Background
PROMID: phase 3, randomized, double-blind, placebo-controlled trial in 85 treatment-naive patients with well-differentiated, locally inoperable or metastatic neuroendocrine tumors of midgut (or presumed midgut) origin, randomized 1:1.
Interventions and follow up
Arm A: Octreotide LAR 30 mg IM every 28 days
Arm B: Placebo
Primary endpoint: Time to tumor progression or tumor-related death (TTP)
mFollow up: NR
Arm B: Placebo
Primary endpoint: Time to tumor progression or tumor-related death (TTP)
mFollow up: NR
Results
TTP: 14.3mo vs 6.0mo (Arm A vs B); HR 0.34, 95% CI 0.20-0.59; P=.000072
Stable disease at 6 months: 66.7% vs 37.2% (Arm A vs B)
Stable disease at 6 months: 66.7% vs 37.2% (Arm A vs B)
Adverse events
Serious adverse events: 11 patients vs 10 patients (Arm A vs B)
Hepatobiliary: Gallstones reported 5 times in Arm A vs 6 times in Arm B; overall tolerability comparable between arms
Hepatobiliary: Gallstones reported 5 times in Arm A vs 6 times in Arm B; overall tolerability comparable between arms
Conclusions
In metastatic midgut neuroendocrine tumors, octreotide LAR significantly prolonged time to progression, establishing an antiproliferative role for somatostatin analogs.
Key Limitations
Small sample (n=85); restricted to midgut primaries; OS underpowered with extensive crossover; predates modern grading and somatostatin-receptor imaging.
Clinical Context
PROMID established octreotide LAR as antiproliferative therapy for midgut NETs. Octreotide is FDA-approved for functional NET symptom control; ASCO/ESMO endorse somatostatin analogs as first-line therapy in well-differentiated, somatostatin-receptor-positive advanced NETs.
References