Introduction: We investigated the potential impact of stage migration because of positron‐emission tomography (PET) scan staging on survival in the locally advanced (stage IIIA/B) NSCLC setting. Methods: In PROCLAIM, 598 patients with stage IIIA/B nonsquamous NSCLC (intent‐to‐treat population) were randomized to either pemetrexed plus cisplatin and concurrent thoracic radiotherapy for 3 cycles followed by 4 cycles of pemetrexed consolidation or etoposide plus cisplatin and concurrent thoracic radiotherapy for 2 cycles followed by a consolidation platinum‐based doublet regimen for up to 2 cycles. Baseline PET scan (PET Yes versus No) was one of the stratification factors. Subgroup analyses (PET Yes versus No) of overall survival (OS) and progression‐free survival (PFS) were conducted on the intent‐to‐treat population regardless of treatment, as the study did not show superior efficacy for either arm. Results: Majority (491 of 598; 82.1%) of patients had a baseline PET scan staging performed. A longer median OS (PET Yes versus No: 27.2 versus 20.8; hazard ratio = 0.81, p = 0.130) and an improved median PFS (PET Yes versus No: 11.3 versus 9.2; hazard ratio = 0.73, p = 0.012) were observed for patients with PET scans compared to those with conventional staging in both treatment arms. Conclusions: Both a significantly improved PFS and a numerically longer OS in the PET Yes subgroup, compared to patients with conventional staging, are consistent with improved survival due to stage migration. The magnitude of differences in OS and PFS based on PET scan is a reminder of the potential for factors other than the therapeutic intervention to affect outcomes.

中文翻译：

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正电子发射断层扫描对局部晚期非小细胞肺癌患者总生存期和无进展生存期的影响

简介：我们研究了由于正电子发射断层扫描 (PET) 扫描分期而导致的分期迁移对局部晚期（IIIA/B 期）NSCLC 环境中生存率的潜在影响。方法：在 PROCLAIM 中，598 名 IIIA/B 期非鳞状 NSCLC（意向治疗人群）患者随机接受培美曲塞加顺铂和同步胸部放疗 3 个周期，然后是 4 个周期培美曲塞巩固或依托泊苷加顺铂和同步胸部放疗。放疗 2 个周期，然后是巩固的基于铂的双药方案，最多 2 个周期。基线 PET 扫描（PET 是与否）是分层因素之一。对意向治疗人群进行了总生存期 (OS) 和无进展生存期 (PFS) 的亚组分析（PET 是与否），无论治疗如何，因为该研究没有显示出任何一个臂的优越疗效。结果：大多数（598 名中的 491 名；82.1%）患者进行了基线 PET 扫描分期。观察到更长的中位 OS（PET 是与否：27.2 与 20.8；风险比 = 0.81，p = 0.130）和改善的中位 PFS（PET 是与否：11.3 与 9.2；风险比 = 0.73，p = 0.012） PET 扫描的患者与两个治疗组中常规分期的患者相比。结论：与常规分期的患者相比，PET Yes 亚组的 PFS 显着改善和 OS 数值更长，与由于分期迁移而提高的生存率一致。基于 PET 扫描的 OS 和 PFS 的差异幅度提醒了治疗干预以外的因素可能会影响结果。