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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 [gastrointestinal cancer]
Journal of Clinical Oncology, 08/28/09
Rinke A et al. – Octreotide LAR significantly lengthens the time to tumor progression compared with placebo in patients with functionally active and inactive metastatic midgut NETs.
Methods- Placebo-controlled, double-blind, phase IIIB study
- 85 patients with well-differentiated metastatic midgut NETs randomly assigned to placebo or octreotide LAR (30 mg im qmo)
- The median time to tumor progression in the octreotide LAR and placebo groups was 14.3 and 6 mos, respectively
- After 6 mos of tx, SD was observed in 66.7% of patients in the octreotide LAR group and 37.2% of patients in the placebo group
- The most favorable effect was observed in patients with low hepatic tumor load and resected primary tumor
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