在常规临床实践中用培美曲塞治疗 III/IV 期非小细胞肺癌（NSCLC）的二线治疗：对体能状态和健康相关生活质量的评估。
Second-line treatment of stage III/IV non-small-cell lung cancer (NSCLC) with pemetrexed in routine clinical practice: evaluation of performance status and health-related quality of life.
机构信息
Hospital Martha-Maria, Halle-Doelau, Department of Internal Medicine II, Halle, Germany.
出版信息
BMC Cancer. 2012 Jan 13;12:14. doi: 10.1186/1471-2407-12-14.
BACKGROUND
Second-line treatment of advanced non-small-cell lung cancer (NSCLC) improves overall survival. There is a lack of data regarding the impact on patients' overall health condition. This prospective, non-interventional study evaluated performance status (PS) and health-related quality of life (HR-QoL) during second-line pemetrexed treatment in routine clinical practice.
METHODS
Stage III/IV NSCLC patients who initiated second-line pemetrexed (standard vitamin and dexamethasone supplementation) were observed for a maximum of 9 treatment cycles. The primary objective was to evaluate the proportion of patients achieving improvement of Karnofsky Index (KI) of ≥ 10% (absolute) or maintaining KI ≥ 80% after the second treatment cycle ("KI benefit response"). HR-QoL was self-rated using the EuroQoL-5D questionnaire (EQ-5D). Factors potentially associated with KI benefit response were evaluated using logistic regression models.
RESULTS
Of 521 eligible patients (73.5% Stage IV, median age 66.3 yrs, 36.1% ≥ 70 yrs, 62.0% with KI ≥ 80%), 471 (90.4%) completed at least 2 treatment cycles. 58.0% (95%CI 53.6%;62.2%) achieved KI benefit response after the second cycle. Patients with baseline KI ≥ 80%, no Grade 3/4 toxicities during the first 2 cycles, or combination regimen as prior first-line therapy were more likely to achieve a KI benefit response. EQ-5D scores improved over time. Grade 3/4 toxicities were reported in 23.8% of patients (mainly fatigue/asthenia 15.9%, neutropenia 8.7%).
CONCLUSIONS
In this large prospective, non-interventional study of second-line pemetrexed treatment in patients with advanced NSCLC, including 36% elderly patients ( ≥ 70 years), physician-rated PS and self-rated HR-QoL were maintained or improved in the majority of patients.
TRIAL REGISTRATION
Registered on ClinicalTrials.gov (NCT00540241) on October 4, 2007.
背景
晚期非小细胞肺癌（NSCLC）的二线治疗可提高总生存期。但是，关于其对患者整体健康状况的影响，目前尚缺乏相关数据。本前瞻性、非干预性研究旨在评估二线培美曲塞治疗在常规临床实践中对患者表现状态（PS）和健康相关生活质量（HR-QoL）的影响。
方法
对接受二线培美曲塞（标准维生素和地塞米松补充）治疗的 III/IV 期 NSCLC 患者进行最多 9 个治疗周期的观察。主要目的是评估第二个治疗周期后卡氏功能状态评分（Karnofsky Index，KI）提高≥10%（绝对值）或 KI≥80%的患者比例（“KI 获益反应”）。采用 EuroQoL-5D 问卷（EQ-5D）对 HR-QoL 进行自我评估。使用逻辑回归模型评估与 KI 获益反应相关的潜在因素。
结果
共纳入 521 例符合条件的患者（73.5%为 IV 期，中位年龄 66.3 岁，36.1%年龄≥70 岁，62.0%的 KI≥80%），其中 471 例（90.4%）完成了至少 2 个治疗周期。第二次治疗周期后，58.0%（95%CI 53.6%；62.2%）的患者达到 KI 获益反应。基线 KI≥80%、前 2 个周期无 3/4 级毒性、联合方案作为一线治疗的患者更有可能获得 KI 获益反应。EQ-5D 评分随时间推移而提高。3/4 级毒性的发生率为 23.8%（主要为疲劳/乏力 15.9%，中性粒细胞减少症 8.7%）。
结论
在这项针对晚期 NSCLC 二线培美曲塞治疗的大型前瞻性、非干预性研究中，包括 36%的老年患者（≥70 岁），大多数患者的医生评估 PS 和自我评估 HR-QoL 得到维持或改善。
试验注册
于 2007 年 10 月 4 日在 ClinicalTrials.gov （NCT00540241）上注册。
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