KEY TAKEAWAYS
- The study aimed to analyze the impact of consolidation Durvalumab on outcomes on subgroups based on cCRT and PCI.
- The primary endpoint was OS and PFS.
- Consolidation Durvalumab improved survival compared to placebo, supporting it as the new standard for LS-SCLC.
In the ADRIATIC trial, consolidation treatment with Durvalumab vs placebo significantly boosted overall survival (OS) and progression-free survival (PFS) for patients with Limited-Stage-Small Cell Lung Cancer (LS-SCLC) who had not progressed after cCRT.
Suresh Senan and the team aimed to share data from specific subgroups based on cCRT-related variables and prophylactic cranial irradiation (PCI) use and analyze how they affected treatment outcomes.
Patients received either once-daily (QD) or twice-daily (BID) thoracic radiotherapy (RT) alongside 3-4 cycles of platinum-etoposide chemotherapy (CT), with or without PCI, based on investigator preference.
Participants (randomized 1-42 days post cCRT) were assigned to Durvalumab (n=264), Durvalumab + tremelimumab (n=200; arm remains blinded), or placebo (n=266), stratified by disease stage and prior PCI. The trial assessed the effects of these treatments on overall PFS in patients with LS-SCLC.
The results showed that consolidation Durvalumab improved OS and PFS compared to placebo across all subgroups, though benefits varied between CT groups. Both Durvalumab and placebo showed longer OS and PFS in the BID versus QD RT subgroups and in patients who received PCI. In carboplatin subgroups, Durvalumab improved survival, but placebo did not.
Treatment-emergent adverse events (TEAEs) were similar between Durvalumab and placebo across subgroups, with higher discontinuation rates for Durvalumab in BID, carboplatin, and PCI-no patients. Multivariable analyses for OS and PFS are ongoing.
Maximum grade 3-4 TEAEs with Durvalumab were 18.8% vs 22.8% with placebo in the BID RT group and 26.4% vs 24.7% in the QD RT group. TEAEs were 31.5% with Durvalumab in the carboplatin group vs 31.8% with placebo. In the cisplatin group, they were 20.8% with Durvalumab versus 20.3% with placebo.
For PCI-yes patients, TEAEs were 28.4% with Durvalumab versus 29.6% with placebo; for PCI-no patients, 19.8% with Durvalumab versus 17.9% with placebo. Rates of TEAEs leading to Durvalumab or placebo discontinuation were 17.4% vs 6.3% in the BID and, 16.1% vs 12.4% in the QD RT subgroups, 16.9% vs 10.2% in the carboplatin and 16.2% vs 10.7% in the cisplatin CT subgroups, and 17.0% vs 15.5% in PCI-yes and 15.7% vs 4.9% in PCI-no pts.
The study concluded that Durvalumab showed a benefit over placebo regardless of prior cCRT components and PCI use, suggesting that consolidation Durvalumab should be considered a new standard of care for patients with LS-SCLC.
The trial was sponsored by AstraZeneca.
Source: https://cslide.ctimeetingtech.com/esmo2024/attendee/confcal/show/session/17
Clinical Trial: https://clinicaltrials.gov/study/NCT03703297
Senan S, Spigel DR, Cho BC, et al. (2024). “Durvalumab (D) as consolidation therapy in limited-stage SCLC (LS-SCLC): Outcomes by prior concurrent chemoradiotherapy (cCRT) regimen and prophylactic cranial irradiation (PCI) use in the ADRIATIC trial,” Presented at the ESMO-2024 (Abstract LBA81).
