Dose Adjustment May Aid With AE Management for Everolimus-Based Therapy for GEP-NETs
Susumu Hijioka, MD, discussed how a lower dose of everolimus may help address certain adverse events like oral mucositis and hypoglycemia.
Dose adjustments may benefit patients with unresectable or recurrent gastroenteropancreatic neuroendocrine tumors who experience adverse events from everolimus (Afinitor) in combination with lanreotide (Somatuline), used as first-line treatment, an expert said.
Results from the phase 3 STARTER-NET trial (jRCT1031200023) were presented at a press briefing prior to the 2025 Gastrointestinal Cancers Symposium. These findings demonstrated a median progression-free survival (PFS) was 29.7 months (95% CI, 20.5-not evaluable [NE]) in the everolimus plus lanreotide group vs 11.5 months (95% CI, 9.0-19.8) in the everolimus monotherapy group. The stratified HR was 0.38 (99.91% CI, 0.15-0.96; one-sided P = .00017).
Regarding safety, adverse events (AEs) of grade 3 or higher occurred in 35.6% of patients in the everolimus and lanreotide group and 14.9% of patients in the everolimus group. The most common AEs of any grade were oral mucositis (62.1% and 67.8%, respectively), hyperglycemia (62.1% and 33.3%), and diarrhea (36.8% and 26.4%). The most common AEs of grade 3 or higher were hyperglycemia (9.1% and 1.1%), oral mucositis (8.0% and 4.6%), and fatigue (5.7% and 1.1%).
Oncology Nursing News spoke with Susumu Hijioka, MD, from the Department of Hepatobiliary and Pancreatic Oncology at the National Cancer Center, to learn more about the oncology nurse and advanced practice provider’s role in potential dose adjustments if AEs occur.
Transcript:
From our trial, basically, the everolimus administered 10 milligram per day, plus lanreotide was administered 120 milligram per day, per one time, with one month.
Most patient can manage adverse effects. However, as I said, some patients [have] hypoglycemia or oral mucositis. And some—that adverse event occurs, we recommend to decrease the everolimus [from] 10 [milligrams] to 5 milligrams. And the lanreotide mostly can use the same duration.
Reference
Susumu H, Honma Y, Machida N, et al. A phase III study of combination therapy with everolimus plus lanreotide versus everolimus monotherapy for unresectable or recurrent gastroenteropancreatic neuroendocrine tumor (JCOG1901, STARTER-NET). J Clin Oncol. 2025;43(suppl 4):652. doi:10.1200/JCO.2025.43.4_suppl.652
