Department of Oncology, Mater Salutis Hospital, Legnago, Italy.
Department of Oncology, Mater Salutis Hospital, Legnago, Italy.
Clin Breast Cancer. 2019 Aug;19(4):e519-e521. doi: 10.1016/j.clbc.2019.02.004. Epub 2019 Feb 16.
To assess the pharmacologic costs of CDK4/6 inhibitors (palbociclib and ribociclib) in hormone receptor-positive (HR)/human epidermal receptor 2-negative (HER2) advanced or metastatic breast cancer (BC). Pivotal phase 3 randomized controlled trials (RCTs) were considered.
Two phase 3 RCTs including 1334 patients were considered. European Society for Medical Oncology Magnitude of Clinical Benefit Scale reached grade 3 for the PALOMA-2 and MONALEESA-2 trials. Pharmacologic costs of palbociclib and ribociclib at full dose were similar, at €3864 and €4002 per month of progression-free survival (PFS) gained, respectively. The reduction of dose of ribociclib (36.1% in the pivotal RCT vs. 36.0% of palbociclib in pivotal RCT) resulted in €2718 and €1348 per month of PFS gained at 400 and 200 mg daily, respectively.
When pharmacologic costs of drugs are combined with the measure of efficacy represented by PFS, both palbociclib and ribociclib are cost-effective first-line treatments in postmenopausal women with HR/HER2 advanced or metastatic BC, with a lower cost in favor of ribociclib in patients with dose reduction.
评估 CDK4/6 抑制剂(帕博西利和瑞博西利)在激素受体阳性(HR)/人表皮生长因子受体 2 阴性(HER2)晚期或转移性乳腺癌(BC)中的药物经济学成本。纳入了关键性的 III 期随机对照试验(RCT)。
纳入了两项包括 1334 例患者的 III 期 RCT。欧洲肿瘤内科学会临床获益幅度量表(Magnitude of Clinical Benefit Scale)对 PALOMA-2 和 MONALEESA-2 试验的评价达到了 3 级。帕博西利和瑞博西利全剂量的药物经济学成本相似,每获得 1 个月无进展生存期(PFS)获益的成本分别为 3864 欧元和 4002 欧元。瑞博西利剂量减少(关键性 RCT 中为 36.1%,而关键性 RCT 中帕博西利为 36.0%)导致 400mg 和 200mg 每日剂量时 PFS 获益分别每月降低 2718 欧元和 1348 欧元。
当将药物的药物经济学成本与 PFS 这一疗效衡量指标相结合时,在接受 CDK4/6 抑制剂治疗的绝经后 HR/HER2 晚期或转移性 BC 患者中,无论全剂量或剂量减少时,帕博西利和瑞博西利均是具有成本效益的一线治疗药物,且剂量减少时瑞博西利的成本更低。