Walker Mark S, Wong William, Ravelo Arliene, Miller Paul J E, Schwartzberg Lee S
Vector Oncology, 6555 Quince, Suite 400, Memphis, TN, 38119, USA.
Genentech, Inc., 1 DNA Way, South San Francisco, CA, 94080, USA.
Health Qual Life Outcomes. 2017 Aug 14;15(1):160. doi: 10.1186/s12955-017-0735-4.
Treatment options for advanced nonsquamous non-small cell lung cancer (NSCLC) in the first line include platinum-based doublet therapy with or without bevacizumab. This study examined efficacy outcomes and patient reported outcomes (PROs) in a community oncology patient sample.
Advanced nonsquamous NSCLC patients from 34 U.S. community oncology practices treated in first line with bevacizumab regimens (A platinum doublet; gemcitabine doublet; pemetrexed with platinum) or non-bevacizumab regimens (B platinum doublet; gemcitabine doublet; C pemetrexed with platinum) were recruited for this prospective study. Patient characteristics and clinical outcomes were accessed from routine care records. Three validated and widely used PRO measures of health related quality of life (HRQOL) and symptom burden were collected prospectively at each visit and up to one-year follow-up. Effectiveness outcomes were progression free survival (PFS) and overall survival (OS) assessed by Kaplan-Meier and Cox regression methods. PROs were analyzed with linear mixed model regression to examine changes over time, and the effect of disease progression.
Of 147 patients in the study, 145 provided PRO data. Patients in treatment groups were: A (n = 66, 44.9%); B (n = 25, 17.0%); C (n = 56, 38.1%). A was associated with significantly longer OS than B (HR = 0.341, p = 0.0012), and significantly longer than C (HR = 0.602, p = 0.0354). PFS results were similar. Irrespective of regimen group and on 12/32 measures, patients showed significant and clinically meaningful worsening of symptoms and HRQOL at disease progression. After disease progression, the pattern of symptom and HRQOL change showed continued worsening.
Bevacizumab-containing regimens were associated with longer PFS and OS compared with non-bevacizumab regimens. PRO measures show disease progression is associated with worsening HRQOL. Delaying disease progression can sustain better HRQL and reduce symptom burden.
一线治疗晚期非鳞状非小细胞肺癌（NSCLC）的选择包括含铂双药治疗，可联合或不联合贝伐单抗。本研究在社区肿瘤患者样本中考察了疗效结果和患者报告结局（PRO）。
本前瞻性研究招募了来自美国34家社区肿瘤诊所的晚期非鳞状NSCLC患者，这些患者一线接受贝伐单抗治疗方案（A铂类双药；吉西他滨双药；培美曲塞联合铂类）或非贝伐单抗治疗方案（B铂类双药；吉西他滨双药；C培美曲塞联合铂类）。患者特征和临床结局从常规护理记录中获取。在每次就诊时前瞻性收集三种经过验证且广泛使用的与健康相关生活质量（HRQOL）和症状负担相关的PRO指标，并进行长达一年的随访。疗效结果为采用Kaplan-Meier法和Cox回归法评估的无进展生存期（PFS）和总生存期（OS）。采用线性混合模型回归分析PRO，以考察随时间的变化以及疾病进展的影响。
研究中的147例患者中，145例提供了PRO数据。治疗组患者情况如下：A组（n = 66，44.9%）；B组（n = 25，17.0%）；C组（n = 56，38.1%）。A组的OS显著长于B组（HR = 0.341，p = 0.0012），且显著长于C组（HR = 0.602，p = 0.0354）。PFS结果相似。无论治疗方案组如何，在12/32项指标上，患者在疾病进展时症状和HRQOL均出现显著且具有临床意义的恶化。疾病进展后，症状和HRQOL的变化模式持续恶化。
与非贝伐单抗治疗方案相比，含贝伐单抗的治疗方案与更长的PFS和OS相关。PRO指标显示疾病进展与HRQOL恶化相关。延缓疾病进展可维持更好的HRQL并减轻症状负担。
