Title: Phase III Trial Comparing Protracted Intravenous Fluorouracil Infusion Alone or With Yttrium-90 Resin Microspheres Radioembolization for Liver-Limited Metastatic Colorectal Cancer Refractory to Standard Chemotherapy
Authors: Hendlisz, Alain ×
Van den Eynde, Marc
Peeters, Marc
Maleux, Geert
Lambert, Bieke
Vannoote, Jaarke
De Keukeleire, Katrien
Verslype, Chris
Defreyne, Luc
Van Cutsem, Eric
Delatte, Philippe
Delaunoit, Thierry
Personeni, Nicola
Paesmans, Marianne
Van Laethem, Jean-Luc
Flamen, Patrick #
Issue Date: Aug-2010
Publisher: Grune & Stratton
Series Title: Journal of Clinical Oncology vol:28 issue:23 pages:3687-3694
Abstract: PURPOSE Liver dissemination is a major cause of mortality among patients with advanced colorectal cancer. Hepatic intra-arterial injection of the beta-emitting isotope yttrium-90 ((90)Y) bound to resin microspheres (radioembolization) delivers therapeutic radiation doses to liver metastases with minimal damage to adjacent tissues. PATIENTS AND METHODS We conducted a prospective, multicenter, randomized phase III trial in patients with unresectable, chemotherapy-refractory liver-limited metastatic CRC (mCRC) comparing arm A (fluorouracil [FU] protracted intravenous infusion 300 mg/m(2) days 1 through 14 every 3 weeks) and arm B (radioembolization plus intravenous FU 225 mg/m(2) days 1 through 14 then 300 mg/m(2) days 1 through 14 every 3 weeks) until hepatic progression. The primary end point was time to liver progression (TTLP). Cross-over to radioembolization was permitted after progression in arm A. Results Forty-six patients were randomly assigned and 44 were eligible for analysis (arm A, n = 23; arm B, n = 21). Median follow-up was 24.8 months. Median TTLP was 2.1 and 5.5 months in arms A and B, respectively (hazard ratio [HR] = 0.38; 95% CI, 0.20 to 0.72; P = .003). Median time to tumor progression (TTP) was 2.1 and 4.5 months, respectively (HR = 0.51; 95% CI, 0.28 to 0.94; P = .03). Grade 3 or 4 toxicities were recorded in six patients after FU monotherapy and in one patient after radioembolization plus FU treatment (P = .10). Twenty-five of 44 patients received further treatment after progression, including 10 patients in arm A who received radioembolization. Median overall survival was 7.3 and 10.0 months in arms A and B, respectively (HR = 0.92; 95% CI, 0.47 to 1.78; P = .80). CONCLUSION Radioembolization with (90)Y-resin microspheres plus FU is well tolerated and significantly improves TTLP and TTP compared with FU alone. This procedure is a valid therapeutic option for chemotherapy-refractory liver-limited mCRC.
ISSN: 0732-183X
Publication status: published
KU Leuven publication type: IT
Appears in Collections:Radiology
Translational Research in GastroIntestinal Disorders
Clinical Digestive Oncology (+)
× corresponding author
# (joint) last author

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