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 (PROMID) Results on long-term survival

SUMMARY: The role of Somatostatin analogs such as SANDOSTATIN® (Octreotide) for symptom control in patients with gastrointestinal and pancreatic NeuroEndocrine Tumors (NETs) is well established. SANDOSTATIN® also demonstrated antiproliferative activity in controlling tumor growth of well-differentiated metastatic midgut NETs (Carcinoid), by lengthening the Time to Tumor Progression (TTP), when compared with placebo (PROMID Study). Whether SANDOSTATIN® prolongs Overall Survival (OS) remained unclear. The study investigators now reported the long term follow up data from the same PROMID trial. Between 2001 and 2008, 85 patients were randomly assigned to receive either SANDOSTATIN® LAR (N=42) or Placebo (N=43). On disease progression, patients in the placebo group were allowed to crossover and receive SANDOSTATIN® LAR. Outcomes in patients with Hepatic tumor Load (HL – percentage of liver replaced by malignancy) at study entry of 10% or less, was compared to those whose HL was more than 10%. The median OS by January 2013 in the Placebo arm was 84 months whereas the median OS in the SANDOSTATIN® LAR group was not reached, suggesting that the OS in this group will exceed 84 months and therefore a longer follow up would be needed. Patients with HL 10% or less benefited the most whereas those with high HL did not have OS benefit with SANDOSTATIN® LAR. The authors concluded that SANDOSTATIN® LAR prolongs TTP as well as OS in patients with metastatic midgut NETs, carrying a Hepatic Load of 10% or less. Arnold R, Wittenberg M, Rinke A, et al. J Clin Oncol 31, 2013 (suppl; abstr 4030)