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Lanreotide in metastatic enteropancreatic neuroendocrine tumors
Martyn E Caplin1, Marianne Pavel, Jarosław B Ćwikła
1From Royal Free Hospital, London (M.E.C.); Charité University Medicine Berlin, Berlin (M.P.); University of Warmia and Mazury, Olsztyn, Poland (J.B.Ć.); University of Texas M.D. Anderson Cancer Center, Houston (A.T.P.); University Hospital, Vienna (M.R.); Department of Oncology of the First Faculty of Medicine and General Teaching Hospital, Prague, Czech Republic (E.S.); Robert-Debré Hospital, Reims (G.C.), Ipsen, Les Ulis, (A.L., S.M., J.B.), Beaujon Hospital, Clichy (P.R.), and Paris Diderot University, Paris (P.R.) - all in France; Samuel Oschin Cancer Center, Cedars-Sinai Medical Center, Los Angeles (E.M.W.); Vall d'Hebron University Hospital, Barcelona (J.C.); Western General Hospital, Edinburgh (L.W.); and Università Cattolica del Sacro Cuore, Rome (G.R.).
Background:
Somatostatin analogues are commonly used to treat symptoms associated with hormone hypersecretion in neuroendocrine tumors; however, data on their antitumor effects are limited.
Methods:
We conducted a randomized, double-blind, placebo-controlled, multinational study of the somatostatin analogue lanreotide in patients with advanced, well-differentiated or moderately differentiated, nonfunctioning, somatostatin receptor-positive neuroendocrine tumors of grade 1 or 2 (a tumor proliferation index [on staining for the Ki-67 antigen] of <10%) and documented disease-progression status. The tumors originated in the pancreas, midgut, or hindgut or were of unknown origin. Patients were randomly assigned to receive an extended-release aqueous-gel formulation of lanreotide (Autogel [known in the United States as Depot], Ipsen) at a dose of 120 mg (101 patients) or placebo (103 patients) once every 28 days for 96 weeks. The primary end point was progression-free survival, defined as the time to disease progression (according to the Response Evaluation Criteria in Solid Tumors, version 1.0) or death. Secondary end points included overall survival, quality of life (assessed with the European Organization for Research and Treatment of Cancer questionnaires QLQ-C30 and QLQ-GI.NET21), and safety.
Results:
Most patients (96%) had no tumor progression in the 3 to 6 months before randomization, and 33% had hepatic tumor volumes greater than 25%. Lanreotide, as compared with placebo, was associated with significantly prolonged progression-free survival (median not reached vs. median of 18.0 months, P<0.001 by the stratified log-rank test; hazard ratio for progression or death, 0.47; 95% confidence interval [CI], 0.30 to 0.73). The estimated rates of progression-free survival at 24 months were 65.1% (95% CI, 54.0 to 74.1) in the lanreotide group and 33.0% (95% CI, 23.0 to 43.3) in the placebo group. The therapeutic effect in predefined subgroups was generally consistent with that in the overall population, with the exception of small subgroups in which confidence intervals were wide. There were no significant between-group differences in quality of life or overall survival. The most common treatment-related adverse event was diarrhea (in 26% of the patients in the lanreotide group and 9% of those in the placebo group).
Conclusions:
Lanreotide was associated with significantly prolonged progression-free survival among patients with metastatic enteropancreatic neuroendocrine tumors of grade 1 or 2 (Ki-67 <10%). (Funded by Ipsen; CLARINET ClinicalTrials.gov number, NCT00353496; EudraCT 2005-004904-35.).
Insights
Lanreotide significantly extended progression-free survival in patients with metastatic neuroendocrine tumors. This somatostatin analogue showed antitumor effects, improving outcomes for advanced disease.
Area of Science:
- Endocrinology
- Oncology
- Clinical Pharmacology
Background:
- Neuroendocrine tumors (NETs) often require symptom management with somatostatin analogues.
- Limited data exist regarding the antitumor efficacy of somatostatin analogues in NETs.
Purpose of the Study:
- To evaluate the antitumor effects of lanreotide in patients with advanced, nonfunctioning, somatostatin receptor-positive neuroendocrine tumors.
- To assess the impact of lanreotide on progression-free survival, overall survival, and quality of life.
Main Methods:
- A randomized, double-blind, placebo-controlled, multinational study (CLARINET) involving 204 patients.
- Patients received either lanreotide (120 mg every 28 days) or placebo for 96 weeks.
- Primary endpoint was progression-free survival; secondary endpoints included overall survival and quality of life.
Main Results:
- Lanreotide significantly prolonged progression-free survival compared to placebo (median not reached vs. 18.0 months; P<0.001).
- 24-month progression-free survival rates were 65.1% for lanreotide versus 33.0% for placebo.
- No significant differences in overall survival or quality of life were observed; diarrhea was the most common adverse event.
Conclusions:
- Lanreotide demonstrated significant antitumor activity by prolonging progression-free survival in patients with metastatic enteropancreatic neuroendocrine tumors (grade 1 or 2, Ki-67 <10%).
- The findings support the use of lanreotide for disease control in this patient population.
