Showing papers by "Sergio Ricci published in 2004"

A multicentric randomized phase III study to evaluate the equivalence between lanreotide PR 60 mg vs lanreotide Autogel 120 mg in well-differentiated neuroendocrine tumours (NETs)

Abstract: 4154 Background: Somatostatin analogues represent the treatment of choice for inoperable well-differentiated NETs, mainly for symptomatic patients (pts). Methods: Sixty pts with histologically proven well-differentiated NETs (accordingly to the WHO classification) were randomized to receive lanreotide prolonged release (PR) 60 mg every 3 weeks or the new drug formulation Autogel (ATG) 120 mg every 6 weeks, Primary end point was to show the equivalence between the PR and the ATG formulations in terms of clinical, symptomatic and biochemical responses. Secondary endpoints were the evaluation of tolerability, progression-free and overall survival. The estimated accrual of 30 pts for each randomization arm was achieved, accordingly to the test of Dunnet and Gent for proving the non-inferiority of the lanreotide ATG formulation. Pts were treated until progression. Globally, 40 males and 20 females were studied (median age 61, range 29–81). Primary tumour site: small bowel 37%, pancreas 27%, lung 13%, unknown 1...