PMID-19704057 – PROMID Octreotide LAR Antiproliferative in Midgut NETs
Rinke A, Muller HH, Schade-Brittinger C, et al. Placebo-controlled, double-blind, prospective, randomized study on the effect of octreotide LAR in the control of tumor growth in patients with metastatic neuroendocrine midgut tumors: a report from the PROMID Study Group. J Clin Oncol. 2009;27(28):4656-4663.
Quick Reference
| Property | Value |
|---|---|
| PMID | 19704057 |
| DOI | 10.1200/JCO.2009.22.8510 |
| Year | 2009 |
| Journal | Journal of Clinical Oncology |
| Study Type | RCT |
| Evidence Level | I |
| Sample | 85 patients, metastatic midgut NETs |
| Peptide(s) Studied | Octreotide |
Key Findings
- Median time to tumor progression was 14.3 months with octreotide LAR vs 6.0 months with placebo (HR 0.34; 95% CI 0.20-0.59; p = 0.000072)
- After 6 months, stable disease was observed in 66.7% of octreotide LAR patients vs 37.2% of placebo patients
- Functionally active and inactive tumors both benefited, though the effect was most pronounced in patients with low hepatic tumor burden (<=10%)
- The antiproliferative effect was independent of the peptide's symptomatic (antisecretory) benefit
- First RCT to demonstrate antiproliferative activity of a somatostatin analog in NETs
Study Design
Prospective, randomized, double-blind, placebo-controlled Phase IIIB trial. Treatment-naive patients with well-differentiated metastatic midgut NETs were randomized to octreotide LAR 30 mg IM monthly or placebo until tumor progression or death. Primary endpoint: time to tumor progression. Conducted across 18 German centers.
Limitations
- Relatively small sample size (n=85) due to rarity of disease and slow enrollment
- Limited to midgut NETs; pancreatic NETs were not included
- Single dose level (30 mg) studied; dose-response relationship not explored
- Study predated RECIST 1.1 criteria; used WHO criteria for response assessment
- Crossover from placebo to active treatment was permitted at progression, confounding overall survival analysis
Clinical Relevance
The PROMID trial was the landmark study establishing that somatostatin analogs have genuine antiproliferative (antitumor) effects in NETs, beyond their well-known ability to control hormonal symptoms. This trial, along with the later CLARINET study for lanreotide, fundamentally changed the treatment paradigm for NETs by demonstrating that somatostatin analogs should be considered first-line therapy for tumor growth control, not just symptom management.
Related
#research #RCT #octreotide #evidence-level-I