PMID- 17438089
OWN - NLM
STAT- MEDLINE
DCOM- 20071004
LR  - 20181201
IS  - 1078-0432 (Print)
IS  - 1078-0432 (Linking)
VI  - 13
IP  - 8
DP  - 2007 Apr 15
TI  - Vorinostat for treatment of cutaneous manifestations of advanced primary 
      cutaneous T-cell lymphoma.
PG  - 2318-22
AB  - PURPOSE: To discuss vorinostat approval for treatment of cutaneous manifestations 
      of advanced cutaneous T-cell lymphoma (CTCL). EXPERIMENTAL DESIGN: Data from 1 
      single-arm, open-label, multicenter pivotal trial and 11 other trials submitted 
      to support the new drug application for vorinostat in the treatment of advanced 
      primary CTCL were reviewed. The pivotal trial assessed responses by changes in 
      overall skin disease score using a severity-weighted assessment tool (SWAT). 
      Vorinostat could be considered active in CTCL if observed response rate was at 
      least 20% and the lower bound of the corresponding 95% confidence interval (95% 
      CI) excluded 5%. Patients reported pruritus relief using a questionnaire and a 
      visual analogue scale. RESULTS: The pivotal trial enrolled 74 patients with stage 
      IB or higher CTCL. Median number of prior treatments was 3, and 61 patients (82%) 
      had stage IIB or higher disease. The objective response rate in the skin disease 
      assessed by change in the overall SWAT score from the baseline was 30% (95% CI, 
      18.5 to 42.6) in patients with stage IIB or higher disease. Median response 
      duration (end of response defined by 50% increase in SWAT score from the nadir) 
      was 168 days. Median time to tumor progression was 148 days for overall 
      population and 169 days for patients with stage IIB or higher disease. Assessment 
      of pruritus relief was considered unreliable. CONCLUSIONS: Vorinostat showed 
      activity in CTCL, and skin responses were a clinical benefit. Vorinostat was 
      approved for treatment of cutaneous manifestations of CTCL. A nonblinded, 
      single-arm trial did not allow a reliable assessment of pruritus relief.
FAU - Mann, Bhupinder S
AU  - Mann BS
AD  - Food and Drug Administration, Silver Spring, Maryland 20993, USA. 
      bhupinder.mann@fda.hhs.gov
FAU - Johnson, John R
AU  - Johnson JR
FAU - He, Kun
AU  - He K
FAU - Sridhara, Rajeshwari
AU  - Sridhara R
FAU - Abraham, Sophia
AU  - Abraham S
FAU - Booth, Brian P
AU  - Booth BP
FAU - Verbois, Leigh
AU  - Verbois L
FAU - Morse, David E
AU  - Morse DE
FAU - Jee, Josephine M
AU  - Jee JM
FAU - Pope, Sarah
AU  - Pope S
FAU - Harapanhalli, Ravi S
AU  - Harapanhalli RS
FAU - Dagher, Ramzi
AU  - Dagher R
FAU - Farrell, Ann
AU  - Farrell A
FAU - Justice, Robert
AU  - Justice R
FAU - Pazdur, Richard
AU  - Pazdur R
LA  - eng
PT  - Journal Article
PL  - United States
TA  - Clin Cancer Res
JT  - Clinical cancer research : an official journal of the American Association for 
      Cancer Research
JID - 9502500
RN  - 0 (Anticarcinogenic Agents)
RN  - 0 (Hydroxamic Acids)
RN  - 58IFB293JI (Vorinostat)
SB  - IM
MH  - Animals
MH  - Anticarcinogenic Agents/*therapeutic use
MH  - Cats
MH  - Clinical Trials, Phase I as Topic
MH  - Clinical Trials, Phase II as Topic
MH  - Dogs
MH  - Humans
MH  - Hydroxamic Acids/pharmacokinetics/*therapeutic use/toxicity
MH  - Lymphoma, T-Cell, Cutaneous/*drug therapy/pathology
MH  - Neoplasm Staging
MH  - Patient Selection
MH  - Pruritus/drug therapy/etiology
MH  - Skin/drug effects/pathology
MH  - United States
MH  - United States Food and Drug Administration
MH  - Vorinostat
EDAT- 2007/04/18 09:00
MHDA- 2007/10/05 09:00
CRDT- 2007/04/18 09:00
PHST- 2007/04/18 09:00 [pubmed]
PHST- 2007/10/05 09:00 [medline]
PHST- 2007/04/18 09:00 [entrez]
AID - 13/8/2318 [pii]
AID - 10.1158/1078-0432.CCR-06-2672 [doi]
PST - ppublish
SO  - Clin Cancer Res. 2007 Apr 15;13(8):2318-22. doi: 10.1158/1078-0432.CCR-06-2672.