Prior to its approval by the European health authorities (EMA) in May 2013, the use of lenalidomide (Revlimid®) for patients (pts) with del5q-MDS was restricted to clinical trials or off-label use. We searched the database of the German MDS Practice Registry to learn about the incidence, treatment and natural course of disease of del5q-MDS in the years before approval of lenalidomide.


The registry was established in 2009 in order to describe diagnostics, treatment and course of disease of MDS pts treated in the community outpatient setting (hospital and private practice). The design of the database is compatible with the large Düsseldorf MDS Registry which collects data from MDS pts primarily treated at academic institutions. All pts with newly diagnosed MDS, confirmed by bone marrow cytology, can be entered online into the MDS Practice Registry, which includes clinical and laboratory parameters at baseline, treatment data, and a 3-monthly update on the course of disease.


Between July 2009 and January 2013, 997 pts from 70 institutions were included in the registry. 951 pts (median age 74y, 41% female) were evaluable with a median observation time of 20.6 months (0.25/0.75 quartile: 11.3/32.0 months). In 672/951 pts (71%) cytogenetic analysis was performed. 247/672 pts (37%) had an abnormal karyotype, with 91/672 pts (13.5%) showing a del5q anomaly. Of these, 42/91 (46%; 42/672 = 6.25%) had an isolated del5q and 49/91 (54%; 49/672 = 7.3%) had a non-isolated del5q-. IPSS was calculated in 653/951 (69%) of all pts and 81/91 (89%) of del5q pts. An IPSS <1 was found in 31/38 (81.6%) of the isolated del5q- and 18/43 (41.9%) of the non-isolated del5q pts, while the IPSS was >1 in 7/38 (18.4%) and 25/43 (58.1%), respectively. The need for red blood cell transfusion (RBC-TX) in pts with isolated del5q was 55% (17/31) vs 86% (6/7), according to IPSS <1 vs >1. RBC-TX was required in 72% (13/18) vs 84% (21/25) in non-isolated del5q with IPSS <1 vs. >1. Within 12 months after diagnosis, pts with isolated del5q and IPSS <1 vs >1 received an average number of 18.4 vs 24.7 RBC-TX. Other forms of therapy (ESA, G-CSF, iron chelation, chemotherapy or epigenetic treatment) were used in 43% of pts, but only 10% received off-label treatment with lenalidomide.


In a real-life outpatient setting, 13.5% of MDS pts had a del5q MDS (isolated del5q in 6.25%), with a relatively high transfusion need in the pre-lenalidomide era. In the future, our registry will allow us to assess the impact of lenalidomide (and other drugs) on transfusion need and course of disease of MDS pts in the community outpatient setting.

Supported by Celgene (Munich) and Novartis (Nürnberg), Germany


Steinmetz:Amgen: Consultancy, Research Funding, Speakers Bureau; Celegene: Research Funding, Speakers Bureau; Novartis: Research Funding. Off Label Use: A minor number of patients received lenalidomide before its approval in Germany, as stated in the abstract. Severin:Novartis: Research Funding; Celegene: Research Funding. Germing:Amgen: Research Funding; GSK: Research Funding; Novartis: Research Funding; Jansen-Cilag: Honoraria; Celgene: Honoraria, Research Funding. Gattermann:Novartis: Honoraria, Research Funding; Celgene: Honoraria, Research Funding. Schmitz:Novartis: Research Funding; Celegene: Consultancy, Research Funding, Speakers Bureau.

Author notes


Asterisk with author names denotes non-ASH members.