Sacha I. Rothschild, MD, Ph.D. from the Department of Medical Oncology and Comprehensive Cancer Center, University Hospital Basel speaks about SAKK 16/14: Durvalumab in Addition to Neoadjuvant Chemotherapy in Patients With Stage IIIA(N2) Non–Small-Cell Lung Cancer—A Multicenter Single-Arm Phase II Trial.
Link to Article:
https://ascopubs.org/doi/abs/10.1200/JCO.21.00276?cid=DM8117&bid=91715470
Summary –
Intention:
The SAKK 16/00 study found that neoadjuvant treatment with cisplatin and docetaxel followed by surgery resulted in a 1-year event-free survival (EFS) rate of 48 percent in patients with resectable stage IIIA(N2) non–small-cell lung cancer. The extra advantage of durvalumab perioperative therapy was explored.
Methodologies:
Three cycles of cisplatin 100 mg/m2 and docetaxel 85 mg/m2 were given every three weeks, followed by two doses of durvalumab 750 mg every two weeks for neoadjuvant therapy. After surgery, Durvalumab was maintained for a year. One-year EFS was the major end goal. The statistical hypothesis was that the 1-year EFS would improve from 48 percent to 65 percent.
Outcomes:
A total of 68 patients were recruited, with 67 making up the entire analysis set. After neoadjuvant chemotherapy, the radiographic response rate was 43 percent (95 percent confidence interval: 31 to 56) and 58 percent (95 percent confidence interval: 45 to 71) after sequential neoadjuvant immunotherapy. Fifty-five patients had their tumors removed, with 34 (62%) achieving a significant pathologic response (MPR; 10% viable tumor cells) and 10 (18%) achieving a full pathologic response. In 37 cases, nodal downstaging (ypN0-1) was found after surgery (67 percent ). A total of 51 (93%) of resected patients had an R0 resection. The expression of PD-L1 before treatment had no influence on MPR or nodal downstaging. The EFS rate was 73 percent after a year (two-sided 90 percent CI, 63 to 82). After a median follow-up of 28.6 months, the median EFS and overall survival were not attained. A total of 59 patients (88%) experienced an adverse event rating of 3 or higher, including two fatal adverse events that were determined to be unrelated to the therapy.
Summary:
In patients with stage IIIA(N2) non–small-cell lung cancer, the addition of perioperative durvalumab to neoadjuvant chemotherapy is safe and outperforms historical data with a high MPR and a promising 1-year EFS rate of 73 percent.