PMID- 28557110
OWN - NLM
STAT- MEDLINE
DCOM- 20180710
LR  - 20181202
IS  - 1468-3083 (Electronic)
IS  - 0926-9959 (Linking)
VI  - 31
IP  - 11
DP  - 2017 Nov
TI  - Dose-escalation study evaluating pegylated interferon alpha-2a in patients with 
      cutaneous T-cell lymphoma.
PG  - 1841-1847
LID - 10.1111/jdv.14366 [doi]
AB  - BACKGROUND: This open-label, multicenter, dose-escalation study evaluated the 
      safety, tolerability, and efficacy of subcutaneous pegylated (40 kD) interferon 
      alpha-2a (PEG-IFN alpha-2a) in patients with cutaneous T-cell lymphoma (CTCL). PATIENTS 
      AND METHODS: PEG-IFN alpha-2a was administered subcutaneously at 180 (n = 4), 270 (n 
      = 6), or 360 mug (n = 3) once weekly for 12 weeks. Efficacy was assessed by the 
      proportion of patients with complete response (CR) or partial response (PR). 
      RESULTS: PEG-IFN alpha-2a was generally well tolerated, with a moderate number of 
      reductions or withholding of doses because of adverse events (AEs) (25% (n = 1), 
      66% (n = 4), and 0% (n = 0) in the 180-, 270-, and 360-mug/week groups, 
      respectively). The only dose-limiting toxicity was a grade 3 elevation of liver 
      enzymes in the 270-mug dose group. The most common AEs were fatigue, acute 
      flu-like symptoms, and hepatic toxicity. The major response rate (CR or PR) was 
      50% in the 180-mug group (CR, 50%; PR, 0%), 83% in the 270-mug group (CR, 67%; PR, 
      17%), and 66% in the 360-mug group (CR, 33%; PR, 33%). CONCLUSION: PEG-IFN alpha-2a at 
      doses up to 360 mug once weekly was well tolerated in patients with CTCL up to the 
      highest dose group and showed good response rates. Due to their good tolerance 
      even in high doses, they might be an option for patients not tolerating standard 
      IFN-alpha preparations. However, for this purpose and to evaluate comparability 
      between standard and PEG-IFN larger clinical trials are needed, alone and in 
      combination with oral photochemotherapy (PUVA).
CI  - (c) 2017 European Academy of Dermatology and Venereology.
FAU - Schiller, M
AU  - Schiller M
AD  - Department of Dermatology, University Hospital of Muenster, Muenster, Germany.
AD  - Dermatological Office Professor Schiller, Coesfeld, Germany.
FAU - Tsianakas, A
AU  - Tsianakas A
AD  - Department of Dermatology, University Hospital of Muenster, Muenster, Germany.
FAU - Sterry, W
AU  - Sterry W
AD  - Department of Dermatology, Charite, Berlin, Germany.
FAU - Dummer, R
AU  - Dummer R
AD  - Department of Dermatology, University Hospital, Zurich, Switzerland.
FAU - Hinke, A
AU  - Hinke A
AD  - WiSP Wissenschaftlicher Service Pharma GmbH, Langenfeld, Germany.
FAU - Nashan, D
AU  - Nashan D
AD  - Department of Dermatology, Klinikum Dortmund, Dortmund, Germany.
FAU - Stadler, R
AU  - Stadler R
AD  - Department of Dermatology, Johannes Wesling Klinikum Minden, University Hospital 
      of Ruhr University of Bochum, Bochum, Germany.
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
DEP - 20170720
PL  - England
TA  - J Eur Acad Dermatol Venereol
JT  - Journal of the European Academy of Dermatology and Venereology : JEADV
JID - 9216037
RN  - 0 (Interferon-alpha)
RN  - 0 (Recombinant Proteins)
RN  - 3WJQ0SDW1A (Polyethylene Glycols)
RN  - Q46947FE7K (peginterferon alfa-2a)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Dose-Response Relationship, Drug
MH  - Female
MH  - Humans
MH  - Interferon-alpha/*administration & dosage/adverse effects/therapeutic use
MH  - Lymphoma, T-Cell, Cutaneous/*drug therapy
MH  - Male
MH  - Middle Aged
MH  - Polyethylene Glycols/*administration & dosage/adverse effects/therapeutic use
MH  - Recombinant Proteins/administration & dosage/adverse effects/therapeutic use
MH  - Treatment Outcome
EDAT- 2017/05/31 06:00
MHDA- 2018/07/11 06:00
CRDT- 2017/05/31 06:00
PHST- 2017/02/05 00:00 [received]
PHST- 2017/04/28 00:00 [accepted]
PHST- 2017/05/31 06:00 [pubmed]
PHST- 2018/07/11 06:00 [medline]
PHST- 2017/05/31 06:00 [entrez]
AID - 10.1111/jdv.14366 [doi]
PST - ppublish
SO  - J Eur Acad Dermatol Venereol. 2017 Nov;31(11):1841-1847. doi: 10.1111/jdv.14366. 
      Epub 2017 Jul 20.