The clinical benefit of ruxolitinib across patient subgroups: analysis of a placebo-controlled, Phase III study in patients with myelofibrosis.
The clinical benefit of ruxolitinib across patient subgroups: analysis of a placebo-controlled, Phase III study in patients with myelofibrosis.
复制标题
鲁索替尼对患者亚组的临床益处：对骨髓纤维化患者的安慰剂对照 III 期研究进行分析。
DOI：
10.1111/bjh.12274
复制
发表时间：
2013
影响因子：
6.5
通讯作者：
Hexner,Eli
中科院分区：
文献类型：
--
作者：
Verstovsek,Srdan;Mesa,RubenA;Gotlib,Jason;Levy,RichardS;Gupta,Vikas;DiPersio,JohnF;Catalano,JohnV;Deininger,Michael;Miller,Carole;Silver,RichardT;Talpaz,Moshe;Winton,ElliottF;HarveyJr,JimmieH;Arcasoy,MuratO;Hexner,Eli
Myelofibrosis (MF) patients can present with a wide spectrum of disease characteristics. We analysed the consistency of ruxolitinib efficacy across patient subgroups in theCOntrolledMyeloFibrosis Study WithORal JAK InhibitorTreatment (COMFORT‐I,) a double‐blind trial, where patients with intermediate‐2 or high‐risk MF were randomized to twice‐daily oral ruxolitinib (n=155) or placebo (n=154). Subgroups analysed included MF subtype (primary, post‐polycythaemia vera, post‐essential thrombocythaemia), age (≤65, > 65 years), International Prognostic Scoring System risk group, baseline Eastern Cooperative Oncology Group performance status (0, 1, ≥2),JAK2V617F mutation (positive, negative), baseline haemoglobin level (≥100, <100 g/l), baseline platelet count (100–200 × 109/l, >200 × 109/l), baseline palpable spleen size (≤10, >10 cm), and baseline quartile of spleen volume and Total Symptom Score (TSS; Q1 = lowest, Q4 = highest). Mean percentage change from baseline to week 24 in spleen volume and TSS were calculated for ruxolitinib and placebo in each subgroup. Overall survival was estimated by Kaplan–Meier method according to original randomization group. In ruxolitinib‐treated patients, reductions in spleen volume and TSS and evidence of improved survival relative to placebo across subgroups were consistent with those seen in the COMFORT‐I population, confirming that ruxolitinib is an effective therapy for the spectrum of MF patients studied in COMFORT‐I.
