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Cancer ; 118(12): 3128-34, 2012 Jun 15.
Article in English | MEDLINE | ID: mdl-22006123

ABSTRACT

BACKGROUND: Few effective therapeutic options exist for patients with refractory diffuse large B-cell lymphoma (DLBCL). YM155 is a survivin suppressant with activity against DLBCL in a phase I trial. This phase II study was conducted to better characterize the toxicity and efficacy of this small molecule in patients with refractory DLBCL. METHODS: Forty-one patients with a median age of 66 years and 3 prior regimens were enrolled and treated with a YM155 dose of 5 mg/m(2)/d by continuous infusion for 168 hours every 21 days for up to 15 cycles of treatment. The median number of completed cycles was 3. RESULTS: One patient had a complete remission (CR) (2.4%) with an additional 2 patients (5.9%) responding, with a median progression-free survival of 58 days. CONCLUSIONS: YM155 was well tolerated with major toxicities including anemia and fatigue. Whereas YM155 had limited single-agent activity, preclinical data suggest its role in combination with other agents, including rituximab, and a study of that combination in ongoing.


Subject(s)
Antineoplastic Agents/therapeutic use , Imidazoles/therapeutic use , Inhibitor of Apoptosis Proteins/antagonists & inhibitors , Lymphoma, Large B-Cell, Diffuse/drug therapy , Naphthoquinones/therapeutic use , Adult , Aged , Aged, 80 and over , Antineoplastic Agents/administration & dosage , Antineoplastic Agents/adverse effects , Disease-Free Survival , Drug Administration Schedule , Early Termination of Clinical Trials , Female , Humans , Imidazoles/administration & dosage , Imidazoles/adverse effects , Male , Middle Aged , Naphthoquinones/administration & dosage , Naphthoquinones/adverse effects , Survivin , Young Adult
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