PHASE 3 STUDY OF LENALIDOMIDE (LEN) VS PLACEBO IN NON-TRANSFUSION
DEPENDENT (TD) LOW RISK MDS DEL(5Q) PATIENTS. INTERIM ANALYSIS OF THE
EUROPEAN SINTRA-REV TRIAL.
Félix López-Cadenas1, Eva Lumbreras2, Bianca Xicoy3, Joaquín Sánchez4, Rosa Coll5, Slama Borhane6,
Jose Ángel Hernández7, Sylvain Thepot8, Teresa Bernal Del Castillo9, Beatriz Arrizabalaga10, Agnès
Guerci-Bresler11, Guillermo Sanz12, Juan Bargay13, Maria Luz Amigo14, Raquel De Paz Arias15, Benet
Nomdedeu16, Aristoteles Giagounidis17, Uwe Platzbecker18, Stefan Wickenhauser19, Katharina Götze20,
Ali Arar21, Jesús-María Hernández-Rivas1, Pierre Fenaux22, Consuelo del Cañizo23 and María Díez-
Campelo1
(1)Hematology, University Hospital of Salamanca, Salamanca, Spain, (2)Hematology Department,
IBSAL, IBMCC, CIC Universidad de Salamanca-CSIC, Hospital Universitario, Salamanca, Spain.,
SALAMANCA, Spain, (3)Institut Català d'Onoclogia-Hospital germans trias i Pujol, Barcelona, Spain,
(4)Hematology Department, Hospital Reina Sofía, Córdoba, Spain, (5)Servei Hematologia-ICO-Hospitla
Josep Trueta, Girona, Spain, (6)hematology, avignon, France, (7)Servicio de Hematología, Hospital
Universitario Infanta Leonor, Universidad Complutense de Madrid, Madrid, Spain, (8)Clinical
Hematology, Angers University Hospital, Angers, France, (9)Hospital Universitario Central de Asturias,
Oviedo, Spain, (10)Hematology Department, Hospital Universitario de Cruces, Barakaldo, Spain,
(11)Hematologie Clinique, CHRU Nancy, Hôpitaux de Brabois, Vandoeuvre-l
es-Nancy, Nancy, France, (12)Department of Hematology, Hospital Universitario La Fe, Valencia, Spain,
and Centro de Investigación Biomédica en Red de Cáncer (CIBERONC), Instituto de Salud Carlos III,,
Madrid, Spain, (13)Hospital Son Llatzer, Palma de Mallorca, Spain, (14)Hematology and Medical
Oncology Department, Hospital Morales Meseguer, IMIB, Murcia, Spain, (15)University Hospital La Paz,
Madrid, Spain, (16)Hematology Department, Hospital Clinic i Provincial de Barcelona, Barcelona, Spain,
(17)Department of Oncology, Hematology and Palliative Care, Marienhospital Düsseldorf, Düsseldorf,
Germany, (18)Leipzig University Hospital, Leipzig, Germany, (19)HôPital Caremeau, Nimes Cedex 9,,
Nimes, France, (20)Medical Department III for Hematology and Oncology, Klinikum rechts der Isar,
Technische Universität München, Munich, Germany, (21)Centre Hospitalier Régional d’Orléans, Orleans,
France, (22)AP-HP, Paris, France, (23)Hospital Universitario de Salamanca, Salamanca, Spain
Medical Center, Cincinnati, (3)Chang Gung University, Taoyuan City, Taiwan
Background: Most low risk del(5q)MDS patients develop RBC TD or need treatment for
symptomatic anemia early after diagnosis. Lenalidomide (LEN) is a reference treatment in
MDS-del(5q) but approved in many countries only when RBC-TD occurs. Data suggest a role
of LEN in non-TD patients, but no randomized trial has assessed the efficacy of LEN before
RBC-TD.
Material: Sintra-Rev is a phase III multicenter study in low-risk MDS-del(5q) patients with
anemia, without TD. Patients were randomized in a double-blind design to LEN (5mg/day
continuously) vs placebo (2:1 randomization) for 2 years of treatment and 2y of follow-up.
The primary endpoint was the time to TD, secondary endpoints included erythroid (HI-E) and
cytogenetic response (CyR) (IWG 2006), overall survival (OS), event free survival (EFS), time to
AML and mutational analysis (NGS). Here, we report results of the interim analysis after
completion of the treatment phase in all patients.
Results: Main clinical characteristics of the 61 patients (ITT population) are summarized in
Table 1. Fifty-seven patients were included in the ITT evaluable population for efficacy and 59
for safety.
Median time on treatment was 23.9 months (LEN arm) and 10.6 months (placebo) (p=0.392).
Forty-seven percent patients in the LEN arm successfully completed the study compared to
33% in the placebo arm. After a median follow up of 25.6 months, median OS was not
POSTER 25
SCIENTIFIC PROGRAMME
SESSION I
ETIOLOGY OF MDS
SESSION II
BIOLOGY OF MDS –
GENETIC ABNORMALITIES
SESSION III
BIOLOGY OF MDS:
STEM CELLS AND THE
MICROENVIRONMENT
SESSION IV
DIAGNOSTIC WORKUP
AND PROGNOSTIC
FACTORS IN MDS
SESSION V
SPECIFIC SUBTYPES
OF MDS, BASED ON
MORPHOLOGY AND
MOLECULAR BIOLOGY
SESSION VI
TREATMENT OF MDS
SESSION VII
CURRENT PROGRESS IN
THE TREATMENT OF MDS
SESSION VIII
FUTURE TREATMENTS
AND TREATMENT
STRATEGIES IN MDS
SESSION IX
LATE-BREAKING TALKS
SELECTED ABSTRACTS
FOR AN ORAL
PRESENTATION
SELECTED ABSTRACTS
AS E-POSTERS
DISCLOSURES