Dovitinib in patients with gastrointestinal stromal tumour refractory and/or intolerant to imatinib.
Dovitinib in patients with gastrointestinal stromal tumour refractory and/or intolerant to imatinib.
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DOI：
10.1038/bjc.2017.290
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发表时间：
2017-10-24
影响因子：
8.8
通讯作者：
Le Cesne A
中科院分区：
文献类型：
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作者：
Joensuu H;Blay JY;Comandone A;Martin-Broto J;Fumagalli E;Grignani G;Del Muro XG;Adenis A;Valverde C;Pousa AL;Bouché O;Italiano A;Bauer S;Barone C;Weiss C;Crippa S;Camozzi M;Castellana R;Le Cesne A
这项多中心 II 期试验 (DOVIGIST) 评估了多韦替尼作为伊马替尼难治性或不耐受伊马替尼的胃肠道间质瘤 (GIST) 患者二线治疗的抗肿瘤活性。患者接受口服多韦替尼 500 mg 天−1，用药 5 天/停药 2 天，直至 GIST 进展或出现不可接受的毒性，目的是评估疗效，以第 12 周时的疾病控制率 (DCR) 进行评估。肿瘤评估和对多韦替尼治疗的反应通过实体瘤反应评估标准 (RECIST v1.1) 和 Choi 标准进行评估。次要目标包括评估无进展生存期 (PFS)、安全性和耐受性以及治疗结束时的 DCR。入组的 39 名患者中有 38 名经组织学证实患有 GIST。 12 周时的 DCR 为 52.6%（90% 置信区间 (CI)，38.2-66.7%），满足主要终点的预设疗效标准。研究结束时，客观缓解率（完全缓解+部分缓解）为 2.6%（38 例中有 1 例；90% CI，0.1-11.9%），5.3%（n=2；90% CI，0.9-15.7%）。中位 PFS 为 4.6 个月（90% CI，2.8-7.4 个月）。 26 例患者（66.7%）需要中断剂量，其中 18 例（69.2%）是由于不良事件。最常见的 3 级不良事件包括高血压 (n=7)、疲劳 (n=5)、呕吐 (n=4)、高甘油三酯血症 (n=4) 和 γ-谷氨酰转移酶增加 (n=4)。多韦替尼是一种针对伊马替尼不耐受或伊马替尼治疗后胃肠道间质瘤进展的胃肠道间质瘤患者的积极治疗方法。
This multicentre phase II trial (DOVIGIST) evaluated the antitumour activity of dovitinib as second-line treatment of patients with gastrointestinal stromal tumour (GIST) refractory to imatinib or who do not tolerate imatinib. Patients received oral dovitinib 500 mg day−1, 5 days on/2 days off, until GIST progression or unacceptable toxicity, with an objective to evaluate efficacy, assessed as the disease control rate (DCR) at 12 weeks. Tumour assessment and response to dovitinib therapy were evaluated by Response Evaluation Criteria In Solid Tumours (RECIST v1.1) and the Choi criteria. Secondary objectives included assessment of progression-free survival (PFS), safety and tolerability, and DCR at the end of treatment. Thirty-eight of the 39 patients enrolled had histologically confirmed GIST. The DCR at 12 weeks was 52.6% (90% confidence interval (CI), 38.2–66.7%) meeting the preset efficacy criterion for the primary end point. The objective response rate (complete response+partial response) was 2.6% (1 of 38; 90% CI, 0.1–11.9%), and 5.3% (n=2; 90% CI, 0.9–15.7%) at the end of the study. The median PFS was 4.6 months (90% CI, 2.8–7.4 months). Dose interruption was required in 26 patients (66.7%), of which 18 (69.2%) were due to adverse events. The most frequently observed grade 3 adverse events included hypertension (n=7), fatigue (n=5), vomiting (n=4), hypertriglyceridaemia (n=4), and γ-glutamyltransferase increase (n=4). Dovitinib is an active treatment for patients with GIST who are intolerant to imatinib or whose GIST progresses on imatinib.
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影响因子：
168.9
作者：
Joensuu, Heikki;Hohenberger, Peter;Corless, Christopher L.
通讯作者：
Corless, Christopher L.
影响因子：
50.5
作者：
Ganjoo, K. N.;Villalobos, V. M.;George, S.
通讯作者：
George, S.
DOI：
10.1016/s0140-6736(12)61857-1
发表时间：
2013-01-26
期刊：
Lancet (London, England)
影响因子：
--
作者：
Demetri GD;Reichardt P;Kang YK;Blay JY;Rutkowski P;Gelderblom H;Hohenberger P;Leahy M;von Mehren M;Joensuu H;Badalamenti G;Blackstein M;Le Cesne A;Schöffski P;Maki RG;Bauer S;Nguyen BB;Xu J;Nishida T;Chung J;Kappeler C;Kuss I;Laurent D;Casali PG;GRID study investigators
通讯作者：
GRID study investigators
影响因子：
3.3
作者：
Muenst, Simone;Thies, Svenja;Dirnhofer, Stephan
通讯作者：
Dirnhofer, Stephan
影响因子：
3.3
作者：
Nishida, Toshirou;Takahashi, Tsuyoshi;Hirota, Seiichi
通讯作者：
Hirota, Seiichi