The Big Ten Cancer Research Consortium reports early-phase data suggesting that adjuvant treatment with the PD-L1 inhibitor durvalumab helps prevent relapse in patients with locally advanced esophageal or gastroesophageal junction (GEJ) adenocarcinoma.

Whereas historical 1-year rates of relapse in patients who do not achieve a pathologic complete response following trimodality therapy are approximately 50%, even with additional postoperative chemotherapy, the current study identified a 1-year relapse-free survival (RFS) rate of 78.6% in this patient population with use of adjuvant durvalumab.

The findings come from a phase II study conducted in 24 patients, 10 with distal esophageal adenocarcinoma and 14 with GEJ adenocarcinoma, who had residual disease after neoadjuvant chemoradiation and R0 resection. Nineteen of the patients—almost 80%—were found to have lymph node involvement at the time of surgery; the other four patients had node-negative disease. Following esophagectomy, all participants received durvalumab 1,500 mg intravenously once a month for up to 1 year.

After 11.7 months of median follow-up, seven patients (29%) experienced disease relapse, whereas 17 patients (67%) remained disease-free. These findings translate to 1-year and projected 26-month RFS rates of 78.6% and 62.9%, respectively.

Monthly use of durvalumab appeared to be safe. Five patients (20.8%) developed grade 3 adverse events, which consisted of diarrhea, hepatitis, encephalopathy, hyperglycemia, and hypoglycemia, each of which occurred in one patient. Fatigue (33.3%), nausea (25.0%), and cough (20.8%) were the most frequently reported grade 1 and 2 adverse events.

This article is news of a study presented at the 2019 Gastrointestinal Cancers Symposium. Read the original here.