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The Impact of Perioperative Durvalumab on Surgical Outcomes: Findings from the AEGEAN Study

The Impact of Perioperative Durvalumab on Surgical Outcomes: Findings from the AEGEAN Study

Introduction:

Surgery is a common treatment option for many types of cancer, but it is not always successful in eradicating the disease completely. To improve surgical outcomes, researchers have been exploring the use of immunotherapy drugs in the perioperative setting. Durvalumab, a monoclonal antibody that targets the programmed death-ligand 1 (PD-L1), has shown promising results in various cancer types. The AEGEAN study aimed to investigate the impact of perioperative durvalumab on surgical outcomes in patients with resectable non-small cell lung cancer (NSCLC).

Background:

NSCLC is the most common type of lung cancer, accounting for approximately 85% of all cases. Despite advances in surgical techniques, the five-year survival rate for NSCLC remains relatively low. Immunotherapy has revolutionized the treatment landscape for advanced NSCLC, but its role in the perioperative setting is still being explored.

Methodology:

The AEGEAN study was a multicenter, randomized, double-blind, placebo-controlled trial that enrolled patients with resectable stage II to IIIA NSCLC. Patients were randomly assigned to receive either durvalumab or placebo for two cycles before surgery and up to 12 months after surgery. The primary endpoint was event-free survival (EFS), defined as the time from randomization to disease recurrence, second primary cancer, or death.

Findings:

The AEGEAN study included 700 patients, with 350 patients in each treatment arm. The median follow-up period was 24 months. The study found that perioperative durvalumab significantly improved EFS compared to placebo. The two-year EFS rate was 74.5% in the durvalumab group compared to 55.9% in the placebo group. This represents a 38% reduction in the risk of disease recurrence, second primary cancer, or death in the durvalumab group.

Furthermore, the study also demonstrated a higher pathological complete response rate in the durvalumab group compared to the placebo group (24.2% vs. 2.8%). Pathological complete response is an important predictor of long-term survival in NSCLC patients undergoing surgery.

Safety Profile:

The safety profile of perioperative durvalumab was consistent with previous studies. The most common adverse events were fatigue, rash, and pruritus. Immune-related adverse events were reported in 29.4% of patients in the durvalumab group compared to 8.6% in the placebo group. However, most of these events were manageable with appropriate intervention.

Implications:

The findings from the AEGEAN study have significant implications for the management of resectable NSCLC. Perioperative durvalumab has shown to improve event-free survival and increase the rate of pathological complete response, indicating a potential for long-term benefits. These results suggest that incorporating immunotherapy into the perioperative treatment plan may enhance surgical outcomes and reduce the risk of disease recurrence.

Conclusion:

The AEGEAN study provides compelling evidence for the use of perioperative durvalumab in patients with resectable NSCLC. The study demonstrated improved event-free survival and increased pathological complete response rates, indicating a potential for long-term benefits. These findings highlight the importance of incorporating immunotherapy into the perioperative treatment strategy to optimize surgical outcomes and reduce the risk of disease recurrence in NSCLC patients. Further research is needed to validate these results and explore the use of perioperative immunotherapy in other cancer types.

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