舒尼替尼治疗晚期肾细胞癌的再挑战：一项多中心回顾性研究的结果。

Sunitinib rechallenge in advanced renal cell carcinoma: outcomes of a multicenter retrospective study.

机构信息

Department of Medical Oncology, Consorci Hospitalari Provincial de Castelló, Castelló, Spain.

Instituto de Investigación Sanitaria La Fe, Valencia, Spain.

出版信息

Cancer Chemother Pharmacol. 2019 Oct;84(4):781-789. doi: 10.1007/s00280-019-03913-3. Epub 2019 Jul 31.

DOI:10.1007/s00280-019-03913-3

PMID:31367791

Abstract

PURPOSE

The aim of this multicenter study was to evaluate the clinical outcomes of patients with metastatic renal cell carcinoma (mRCC) who received sunitinib retreatment.

METHODS

Clinical data from patients treated with sunitinib rechallenge in nine Spanish centers were retrospectively analyzed. All patients received first-line sunitinib until progression or intolerance, followed by one or more successive drugs and rechallenge with sunitinib thereafter.

RESULTS

Thirty-seven patients were included. At first-line treatment, objective response rate (ORR) was 69.4% and median progression-free survival (PFS) was 19.4 months. At rechallenge, ORR was 27.2% and 39.4% of patients obtained stabilization of disease. Median PFS was 6.2 months. Clinical benefit was obtained by 21 patients (75%) with > 6-month interval between sunitinib treatments and by 1 patient (20%) among those with ≤ 6-month interval (P = 0.016). Hemoglobin levels ≥ lower level of normal were associated with clinical benefit (P = 0.019) and with PFS (P = 0.004). Median overall survival from start of first-line sunitinib was 52.7 months. No new adverse events were observed at rechallenge.

CONCLUSIONS

Sunitinib rechallenge is a feasible treatment option for selected patients with mRCC.

摘要

目的

本多中心研究旨在评估接受舒尼替尼再治疗的转移性肾细胞癌（mRCC）患者的临床结局。

方法

回顾性分析了 9 家西班牙中心接受舒尼替尼再挑战治疗的患者的临床数据。所有患者均接受一线舒尼替尼治疗，直至疾病进展或不耐受，随后接受一种或多种后续药物治疗，随后再接受舒尼替尼治疗。

结果

共纳入 37 例患者。一线治疗时，客观缓解率（ORR）为 69.4%，中位无进展生存期（PFS）为 19.4 个月。再挑战时，ORR 为 27.2%，39.4%的患者疾病稳定。中位 PFS 为 6.2 个月。21 例（75%）患者在舒尼替尼治疗间隔>6 个月时获得临床获益，1 例（20%）患者在间隔≤6 个月时获得临床获益（P=0.016）。血红蛋白水平≥正常下限与临床获益（P=0.019）和 PFS（P=0.004）相关。从一线舒尼替尼开始的中位总生存期为 52.7 个月。再挑战时未观察到新的不良事件。