甲磺酸伊马替尼治疗51例晚期胃肠道间质瘤患者的疗效分析

Imatinib mesylate in the treatment of advanced gastrointestinal stromal tumors

目的评价甲磺酸伊马替尼进行术前辅助治疗及治疗术后复发和／或转移性胃肠间质瘤（GIST）的临床疗效及不良反应。方法经病理组织学证实的GIST51例，其中CD117阳性47例、阴性4例。行术前辅助化疗4例，术后复发或已转移并失去手术机会者47例，给予甲磺酸伊马替尼300～800mg／d口服。结果51例患者中，1例失访，50例可评价客观疗效。完全缓解（CR）3例（6．0％），部分缓解（PR）34例（68．0％），病情稳定（SD）者5例（10．0％），疾病进展（PD）者8例（16．0％），患者获益（CR＋PR＋SD）率84％，获益者中位无进展生存期（TTP）16个月。随访1年以上者32例，1年和2年生存率分别为95．3％、89％。50例可评价不良反应，其中轻度水肿36例（72．0％），Ⅰ～Ⅱ度白细胞减少23例（46％），Ⅰ～Ⅱ度乏力14例（28％），轻度腹痛7例（14．0％），Ⅰ～Ⅱ度恶心呕吐9例（18．0％），轻度皮疹9例（18．0％），肿瘤出血2例（4．0％）。结论酪氨酸激酶抑制剂甲磺酸伊马替尼治疗GIST疗效肯定，不良反应较轻，且毒性能够耐受。

Objective To evaluate the efficacy and safety of imatinib mesylate in the treatment of patients as preoperative supplement,or used alone for unresectable and/or metastatic gastrointestinal stromal tumors（GIST）. Methods A total of 51 cases with advanced GIST were proved pathologically. Among them, CD117 was detected positive in 47 patients and negative in 4 patients ;4 patients received imatinib mesylate before operation and 47 patients with unresectable and（or） metastatic GIST received oral imatinib mesylate daily at dose of 300 - 800 mg. One patient was lost in follow-up and the objective effect was evaluated in 50 patients. Results 3 of the 50 patients （ 6. 0% ） achieved complete response （ CR ） , 34 （ 68% ） had partial response （ PR ）, 5 （ 10. 0% ） had stable disease （ SD ） and 8 （ 20. 0% ） had progression disease（PD）. The median time to progression （mTYP） was 16 months during which most of the patients experienced benefit. 32 patients bad been followed up for more then 1 year. The 1-year and 2-year survival rate were 95.3% ,89% respectively. 50 patients were valuable for the toxicity assessment according to the WHO standard. The main toxicity included grade Ⅰ - Ⅱ edema of periorbital area and lower limb in 72. 0% （36/50） patients, leukopenia was present in 46% （23/50） and intratumoral bleeding in 4. 0% （2/50）. Other toxicities included mild fatigue （ 28.0% ） , abdominal pain （ 14. 0% ） , efflorescence （ 18. 0% ） , nausea and vomiting（ 18.0% ）. Conclusions As an inhibitor of tyrosine kinase, imatinib mesylate is generally well tolerated and has been proved to be effective and safe during prolonged treatment of patients with advanced gastrointestinal stromal tumors. Its toxicity is acceptable.