title: A multicenter, open-label, noncomparative screening study of enzastaurin in adult patients with non-Hodgkin lymphomas.
abstract: OBJECTIVE
  To assess the antitumor activity of enzastaurin in patients with non-Hodgkin lymphomas: T-cell lymphoma (n = 23): cutaneous and peripheral T-cell lymphoma; indolent B-cell lymphomas (n = 19): small lymphocytic, follicular grade 1 or 2, marginal zone lymphomas; and aggressive B-cell lymphomas (n = 15): follicular lymphomas grade 3, aggressive lymphoma with a clinical history. The primary objective was to determine overall tumor response. Secondary objectives included duration of response and safety.
  
  
  METHODS
  In this multicenter, open-label, noncomparative, screening study conducted between December 2007 and February 2009, patients (≥ 18 years) who relapsed after ≥ 1 prior systemic treatment or who were intolerant to standard systemic therapy received 250 mg oral enzastaurin (125 mg tablets twice a day; a 1125-mg loading dose on day 1), in 28-day cycles for up to 2 years unless unacceptable toxicity or progressive disease occurred.
  
  
  RESULTS
  Responses were seen in follicular lymphomas grade 3 (1/5, 20.0%), cutaneous T-cell lymphoma (2/11, 18.2%), small lymphocytic lymphomas (1/7, 14.3%), and aggressive lymphoma with a clinical history (1/10, 10.0%) in this heavily pretreated patient population (median prior therapies range from 4 to 10). Most drug-related toxicities were grade 1/2, the most common being diarrhea, peripheral edema, and pruritus.
  
  
  CONCLUSIONS
  Enzastaurin was well tolerated but demonstrated modest responses across subgroups in this heavily pretreated patient population.
authors.affiliation: Department of Haematology Wyong Hospital, Kanwal, Australia. cecily.forsyth@people.net.au
authors.forename: Cecily J
authors.initials: CJ
authors.lastname: Forsyth
authors.forename: David
authors.initials: D
authors.lastname: Gomez-Almaguer
authors.forename: Johnny F C
authors.initials: JF
authors.lastname: Camargo
authors.forename: Paul E
authors.initials: PE
authors.lastname: Eliadis
authors.forename: Erick
authors.initials: E
authors.lastname: Crespo-Solis
authors.forename: Juliana
authors.initials: J
authors.lastname: Pereira
authors.forename: Cesar H
authors.initials: CH
authors.lastname: Gutierrez-Aguirre
authors.forename: Silvia
authors.initials: S
authors.lastname: Rivas-Vera
authors.forename: Stephanie
authors.initials: S
authors.lastname: Roberson
authors.forename: Boris
authors.initials: B
authors.lastname: Lin
authors.forename: Neil V
authors.initials: NV
authors.lastname: Smith
authors.forename: Oday
authors.initials: O
authors.lastname: Hamid
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D005260:Female; D006801:Humans; D007211:Indoles / Q000009:adverse effects / Q000627:therapeutic use*; D008228:Lymphoma, Non-Hodgkin / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D055815:Young Adult
chemical_list: D007211:Indoles; C504878:enzastaurin
keywords: Best response; Enzastaurin; Non-Hodgkin lymphomas; Protein kinase Cβ; Toxicity