Background: The efficacy and safety of tivozanib for the treatment of advanced or metastatic renal cell carcinoma (mRCC) have been established in the first-line setting in the Phase III trial TIVO-1. Methods: The prospective T-Rex study conducted in German clinical practice evaluated the safety, effectiveness and impact on quality of life (QoL) of first-line treatment with tivozanib in 32 patients with mRCC recruited between May 2019 and April 2021. Results: Recruited patients were predominantly elderly, with 53.1% aged over 75 years. Patients received a median of 6.5 tivozanib treatment cycles and the median time on treatment was 5.7 months. Overall, 78.1% of patients experienced treatment-related adverse events, including diarrhea, nausea and hypotension/hypertension. A clinical (i.e., complete or partial) response was observed in 46.9% of patients. Patients’ QoL remained stable from baseline to the end of treatment and most symptomatic toxicities resolved by the final treatment cycle, with the exclusion of dry skin, itching, and hand–foot syndrome. Conclusions: These data demonstrate that first-line treatment with tivozanib was associated with clinical activity, favorable tolerability, and stable QoL in patients with mRCC treated in everyday clinical practice across Germany, including those with advanced age.
背景：III期临床试验TIVO-1已证实替沃扎尼在晚期或转移性肾细胞癌（mRCC）一线治疗中的疗效与安全性。方法：在德国临床实践中开展的前瞻性T-Rex研究，评估了2019年5月至2021年4月期间入组的32例mRCC患者接受替沃扎尼一线治疗的安全性、有效性及对生活质量（QoL）的影响。结果：入组患者以高龄为主，53.1%年龄超过75岁。患者中位接受6.5个治疗周期替沃扎尼，中位治疗时长为5.7个月。总体而言，78.1%的患者出现治疗相关不良事件，包括腹泻、恶心及低血压/高血压。46.9%的患者达到临床（完全或部分）缓解。从基线至治疗结束期间患者生活质量保持稳定，除皮肤干燥、瘙痒和手足综合征外，多数症状性毒性在最终治疗周期前得到缓解。结论：这些数据表明，在德国日常临床实践中，替沃扎尼一线治疗与mRCC患者的临床活性、良好耐受性及生活质量稳定相关，其中也包括高龄患者群体。
肿瘤(癌症)患者之家