转移性肾细胞癌中不同舒尼替尼给药方案的生存结局

Survival outcomes associated with different sunitinib dosing regimens in metastatic renal cell carcinoma.

作者信息

Cheng Winnie, Kletas Victoria, Kollmannsberger Christian, de Lemos Mário

机构信息

BC Cancer Agency, Vancouver, BC, Canada.

出版信息

J Oncol Pharm Pract. 2020 Jan;26(1):67-73. doi: 10.1177/1078155219837333. Epub 2019 Mar 25.

DOI:10.1177/1078155219837333

PMID:30909792

Abstract

BACKGROUND

Standard dosing regimen of sunitinib for metastatic renal cell carcinoma consists of four weeks treatment followed by two weeks rest (intermittent dosing). Alternative regimens have been suggested, including continuous daily dosing (continuous dosing) and non-conventional dosing (non-conventional dosing: e.g. two weeks on/one week off, non-conventional dosing), to provide more individualized therapy with less toxicities. It is unclear whether non-standard sunitinib dosing affects survival outcomes.

PATIENTS

Metastatic renal cell carcinoma patients treated with sunitinib between 1 July 2007 and 1 July 2011 at our institution.

METHODS

Medical records and dispensing data were reviewed retrospectively to categorize sunitinib dosing as intermittent dosing, continuous dosing, or non-conventional dosing. Primary outcome was to compare overall survival associated with varying regimens, with secondary outcomes of progression-free survival and incidence of treatment discontinuation due to adverse effects.

RESULTS

A total of 180 patients were identified. Most patients received intermittent dosing ( = 120, 67%), followed by continuous dosing ( = 32, 18%) and non-conventional dosing ( = 28, 16%). Compared to intermittent dosing, continuous dosing was associated with similar overall survival (median 9 vs. 13 months, HR 0.67, 95% CI: 0.43-1.06, p = 0.088) while non-conventional dosing was associated with significantly longer overall survival (median 9 vs. 23 months, HR 0.55, 95% CI: 0.34-0.90, p = 0.016). Progression-free survival was significantly better for continuous dosing (median 4 vs. 9 months, HR 0.61, 95% CI: 0.40-0.94, p = 0.025) and non-conventional dosing (median 4 vs. 10 months, HR 0.61, 95% CI: 0.39-0.95, p = 0.03) when compared to intermittent dosing. Similar to prior sunitinib trials, a significant proportion of patients (20%) discontinued sunitinib therapy due to adverse effects.

CONCLUSIONS

Based on retrospective, real-world data, alternative sunitinib dosing regimens appear to be viable options for patients with metastatic renal cell carcinoma.

摘要

背景

舒尼替尼治疗转移性肾细胞癌的标准给药方案为四周治疗后休息两周（间歇给药）。已有人提出替代方案，包括每日持续给药（持续给药）和非常规给药（非常规给药：例如两周用药/一周停药，非常规给药），以提供毒性更小的更个体化治疗。尚不清楚非标准舒尼替尼给药是否会影响生存结果。

患者

2007年7月1日至2011年7月1日在我院接受舒尼替尼治疗的转移性肾细胞癌患者。

方法

回顾性查阅病历和配药数据，将舒尼替尼给药分类为间歇给药、持续给药或非常规给药。主要结局是比较不同给药方案的总生存期，次要结局是无进展生存期以及因不良反应导致治疗中断的发生率。

结果

共纳入180例患者。大多数患者接受间歇给药（n = 120，67%），其次是持续给药（n = 32，18%）和非常规给药（n = 28，16%）。与间歇给药相比，持续给药的总生存期相似（中位生存期9个月对13个月，HR 0.67，95%CI：0.43 - 1.06，p = 0.088），而非常规给药的总生存期显著更长（中位生存期9个月对23个月，HR 0.55，95%CI：0.34 - 0.90，p = 0.016）。与间歇给药相比，持续给药（中位生存期4个月对9个月，HR 0.61，95%CI：0.40 - 0.94，p = 0.025）和非常规给药（中位生存期4个月对10个月，HR 0.61，95%CI：0.39 - 0.95，p = 0.03）的无进展生存期显著更好。与既往舒尼替尼试验相似，相当一部分患者（20%）因不良反应而中断舒尼替尼治疗。