Interim analysis of the Phase III ADRIATIC study: Durvalumab consolidation therapy significantly prolongs survival in limited-stage small cell lung cancer.
在2024年ASCO年會上公佈的第三期ADRIATIC研究（摘要LBA5）顯示，對於局限期小細胞Lung cancer（SCLC）患者，在完成化放療後使用durvalumab進行鞏固治療，相較於單獨化放療可顯著延長生存期。這項由David R. Spigel醫學博士團隊主導的研究，標誌著數十年來局限期SCLC治療的首個重大突破。
Research design and key data
Patient grouping
- Durvalumab group (n=264): Intravenous administration of durvalumab 1500 mg every 4 weeks, starting within 42 days after completion of chemoradiotherapy.
- Placebo group (n=266)
- Some patients receive preventive brain irradiation
Survival benefits (as of January 15, 2024)
| Indicator | Durvalumab group | Placebo group | Risk reduction |
|---|---|---|---|
| Median total lifetime (OS) | 56 months | 33 months | 27% |
| Median progression-free survival (PFS) | 17 months | 9 months | 24% |
| 36-month OS rate | 57% | 48% | – |
| 24-month PFS rate | 46% | 34% | – |
Security analysis
- Incidence of adverse events at level 3-4: 24 in both groups%
- Treatment suspension rate：
- 16% in the Durvalumab group (vs. 11% in the placebo group)
- Incidence of radioactive pneumonia：
- 38% of Durvalumab group (3.0% for grade 3-4)
- 30% (2.6%) of the placebo group
Clinical significance
David R. Spigel, M.D.
Chief Scientific Officer, Sarah Cannon Institute
Dr. Spigel noted: "Immunotherapy has transformed the treatment landscape for non-small cell lung cancer (NSCLC), but ADRIATIC is the first trial to demonstrate the effectiveness of immunotherapy in limited-stage SCLC. This sets a new standard for this aggressive disease with limited treatment options."
ASCO Expert View
Lauren Byers, M.D.
Professor of Thoracic/Head and Neck Internal Medicine, MD Anderson Cancer Center
Dr. Byers emphasized: "The standard treatment for limited-stage SCLC has remained unchanged since the 1980s. This trial demonstrates that adding immunotherapy after traditional chemoradiotherapy can significantly prolong survival and reduce the risk of recurrence."
Next research direction
- Evaluating the potential benefits of durvalumab in combination with tremelimumab (current data is not yet unblinded).
- Analyze biomarkers to identify the subgroup of patients who will benefit most.
- Explore the optimal treatment timing and combination strategy
Conflict of interest and sources of information
Conflict of Interest Statement: This study was funded by AstraZeneca. Author conflict of interest disclosures can be found on theASCO conflict of interest disclosure page.
Related authoritative information in Hong Kong：Hong Kong Hospital Authority-Lung Cancer Treatment Information
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