Dr. Kelly on the Safety Profile of Adjuvant Nivolumab in Resected Esophageal/GEJ Cancer

Ronan J. Kelly, MD, MBA, chief of oncology for the 10 Baylor Scott & White Health’s North Texas Cancer Centers and director of oncology on the campus of Baylor Charles A. Sammons Cancer Center at Baylor University Medical Center, discusses the safety profile of adjuvant nivolumab (Opdivo) in resected esophageal or gastroesophageal junction (GEJ) cancer.

Tolerability is an important factor regarding novel treatments in the adjuvant setting of esophageal/GEJ cancers, explains Kelly. As such, safety was a key measure in the initial findings from the CheckMate-577 trial, which were presented virtually during the 2020 ESMO Virtual Congress. The trial evaluated adjuvant nivolumab in this patient population following chemoradiation.

Notably, as demonstrated in previous research, patients in this setting are not always able to tolerate adjuvant chemotherapy, Kelly says. For example, data from the FLOT4 trial, which evaluated the efficacy of 4 cycles of FLOT chemotherapy (fluorouracil, leucovorin, oxaliplatin, and docetaxel), followed by 4 additional cycles after surgery, showed that 46% of patients were able to finish the course of therapy. However, in CheckMate-577, 89% of patients reached at least 90% dose intensity with nivolumab.

Regarding safety with adjuvant nivolumab, no unexpected adverse effects (AEs) were observed. Most AEs were grade 1 or 2; however, any grade 3 or 4 treatment-related AEs (TRAEs) occurred in 13% of patients with nivolumab (Opdivo) and 6% with placebo. In addition, serious TRAEs were observed in 5% and 1% of patients, respectively, Kelly concludes.