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/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.
authors: Georgetown University Hospital, Lombardi Comprehensive Cancer Center, Washington, DC 20007, USA. bdc4@georgetown.edu
authors: Bruce D
authors: BD
authors: Cheson
authors: Nancy L
authors: NL
authors: Bartlett
authors: Julie M
authors: JM
authors: Vose
authors: Andres
authors: A
authors: Lopez-Hernandez
authors: Amanda L
authors: AL
authors: Seiz
authors: Anne T
authors: AT
authors: Keating
authors: Setareh
authors: S
authors: Shamsili
authors: Kyriakos P
authors: KP
authors: Papadopoulos
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D018572:Disease-Free Survival; D004334:Drug Administration Schedule; D057239:Early Termination of Clinical Trials; D005260:Female; D006801:Humans; D007093:Imidazoles / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D051034:Inhibitor of Apoptosis Proteins / Q000037:antagonists & inhibitors*; D016403:Lymphoma, Large B-Cell, Diffuse / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D009285:Naphthoquinones / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D000077022:Survivin; D055815:Young Adult
chemical_list: D000970:Antineoplastic Agents; C107489:BIRC5 protein, human; D007093:Imidazoles; D051034:Inhibitor of Apoptosis Proteins; D009285:Naphthoquinones; D000077022:Survivin; C523798:sepantronium