Phase II study of sunitinib as second-line treatment for advanced gastric cancer.
Phase II study of sunitinib as second-line treatment for advanced gastric cancer.
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DOI：
10.1007/s10637-010-9438-y
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发表时间：
2011-12
影响因子：
3.4
通讯作者：
Sobrero, Alberto
中科院分区：
文献类型：
--
作者：
Bang, Yung-Jue;Kang, Yoon-Koo;Kang, Won K.;Boku, Narikazu;Chung, Hyun C.;Chen, Jen-Shi;Doi, Toshihiko;Sun, Yan;Shen, Lin;Qin, Shukui;Ng, Wai-Tong;Tursi, Jennifer M.;Lechuga, Maria J.;Lu, Dongrui Ray;Ruiz-Garcia, Ana;Sobrero, Alberto
目的。这项 II 期、开放标签、多中心研究评估了口服多靶点酪氨酸激酶抑制剂舒尼替尼治疗既往接受过化疗的晚期胃或胃食管交界腺癌患者的情况。实验设计。患者按照时间表 4/2 接受 50 毫克/天的舒尼替尼治疗（治疗 4 周，然后停止治疗 2 周）。主要终点是客观缓解率；次要终点包括临床获益率、缓解持续时间、无进展生存期（PFS）、总生存期（OS）、药代动力学、药效学、安全性和耐受性以及生活质量。结果。在入组的 78 名患者中，大多数患有胃腺癌 (93.6%) 和转移性疾病 (93.6%)。所有这些都可以评估安全性和有效性。两名患者 (2.6%) 获得部分缓解，25 名患者 (32.1%) 获得疾病稳定的最佳缓解，持续时间≥6 周。中位 PFS 为 2.3 个月（95% 置信区间 [CI]，1.6-2.6 个月），中位 OS 为 6.8 个月（95% CI，4.4-9.6 个月）。 ≥3级血小板减少症和中性粒细胞减少症的发生率分别为34.6%和29.4%，最常见的非血液学不良事件是疲劳、厌食、恶心、腹泻和口腔炎。舒尼替尼及其活性代谢物的药代动力学与之前的报道一致。基线可溶性蛋白水平或基线变化与临床结果测量之间没有显着关联。结论。本研究中观察到的舒尼替尼的延缓进展作用和可控制的毒性表明，尽管单药舒尼替尼作为晚期胃癌二线治疗的临床价值不足，但其与化疗联合的作用值得进一步研究。
Purpose. This phase II, open-label, multicenter study assessed the oral, multitargeted, tyrosine kinase inhibitor sunitinib in patients with advanced gastric or gastroesophageal junction adenocarcinoma who had received prior chemotherapy. Experimental design. Patients received sunitinib 50 mg/day on Schedule 4/2 (4 weeks on treatment, followed by 2 weeks off treatment). The primary endpoint was objective response rate; secondary endpoints included clinical benefit rate, duration of response, progression-free survival (PFS), overall survival (OS), pharmacokinetics, pharmacodynamics, safety and tolerability, and quality of life. Results. Of 78 patients enrolled, most had gastric adenocarcinoma (93.6%) and metastatic disease (93.6%). All were evaluable for safety and efficacy. Two patients (2.6%) had partial responses and 25 patients (32.1%) had a best response of stable disease for ≥6 weeks. Median PFS was 2.3 months (95% confidence interval [CI], 1.6–2.6 months) and median OS was 6.8 months (95% CI, 4.4–9.6 months). Grade ≥3 thrombocytopenia and neutropenia were reported in 34.6% and 29.4% of patients, respectively, and the most common non-hematologic adverse events were fatigue, anorexia, nausea, diarrhea, and stomatitis. Pharmacokinetics of sunitinib and its active metabolite were consistent with previous reports. There were no marked associations between baseline soluble protein levels, or changes from baseline, and measures of clinical outcome. Conclusions. The progression-delaying effect and manageable toxicity observed with sunitinib in this study suggest that although single-agent sunitinib has insufficient clinical value as second-line treatment for advanced gastric cancer, its role in combination with chemotherapy merits further study.
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影响因子：
45.3
作者：
Burstein, Harold J.;Elias, Anthony D.;Miller, Kathy D.
通讯作者：
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影响因子：
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作者：
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