Hijioka Discusses STARTER-NET: Everolimus Plus Lanreotide in GEP-NETs

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Susumu Hijioka, MD, discusses the key takeaways from the phase 3 STARTER-NET trial evaluating the combination of everolimus with lanreotide when used for the first-line treatment of patients with unresectable or recurrent gastroenteropancreatic neuroendocrine tumors.

Susumu Hijioka, MD, from the Department of Hepatobiliary and Pancreatic Oncology at the National Cancer Center, discusses the key takeaways from the phase 3 STARTER-NET trial (jRCT1031200023) evaluating the combination of everolimus (Afinitor) with lanreotide (Somatuline) when used for the first-line treatment of patients with unresectable or recurrent gastroenteropancreatic neuroendocrine tumors.

According to findings presented at a press briefing prior to the 2025 Gastrointestinal Cancers Symposium, everolimus plus lanreotide led to a significant improvement in progression-free survival (PFS) when compared with everolimus monotherapy as a first-line treatment of patients with unresectable or recurrent gastroenteropancreatic neuroendocrine tumors.

The median PFS was 29.7 months (95% CI, 20.5-not evaluable [NE]) in the everolimus plus lanreotide arm vs 11.5 months (95% CI, 9.0-19.8) in the everolimus monotherapy arm, with a stratified HR of 0.38 (99.91% CI, 0.15-0.96; one-sided P = .00017). The 1-year survival in the everolimus plus lanreotide group was 96.2% (range, 88.8%-98.8%) in the everolimus plus lanreotide group and 97.0% (range, 88.4%-99.2%) in the everolimus group, and the HR for overall survival was 0.74 (95% CI, 0.25-2.24).

For objective response rate (ORR), the ORR was 23.0% (95% CI, 14.6%-33.3%) in the everolimus plus lanreotide group (n = 87) and 8.3% (95% CI, 3.4%-16.4%) in the everolimus group (P =.011). Twenty-three percent and 8.3% of patients, respectively, had partial responses (PRs), 69.0% and 76.2% had stable disease (SD), 2.3% and 10.7% had progressive disease, and 5.7% and 4.8% were NE. The disease control rate (DCR) was 92.0% (95% CI, 84.1%-96.7%) and 84.5% (95% CI, 75.0%-91.5%), respectively (P = .16).

Transcription:

0:10 | Unresectable or recurrent neuroendocrine tumors have a relatively good prognosis. So, that is why I agree. I recommend to use…for the indolent patient, indolent head and neck patient. However, the more aggressive patient, our study of the combination therapy [led to a] higher progression-free survival, so we recommend that you use a combination therapy for patients with prognostic factors.

REFERENCES:
1. 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

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