Time to Definitive Failure to the First Tyrosine Kinase Inhibitor in Localized GI Stromal Tumors Treated With Imatinib As an Adjuvant: A European Organisation for Research and Treatment of Cancer Soft Tissue and Bone Sarcoma Group Intergroup Randomized Trial in Collaboration With the Australasian Gastro-Intestinal Trials Group, UNICANCER, French Sarcoma Group, Italian Sarcoma Group, and Spanish Group for Research on Sarcomas

Paolo G. Casali

首页> 外文期刊>Journal of Clinical Oncology >Time to Definitive Failure to the First Tyrosine Kinase Inhibitor in Localized GI Stromal Tumors Treated With Imatinib As an Adjuvant: A European Organisation for Research and Treatment of Cancer Soft Tissue and Bone Sarcoma Group Intergroup Randomized Trial in Collaboration With the Australasian Gastro-Intestinal Trials Group, UNICANCER, French Sarcoma Group, Italian Sarcoma Group, and Spanish Group for Research on Sarcomas

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Time to Definitive Failure to the First Tyrosine Kinase Inhibitor in Localized GI Stromal Tumors Treated With Imatinib As an Adjuvant: A European Organisation for Research and Treatment of Cancer Soft Tissue and Bone Sarcoma Group Intergroup Randomized Trial in Collaboration With the Australasian Gastro-Intestinal Trials Group, UNICANCER, French Sarcoma Group, Italian Sarcoma Group, and Spanish Group for Research on Sarcomas

机译：伊马替尼作为佐剂治疗的局部胃肠道间质瘤中第一种酪氨酸激酶抑制剂确定性失败的时间：一个研究和治疗癌症软组织和骨肉瘤组的欧洲组织与澳大利亚胃肠道试验组合作进行的组间随机试验，UNICANCER，法国肉瘤小组，意大利肉瘤小组和西班牙肉瘤研究小组

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Purpose In 2004, we started an intergroup randomized trial of adjuvant imatinib versus no further therapy after R0-R1 surgery patients with localized, high- or intermediate-risk GI stromal tumor (GIST). Patients and Methods Patients were randomly assigned to 2 years of imatinib 400 mg daily or no further therapy after surgery. The primary end point was overall survival; relapse-free survival (RFS), relapse-free interval, and toxicity were secondary end points. In 2009, given the concurrent improvement in prognosis of patients with advanced GIST, we changed the primary end point to imatinib failure–free survival (IFFS), with agreement of the independent data monitoring committee. We report on a planned interim analysis.

机译：目的2004年，我们开始了一项针对伊马替尼的辅助治疗的随机对照试验，该试验针对患有局部，高危或中危胃肠道间质瘤（GIST）的R0-R1手术患者，未进行进一步的治疗。患者和方法患者被随机分配为2年每天400 mg的伊马替尼治疗，或术后无进一步治疗。主要终点是总体生存率。无复发生存期（RFS），无复发间隔和毒性是次要终点。 2009年，鉴于晚期GIST患者的预后同时得到改善，我们在独立数据监测委员会的同意下将主要终点改为了伊马替尼无衰竭生存期（IFFS）。我们报告了计划中的中期分析。

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《Journal of Clinical Oncology》 |2015年第36期|共8页
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Paolo G. Casali;
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1. Time to Definitive Failure to the First Tyrosine Kinase Inhibitor in Localized GI Stromal Tumors Treated With Imatinib As an Adjuvant: A European Organisation for Research and Treatment of Cancer Soft Tissue and Bone Sarcoma Group Intergroup Randomized Trial in Collaboration With the Australasian Gastro-Intestinal Trials Group, UNICANCER, French Sarcoma Group, Italian Sarcoma Group, and Spanish Group for Research on Sarcomas [J] . Paolo G. Casali Journal of Clinical Oncology . 2015,第36期

机译：伊马替尼作为佐剂治疗的局部胃肠道间质瘤中第一种酪氨酸激酶抑制剂确定性失败的时间：一个研究和治疗癌症软组织和骨肉瘤组的欧洲组织与澳大利亚胃肠道试验组合作进行的组间随机试验，UNICANCER，法国肉瘤小组，意大利肉瘤小组和西班牙肉瘤研究小组
2. Adjuvant treatment of GIST with imatinib: solid ground or still quicksand? A comment on behalf of the EORTC Soft Tissue and Bone Sarcoma Group, the Italian Sarcoma Group, the NCRI Sarcoma Clinical Studies Group (UK), the Japanese Study Group on GIST, the French Sarcoma Group and the Spanish Sarcoma Group (GEIS). [J] . Gronchi A, Judson I, Nishida T European journal of cancer: official journal for European Organization for Research and Treatment of Cancer (EORTC) [and] European Association for Cancer Research (EACR) . 2009,第7期

机译：伊马替尼对GIST的辅助治疗：坚实的地面还是流沙？代表EORTC软组织和骨肉瘤小组，意大利肉瘤小组，NCRI肉瘤临床研究小组（英国），日本GIST研究小组，法国肉瘤小组和西班牙肉瘤小组（GEIS）发表评论。
3. Initial and late resistance to imatinib in advanced gastrointestinal stromal tumors are predicted by different prognostic factors: a European organisation for research and treatment of cancer-italian sarcoma group-australasian gastrointestinal trials [J] . Van Glabbeke M, Verweij J, Casali PG, Journal of Clinical Oncology . 2005,第24期

机译：通过不同的预后因素可以预测晚期胃肠道间质瘤对伊马替尼的初始和晚期耐药性：欧洲一家研究和治疗癌症的机构-意大利肉瘤组-澳大利亚胃肠道试验
4. Performance status is the most powerful risk factor for early death among patients with advanced soft tissue sarcomaThe European Organisation for Research and Treatment of Cancer – Soft Tissue and Bone Sarcoma Group (STBSG) and French Sarcoma Group (FSG) study [O] . N Penel, M V Glabbeke, S Mathoulin-Pelissier, 2011

机译：表现状态是晚期软组织肉瘤患者早期死亡的最有力危险因素欧洲癌症研究和治疗组织–软组织和骨肉瘤小组（STBSG）和法国肉瘤小组（FSG）的研究
5. Time to definitive failure to the first tyrosine kinase inhibitor in localized GI stromal tumors treated with imatinib as an adjuvant: A European Organisation for Research and Treatment of Cancer Soft Tissue and Bone Sarcoma Group Intergroup Randomized Trial in collaboration with the Australasian Gastro-Intestinal Trials Group, UNICANCER, French Sarcoma Group, Italian Sarcoma Group, and Spanish Group for Research on Sarcomas [O] . Casali, Paolo G, Le Cesne, Axel, Velasco, Andres Poveda, 2015

机译：在伊马替尼作为佐剂治疗的局部胃肠道间质瘤中，确定第一种酪氨酸激酶抑制剂最终失效的时间：欧洲癌症软组织和骨肉瘤组的研究和治疗组织与澳大利亚胃肠道试验组合作进行了组间随机试验，UNICANCER，法国肉瘤小组，意大利肉瘤小组和西班牙肉瘤研究小组

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