甲磺酸伊马替尼治疗国人胃肠间质瘤的临床研究

Clinical Study of Chinese Gastrointestinal Stromal Tumors Patients Treated with Imatinib Mesylate

目的观察和评价甲磺酸伊马替尼(Imatinibmesylate)治疗国人胃肠间质瘤(GIST)的有效性和安全性。方法2002年8月至2004年12月,在本院通过病理形态学及免疫组化确诊的GIST共52例,其中36例应用伊马替尼治疗,用法为伊马替尼400mg,口服,1/日。参照WHO实体瘤客观疗效标准观察和判定疗效,NCICTC2.0版抗癌药的毒性标准观察和判定毒性。结果伊马替尼治疗的36例患者中,包括新辅助治疗和姑息治疗在内可以评价疗效的有28例,用药后获得部分缓解为14例(50%),疾病稳定10例(35.7%),疾病进展4例(14.3%);即有效率(RR)为50%,疾病控制率(DCR)达到85.7%。36例均可进行毒性评价,除了1例因胃部GIST合并脾脏B细胞型非霍奇金淋巴瘤,姑息切除术后口服格列卫同时进行CHOP方案化疗,结果发生了III级骨髓抑制外,其他35例中毒副反应均为I～II级,而且大多数毒性可以控制或恢复正常。结论与国外文献报道一致,甲磺酸伊马替尼治疗国人GIST安全高效,耐受性好。

Objective To investigate the safety and efficacy of Gastrointestinal Stromal Tumors （GIST） treated with Imatinib mesylate in the Chinise patients. Methods 52 Chinese GIST patients were diagnosed according to pathology evidence as well as IHC positive CD117 strain and treated in Bayi hospital from Aug. 2002 to Dec. 2004. The GIST pts treated with Imatinib mesylate （usage： 400 mg, PO, qd） were carefully observed for efficacy and safety according to WHO and NCI- CTC V2. 0 standards, respectively. Results Totally, there are 36 GIST pts treated with Imatinib, 28 pts might be evaluated for the efficacy. There were 14 patients （5{）%） got PR, 10 pts（35. 7~）SD over 6 months, only 4 pts （14. 3%）got PD. That was RR 50% or DCR 85. 7%. 36 pts might be evaluated for the toxicity. Except one GIST patient complicated with Non Hodgkin＇s lymphoma treated with Imatinib and CHOP regimen chemotherapy showed Ⅲ grade hypohematocyte, only Ⅰ-Ⅱ grade adverse reactions occurred in other 35 pts. Conclusion Those results are consistent with foreigner＇s reports. Imatinib is a safe and efficacious molecular target drug used for Chinese GIST. Only mild adverse reactions occur in treated patients. It is worth to use Imatinib widely and clinically.