OT2-07-01: Pasireotide Long Acting Release (LAR) in Breast Cancer Patients To Prevent Lymphocele after Mastectomy and Axillary Node Dissection: A Randomized, Multicenter, Phase II Study.

Abstract

Abstract Background: Lymphocele is the principal post-operative morbidity following axillary node dissection. According to the literature, incidence can vary from 4 to 89%. Encouraging results in terms of reducing postoperative lymphoceles as well as drainage duration and volume using octreotide have been recorded recently. A new molecule, namely pasireotide, developed by Novartis Pharma AG, Basle Switzerland, is a somatostatin analog possessing high binding affinity to 4 of the 5 somatostatin receptors. Trial design: We are performing a prospective, randomized 1:1, double blind, multicenter trial against placebo with a Bayesian design. Eligibility criteria: any female patient scheduled for breast surgery with mastectomy and axillary node dissection indicated at the pre-surgical stage. Specific aims: The purpose of this trial is to assess the efficacy of a single pre-surgical injection of pasireotide LAR 60 mg im in reducing the postoperative incidence of symptomatic lymphoceles following mastectomy with axillary node dissection for breast cancer. Patients are followed up for 4 weeks Statistical methods: The statistical analysis will be carried out sequentially after observing the principal criterion (i.e. success is defined as a total volume of lymphocele following single or repeated aspiration ≤ 60 cc in the 28 days following surgery or a routine aspiration volume on the 28th day ≤ 120cc) of each patient included for each randomization group, with or without treatment. It involves estimating the probability of a response in each group using a Bayesian design based on a beta-binomial model. With the Bayesian approach, the response rate in each group (πi) is considered as a random variable, with a priori density focused on the anticipated response rate of 80% in the group receiving treatment and 60% in the non-treatment group, which will be sequentially updated as the observations are made according to a so-called a posteriori law. Present accrual and target accrual: The sample size consists of a total of 90 patients with 45 patients in the active treatment group and 45 patients in the placebo one. To date more than 50% of the patients have been included. Citation Information: Cancer Res 2011;71(24 Suppl):Abstract nr OT2-07-01.