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NCCN adds octreotide therapy to neuroendocrine tumor guidelines
The therapy lengthened time to tumor progression in neuroendocrine tumors of the midgut.
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The National Comprehensive Cancer Network has updated its Guidelines in Oncology for Neuroendocrine Tumors by incorporating octreotide therapy as an option for the management of asymptomatic patients with recurrent unresectable carcinoid tumors.
The update is based on interim findings from PROMID, a randomized placebo-controlled phase-3b trial presented at the 2009 ASCO Annual Meeting.
Researchers enrolled 85 treatment-naive patients with confirmed locally inoperable or metastasized well-differentiated neuroendocrine tumors and a Karnofsky index >60. Patients were randomly assigned 30 mg per month of octreotide LAR (Sandostatin LAR, Novartis) or placebo for 18 months. Median time to progression was the primary endpoint.
The preliminary results of the PROMID trial were previously reported in HemOnc Today. In the treatment group, the median time to tumor progression was 15.6 months compared with 5.9 months in the placebo group (HR=0.33; 95% CI, 0.19-0.55). After six months, stable disease was observed in 67% of patients in the treatment group vs. 37.2% in the placebo group, according to the researchers.
There were no treatment-related deaths, although treatment was discontinued due to adverse events in five patients assigned to octreotide LAR. The most serious, frequent adverse events affected the gastrointestinal tract, the hematopoietic system and general health status, according to Arnold.
“Octreotide LAR 30 mg significantly prolonged time to progression in all patients, and patients with low tumor load (<10%) showed an even more impressive response; thus initiating octreotide LAR early may improve patient outcomes, even following cytoreductive surgery,” Rudolph Arnold, MD, professor of medicine at Philipps University in Marburg, Germany, said during his presentation.
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