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Prospective International Multicenter Phase II Trial of Intravenous Pegylated Liposomal Doxorubicin Monochemotherapy in Patients With Stage IIB, IVA, or IVB Advanced Mycosis Fungoides: Final Results From EORTC 21012.
MedLine Citation:
PMID:  23045580     Owner:  NLM     Status:  Publisher    
Abstract/OtherAbstract:
PURPOSEMycosis fungoides (MF) is the most common primary cutaneous T-cell lymphoma. There is a need for multicenter trials involving defined patient populations using rigorous assessment criteria. We have investigated pegylated liposomal doxorubicin (PLD) in a clearly defined patient population with advanced MF. PATIENTS AND METHODSEligible patients had stage IIB, IVA, or IVB MF, refractory or recurrent after at least two previous systemic therapies. Patients were registered to receive a maximum of six cycles of PLD 20 mg/m(2) on days 1 and 15, every 28 days (one cycle). The primary end point was response rate (RR). RESULTS: three (6.1%) experienced CCRs, and 17 (34.7%) experienced PRs. A 50% or greater reduction of cutaneous manifestations was observed in 26 (60.5%) of 43 assessable patients. Two early deaths were reported, resulting from related cardiovascular toxicity and disease progression. The lower limit of the one-sided 90% CI for RR was 31.2%. Median time to progression and median duration of response were 7.4 and 6 months, respectively. CONCLUSIONPLD has an acceptable safety profile in patients with advanced MF. The efficacy of PLD seems promising.
Authors:
Reinhard Dummer; Pietro Quaglino; Jürgen C Becker; Baktiar Hasan; Matthias Karrasch; Sean Whittaker; Stephen Morris; Michael Weichenthal; Rudolf Stadler; Martine Bagot; Antonio Cozzio; Maria G Bernengo; Robert Knobler
Publication Detail:
Type:  JOURNAL ARTICLE     Date:  2012-10-8
Journal Detail:
Title:  Journal of clinical oncology : official journal of the American Society of Clinical Oncology     Volume:  -     ISSN:  1527-7755     ISO Abbreviation:  J. Clin. Oncol.     Publication Date:  2012 Oct 
Date Detail:
Created Date:  2012-10-9     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  8309333     Medline TA:  J Clin Oncol     Country:  -    
Other Details:
Languages:  ENG     Pagination:  -     Citation Subset:  -    
Affiliation:
Reinhard Dummer and Antonio Cozzio, University Hospital of Zurich, Zurich, Switzerland; Pietro Quaglino and Maria G. Bernengo, University of Turin, Turin, Italy; Jürgen C. Becker, Medical University of Graz, Graz; Robert Knobler, Medical University of Vienna, Vienna, Austria; Baktiar Hasan and Matthias Karrasch, European Organisation for Research and Treatment of Cancer, Brussels, Belgium; Sean Whittaker and Stephen Morris, St John's Institute of Dermatology, Kings College London, London, United Kingdom; Michael Weichenthal, University of Kiel, Kiel; Rudolf Stadler, Johannes Wesling Klinikum, Minden, Germany; and Martine Bagot, Hôpital Saint Louis, Paris, France.
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