Eli Lilly and Company, Indianapolis, IN 46285, USA.
Ann Oncol. 2013 Jun;24(6):1534-42. doi: 10.1093/annonc/mdt123. Epub 2013 Apr 4.
This was a post hoc analysis of patients with non-squamous histology from a phase III maintenance pemetrexed study in advanced non-small cell lung cancer (NSCLC).
The six symptom items' [average symptom burden index (ASBI)] mean at baseline was calculated using the lung cancer symptom scale (LCSS). Low and high symptom burden (LSB, ASBI < 25; HSB, ASBI ≥ 25) and performance status (PS: 0, 1) subgroups were analyzed for treatment effect on progression-free survival (PFS) and overall survival (OS) using the Cox proportional hazard models adjusted for demographic/clinical factors.
Significantly longer PFS and OS for pemetrexed versus placebo occurred in LSB patients [PFS: median 5.1 versus 2.4 months, hazard ratio (HR) 0.49, P < 0.0001; OS: median 17.5 versus 11.0 months, HR 0.63, P = 0.0012] and PS 0 patients (PFS: median 5.5 versus 1.7 months, HR 0.36, P < 0.0001; OS: median 17.7 versus 10.3 months, HR 0.54, P = 0.0019). Significantly longer PFS, but not OS, occurred in HSB patients (median 3.7 versus 2.8 months, HR 0.50, P = 0.0033) and PS 1 patients (median 4.4 versus 2.8 months, HR 0.60, P = 0.0002).
ASBI and PS are associated with survival for non-squamous NSCLC patients, suggesting that maintenance pemetrexed is useful for LSB or PS 0 patients following induction.
这是一项对晚期非小细胞肺癌（NSCLC）III 期培美曲塞维持治疗研究中鳞外组织学患者的事后分析。
使用肺癌症状量表（LCSS）计算基线时六个症状项目的平均症状负担指数（ASBI）。分析低和高症状负担（LSB，ASBI<25；HSB，ASBI≥25）和表现状态（PS：0，1）亚组，采用 Cox 比例风险模型，根据人口统计学/临床因素调整，评估无进展生存期（PFS）和总生存期（OS）的治疗效果。
培美曲塞与安慰剂相比，LSB 患者的 PFS 和 OS 显著延长[PFS：中位 5.1 个月 vs 2.4 个月，风险比（HR）0.49，P<0.0001；OS：中位 17.5 个月 vs 11.0 个月，HR 0.63，P=0.0012]和 PS 0 患者（PFS：中位 5.5 个月 vs 1.7 个月，HR 0.36，P<0.0001；OS：中位 17.7 个月 vs 10.3 个月，HR 0.54，P=0.0019）。HSB 患者（中位 3.7 个月 vs 2.8 个月，HR 0.50，P=0.0033）和 PS 1 患者（中位 4.4 个月 vs 2.8 个月，HR 0.60，P=0.0002）的 PFS 显著延长，但 OS 无显著差异。
ASBI 和 PS 与非鳞 NSCLC 患者的生存相关，提示培美曲塞维持治疗对诱导治疗后 LSB 或 PS 0 患者有效。
