Unidad de Oncología Médica, Hospital General de Elda, Elda, Alicante, Spain.
Clin Transl Oncol. 2011 May;13(5):341-7. doi: 10.1007/s12094-011-0664-3.
Cancer patients with chemotherapy-induced anaemia (CIA) often experience cancer-related fatigue (CRF). Darbepoetin alfa (DA) once every 3 weeks (q3w) is an effective and well tolerated erythropoiesis-stimulating agent. This study evaluated DA effectiveness and psychometric properties of the Functional Assessment of Cancer Therapy Fatigue-Subscale (FACT-F) and the Fatigue Symptom Inventory (FSI) in CIA patients.
This was a single-centre, prospective study in 100 patients with solid tumour and moderate to severe CRF (visual analogue scale [VAS-F] ≥ 30 mm) who received DA 500 μg q3w during chemotherapy (CT). Clinical data, VAS-F, FACT-F and FSI scores were collected at the beginning and at the end of CT (EOCT).
Mean age was 62.7 years (SD: 12.1), 53.0% were women, 92.0% had ECOG 0-1 and 64% had stage IV tumours. Mean haemoglobin (Hb) significantly increased from baseline 10.2 g/dl to 11.3 g/dl at EOCT. Sixty-five percent of patients showed haematopoietic response at any study point (Hb ≥ 12 g/dl or an increase of ≥ 2 g/dl from baseline), 77% achieved Hb ≥ 11 g/dl and 7% required blood transfusions from week 5 to EOCT. CRF improvement was demonstrated by significant changes in VAS-F, FACT-F and FSI scores (decreases of 21.54, 3.56 and 12.97 points, respectively). FACT-F and FSI questionnaires showed high internal consistency (Cronbach's alpha of 0.98 and 0.98 for FACT-F and FSI, respectively, at the end of study) and satisfactory intra-class coefficients (FACT-F, r=0.73; FSI, r=0.83). There were significant correlations between scores and Hb changes (FACT-F, r=-0.44; FSI, r=-0.54).
DA 500 μg q3w showed effectiveness in improving Hb and inducing a clinically significant decrease in CRF of patients with solid tumours undergoing CT. The three instruments, VAS-F, FACT-F and FSI, could be suitable for assessing CRF.
接受化疗引起贫血（CIA）的癌症患者常经历与癌症相关的疲劳（CRF）。达贝泊汀α（DA）每 3 周（q3w）给药一次是一种有效的且耐受性良好的促红细胞生成刺激剂。本研究评估了 CIA 患者中 DA 的有效性和功能评估癌症治疗疲劳量表（FACT-F）和疲劳症状量表（FSI）的心理计量学特性。
这是一项在 100 名患有实体瘤和中重度 CRF（视觉模拟量表[VAS-F]≥30mm）的患者中进行的单中心前瞻性研究，他们在化疗（CT）期间接受了 500μg q3w 的 DA。在 CT 开始时（基线）和结束时（EOCT）收集临床数据、VAS-F、FACT-F 和 FSI 评分。
平均年龄为 62.7 岁（SD：12.1），53.0%为女性，92.0%ECOG 0-1，64%为 IV 期肿瘤。平均血红蛋白（Hb）从基线时的 10.2g/dl 显著增加到 EOCT 时的 11.3g/dl。65%的患者在任何研究点均显示出造血反应（Hb≥12g/dl 或较基线增加≥2g/dl），77%的患者达到 Hb≥11g/dl，7%的患者从第 5 周开始至 EOCT 期间需要输血。VAS-F、FACT-F 和 FSI 评分的显著变化表明 CRF 得到了改善（分别下降 21.54、3.56 和 12.97 分）。FACT-F 和 FSI 问卷在研究结束时表现出较高的内部一致性（FACT-F 的 Cronbach's alpha 为 0.98，FSI 的 Cronbach's alpha 为 0.98）和满意的组内系数（FACT-F，r=0.73；FSI，r=0.83）。评分与 Hb 变化之间存在显著相关性（FACT-F，r=-0.44；FSI，r=-0.54）。
DA 500μg q3w 可有效改善 Hb，并诱导接受 CT 的实体瘤患者的 CRF 显著下降。VAS-F、FACT-F 和 FSI 这三种工具可用于评估 CRF。
