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PROMID: Octreotide LAR delayed progression in neuroendocrine midgut tumors

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2009 Gastrointestinal Cancers Symposium

Octreotide LAR more than doubled time to progression for patients with metastatic neuroendocrine midgut tumors compared with placebo, according to the results of the phase-3b PROMID trial.

Rudolf Arnold, MD, a professor of medicine at Philipps University in Marburg, Germany, presented the results Tuesday during a press conference in advance of the 2009 Gastrointestinal Cancers Symposium.

Arnold and colleagues randomly assigned 85 treatment-naive patients to 30 mg monthly octreotide LAR (Sandostatin LAR, Novartis) or placebo.

The researchers observed that median time to progression was 14.3 months in the study arm compared with six months in the placebo arm (HR=0.34; 95% CI, 0.20-0.59). After six months, 67% of patients in the study arm had stable disease compared with 37.2% in patients assigned to placebo.

“This was to be expected,” Arnold told HemOnc Today. “These tumors are highly differentiated and a highly differentiated tumor can only minimally regress — the best result is stabilization of the disease. At six months, the difference between placebo and octreotide LAR was highly significant.”

Researchers also evaluated patients for hepatic tumor load and found that 70% of patients in the study had a tumor load ≤10%. Patients with low hepatic tumor load responded more favorably to octreotide LAR than patients with a higher tumor load. Patients with a high tumor load may have had a more aggressive form of disease, he said.

The researchers could not calculate survival because patients in the treatment arm had not yet reached median survival.

“We can say that octreotide LAR is considered standard of care for patients with newly diagnosed well-differentiated, metastatic midgut tumors and a low hepatic tumor load,” Arnold said. “In addition, octreotide LAR is a promising treatment option for patients following cytoreductive surgery with few remaining metastases.” – by Jason Harris

For more information:

• Arnold R. #121. Presented at: 2009 Gastrointestinal Cancers Symposium; Jan. 14-17, 2009; San Francisco.