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Cohen SJ , Konski AA , Putnam S , Ball DS , Meyer JE , Yu JQ , Astsaturov I , Marlow C , Dickens A , Cade DN , Meropol NJ
Phase I study of capecitabine combined with radioembolization using yttrium-90 resin microspheres (SIR-Spheres) in patients with advanced cancer
Br J Cancer. 2014 Jul 15;111(2) :265-71
PMID: 24983373    PMCID: PMC4102951   
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Abstract
Background:This was a prospective single-centre, phase I study to document the maximum tolerated dose (MTD), dose-limiting toxicity (DLT), and the recommended phase II dose for future study of capecitabine in combination with radioembolization.Methods:Patients with advanced unresectable liver-dominant cancer were enrolled in a 3+3 design with escalating doses of capecitabine (375-1000 mg/m(2) b.i.d.) for 14 days every 21 days. Radioembolization with (90)Y-resin microspheres was administered using a sequential lobar approach with two cycles of capecitabine.Results:Twenty-four patients (17 colorectal) were enrolled. The MTD was not reached. Haematologic events were generally mild. Common grade 1/2 non-haematologic toxicities included transient transaminitis/alkaline phosphatase elevation (9 (37.5%) patients), nausea (9 (37.5%)), abdominal pain (7 (29.0%)), fatigue (7 (29.0%)), and hand-foot syndrome or rash/desquamation (7 (29.0%)). One patient experienced a partial gastric antral perforation with a capecitabine dose of 750 mg/m(2). The best response was partial response in four (16.7%) patients, stable disease in 17 (70.8%) and progression in three (12.5%). Median time to progression and overall survival of the metastatic colorectal cancer cohort was 6.4 and 8.1 months, respectively.Conclusions:This combined modality treatment was generally well tolerated with encouraging clinical activity. Capecitabine 1000 mg/m(2) b.i.d. is recommended for phase II study with sequential lobar radioembolization.
Notes
1532-1827 Cohen, S J Konski, A A Putnam, S Ball, D S Meyer, J E Yu, J Q Astsaturov, I Marlow, C Dickens, A Cade, D N Meropol, N J Journal Article England Br J Cancer. 2014 Jul 15;111(2):265-71. doi: 10.1038/bjc.2014.344. Epub 2014 Jul 1.