测因素,原发部位、核分裂像、肿瘤是否破裂、复发部位、不同获益疗效之间的差异无统计学意义。单因素分析显示,仅肿瘤长径≤10 cm、Exon 11突变以及CR/PR患者的OS获益更多;经校正其他因素后,Cox多因素分析尚未发现预测OS的独立风险因素。结论对于肿瘤长径≤10 cm、Exon 11突变的国人晚期胃肠间质瘤患者,伊马替尼一线治疗的TTP显著延长,且包括获得CR/PR者的OS可能获益更多,建议持续使用。

Objective To analyze retrospectively clinical pathology features for responders on imatinib mesylate （IM） to Chi- nese patients with advanced gastrointestinal stromal tumor （GIST） as first-line treatment, and provide evidence for long-term use of IM. Methods Clinical pathology features for responders （including CR, PR and SD） on IM as first-fine treatment to Chinese patients with advanced GIST were collected from four comprehensive Rank 3, Grade A hospitals. All patients were pathologically diagnosed before 31 Oct, 2007 with a more than 8-year life span. Kaplan-Meier method （Log-rank test） was used for survival statistics and Cox proportional hazard model （Enter method） for multivariable independent risk factors analyses. Results Till deadline of followed-up, 92 cases met the criteria for survival analyses, in which there were 25 cases died （ 27.2% ）. Medium time to progression （TTP） and overall survival （OS） were 97. 0 months （95%CI： 86. 2-107. 8） and 115.0 months （95%CI： 105.3-124. 7）, respectively. The 1-,3-,5-,8-,10-year TTP rates were 94. 6%, 86. 9%, 74. 8%, 49.0% and 24.4% ; Accordingly, OS rates were 96. 7%, 91.3%, 85.8%, 76. 5% and 67.0%, respectively. Beneficial predictors for TTP in univariable analyses included female, age less than 60 years old, tumor diameter less than 10 em and exon 11 mutation, in coincidence with the result of multivariable analyses. Primary location, mitotic rate, tumor rapture, recurrence Site and different response maybe not act as predictors in setting of IM continuous administration. As for OS, only tumor diameter less than 10 cm, exon 11 mutation and CR/PR patients have longer survival. After calibrated, no independent predic-rive risk factors found in multivariable analyses. Conclusion For GIST patients with tumor diameter less than 10 cm, exon 11 muta- tion and CR/PR on IM, IM maybe provide longer survival in first-line setting and continuous using is recommended.