Surgical Outcomes With Neoadjuvant Durvalumab Plus Chemotherapy Followed by Adjuvant Durvalumab in Resectable NSCLC.

Abstract

Introduction: In AEGEAN, perioperative durvalumab plus neoadjuvant chemotherapy, versus neoadjuvant chemotherapy alone, significantly improved event-free survival (p = 0.004) and pathologic complete response (p < 0.001; primary end points; modified intention-to-treat [mITT] population, which excluded patients with known EGFR or ALK aberrations) with a manageable safety profile in patients with resectable (R)-NSCLC. Here, we report surgical outcomes from AEGEAN.

Methods: Patients with treatment-naive R-NSCLC (stage II-IIIB [N2]) and Eastern Cooperative Oncology Group performance status 0 or 1 were randomized (1:1) to platinum-based chemotherapy plus durvalumab or placebo intravenously (every 3 wk, 4 cycles) before surgery, followed by durvalumab or placebo (every 4 wk, 12 cycles). Surgical outcomes were summarized for the mITT population using descriptive statistics.

Results: A total of 737 out of 740 mITT patients received treatment, 366 and 371 in the durvalumab and placebo arms, respectively; 80.6% and 80.7% underwent surgery, 77.6% and 76.7% completed surgery, and of the 295 and 302 patients who underwent surgery, 17.3% and 22.2% had delayed surgery. The median time from last neoadjuvant dose to surgery was 34.0 days in both arms. Of the patients who underwent surgery, similar proportions had open (49.2% versus 50.7%) and minimally invasive (49.2% versus 47.0%) procedures; lobectomy was the most common procedure (88.1% versus 85.4%). R0 resection rates were numerically higher in the durvalumab versus placebo arm (94.7% versus 91.3%). The median time from surgery to first adjuvant dose was 50.0 versus 52.0 days. In exploratory analyses, a numerically higher proportion of patients in the durvalumab versus placebo arm with baseline N2 nodal status had downstaging from N2 to N0 (47.3% versus 40.2%) or, with baseline N1 nodal status, from N1 to N0 (53.6% versus 46.2%) after surgery. Similar proportions had surgical complication(s) (59.1% versus 60.1%), primarily grade 1 or 2 (53.0% versus 51.8%, modified safety analysis set).

Conclusion: The addition of durvalumab to neoadjuvant chemotherapy had no detrimental effect on the feasibility, approach, type, or timing of surgery and was associated with a tolerable surgical safety profile, versus neoadjuvant chemotherapy alone.

Clinical trial information: ClinicalTrials.Gov Identifier: NCT03800134.