Cancer · 2011
A phase II study of the survivin suppressant YM155 in patients with refractory diffuse large B-cell lymphoma.
Клиническое исследование II фазыСтатьяНазвание и аннотация: Перевод пока не подготовлен
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Cheson Bruce D, Bartlett Nancy L, Vose Julie M, Lopez-Hernandez Andres, Seiz Amanda L, Keating Anne T, Shamsili Setareh, Papadopoulos Kyriakos P
Аннотация
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.
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.