Phase II study of neoadjuvant imatinib in large gastrointestinal stromal tumours of the stomach.
Phase II study of neoadjuvant imatinib in large gastrointestinal stromal tumours of the stomach.
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DOI：
10.1038/bjc.2017.144
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发表时间：
2017-06-27
影响因子：
8.8
通讯作者：
Kang YK
中科院分区：
文献类型：
--
作者：
Kurokawa Y;Yang HK;Cho H;Ryu MH;Masuzawa T;Park SR;Matsumoto S;Lee HJ;Honda H;Kwon OK;Ishikawa T;Lee KH;Nabeshima K;Kong SH;Shimokawa T;Yook JH;Doki Y;Im SA;Hirota S;Hahn S;Nishida T;Kang YK
具有高危特征的胃肠道间质瘤（GIST）即使给予辅助治疗，预后也很差。新辅助伊马替尼可以通过缩小大的GIST和保护器官功能来提高治愈率。我们对胃GIST ≥10 cm的患者进行了一项亚洲多国II期研究。患者接受新辅助伊马替尼（400 mg/天）治疗6-9个月。主要终点为R 0切除率。共有56例患者入组本研究。在53例患者的全分析集中，46例患者完成了≥6个月的新辅助伊马替尼治疗。3-4级中性粒细胞减少和皮疹的发生率分别为8%和9%，但无治疗相关死亡。根据RECIST，缓解率为62%（95% CI，48-75%）。R 0切除率为91%（48/53）（95% CI，79-97%）。48例R 0切除术患者中有42例至少保留了一半的胃。中位随访时间为32个月，2年总体生存率和无进展生存率分别为98%和89%。新辅助伊马替尼治疗6-9个月是治疗大型胃GIST的一种有希望的治疗方法，可实现高R 0切除率，且毒性可接受。
Gastrointestinal stromal tumours (GISTs) with high-risk features have poor prognosis even if adjuvant treatment is given. Neoadjuvant imatinib may increase the cure rate by shrinking large GISTs and preserve organ function. We conducted an Asian multinational phase II study for patients with gastric GISTs ≥10 cm. Patients received neoadjuvant imatinib (400 mg/day) for 6–9 months. The primary end point was R0 resection rate. A total of 56 patients were enroled in this study. In the full analysis set of 53 patients, neoadjuvant imatinib for ≥6 months was completed in 46 patients. Grade 3–4 neutropenia and rash occurred in 8% and 9%, respectively, but there were no treatment-related deaths. The response rate by RECIST was 62% (95% CI, 48–75%). The R0 resection rate was 91% (48/53) (95% CI, 79–97%). Preservation of at least half of the stomach was achieved in 42 of 48 patients with R0 resection. At the median follow-up time of 32 months, 2-year overall and progression-free survival rates were 98% and 89%, respectively. Neoadjuvant imatinib treatment for 6–9 months is a promising treatment for large gastric GISTs, allowing a high R0 resection rate with acceptable toxicity.
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DOI：
10.1016/j.jamcollsurg.2012.05.008
发表时间：
2012-07
影响因子：
5.2
作者：
McCarter, Martin D.;Antonescu, Cristina R.;Ballman, Karla V.;Maki, Robert G.;Pisters, Peter W. T.;Demetri, George D.;Blanke, Charles D.;von Mehren, Margaret;Brennan, Murray F.;McCall, Linda;Ota, David M.;DeMatteo, Ronald P.
通讯作者：
DeMatteo, Ronald P.
影响因子：
8.4
作者：
Eisenhauer, E. A.;Therasse, P.;Verweij, J.
通讯作者：
Verweij, J.
影响因子：
45.3
作者：
Choi, Haesun;Charnsangavej, Chuslip;Benjamin, Robert S.
通讯作者：
Benjamin, Robert S.
影响因子：
45.3
作者：
Casali, Paolo G.;Le Cesne, Axel;Blay, Jean-Yves
通讯作者：
Blay, Jean-Yves
影响因子：
6.2
作者：
DeMatteo, Ronald P.;Gold, Jason S.;Antonescu, Cristina R.
通讯作者：
Antonescu, Cristina R.