国产伊马替尼治疗胃肠间质瘤的临床效果及安全性分析

Clinical efficacy and safety analysis of domestic imatinib for treatment of gastrointestinal stromal tumor

目的 探讨国产伊马替尼治疗胃肠间质瘤（GIST）的临床效果和安全性.方法 回顾性分析2014年1月至2017年12月华中科技大学同济医学院附属协和医院服用国产伊马替尼的GIST患者临床病理资料及随访资料,分析患者近期疗效及不良反应发生情况.结果 共纳入35例患者,其中男性20例,女性15例,中位年龄53岁（28～79岁）.接受手术完整切除原发GIST 25例,术后危险度分级示高危20例,中危5例;另外10例中,肝脏转移6例,腹膜转移2例,腹腔、盆腔广泛转移1例,原发不可切除1例.35例患者均获得有效随访,中位随访时间25个月（4～49个月）.25例手术切除的原发GIST患者中位辅助治疗14个月（4～44个月）,中位随访25个月（4～49个月）,未发现肿瘤复发或转移.10例复发转移或不可切除GIST患者中位服药时间为24个月（3～49个月）;其中,7例单纯药物治疗后,5例部分缓解,2例疾病稳定;3例局限性进展患者手术完整切除肿瘤后加药物治疗,疾病控制良好.77.1％（27/35）的患者出现伊马替尼相关不良反应,仅1例（2.9％）发生Ⅲ级不良反应.结论国产伊马替尼用于原发GIST完整切除术后辅助治疗及复发转移或不可切除的晚期GIST治疗有效,安全性较好,但结果仍需大样本前瞻性研究进一步证实.

Objective To investigate the clinical efficacy and safety of domestic imatinib in the treatment of gastrointestinal stromal tumor （GIST）. Methods Clinicopathological and follow-up data of GIST patients who received domestic imatinib treatment from January 2014 to December 2017 in Union Hospital, Tongji Medical College, Huazhong University of Science and Technology were analyzed retrospectively. The treatment efficacy and adverse reactions were analyzed. Results A total of 35 patients included 20 males and 15 females with a median age of 53 years old （28-79 years old）. Among all the patients, 25 with primary GIST underwent complete resection, in which 20 cases were classified as high risk and 5 as moderate risk according to the risk stratification. Of the remaining 10 recurrent/metastatic or unresectable GIST patients, 6 cases had metastasis in liver, 2 cases had metastasis in peritoneum, 1 case had extensive abdominal and pelvic metastasis, and the other 1 case was initially unresectable. The follow-up data of all the 35 patients were available, with a median follow-up time of 25 months （4-49 months）. Twenty-five primary patients with complete resection received adjuvant therapy with a median time of 14 months （4-44 months）. The median time of follow-up was 25 months （4-49 months）, and none of the primary patients was detected with recurrence or metastasis of GIST. Meanwhile, of the 10 patients with recurrent/metastatic or unresectableGIST, the median time of medicine-taking was 24 months （3-49 months）. Seven of 10 patients received imatinib monotherapy, including 5 cases of partial remission and 2 cases of stable disease. The other 3 patients with localized progression received complete resection along with imatinib therapy. All the 10 patients achieved durable clinical benefit. Twenty-seven patients （77.1％） experienced adverse events, and only 1 case （2.9 ％） had grade 3 adverse events. Conclusion Domestic imatinib is effective and safe for patients who received adjuvant therapy after complete resection of primary GIST as well as those with recurrent/metastatic or unresectable GIST, but it remains to be further confirmed by large samples of prospective studies.