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首页> 外文期刊>British Journal of Haematology >Phase II study of sorafenib in patients with relapsed or refractory lymphoma
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Phase II study of sorafenib in patients with relapsed or refractory lymphoma

机译：索拉非尼在复发或难治性淋巴瘤患者中的II期研究

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The safety and activity of the multikinase inhibitor sorafenib were investigated in patients with relapsed or refractory lymphoproliferative disorders who received sorafenib (400 mg) twice daily until disease progression or appearance of significant clinical toxicity. The primary endpoint was overall response rate (ORR). Biomarkers of sorafenib activity were analysed at baseline and during treatment. Thirty patients (median age, 61 years; range, 18-74) received a median of 4 months of therapy. Grade 3-4 toxicities included hand/foot skin reactions (20%), infections (12%), neutropenia (20%) and thrombocytopenia (14%). Two patients achieved complete remission (CR), and two achieved partial remission (PR) for an ORR of 13%. Stable disease (SD) and progressive disease (PD) was observed in 15 (50%) and 11 patients (37%), respectively. The median overall survival (OS) for all patients was 16 months. For patients who achieved CR, PR and SD, the median time to progression and OS was 5 and 24 months, respectively. Compared with patients with PD, responsive patients had significantly higher baseline levels of extracellular signal-regulated kinase phosphorylation and autophagy and presented a significant reduction of these parameters after 1 month of therapy. Sorafenib was well tolerated and had a clinical activity that warrants development of combination regimens.
机译：在患有复发或难治性淋巴增生性疾病的患者中研究了多激酶抑制剂索拉非尼的安全性和活性，这些患者每天两次接受索拉非尼（400 mg）直至疾病进展或出现明显的临床毒性。主要终点是总体缓解率（ORR）。在基线和治疗过程中分析了索拉非尼活性的生物标志物。 30名患者（中位年龄61岁;范围18-74）接受了4个月的中位治疗。 3-4级毒性包括手/足皮肤反应（20％），感染（12％），中性粒细胞减少症（20％）和血小板减少症（14％）。两名患者获得了完全缓解（CR），两名患者获得了部分缓解（PR），ORR为13％。分别在15名（50％）和11名患者（37％）中观察到稳定疾病（SD）和进行性疾病（PD）。所有患者的中位总生存期（OS）为16个月。对于获得CR，PR和SD的患者，中位进展时间和OS分别为5个月和24个月。与PD患者相比，反应性患者的细胞外信号调节激酶磷酸化和自噬基线水平明显更高，并且在治疗1个月后这些参数显着降低。索拉非尼具有良好的耐受性，并具有保证联合治疗方案发展的临床活性。

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