Erythropoiesis-stimulating agents (ESA) are effective for chemotherapy-induced anemia (CIA) but associated with serious adverse events. Safer alternatives would be beneficial in this population. The efficacy and safety of ferric carboxymaltose (FCM) as monotherapy for CIA was evaluated. This Phase 3, 18-week, double-blind, placebo-controlled study randomized adults with ≥ 4 weeks of chemotherapy remaining for treatment of nonmyeloid malignancies with CIA to FCM (two 15 mg/kg infusions 7 days apart; maximum dose, 750 mg single/1500 mg total) or placebo. The primary efficacy endpoint was percentage of patients with decreases in hemoglobin (Hb) ≥ 0.5 g/dL from weeks 3 to 18; the key secondary efficacy endpoint was change in Hb from baseline to week 18. Inclusion criteria included: (Hb) 8–11 g/dL, ferritin 100–800 ng/mL, and transferrin saturation (TSAT) ≤35%. In 244 patients (n = 122, both groups), the percent of patients who maintained Hb within 0.5 g/dL of baseline from weeks 3 to 18 was significantly higher with FCM versus placebo (50.8% vs. 35.3%; p = 0.01). Mean change in Hb from baseline to week 18 was similar between FCM and placebo (1.04 vs. 0.87 g/dL) but significantly greater with FCM with baseline Hb ≤ 9.9 g/dL (1.08 vs. 0.42 g/dL; p = 0.01). The percent with ≥ 1 g/dL increase from baseline was significantly higher with FCM versus placebo (71% vs. 54%; p = 0.01), occurring in a median 43 versus 85 days (p = 0.001). Common adverse events in the FCM arm included neutropenia (17%), hypophosphatemia (16%), and fatigue (15%). FCM monotherapy effectively maintained Hb and was well tolerated in CIA.

中文翻译：

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羧麦芽糖铁输注在减少非髓系恶性肿瘤接受化疗患者贫血方面的疗效和安全性：一项随机、安慰剂对照研究 (IRON-CLAD)

红细胞生成刺激剂 (ESA) 对化疗引起的贫血 (CIA) 有效，但与严重的不良事件相关。更安全的替代品将有益于这一人群。评估了铁羧基麦芽糖 (FCM) 作为 CIA 单一疗法的有效性和安全性。这项为期 18 周、双盲、安慰剂对照的 3 期研究将接受 CIA 治疗非髓系恶性肿瘤的化疗剩余 ≥ 4 周的成人随机分配至 FCM（两次 15 mg/kg 输注，间隔 7 天；最大剂量，750 mg单/1500 mg 总）或安慰剂。主要疗效终点是第 3 周至第 18 周血红蛋白 (Hb) 下降≥ 0.5 g/dL 的患者百分比；关键的次要疗效终点是 Hb 从基线到第 18 周的变化。纳入标准包括：（Hb）8-11 g/dL，铁蛋白 100-800 ng/mL，转铁蛋白饱和度（TSAT）≤35%。在 244 名患者中（n  = 122，两组），从第 3 周到第 18 周，将 Hb 维持在基线 0.5 g/dL 范围内的患者百分比显着高于使用 FCM 的患者（50.8% 对 35.3%；p  = 0.01）。从基线到第 18 周的 Hb 平均变化在 FCM 和安慰剂之间相似（1.04 对 0.87 g/dL），但在基线 Hb ≤ 9.9 g/dL 的 FCM 中显着更大（1.08 对 0.42 g/dL；p  = 0.01） . FCM 与安慰剂组相比基线增加≥ 1 g/dL 的百分比显着高于安慰剂组（71% 与 54%；p  = 0.01），发生在中位 43 天与 85 天（p = 0.001)。FCM 组的常见不良事件包括中性粒细胞减少 (17%)、低磷血症 (16%) 和疲劳 (15%)。FCM 单一疗法可有效维持 Hb，并且在 CIA 中具有良好的耐受性。