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AVAPERL(MO22089)研究中贝伐珠单抗或贝伐珠单抗联合培美曲塞维持治疗晚期非鳞状非小细胞肺癌患者的健康相关生活质量。

Health-related quality of life in patients with advanced nonsquamous non-small-cell lung cancer receiving bevacizumab or bevacizumab-plus-pemetrexed maintenance therapy in AVAPERL (MO22089).

机构信息

*Department of Thoracic Oncology, Lungenfachklinik Immenhausen, Immenhausen, Germany; †N.N. Blokhin Cancer Research Center of Russia, Moscow, Russia; ‡Department of Pulmonary Medicine, Lungkliniken, Linköping, Sweden; §Pulmonary and Thoracic Oncology Department, Hôpital Albert Calmette, CHRU de Lille, Lille, France; ‖Department of Medical Oncology, Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, Korea; ¶Department of Hematology and Oncology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea; #Department of Cardio-Thoracic Medicine, University of Pisa, Pisa, Italy; **Service de Pneumologie, Assistance Publique - Hopitaux de Paris, Hôpital Saint-Antoine, Paris, France; ††Global Medical Affairs, Genentech, Inc., South San Francisco, California; and ‡‡Service d' Oncologie Multidisciplinaire & Innovations Thérapeutiques, Aix Marseille University, Assistance Publique Hopitaux de Marseille, INSERM CIC, Multidisciplinary Oncology and Therapeutic Innovations, Marseille, France.

出版信息

J Thorac Oncol. 2013 Nov;8(11):1409-16. doi: 10.1097/JTO.0b013e3182a46bcf.

Abstract

INTRODUCTION

In the phase III AVAPERL trial, patients with advanced nonsquamous non-small-cell lung cancer receiving bevacizumab-plus-pemetrexed maintenance after first-line induction had a significant progression-free survival benefit relative to those treated with single-agent bevacizumab maintenance but with an increase in grade ≥3 adverse events. Here, we compare health-related quality of life (HRQOL) between AVAPERL maintenance arms.

METHODS

Patient-reported outcomes were collected at designated intervals from preinduction to final visits. HRQOL was assessed using the self-administered European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 and the Quality of Life Lung Cancer-Specific Module 13. Differences in scores of 10 points or more between arms were above the minimum important difference threshold and considered clinically meaningful.

RESULTS

During induction, patient-reported coughing symptoms improved slightly, whereas fatigue and appetite loss scores worsened relative to preinduction baseline. During maintenance, changes in mean global health status and the majority of Quality of Life Questionnaire Core 30 and Quality of Life Lung Cancer-Specific Module 13 subscale scores did not differ between trial arms by the minimum important difference defining clinically meaningful (better or worse) patient-reported outcomes. Exceptions were patient-reported role functional status, fatigue symptoms and appetite loss symptoms (favoring bevacizumab), and pain in arm or shoulder symptoms (favoring bevacizumab-plus-pemetrexed maintenance), which differed by clinically meaningful amounts at more than one maintenance assessment.

CONCLUSIONS

In AVAPERL, HRQOL remained relatively stable throughout maintenance and was generally similar in both arms. Despite an increase in adverse event rates, the addition of pemetrexed to bevacizumab maintenance resulted in similar stabilization of disease symptoms with improved efficacy outcomes.

摘要

简介

在 III 期 AVAPERL 试验中,接受贝伐珠单抗联合培美曲塞维持治疗的一线诱导后晚期非鳞状非小细胞肺癌患者与接受单药贝伐珠单抗维持治疗的患者相比,无进展生存期有显著改善,但 3 级及以上不良事件发生率增加。在此,我们比较了 AVAPERL 维持治疗组之间的健康相关生活质量(HRQOL)。

方法

患者报告的结果在从诱导前到最后一次就诊的指定时间间隔内收集。使用自我管理的欧洲癌症研究与治疗组织生活质量问卷核心 30 量表和肺癌特异性生活质量模块 13 量表评估 HRQOL。评分差值大于等于 10 分被认为有临床意义。

结果

在诱导期,与诱导前基线相比,患者报告的咳嗽症状略有改善,而疲劳和食欲丧失评分恶化。在维持期,试验臂之间平均总体健康状况和大部分生活质量问卷核心 30 量表和肺癌特异性生活质量模块 13 量表子量表评分的变化没有达到定义有临床意义(更好或更差)的患者报告结局的最小重要差异阈值。例外的是患者报告的角色功能状态、疲劳症状和食欲丧失症状(贝伐珠单抗有利)以及手臂或肩部疼痛症状(贝伐珠单抗联合培美曲塞维持有利),在多次维持评估中,这些症状的差异达到了有临床意义的程度。

结论

在 AVAPERL 中,HRQOL 在整个维持期间保持相对稳定,并且在两个臂之间基本相似。尽管不良事件发生率增加,但培美曲塞联合贝伐珠单抗维持治疗可稳定疾病症状,同时改善疗效。

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