The Clatterbridge Cancer Centre, Clatterbridge Road, Bebington, Liverpool, CH63 4JY, UK.
The University of Liverpool, Liverpool, UK.
Target Oncol. 2023 Jul;18(4):593-599. doi: 10.1007/s11523-023-00972-8. Epub 2023 Jun 7.
Tivozanib is a licensed as first-line treatment for metastatic renal cell carcinoma (mRCC).
To evaluate the outcomes from tivozanib in a real-world mRCC population.
Patients with mRCC commencing first-line tivozanib between March 2017 and May 2019 were identified across four specialist cancer centres in the UK. Data relating to response, overall survival (OS), progression-free survival (PFS) and adverse events (AEs) were collected retrospectively with censoring on 31 December 2020.
A total of 113 patients were identified: median age was 69 years; 78% had ECOG PS 0-1; 82% had clear cell histology; 66% had previous nephrectomy; International Metastatic RCC Database Consortium (IMDC) score was 22% favourable (F), 52% intermediate (I) and 26% poor (P). Twenty-six per cent were switched from another tyrosine kinase inhibitor (TKI) to tivozanib due to toxicity. Median follow-up was 26.6 months with 18% remaining on treatment at data censoring. Median PFS was 8.75 months. Median PFS by IMDC risk group was: F = 23.0 months; I = 10.0 months; P = 3.0 months, p value < 0.0001. Median OS was 25.0 months (F = not reached (NR) with 72% alive at data cut-off; I = 26.0 months; P = 7.0 months, p value < 0.0001). Seventy-seven per cent had an AE of any grade, and 13% had a grade ≥ 3 AE. Eighteen per cent of patients discontinued treatment due to toxicity. No patients who discontinued a prior TKI due to AEs stopped tivozanib due to AEs.
These data suggest comparable activity of tivozanib with the pivotal trial data and other TKIs in a real-world population. Its tolerability positions tivozanib as an attractive first-line option for those unsuitable for combination therapies or unable to tolerate other TKIs.
替沃扎尼布已获许可，作为转移性肾细胞癌（mRCC）的一线治疗药物。
评估替沃扎尼布在真实世界的 mRCC 人群中的疗效。
在英国的四家专业癌症中心，自 2017 年 3 月至 2019 年 5 月，共发现了 113 名接受一线替沃扎尼布治疗的 mRCC 患者。回顾性收集了与反应、总生存期（OS）、无进展生存期（PFS）和不良事件（AE）相关的数据，并于 2020 年 12 月 31 日截止。
共发现 113 名患者：中位年龄为 69 岁；78%患者的 ECOG PS 评分为 0-1；82%患者的组织学类型为透明细胞癌；66%患者曾行肾切除术；国际转移性肾细胞癌数据库联盟（IMDC）评分中，22%为有利（F），52%为中等（I），26%为不良（P）。由于毒性，26%的患者从另一种酪氨酸激酶抑制剂（TKI）转换为替沃扎尼布。中位随访时间为 26.6 个月，数据截止时仍有 18%的患者在接受治疗。中位 PFS 为 8.75 个月。按 IMDC 风险组分层的中位 PFS 为：F 组为 23.0 个月；I 组为 10.0 个月；P 组为 3.0 个月，p 值<0.0001。中位 OS 为 25.0 个月（F 组未达到，72%的患者在数据截止时仍存活；I 组为 26.0 个月；P 组为 7.0 个月，p 值<0.0001）。77%的患者出现任何等级的 AE，13%的患者出现≥3 级 AE。18%的患者因毒性而停止治疗。由于 AE 而停止先前 TKI 治疗的患者中，没有因 AE 而停止替沃扎尼布治疗的患者。
这些数据表明，在真实世界人群中，替沃扎尼布与关键性试验数据和其他 TKI 相比具有相似的活性。其可耐受的特性使替沃扎尼布成为一种有吸引力的一线治疗选择，适用于不适合联合治疗或不能耐受其他 TKI 的患者。
