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.
Authors
Bagot, MHasan, 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
Affiliation
Department of Dermatology, AEuropean Organisation for Research and Treatment of Cancer, Headquarters, Brussels, BelgiumIssue Date
2017-05-03
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Show full item recordAbstract
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 DermatolJournal
European Journal of DermatologyDOI
10.1684/ejd.2017.3008PubMed ID
28468739Type
ArticleLanguage
enISSN
1952-4013ae974a485f413a2113503eed53cd6c53
10.1684/ejd.2017.3008
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