Medical Oncology Department, Hospital Universitario 12 de Octubre, Madrid, Spain.
Translational Genomics and Targeted Therapeutics in Solid Tumours Lab, Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Barcelona, Spain.
BJU Int. 2021 Aug;128(2):254-261. doi: 10.1111/bju.15356. Epub 2021 Apr 19.
To assess the efficacy and tolerability of rechallenge with sunitinib and other targeted therapies (TTs) in patitents with relapsed recurrent renal cell carcinoma (RCC) in the advanced setting.
In this multi-institutional retrospective study, patients with relapsed RCC were rechallenged with sunitinib or other systemic TTs as a first-line therapeutic approach after failed adjuvant sunitinib treatment. Patient characteristics, treatments and clinical outcomes were recorded. The primary endpoint was progression-free survival (PFS). Secondary endpoints were objective response rate (ORR) and overall survival (OS).
A total of 34 patients with relapses were recorded, and 25 of these (73.5%) were men. Twenty-five patients were treated with systemic TT: 65% of patients received TT against the vascular endothelial growth factor pathway (including sunitinib), 21.7% received mammalian target of rapamycin inhibitors and 13% received immunotherapy. The median (interquartile range) time to relapse was 20.3 (5.2-20.4) months from diagnosis, and 7.5 months (1.0-8.5) from the end of adjuvant suntinib treatment. At a median follow-up of 23.5 months, 24 of the 25 patients had progressed on first-line systemic therapy. The median PFS was 12.0 months (95% confidence interval [CI] 5.78-18.2). There were no statistical differences in PFS between different treatments or sunitinib rechallenge. PFS was not statistically different in patients relapsing on or after adjuvant suntinib treatment (≤ 6 or >6 months after adjuvant suntinib ending). The ORR was 20.5%. The median OS was 29.1 months (95% CI 16.4-41.8).
Rechallenge with sunitinib or other systemic therapies is still a feasible therapeutic option that provides patients with advanced or metastastic RCC with additional clinical benefits with regard to PFS and OS after failed response to adjuvant sunitinib.
评估索坦或其他靶向治疗药物（TTs）在辅助索坦治疗失败后复发/转移的晚期肾细胞癌（RCC）患者中的有效性和耐受性。
本多机构回顾性研究中，对辅助索坦治疗失败后复发的 RCC 患者进行索坦或其他全身 TTs 重新治疗，作为一线治疗方法。记录患者特征、治疗方法和临床结局。主要终点是无进展生存期（PFS）。次要终点是客观缓解率（ORR）和总生存期（OS）。
共记录了 34 例复发患者，其中 25 例（73.5%）为男性。25 例患者接受了全身 TT 治疗：65%的患者接受了血管内皮生长因子通路的 TT（包括索坦），21.7%的患者接受了哺乳动物雷帕霉素抑制剂，13%的患者接受了免疫治疗。从诊断到复发的中位（四分位间距）时间为 20.3（5.2-20.4）个月，从辅助索坦治疗结束到复发的时间为 7.5 个月（1.0-8.5）。在中位随访 23.5 个月时，25 例患者中有 24 例在一线全身治疗中进展。中位 PFS 为 12.0 个月（95%置信区间 [CI] 5.78-18.2）。不同治疗方法或索坦重新治疗之间的 PFS 无统计学差异。在辅助索坦治疗后复发（辅助索坦结束后≤6 个月或>6 个月）的患者中，PFS 无统计学差异。ORR 为 20.5%。中位 OS 为 29.1 个月（95% CI 16.4-41.8）。
索坦或其他全身治疗的重新治疗仍然是一种可行的治疗选择，为辅助索坦治疗失败后复发/转移的晚期或转移性 RCC 患者提供了额外的临床获益，包括 PFS 和 OS。
