Department of Oncology, Military Institute of Medicine, Warsaw, Poland.
Kidney Blood Press Res. 2012;35(1):18-25. doi: 10.1159/000329933. Epub 2011 Aug 18.
BACKGROUND/AIMS: This retrospective analysis compared progression-free survival (PFS) in 111 patients who developed or had preexisting hypertension with those who did not during treatment with second-line sunitinib. Secondary objectives included overall survival (OS) and safety.
Patients with metastatic renal cell carcinoma (mRCC) received sunitinib 50 mg orally once daily in 6-week cycles according to a 4-week on/2-week off treatment schedule. Treatment was continued until disease progression, unacceptable toxicity, withdrawal of consent, or death. Resting blood pressure (BP) was monitored by clinic and home measurements. Hypertension was defined as systolic BP ≥140 and/or diastolic BP ≥90 mm Hg. Subsequent antihypertensive treatment was empirical, depending on the patient.
Fifty-four (48.6%) patients experienced elevated BP related to sunitinib. Of these, 10 had preexisting hypertension. Patients who developed hypertension related to sunitinib treatment experienced significantly longer PFS and OS compared to those who did not (p < 0.00001). Patients who required at least 3 antihypertensive drugs had the longest PFS (p = 0.00002) and OS (p = 0.00001).
The development of hypertension during sunitinib treatment was a positive predictive factor associated with a significantly longer PFS and OS in patients with mRCC.
背景/目的:本回顾性分析比较了在接受二线舒尼替尼治疗期间发生或存在高血压的 111 例患者与未发生高血压的患者的无进展生存期(PFS)。次要目标包括总生存期(OS)和安全性。
转移性肾细胞癌(mRCC)患者接受舒尼替尼 50mg 口服,每日一次,6 周为一个周期,按照 4 周用药/2 周停药的治疗方案进行。治疗持续到疾病进展、不可接受的毒性、患者撤回同意或死亡。通过诊所和家庭测量监测静息血压(BP)。高血压定义为收缩压≥140mmHg 和/或舒张压≥90mmHg。随后的降压治疗是经验性的,取决于患者的情况。
54 例(48.6%)患者出现与舒尼替尼相关的血压升高。其中 10 例有高血压病史。与舒尼替尼治疗相关的高血压患者的 PFS 和 OS 明显长于未发生高血压的患者(p<0.00001)。需要至少 3 种降压药物的患者具有最长的 PFS(p=0.00002)和 OS(p=0.00001)。
舒尼替尼治疗期间发生高血压是一个阳性预测因子,与 mRCC 患者的 PFS 和 OS 显著延长相关。