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    A phase III study of lenalidomide maintenance after debulking therapy in patients with advanced cutaneous T-cell lymphoma - EORTC 21081 (NCT01098656): results and lessons learned for future trial designs.

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    Authors
    Bagot, M
    Hasan, B
    Whittaker, S
    Beylot-Barry, M
    Knobler, R
    Shah, E
    Marreaud, S
    Morris, S
    Dalle, S
    Servitje, O
    Cowan, Richard A
    Väkevä, L
    Chaby, G
    Jonak, C
    Fox, C
    Ritchie, D
    Vermeer, M
    Stadler, R
    Romero, P
    Scarisbrick, J
    Quaglino, P
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    Affiliation
    Department of Dermatology, AEuropean Organisation for Research and Treatment of Cancer, Headquarters, Brussels, Belgium
    Issue Date
    2017-05-03
    
    Metadata
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    Abstract
    EORTC 21081 was a randomized phase III study of observation alone versus lenalidomide maintenance (25 mg po for 21 days) after debulking therapy in patients with advanced-stage cutaneous T-cell lymphomas (CTCLs). The aim was to investigate whether maintenance treatment with lenalidomide prolonged response after debulking in patients who had not been previously treated with intravenous chemotherapy. A total of 26 centres from 10 different European countries registered 30 patients with advanced CTCL. Twenty-one patients were randomized (20% of the 105 patients initially deemed necessary for the study; the study was terminated early following withdrawal of funding support from Celgene). Of 30 registered patients, nine failed to be randomized, 12 were randomized to observation alone, and nine to lenalidomide maintenance. Median progression-free survival was 5.3 months (95% CI: 1.87-22.54) in the maintenance lenalidomide group and two months (95% CI: 0.92-7.82) in the observation alone group. Although statistical comparison in the study was severely underpowered and would not be meaningful, this study provides useful information, revealing rapid disease progression within four weeks in a third of patients, highlighting the need for maintenance therapy.
    Citation
    A phase III study of lenalidomide maintenance after debulking therapy in patients with advanced cutaneous T-cell lymphoma - EORTC 21081 (NCT01098656): results and lessons learned for future trial designs. 2017 Eur J Dermatol
    Journal
    European Journal of Dermatology
    URI
    http://hdl.handle.net/10541/620397
    DOI
    10.1684/ejd.2017.3008
    PubMed ID
    28468739
    Type
    Article
    Language
    en
    ISSN
    1952-4013
    ae974a485f413a2113503eed53cd6c53
    10.1684/ejd.2017.3008
    Scopus Count
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