TY  - JOUR
A1  - Schimanski, Carl Christoph
A1  - Möhler, Markus
A1  - Schön, Michael
A1  - Van Cutsem, Eric
A1  - Greil, Richard
A1  - Bechstein, Wolf Otto
A1  - Hegewisch-Becker, Susanna
A1  - Wichert, Götz Peter Lothar von
A1  - Vöhringer, Matthias
A1  - Heike, Michael
A1  - Heinemann, Volker
A1  - Peeters, Marc
A1  - Kanzler, Stephan
A1  - Kasper, Stefan
A1  - Overkamp, Friedrich
A1  - Schröder, Jan
A1  - Seehofer, Daniel
A1  - Kullmann, Frank
A1  - Linz, Bernhard
A1  - Schmidtmann, Irene
A1  - Smith-Machnow, Victoria
A1  - Gockel, Ines
A1  - Lang, Hauke
A1  - Galle, Peter R.
T1  - LICC: L-BLP25 in patients with colorectal carcinoma after curative resection of hepatic metastases-a randomized, placebo-controlled, multicenter, multinational, double-blinded phase II trial
T2  - BMC cancer
N2  - Background: 15-20% of all patients initially diagnosed with colorectal cancer develop metastatic disease and surgical resection remains the only potentially curative treatment available. Current 5-year survival following R0-resection of liver metastases is 28-39%, but recurrence eventually occurs in up to 70%. To date, adjuvant chemotherapy has not improved clinical outcomes significantly. The primary objective of the ongoing LICC trial (L-BLP25 In Colorectal Cancer) is to determine whether L-BLP25, an active cancer immunotherapy, extends recurrence-free survival (RFS) time over placebo in colorectal cancer patients following R0/R1 resection of hepatic metastases. L-BLP25 targets MUC1 glycoprotein, which is highly expressed in hepatic metastases from colorectal cancer. In a phase IIB trial, L-BLP25 has shown acceptable tolerability and a trend towards longer survival in patients with stage IIIB locoregional NSCLC.

Methods: This is a multinational, phase II, multicenter, randomized, double-blind, placebo-controlled trial with a sample size of 159 patients from 20 centers in 3 countries. Patients with stage IV colorectal adenocarcinoma limited to liver metastases are included. Following curative-intent complete resection of the primary tumor and of all synchronous/metachronous metastases, eligible patients are randomized 2:1 to receive either L-BLP25 or placebo. Those allocated to L-BLP25 receive a single dose of 300 mg/m2 cyclophosphamide (CP) 3 days before first L-BLP25 dose, then primary treatment with s.c. L-BLP25 930 mug once weekly for 8 weeks, followed by s.c. L-BLP25 930 mug maintenance doses at 6-week (years 1&2) and 12-week (year 3) intervals unless recurrence occurs. In the control arm, CP is replaced by saline solution and L-BLP25 by placebo. Primary endpoint is the comparison of recurrence-free survival (RFS) time between groups. Secondary endpoints are overall survival (OS) time, safety, tolerability, RFS/OS in MUC-1 positive cancers. Exploratory immune response analyses are planned. The primary endpoint will be assessed in Q3 2016. Follow-up will end Q3 2017. Interim analyses are not planned.

Discussion: The design and implementation of such a vaccination study in colorectal cancer is feasible. The study will provide recurrence-free and overall survival rates of groups in an unbiased fashion. Trial Registration EudraCT Number 2011-000218-20
Y1  - 2012
UR  - http://publikationen.ub.uni-frankfurt.de/frontdoor/index/index/docId/24074
UR  - https://nbn-resolving.org/urn:nbn:de:hebis:30:3-240748
SN  - 1471-2407
VL  - 12
IS  - 144
PB  - BioMed Central
CY  - London
ER  -