二线治疗转移性肾细胞癌患者：意大利多中心真实世界 SAX 研究最终结果。
Second line therapy with axitinib after only prior sunitinib in metastatic renal cell cancer: Italian multicenter real world SAX study final results.
机构信息
Departmental Unit of Clinical and Experimental Uro-Andrologic Oncology, Istituto Nazionale Tumori-IRCCS-Fondazione G. Pascale, Via M. Semmola, 80131, Napoli, Italy.
Department of Medical Oncology, Centro di Riferimento Oncologico, Istituto Nazionale Tumori CRO, Aviano, PN, Italy.
出版信息
J Transl Med. 2019 Aug 29;17(1):296. doi: 10.1186/s12967-019-2047-4.
BACKGROUND
This multi-institutional retrospective real life study was conducted in 22 Italian Oncology Centers and evaluated the role of Axitinib in second line treatment in not selected mRCC patients.
METHODS
148 mRCC patients were evaluated. According to Heng score 15.5%, 60.1% and 24.4% of patients were at poor risk, intermediate and favorable risk, respectively.
RESULTS
PFS, OS, DCR and ORR were 7.14 months, 15.5 months, 70.6% and 16.6%, respectively. The duration of prior sunitinib treatment correlated with a longer significant mPFS, 8.8 vs 6.3 months, respectively. Axitinib therapy was safe, without grade 4 adverse events. The most frequent toxicities of all grades were: fatigue (50%), hypertension (26%), and hypothyroidism (18%). G3 blood pressure elevation significantly correlated with longer mPFS and mOS compared to G1-G2 or no toxicity. Dose titration (DT) to 7 mg and 10 mg bid was feasible in 24% with no statistically significant differences in mPFS and mOS. The sunitinib-axitinib sequence was safe and effective, the mOS was 41.15 months. At multivariate analysis, gender, DCR to axitinib and to previous sunitinib correlated significantly with PFS; whereas DCR to axitinib, nephrectomy and Heng score independently affected overall survival.
CONCLUSIONS
Axitinib was effective and safe in a not selected real life mRCC population. Trial registration INT - Napoli - 11/16 oss. Registered 20 April 2016. http://www.istitutotumori.na.it.
背景
这项多机构回顾性真实世界研究在 22 家意大利肿瘤中心进行，评估了阿昔替尼在未经选择的 mRCC 患者二线治疗中的作用。
方法
评估了 148 名 mRCC 患者。根据 Heng 评分，分别有 15.5%、60.1%和 24.4%的患者为低危、中危和高危。
结果
PFS、OS、DCR 和 ORR 分别为 7.14 个月、15.5 个月、70.6%和 16.6%。先前舒尼替尼治疗的持续时间与更长的 mPFS 显著相关，分别为 8.8 个月和 6.3 个月。阿昔替尼治疗是安全的，没有 4 级不良事件。所有级别中最常见的毒性为：乏力（50%）、高血压（26%）和甲状腺功能减退（18%）。与 G1-G2 或无毒性相比，G3 血压升高与更长的 mPFS 和 mOS 显著相关。以 7mg 和 10mg bid 进行剂量滴定（DT）在 24%的患者中是可行的，但在 mPFS 和 mOS 方面没有统计学差异。舒尼替尼-阿昔替尼序贯治疗是安全有效的，mOS 为 41.15 个月。多变量分析显示，性别、对阿昔替尼和先前舒尼替尼的 DCR 与 PFS 显著相关；而对阿昔替尼的 DCR、肾切除术和 Heng 评分独立影响总生存。
结论
阿昔替尼在未选择的真实世界 mRCC 人群中是有效和安全的。试验注册 INT - Napoli - 11/16 oss. 于 2016 年 4 月 20 日注册。http://www.istitutotumori.na.it。
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