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Afinitor plus Somatuline showed an improved survival compared with Afinitor monotherapy in patients with gastroenteropancreatic neuroendocrine tumors.
Among patients with unresectable or recurrent gastroenteropancreatic neuroendocrine tumors (GEP-NETs), Afinitor (everolimus) plus Somatuline (lanreotide) demonstrated a significant improvement in progression-free survival (PFS) compared with Afinitor monotherapy, as well as an acceptable safety profile in the first-line treatment, according to study findings presented at a press briefing prior to the 2025 American Society of Clinical Oncology Gastrointestinal Cancers Symposium.
At the interim analysis from the phase 3 STARTER-NET trial conducted in June 2024, the median PFS was 29.7 months in the Afinitor plus Somatuline group versus 11.5 months in the Afinitor monotherapy group.
The median overall survival (OS) analysis conducted in November 2024 was not evaluable (NE) in both groups. The one-year survival in the Afinitor plus Somatuline group was 96.2% in the Afinitor plus Somatuline group and 97% in the Afinitor group. A total of 13 events were observed; 11 were deaths from the primary disease, one was death from another disease and one was unknown.
The objective response rate (ORR) was 23% in the Afinitor plus Somatuline group (87 patients) and 8.3% in the Afinitor group. Twenty-three percent and 8.3% of patients, respectively, experienced partial responses (PRs), 69% and 76.2% had stable disease (SD), 2.3% and 10.7% had progressive disease, and 5.7% and 4.8% were NE.
Progression-free survival (PFS): time without disease worsening.
Overall survival (OS): time from diagnosis to death.
Disease control rate (DCR): percentage of patients with stable or shrinking tumors.
Hyperglycemia: high blood sugar.
Grade 1 or 2 GEP-NETs: less aggressive neuroendocrine tumors.
Objective response rate (ORR): percentage of patients with tumor shrinkage.
Partial response (PR): tumor shrinks by at least 30%.
Stable disease (SD): tumor size remains unchanged.
The disease control rate (DCR) was 92% and 84.5% respectively.
“The combination of [Somatuline] and [Afinitor] significantly prolonged PFS in poor prognostic population of [grade 1 or 2 gastroenteropancreatic neuroendocrine tumors], with a manageable toxicity,” Dr. Susumu Hijioka, from the Department of Hepatobiliary and Pancreatic Oncology at the National Cancer Center, wrote in the presentation. “Afinitor plus Somatuline has the potential to become a new standard first-line treatment for patients with unresectable or recurrent [gastroenteropancreatic neuroendocrine tumors] of poor prognostic population.”
Regarding safety, side effects of grade 3 (severe) or worse occurred in 35.6% of patients in the Afinitor and Somatuline group and 14.9% of patients in the Afinitor group. The most common side effects 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 side effects of grade 3 or worse were hyperglycemia (9.1% and 1.1%), oral mucositis (8.0% and 4.6%) and fatigue (5.7% and 1.1%).
A total of 250 patients were randomly assigned, in a 1:1 ratio, to either the Afinitor at 10 milligrams per day plus Somatuline at 120 milligrams every 28 days or the Afinitor monotherapy group was given Afinitor at 10 milligrams per day.
Per a subgroup analysis for PFS, the first primary site of disease was the pancreas (118 patients) and the gastrointestinal tract (50 patients). The second primary site of disease was the pancreas (118 patients); the duodenum, jejunum, ileum, cecum or appendix (15 patients); and the stomach, colon or rectum (35 patients).
Hijioka noted that the trial was terminated early due to efficacy.
“While [Somatuline] and [Afinitor] have each previously demonstrated the ability to extend PFS in patients with gastroenteropancreatic neuroendocrine tumors, combination treatment of [Somatuline] with [Afinitor] was previously unstudied. Establishing this new treatment option benefits patients by expanding their therapeutic choices and potentially improving their prognosis and quality of life,” Dr. Laura Vater, assistant professor of clinical medicine at Indiana University Simon Cancer Center, stated in a press release on the findings.
Reference:
“A phase III study of combination therapy with everolimus plus lanreotide versus everolimus monotherapy for unresectable or recurrent gastroenteropancreatic neuroendocrine tumor (JCOG1901, STARTER-NET),” by Dr. Susumu Hijioka et al. J Clin Oncol. suppl.652
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