Durvalumab Consolidation in Limited-Stage SCLC: Outcomes by Prior Concurrent Chemoradiotherapy and Prophylactic Cranial Irradiation in the Phase 3 ADRIATIC Trial.

Exploratory analyses were conducted in prespecified subgroups per protocol-permitted cCRT components, prophylactic cranial irradiation (PCI) receipt, and time from end of cCRT to randomization.

根据方案允许的cCRT组成部分、预防性颅脑放疗（PCI）的接受情况以及从cCRT结束到随机分组的时间，对预先设定的亚组进行了探索性分析。

Methods

Prior cCRT comprised cisplatin-etoposide or carboplatin-etoposide with thoracic radiotherapy (60-66 Gy once daily over 6 weeks or 45 Gy twice daily over 3 weeks), with or without PCI.

先前的cCRT包括顺铂-依托泊苷或卡铂-依托泊苷联合胸部放疗（60-66 Gy，每天一次，持续6周或45 Gy，每天两次，持续3周），可选择性地包括PCI。

Patients received durvalumab (n = 264) or placebo (n = 266) for up to 24 months.

患者接受durvalumab（n = 264）或安慰剂（n = 266）治疗，最长可达24个月。

Multivariable Cox proportional hazards models compared treatment effect across subgroups.

多变量Cox比例风险模型比较了不同亚组的治疗效果。

Results

OS hazard ratios (HRs) generally favored durvalumab versus placebo across subgroups, including cisplatin-etoposide (HR = 0.82 [95% confidence interval{CI}: 0.61-1.10]) and carboplatin-etoposide (HR = 0.56 [95% CI: 0.35-0.89]) chemotherapy, once-daily (HR = 0.72 [95% CI: 0.55-0.96]) and twice-daily (HR = 0.68 [95% CI: 0.40-1.14]) radiotherapy, PCI-yes (HR = 0.75 [95% CI: 0.52-1.07]) and PCI-no (HR = 0.71 [95% CI: 0.51-0.99]), as well as time from cCRT completion to randomization subgroups.

总生存（OS）风险比（HRs）普遍倾向于durvalumab与安慰剂相比，在包括顺铂-依托泊苷（HR = 0.82 [95% 置信区间 {CI}: 0.61-1.10]）和卡铂-依托泊苷（HR = 0.56 [95% CI: 0.35-0.89]）化疗，每日一次（HR = 0.72 [95% CI: 0.55-0.96]）和每日两次（HR = 0.68 [95% CI: 0.40-1.14]）放疗，PCI-是（HR = 0.75 [95% CI: 0.52-1.07]）和PCI-否（HR = 0.71 [95% CI: 0.51-0.99]），以及从cCRT完成到随机分组的时间亚组中。

PFS also favored durvalumab across subgroups.

无进展生存期（PFS）在各亚组中也倾向于支持durvalumab。

OS and PFS HRs were consistent in multivariable analyses, with no significant interactions between treatment and subgroup pairs or time from cCRT completion to randomization (all p > 0.05).

在多变量分析中，总生存（OS）和无进展生存期（PFS）的危险比（HRs）保持一致，治疗与亚组对或从cCRT完成到随机分组的时间之间没有显著的相互作用（所有p > 0.05）。

Safety profiles were generally consistent across subgroups.

安全性特征在各亚组中总体上是一致的。

Conclusions

Consolidation durvalumab demonstrated consistent benefit versus placebo irrespective of prior cCRT components, PCI use, and time from cCRT completion to randomization, supporting its role as the new standard-of-care treatment in limited-stage SCLC.

巩固治疗使用durvalumab与安慰剂相比，在之前接受过cCRT（同步放化疗）的组成部分、PCI（预防性脑照射）使用以及从cCRT完成到随机分组的时间等方面显示出一致的益处，支持其作为局限期小细胞肺癌新标准治疗的地位。

trial_registration

ClinicalTrials.gov: NCT03703297 (ADRIATIC).

ClinicalTrials.gov: NCT03703297 (ADRIATIC) 试验。