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使用MD安德森症状量表评估化疗所致贫血患者的症状负担:一项多中心、开放标签研究(SURPASS)的结果,该研究中患者接受每2周一次200微克剂量的达贝泊汀-α治疗。

Assessing symptom burden using the M. D. Anderson symptom inventory in patients with chemotherapy-induced anemia: results of a multicenter, open-label study (SURPASS) of patients treated with darbepoetin-alpha at a dose of 200 microg every 2 weeks.

作者信息

Gabrilove Janice L, Perez Edith A, Tomita Dianne K, Rossi Greg, Cleeland Charles S

机构信息

Division of Hematology/Oncology, Mount Sinai Medical Center, New York, New York, USA.

出版信息

Cancer. 2007 Oct 1;110(7):1629-40. doi: 10.1002/cncr.22943.

Abstract

BACKGROUND

Patients with cancer who are receiving chemotherapy often experience chemotherapy-induced anemia (CIA), which is associated with symptoms that reduce quality of life. The M. D. Anderson Symptom Inventory (MDASI) is a brief, self-rating assessment scale that measures the severity of core symptoms and symptom interference with function. The current study used the MDASI to prospectively assess the correlation between hemoglobin and self-perceived cancer-related symptoms in a large patient population with CIA who were receiving darbepoetin-alpha at a dose of 200 mug every 2 weeks.

METHODS

Eligible patients enrolled in this multicenter, open-label study were age > or =18 years, had a nonmyeloid malignancy, were receiving multicycle chemotherapy, and were anemic (hemoglobin < or = 11 g/dL). Hemoglobin was measured every 2 weeks; the MDASI was administered weekly. For hemoglobin-based endpoints, patients were stratified by baseline hemoglobin (< 10 g/dL or > or =10 g/dL).

RESULTS

Of 2422 enrolled patients, 2401 received > or =1 dose of darbepoetin-alpha. Eighty percent of patients (95% confidence limit, 78-82 patients) achieved target hemoglobin levels (> or =11 g/dL) during the study. Patients with a baseline hemoglobin < 10 g/dL had a greater increase in hemoglobin, took longer to achieve the target hemoglobin, and received more red blood cell transfusions than patients with a baseline hemoglobin > or =10 g/dL. The percentage of patients with moderate to severe MDASI scores (> or =5 points) for fatigue, distress, loss of appetite, disturbed sleep, and interference with function was reduced during the study. Improvement in symptom burden was associated with an increase in hemoglobin concentration.

CONCLUSIONS

Treatment with darbepoetin-alpha at a dose of 200 mug every 2 weeks is associated with improvement in symptom burden as measured by the MDASI, a simple tool that may improve symptom management for cancer patients with CIA.

摘要

背景

接受化疗的癌症患者常出现化疗引起的贫血(CIA),这与降低生活质量的症状相关。MD安德森症状问卷(MDASI)是一种简短的自评评估量表,用于测量核心症状的严重程度以及症状对功能的干扰。本研究使用MDASI前瞻性评估接受每2周一次200微克剂量的达贝泊汀α治疗的大量CIA患者中血红蛋白与自我感知的癌症相关症状之间的相关性。

方法

纳入本多中心、开放标签研究的合格患者年龄≥18岁,患有非髓系恶性肿瘤,接受多周期化疗,且贫血(血红蛋白≤11g/dL)。每2周测量一次血红蛋白;每周进行一次MDASI评估。对于基于血红蛋白的终点指标,患者按基线血红蛋白水平(<10g/dL或≥10g/dL)分层。

结果

在2422名登记患者中,2401名接受了≥1剂达贝泊汀α。80%的患者(95%置信区间,78 - 82名患者)在研究期间达到目标血红蛋白水平(≥11g/dL)。与基线血红蛋白≥10g/dL的患者相比,基线血红蛋白<10g/dL的患者血红蛋白升高幅度更大,达到目标血红蛋白所需时间更长,接受的红细胞输注更多。在研究期间,疲劳、痛苦、食欲不振、睡眠障碍和功能干扰的中度至重度MDASI评分(≥5分)患者的百分比有所降低。症状负担的改善与血红蛋白浓度的升高相关。

结论

每2周一次200微克剂量的达贝泊汀α治疗与MDASI测量的症状负担改善相关,MDASI是一种简单的工具,可能改善CIA癌症患者的症状管理。

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