贫血是骨髓抑制化疗的常见副作用，但化疗引起的贫血治疗选项并不理想。我们评估了罗克沙单抗在这种情况下的疗效和安全性。这项开放性2期研究包括非造血恶性肿瘤和血红蛋白[Hb]≤10 g/dL同时计划进行≥8个额外周的骨髓抑制化疗的患者。口服罗克沙单抗的疗程为≤16周（起始剂量为2.0或2.5 mg/kg，然后每4周逐渐加量）。主要疗效终点是16周基线后无红细胞[RBC]输血的平均最大Hb变化。患者被分配到罗克沙单抗2.0（n = 31）或2.5 mg/kg（n = 61）的起始剂量，并有89人进行了疗效评估。罗克沙单抗2.0和2.5 mg/kg组的平均（标准差）最大Hb变化均为2.4（1.5）和2.5（1.5）g/dL。达到Hb增加≥2 g/dL的中位数（范围）时间为71（57-92）天。12名患者（14.5％）在治疗期间需要RBC输血（第5周至治疗结束）。罗克沙单抗在不同肿瘤类型和化疗方案下均具有疗效。14名（15.2％）患者发生深静脉血栓形成[DVT]和9名（9.8％）患者发生肺栓塞[PE]，而有3例患者在调查人员的意见下与罗克沙单抗有关的严重不良事件（PE：n = 2 [2.2％]；DVT：n = 1 [1.1％]）。 不论肿瘤类型和化疗方案如何，罗克沙单抗都可以提高患有化疗相关贫血的患者的Hb水平。不良事件与高级别恶性肿瘤患者的观察结果一致。©2023作者。Wiley Periodicals LLC出版的《美国血液学杂志》发表。

Anemia is a common side effect of myelosuppressive chemotherapy; however, chemotherapy-induced anemia (CIA) management options are suboptimal. We evaluated the efficacy and safety of roxadustat in this setting. This open-label Phase 2 study included patients with non-myeloid malignancies and CIA (hemoglobin [Hb] ≤10 g/dL) who had planned concurrent myelosuppressive chemotherapy for ≥8 additional weeks. Oral roxadustat was administered for ≤16 weeks (starting dose 2.0 or 2.5 mg/kg, then titrated every 4 weeks). The primary efficacy endpoint was mean maximum change in Hb within 16 weeks of baseline without red blood cell (RBC) transfusion. Patients were assigned to roxadustat 2.0 (n = 31) or 2.5 mg/kg (n = 61) starting doses, and 89 were assessed for efficacy. The mean (standard deviation) maximum Hb change from baseline without RBC transfusion was 2.4 (1.5) and 2.5 (1.5) g/dL in the roxadustat 2.0 and 2.5 mg/kg groups, respectively. Median (range) time to Hb increase of ≥2 g/dL was 71 (57-92) days. Twelve patients (14.5%) had RBC transfusions (Week 5 to the end of treatment). Roxadustat was efficacious regardless of tumor type and chemotherapy regimen. Deep vein thrombosis (DVT) and pulmonary embolism (PE) occurred in 14 (15.2%) and nine (9.8%) patients, respectively, and three had serious adverse events attributed to roxadustat in the opinion of the investigators (PE: n = 2 [2.2%]; DVT: n = 1 [1.1%]). Roxadustat increased Hb in patients with CIA regardless of tumor type and chemotherapy regimen. Adverse events were consistent with observations in patients with advanced-stage malignancies.© 2023 The Authors. American Journal of Hematology published by Wiley Periodicals LLC.