PMID- 19951879
OWN - NLM
STAT- MEDLINE
DCOM- 20100127
LR  - 20181201
IS  - 1938-0712 (Electronic)
IS  - 1557-9190 (Linking)
VI  - 9
IP  - 6
DP  - 2009 Dec
TI  - Evaluation of the long-term tolerability and clinical benefit of vorinostat in 
      patients with advanced cutaneous T-cell lymphoma.
PG  - 412-6
LID - 10.3816/CLM.2009.n.082 [doi]
AB  - INTRODUCTION: Vorinostat, an orally active histone deacetylase inhibitor, was 
      approved in October 2006 by the US Food and Drug Administration for the treatment 
      of cutaneous manifestations of cutaneous T-cell lymphoma (CTCL) in patients with 
      progressive, persistent, or recurrent disease during or after treatment with 2 
      systemic therapies. PATIENTS AND METHODS: A multicenter, open-label phase IIb 
      trial evaluated the activity and safety of vorinostat 400 mg orally daily in 
      patients with > or = stage IB, persistent, progressive, or treatment-refractory 
      mycosis fungoides or Sezary syndrome CTCL subtypes. We report the safety and 
      tolerability of long-term vorinostat therapy in patients who experienced clinical 
      benefit in the previous phase IIb study. RESULTS: As of December 11, 2008, 6 of 
      74 patients enrolled in the original study had received vorinostat for > or = 2 
      years: median age, 65 years; median number of previous therapies, 2.5; median 
      time from diagnosis to enrollment, 1.8 years. At enrollment into the continuation 
      phase, 5 of the 6 patients had achieved an objective response, and 1 patient had 
      prolonged stable disease. During the follow-up study, the most common 
      drug-related grade 1-4 adverse events (AEs) were diarrhea, nausea, fatigue, and 
      alopecia (6, 5, 4, and 3 patients, respectively). Incidence of grade 3/4 AEs was 
      low: anorexia (n = 1), increased creatinine phosphokinase (n = 1), pulmonary 
      embolism (n = 1), rash (n = 1), and thrombocytopenia (n = 1). Five patients have 
      discontinued the study drug, and 1 patient is continuing therapy. CONCLUSION: 
      This post hoc subset analysis provides evidence for the long-term safety and 
      clinical benefit of vorinostat in heavily pretreated patients with CTCL, 
      regardless of previous treatment failures.
FAU - Duvic, Madeleine
AU  - Duvic M
AD  - Department of Dermatology, The University of Texas M. D. Anderson Cancer Center, 
      Box 1492, 1515 Holcombe Blvd, Houston, TX 77030, USA. mduvic@mdanderson.org
FAU - Olsen, Elise A
AU  - Olsen EA
FAU - Breneman, Debra
AU  - Breneman D
FAU - Pacheco, Theresa R
AU  - Pacheco TR
FAU - Parker, Sareeta
AU  - Parker S
FAU - Vonderheid, Eric C
AU  - Vonderheid EC
FAU - Abuav, Rachel
AU  - Abuav R
FAU - Ricker, Justin L
AU  - Ricker JL
FAU - Rizvi, Syed
AU  - Rizvi S
FAU - Chen, Cong
AU  - Chen C
FAU - Boileau, Kathleen
AU  - Boileau K
FAU - Gunchenko, Alexandra
AU  - Gunchenko A
FAU - Sanz-Rodriguez, Cesar
AU  - Sanz-Rodriguez C
FAU - Geskin, Larisa J
AU  - Geskin LJ
LA  - eng
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - Clin Lymphoma Myeloma
JT  - Clinical lymphoma & myeloma
JID - 101256500
RN  - 0 (Antineoplastic Agents)
RN  - 0 (Histone Deacetylase Inhibitors)
RN  - 0 (Hydroxamic Acids)
RN  - 58IFB293JI (Vorinostat)
SB  - IM
MH  - Aged
MH  - Antineoplastic Agents/*therapeutic use
MH  - Female
MH  - Histone Deacetylase Inhibitors/*therapeutic use
MH  - Humans
MH  - Hydroxamic Acids/adverse effects/*therapeutic use
MH  - Lymphoma, T-Cell, Cutaneous/*drug therapy
MH  - Male
MH  - Middle Aged
MH  - Skin Neoplasms/*drug therapy
MH  - Vorinostat
EDAT- 2009/12/03 06:00
MHDA- 2010/01/28 06:00
CRDT- 2009/12/03 06:00
PHST- 2009/12/03 06:00 [entrez]
PHST- 2009/12/03 06:00 [pubmed]
PHST- 2010/01/28 06:00 [medline]
AID - S1557-9190(11)70031-2 [pii]
AID - 10.3816/CLM.2009.n.082 [doi]
PST - ppublish
SO  - Clin Lymphoma Myeloma. 2009 Dec;9(6):412-6. doi: 10.3816/CLM.2009.n.082.