Durvalumab Consolidation in Limited-Stage SCLC: Outcomes by Prior Concurrent Chemoradiotherapy and Prophylactic...

In ADRIATIC, consolidation durvalumab significantly improved overall survival (OS) and progression-free survival (PFS) versus placebo in patients with limited-stage SCLC without progression after concurrent chemoradiotherapy (cCRT). 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.

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. Patients received durvalumab (n = 264) or placebo (n = 266) for up to 24 months. Multivariable Cox proportional hazards models compared treatment effect across subgroups.

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. PFS also favored durvalumab across subgroups. 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). Safety profiles were generally consistent across subgroups.

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.

ClinicalTrials.gov: NCT03703297 (ADRIATIC).