title: Efficacy of hydralazine and valproate in cutaneous T-cell lymphoma, a phase II study.
abstract: OBJECTIVE
  To evaluate the activity and safety of hydralazine and valproate (Transkrip) in cutaneous T-cell lymphoma (CTCL).
  
  
  METHODS
  Previously untreated and progressive/refractory CTCL patients received hydralazine at 83 mg or 182 mg/day for slow and rapid acetylators respectively plus magnesium valproate at a total dose of 30 mg/Kg t.i.d daily in continuous 28-day cycles in this phase II study. The primary objective was overall response rate (ORR) measured by the modified severity weighted assessment tool (m-SWAT), secondary end-points were time to response (TTR), time to progression (TTP), duration of response (DOR), progression-free survival (PFS), overall survival (OS) and safety.
  
  
  RESULTS
  Fourteen patients were enrolled (7 untreated and 7 pretreated). ORR was 71% with 50% complete and 21% partial. Two had stable disease and two progressed. At a median follow-up of 36 months (5-52), median TTR was 2 months (1-4); median DOR was 28 months (5-45); median PFS 36 and not reached for OS. There were no differences in median TTR, DOR, and PFS between treated and pretreated patients. Pruritus relieve was complete in 13 out of 14 patients. No grade 3 or 4 toxicities were observed.
  
  
  CONCLUSIONS
  The combination of hydralazine and valproate is safe, very well tolerated and effective in CTCL.
authors.affiliation: a Department of Hematology , Instituto Nacional de Cancerología , Mexico City , Mexico.
authors.forename: Jose Ramiro
authors.initials: JR
authors.lastname: Espinoza-Zamora
authors.affiliation: a Department of Hematology , Instituto Nacional de Cancerología , Mexico City , Mexico.
authors.forename: Juan
authors.initials: J
authors.lastname: Labardini-Méndez
authors.affiliation: a Department of Hematology , Instituto Nacional de Cancerología , Mexico City , Mexico.
authors.forename: Alejandro
authors.initials: A
authors.lastname: Sosa-Espinoza
authors.affiliation: a Department of Hematology , Instituto Nacional de Cancerología , Mexico City , Mexico.
authors.forename: Celia
authors.initials: C
authors.lastname: López-González
authors.affiliation: a Department of Hematology , Instituto Nacional de Cancerología , Mexico City , Mexico.
authors.forename: Magnolia
authors.initials: M
authors.lastname: Vieyra-García
authors.affiliation: b Division of Clinical Research , Instituto Nacional de Cancerología , Mexico City , Mexico.
authors.forename: Myrna
authors.initials: M
authors.lastname: Candelaria
authors.affiliation: a Department of Hematology , Instituto Nacional de Cancerología , Mexico City , Mexico.
authors.forename: Valentin
authors.initials: V
authors.lastname: Lozano-Zavaleta
authors.affiliation: a Department of Hematology , Instituto Nacional de Cancerología , Mexico City , Mexico.
authors.forename: Diana Vanesa
authors.initials: DV
authors.lastname: Toledano-Cuevas
authors.affiliation: a Department of Hematology , Instituto Nacional de Cancerología , Mexico City , Mexico.
authors.forename: Nidia
authors.initials: N
authors.lastname: Zapata-Canto
authors.affiliation: a Department of Hematology , Instituto Nacional de Cancerología , Mexico City , Mexico.
authors.forename: Eduardo
authors.initials: E
authors.lastname: Cervera
authors.affiliation: c Unidad de Investigación Biomédica en Cáncer , Instituto de Investigaciones Biomédicas UNAM/Instituto Nacional de Cancerología , Mexico City , Mexico.
authors.forename: Alfonso
authors.initials: A
authors.lastname: Dueñas-González
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D018572:Disease-Free Survival; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D006830:Hydralazine / Q000008:administration & dosage; D016410:Lymphoma, T-Cell, Cutaneous / Q000188:drug therapy* / Q000473:pathology; D008297:Male; D008875:Middle Aged; D011537:Pruritus / Q000188:drug therapy* / Q000209:etiology; D015996:Survival Rate; D013997:Time Factors; D016896:Treatment Outcome; D014635:Valproic Acid / Q000008:administration & dosage; D055815:Young Adult
chemical_list: D006830:Hydralazine; D014635:Valproic Acid
keywords: Hydralazine; cutaneous T-cell lymphoma; phase II; valproate