Abstract
The somatostatin analogue lanreotide can prolong progression-free survival in patients with advanced enteropancreatic neuro endocrine tumours (NETs), according to the fi ndings of the CLARINET study. Although NETs of the pancreas, midgut, and hindgut are rare, patients commonly present with advanced stages of disease. Somatostatin analogues are often used to ameliorate symptoms that might occur as a result of tumour overproduction of hormones. To determine the eff ect of the analogue lanreotide on disease progression in patients with enteropancreatic NETs, the international placebo-controlled, double-blind, CLARINET phase 3 study was conducted (NCT00353496). 204 patients were enrolled with metastatic enteropancreatic NETs that were grade 1 or 2 (Ki-67 staining value <10%); most participants (84%) were treatmentnaive, and 33% had hepatic tumour volumes that exceeded 25%. Participants were randomly assigned to receive either lanreotide in an extended-release, aqueous-gel form (120 mg) or placebo (sodium chloride). After 2 years of treatment, the median progression-free survival in patients in the lanreotide group had not been reached, whereas it was 18 months (95% CI 12·1–24·0) for participants in the placebo group (p<0·001). The risk of disease progression was reduced with lanreotide compared with placebo (progression or death hazard ratio 0·47, 95% CI 0·30–0·73). Overall survival and quality of life did not diff er signifi cantly between groups. First author Martyn Caplin (Royal Free Hospital, London, UK) said, “The CLARINET study demonstrated not only signifi cant anti-tumour eff ect of lanreotide autogel in both intestinal and pancreatic NET cohorts but also demonstrated impressive results in patients with grade 2 NETs and in patients who had more than 25% of their liver replaced by tumour metastases.” Caplin added, “In the treatment algorithm lanreotide may now be considered a potential fi rstline anti-tumour agent in treatment of grade 1 and 2 enteropancreatic NETs.” “This is an important study”, Matthew Kulke (Dana-Farber Cancer Institute, Boston, MA, USA) told The Lancet Oncology. “It adds an important treatment option for patients with this disease, who, at present, have relatively few options.” Kulke added, “This study will change practice. Somatostatin analogues will increasingly be used for control of tumour growth—they have the advantage of being eff ective and are also very well tolerated.”
Published Version
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