A phase II study of the survivin suppressant YM155 in patients with refractory diffuse large B-cell lymphoma

Bruce D. Cheson; Nancy L. Bartlett; Julie M. Vose; Andres Lopez-Hernandez; Amanda L. Seiz; Anne T. Keating; Setareh Shamsili

doi:10.1002/cncr.26510

A phase II study of the survivin suppressant YM155 in patients with refractory diffuse large B-cell lymphoma

Bruce D. Cheson, Nancy L. Bartlett, Julie M. Vose, Andres Lopez-Hernandez, Amanda L. Seiz, Anne T. Keating, Setareh Shamsili

Research output: Contribution to journal › Article › peer-review

98 Scopus citations

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/m²/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.

Original language	English
Pages (from-to)	3128-3134
Number of pages	7
Journal	Cancer
Volume	118
Issue number	12
DOIs	https://doi.org/10.1002/cncr.26510
State	Published - Jun 15 2012

Keywords

Biological therapy
Clinical trial
Diffuse large B-cell
Non-Hodgkin's lymphoma
Survivin

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title = "A phase II study of the survivin suppressant YM155 in patients with refractory diffuse large B-cell lymphoma",

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/m2/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.",

keywords = "Biological therapy, Clinical trial, Diffuse large B-cell, Non-Hodgkin's lymphoma, Survivin",

author = "Cheson, {Bruce D.} and Bartlett, {Nancy L.} and Vose, {Julie M.} and Andres Lopez-Hernandez and Seiz, {Amanda L.} and Keating, {Anne T.} and Setareh Shamsili",

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doi = "10.1002/cncr.26510",

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T1 - A phase II study of the survivin suppressant YM155 in patients with refractory diffuse large B-cell lymphoma

AU - Cheson, Bruce D.

AU - Bartlett, Nancy L.

AU - Vose, Julie M.

AU - Lopez-Hernandez, Andres

AU - Seiz, Amanda L.

AU - Keating, Anne T.

AU - Shamsili, Setareh

PY - 2012/6/15

Y1 - 2012/6/15

N2 - 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/m2/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.

AB - 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/m2/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.

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KW - Clinical trial

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KW - Non-Hodgkin's lymphoma

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A phase II study of the survivin suppressant YM155 in patients with refractory diffuse large B-cell lymphoma

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