PMID- 20212249
OWN - NLM
STAT- MEDLINE
DCOM- 20100429
LR  - 20130603
IS  - 1527-7755 (Electronic)
IS  - 0732-183X (Linking)
VI  - 28
IP  - 11
DP  - 2010 Apr 10
TI  - Phase III placebo-controlled trial of denileukin diftitox for patients with 
      cutaneous T-cell lymphoma.
PG  - 1870-7
LID - 10.1200/JCO.2009.26.2386 [doi]
AB  - PURPOSE This phase III, placebo-controlled, randomized trial was designed to 
      investigate efficacy and safety of two doses of denileukin diftitox (DD; 
      DAB(389)-interleukin-2 [IL-2]), a recombinant fusion protein targeting IL-2 
      receptor-expressing malignant T lymphocytes, in patients with stage IA to III, 
      CD25 assay-positive cutaneous T-cell lymphoma (CTCL), including the mycosis 
      fungoides and Sezary syndrome forms of the disease, who had received up to three 
      prior therapies. The primary end point was overall response rate (ORR). PATIENTS 
      AND METHODS Patients (N = 144) with biopsy-confirmed, CD25 assay-positive CTCL 
      were randomly assigned to DD 9 microg/kg/d (n = 45), DD 18 microg/kg/d (n = 55), 
      or placebo infusions (n = 44), administered for 5 consecutive days every 3 weeks 
      for up to eight cycles. Patients were monitored for drug efficacy, clinical 
      benefit, and safety of DD. RESULTS ORR was 44% for all participants treated with 
      DD (n = 100; 10% complete response [CR] and 34% partial response [PR]) compared 
      with 15.9% for placebo-treated patients (2% CR and 13.6% PR). ORR was higher in 
      the 18 microg/kg/d group versus the 9 microg/kg/d group (49.1% v 37.8%, 
      respectively), and both doses were significantly superior to placebo. 
      Progression-free survival (PFS) was significantly longer (median, > 2 years) for 
      both DD doses compared with placebo (median, 124 days; P < .001). Rates of 
      moderately severe and severe adverse events (AEs) were slightly higher in the DD 
      groups, whereas moderate and mild AEs were similar to placebo. No statistical 
      differences were observed for drug-related serious AEs. CONCLUSION DD had a 
      significant and durable effect on ORR and PFS with an acceptable safety profile 
      in patients with early- and late-stage CTCL.
FAU - Prince, H Miles
AU  - Prince HM
AD  - TransMed Institute, 2425 L St NW, Ste 440, Washington, DC 20037, USA. 
      negrovilar@gmail.com
FAU - Duvic, Madeleine
AU  - Duvic M
FAU - Martin, Ann
AU  - Martin A
FAU - Sterry, Wolfram
AU  - Sterry W
FAU - Assaf, Chalid
AU  - Assaf C
FAU - Sun, Yijun
AU  - Sun Y
FAU - Straus, David
AU  - Straus D
FAU - Acosta, Mark
AU  - Acosta M
FAU - Negro-Vilar, Andres
AU  - Negro-Vilar A
LA  - eng
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20100308
PL  - United States
TA  - J Clin Oncol
JT  - Journal of clinical oncology : official journal of the American Society of 
      Clinical Oncology
JID - 8309333
RN  - 0 (Antineoplastic Agents)
RN  - 0 (Diphtheria Toxin)
RN  - 0 (Interleukin-2)
RN  - 0 (Placebos)
RN  - 0 (Recombinant Fusion Proteins)
RN  - 25E79B5CTM (denileukin diftitox)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Antineoplastic Agents/*therapeutic use
MH  - Diphtheria Toxin/*therapeutic use
MH  - Double-Blind Method
MH  - Female
MH  - Humans
MH  - Interleukin-2/*therapeutic use
MH  - International Agencies
MH  - Lymphoma, T-Cell, Cutaneous/*drug therapy/genetics/pathology
MH  - Male
MH  - Middle Aged
MH  - Neoplasm Staging
MH  - Placebos
MH  - Recombinant Fusion Proteins/*metabolism/therapeutic use
MH  - Safety
MH  - Skin Neoplasms/*drug therapy/genetics/pathology
MH  - Survival Rate
MH  - Treatment Outcome
MH  - Young Adult
EDAT- 2010/03/10 06:00
MHDA- 2010/04/30 06:00
CRDT- 2010/03/10 06:00
PHST- 2010/03/10 06:00 [entrez]
PHST- 2010/03/10 06:00 [pubmed]
PHST- 2010/04/30 06:00 [medline]
AID - JCO.2009.26.2386 [pii]
AID - 10.1200/JCO.2009.26.2386 [doi]
PST - ppublish
SO  - J Clin Oncol. 2010 Apr 10;28(11):1870-7. doi: 10.1200/JCO.2009.26.2386. Epub 2010 
      Mar 8.