Validation and reduction of FACT/GOG-Ntx subscale for platinum/paclitaxel-induced neurologic symptoms: a gynecologic oncology group study
Validation and reduction of FACT/GOG-Ntx subscale for platinum/paclitaxel-induced neurologic symptoms: a gynecologic oncology group study
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DOI：
10.1111/j.1525-1438.2007.00794.x
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发表时间：
2007-03-01
影响因子：
4.8
通讯作者：
Fleming, G.
中科院分区：
文献类型：
--
作者：
Huang, H. Q.;Brady, M. F.;Fleming, G.
评估了用于评估铂/紫杉醇引起的神经系统症状的 FACT/GOG（妇科肿瘤组）神经毒性（Ntx）子量表。在 GOG 177 中，在治疗 1-7 个周期之前，对接受阿霉素/顺铂 (AP) 或阿霉素/顺铂/紫杉醇 (TAP) 治疗的晚期子宫内膜癌患者进行了 11 项问卷调查。在 TAP 组的 134 名患者中评估了该分量表的内部可靠性、结构有效性、标准有效性、对治疗差异的敏感性和变化 随着时间的推移。第 1-7 周期之前的内部一致性 Cronbach 系数分别为 0.85、0.80、0.84、0.82、0.82、0.85 和 0.84。第 3 周期之前 Ntx 评分的受试者工作特征曲线下面积为 0.81。TAP 组 Ntx 评分从基线时的 3.67 显着增加到第 7 周期之前的 8.13；这些高于 AP 组 Ntx 评分，后者从基线时的 3.54 增加到第 7 周期之前的 4.72。四种感觉项目占治疗差异的 80% 和观察到的子量表评分纵向变化的 63%。 11 项 Ntx 分量表可靠有效地评估铂/紫杉醇引起的周围神经病变。减少的四项版本是在临床试验中测量这种毒性的有效替代方案，而不影响其性能。
The FACT/GOG (Gynecologic Oncology Group) Neurotoxicity (Ntx) subscale for assessing platinum/paclitaxel-induced neurologic symptoms was evaluated. The 11-item questionnaire was administered to patients with advanced endometrial cancer treated with doxorubicin/cisplatin (AP) or doxorubicin/cisplatin/paclitaxel (TAP) prior to 1-7 cycles of treatment in GOG 177. The subscale was evaluated in 134 patients in the TAP group for internal reliability, construct validity, criteria validity, sensitivity to treatment differences, and change over time. Cronbach coefficients for internal consistency prior to cycles 1-7 were 0.85, 0.80, 0.84, 0.82, 0.82, 0.85, and 0.84, respectively. The area under the receiver operating characteristic curve was 0.81 for the Ntx score prior to cycle 3. The TAP arm Ntx scores increased significantly from 3.67 at baseline to 8.13 prior to cycle 7; these were higher than the AP arm Ntx scores, which increased from 3.54 at baseline to 4.72 prior to cycle 7. The four sensory items accounted for 80% of treatment differences and 63% of longitudinal changes in the observed subscale score. The 11-item Ntx subscale reliably and validly assesses platinum/paclitaxel-induced peripheral neuropathy. A reduced four-item version is an efficient alternative in measuring this toxicity in clinical trials without compromising its performance.