[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 analy...
Document type : Article de périodique (Journal article)Référence bibliographique
A B S T R A C T PurposeLiver dissemination is a major cause of mortality among patients with advanced colorectal cancer. Hepatic intra-arterial injection of the -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 MethodsWe 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.
ResultsForty-six patients were randomly assigned and 44 were eligible for analysis (arm A, n ϭ 23; arm B, n ϭ 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] ϭ 0.38; 95% CI, 0.20 to 0.72; P ϭ .003). Median time to tumor progression (TTP) was 2.1 and 4.5 months, respectively (HR ϭ 0.51; 95% CI, 0.28 to 0.94; P ϭ .03). Grade 3 or 4 toxicities were recorded in six patients after FU monotherapy and in one patient after radioembolization plus FU treatment (P ϭ .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 ϭ 0.92; 95% CI, 0.47 to 1.78; P ϭ .80).
Conclusion
Radioembolization with90 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.
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