Cleveland Clinic Taussig Cancer Institute, Cleveland, OH 44195, USA.
Clin Cancer Res. 2011 Jun 1;17(11):3841-9. doi: 10.1158/1078-0432.CCR-10-2806. Epub 2011 Apr 29.
To evaluate if diastolic blood pressure (dBP) ≥90 mm Hg during axitinib treatment is a marker of efficacy.
The relationship between dBP ≥90 mm Hg and efficacy was retrospectively explored across 5 phase II studies of single-agent axitinib for the treatment of 4 different tumor types. All patients had baseline BP ≤140/90 mm Hg and were stratified into 2 groups based on in-clinic BP measurements after initiating therapy: those with dBP <90 mm Hg throughout therapy and those with at least 1 dBP ≥90 mm Hg. Median overall survival (mOS), median progression-free survival (mPFS), objective response rate (ORR), and adverse events were evaluated by dBP group in individual and pooled analyses.
Two-hundred thirty patients were evaluated. Patients with dBP ≥90 mm Hg had a significantly lower relative risk of death than those with dBP <90 mm Hg [adjusted HR (95% CI) = 0.55 (0.39, 0.77); P < 0.001]. The relative risk of progression was also lower in patients with dBP ≥90 mm Hg [HR (95% CI) = 0.76 (0.54, 1.06), P = 0.107], and ORR was significantly higher (43.9% vs. 12.0%; P < 0.001). In an 8-week landmark analysis, mOS (25.8 vs. 14.9 months) and mPFS (10.2 vs. 7.1 months) were greater for patients in the ≥90 mm Hg group. Adverse events were similar between groups.
Axitinib efficacy correlated with dBP ≥90 mm Hg. Further investigation of dBP as a predictive biomarker of efficacy in patients receiving axitinib is warranted.
评估阿昔替尼治疗期间舒张压(dBP)≥90mmHg 是否是疗效的标志物。
回顾性研究了 5 项阿昔替尼单药治疗 4 种不同肿瘤类型的 II 期研究中 dBP≥90mmHg 与疗效的关系。所有患者基线血压(BP)≤140/90mmHg,根据治疗开始后门诊 BP 测量值将患者分为 2 组:整个治疗过程中 dBP<90mmHg 的患者和至少有 1 次 dBP≥90mmHg 的患者。个体和汇总分析中按 dBP 组评估中位总生存期(mOS)、中位无进展生存期(mPFS)、客观缓解率(ORR)和不良事件。
共评估了 230 例患者。dBP≥90mmHg 的患者死亡风险明显低于 dBP<90mmHg 的患者[校正 HR(95%CI)=0.55(0.39,0.77);P<0.001]。dBP≥90mmHg 的患者进展风险也较低[HR(95%CI)=0.76(0.54,1.06),P=0.107],ORR 显著更高(43.9% vs. 12.0%;P<0.001)。在 8 周的里程碑分析中,dBP≥90mmHg 组的 mOS(25.8 个月 vs. 14.9 个月)和 mPFS(10.2 个月 vs. 7.1 个月)更长。两组间不良反应相似。
阿昔替尼的疗效与 dBP≥90mmHg 相关。需要进一步研究 dBP 是否可以作为接受阿昔替尼治疗的患者疗效的预测生物标志物。