Lenalidomide Efficacy in Patients with MDS and Del-5q: Real-World Data from the Hellenic (Greek) National Myelodysplastic & Hypoplastic Syndromes Registry (EAKMYS)

Argiris Symeonidis¹, Panagiotis Diamantopoulos², Athanasios Galanopoulos³, Alexandra Kourakli¹, Eleni Sazakli⁴, Eleftheria Hatzimichael⁵, Maria Pagoni⁶, Panagiotis Zikos⁷, Theodoros P Vassilakopoulos⁸, Eleni Gavrilaki⁹, Anthi Bouchla¹⁰, Anna Kioumi¹¹, Katerina Palla¹², Ioannis Kotsianidis¹³, Evridiki Michali³, Zafiris Kartassis¹⁴, Eirini Katodritou¹⁵, Vasileios Lazaris¹, Maria Vagia⁶, George Xanthopoulidis¹⁶, Theodora Assimakopoulou¹⁷, Charalampos Pontikoglou¹⁸, Maria Dimou¹⁹, Maria Dalekou-Tsolakou²⁰, Dimitra Liapi²¹, Maria Kotsopoulou²², Vassiliki Labropoulou¹, Menelaos Papoutselis¹³, Despina Barmparousi²³, Efthymia Vlachaki²⁴, Georgia Kaiafa²⁵, Eleni Chandrinou²⁶, Panagiotis Karmas²⁷, Evangelos Terpos²⁸, George Vassilopoulos²⁹, Panayiotis Panayiotidis¹⁹, Nora-Athina Viniou², Vassiliki Pappa¹⁰; Hellenic [Greek] Myelodysplastic Syndromes Study Group

Affiliations

¹ Hematology Division, Department of Internal Medicine, University of Patras, 265 04 Patras, Greece.
² First Department of Internal Medicine, National and Kapodistrian University of Athens, Laikon General Hospital, 115 27 Athens, Greece.
³ Department of Hematology, G. Gennimatas General Hospital, 115 27 Athens, Greece.
⁴ Laboratory of Public Health, University of Patras, Medical School, 265 04 Patras, Greece.
⁵ Department of Hematology, University of Ioannina, School of Medicine, 451 10 Ioannina, Greece.
⁶ Hematology-Lymphoma Department-BMT Unit, Evangelismos Hospital, 106 76 Athens, Greece.
⁷ Department of Hematology, "St Andreas" General Hospital, 263 32 Patras, Greece.
⁸ Department of Hematology, Laikon General Hospital, National and Kapodistrian University of Athens, 115 27 Athens, Greece.
⁹ Department of Hematology & Stem Cell Transplantation, G. Papanicolaou General Hospital of Thessaloniki, 570 10 Exochi, Greece.
¹⁰ Second Department of Internal Medicine, University General Hospital Attikon, 124 62 Athens, Greece.
¹¹ Department of Hematology, "Papageorgiou" Hospital, 546 24 Thessaloniki, Greece.
¹² Department of Hematology, General Hospital of Chania, 733 00 Chania, Greece.
¹³ Department of Hematology, Democritus University of Thrace Medical School, 681 00 Alexandroupolis, Greece.
¹⁴ Hematology Unit, General Hospital of Halkida, 341 00 Halkida, Greece.
¹⁵ Department of Hematology, Theageneion Hospital, 546 39 Thessaloniki, Greece.
¹⁶ Department of Hematology, General Hospital of Xanthi, 671 00 Xanthi, Greece.
¹⁷ Department of Hematology, Sismanogleion Hospital, 151 26 Athens, Greece.
¹⁸ Department of Hematology, University of Crete Medical School, 710 03 Heraklion, Greece.
¹⁹ First Propedeutic Department of Internal Medicine, National and Kapodistrian University of Athens, Laikon General Hospital, 115 27 Athens, Greece.
²⁰ Hematology and Thalassemia Unit, General Hospital of Kalamata, 241 00 Antikalamos, Greece.
²¹ Department of Hematology, Venizeleion Hospital, 714 09 Heraklion, Greece.
²² Department of Hematology, Metaxa Anti-Cancer Hospital, 185 37 Piraeu, Greece.
²³ Department of Hematology, Alexandra General Hospital, 115 28 Athens, Greece.
²⁴ Second Department of Internal Medicine, Hippokration Hospital, Aristotle University, 541 24 Thessaloniki, Greece.
²⁵ First Propedeutic Department of Internal Medicine, AHEPA University Hospital, 546 36 Thessaloniki, Greece.
²⁶ Department of Hematology, Athens Medical Center, 151 25 Athens, Greece.
²⁷ Department of Hematology, Army Share Fund Hospital "NIMTS", 115 24 Athens, Greece.
²⁸ Department of Clinical Therapeutics, National & Kapodistrian University of Athens, School of Medicine, Alexandra Hospital, 106 79 Athens, Greece.
²⁹ Department of Hematology, University of Thessaly, School of Medicine, 413 34 Larissa, Greece.

PMID: 40361316
PMCID: PMC12071050
DOI: 10.3390/cancers17091388

Lenalidomide Efficacy in Patients with MDS and Del-5q: Real-World Data from the Hellenic (Greek) National Myelodysplastic & Hypoplastic Syndromes Registry (EAKMYS)

Argiris Symeonidis et al. Cancers (Basel). 2025.

. 2025 Apr 22;17(9):1388.

doi: 10.3390/cancers17091388.

Authors

Affiliations

¹ Hematology Division, Department of Internal Medicine, University of Patras, 265 04 Patras, Greece.
² First Department of Internal Medicine, National and Kapodistrian University of Athens, Laikon General Hospital, 115 27 Athens, Greece.
³ Department of Hematology, G. Gennimatas General Hospital, 115 27 Athens, Greece.
⁴ Laboratory of Public Health, University of Patras, Medical School, 265 04 Patras, Greece.
⁵ Department of Hematology, University of Ioannina, School of Medicine, 451 10 Ioannina, Greece.
⁶ Hematology-Lymphoma Department-BMT Unit, Evangelismos Hospital, 106 76 Athens, Greece.
⁷ Department of Hematology, "St Andreas" General Hospital, 263 32 Patras, Greece.
⁸ Department of Hematology, Laikon General Hospital, National and Kapodistrian University of Athens, 115 27 Athens, Greece.
⁹ Department of Hematology & Stem Cell Transplantation, G. Papanicolaou General Hospital of Thessaloniki, 570 10 Exochi, Greece.
¹⁰ Second Department of Internal Medicine, University General Hospital Attikon, 124 62 Athens, Greece.
¹¹ Department of Hematology, "Papageorgiou" Hospital, 546 24 Thessaloniki, Greece.
¹² Department of Hematology, General Hospital of Chania, 733 00 Chania, Greece.
¹³ Department of Hematology, Democritus University of Thrace Medical School, 681 00 Alexandroupolis, Greece.
¹⁴ Hematology Unit, General Hospital of Halkida, 341 00 Halkida, Greece.
¹⁵ Department of Hematology, Theageneion Hospital, 546 39 Thessaloniki, Greece.
¹⁶ Department of Hematology, General Hospital of Xanthi, 671 00 Xanthi, Greece.
¹⁷ Department of Hematology, Sismanogleion Hospital, 151 26 Athens, Greece.
¹⁸ Department of Hematology, University of Crete Medical School, 710 03 Heraklion, Greece.
¹⁹ First Propedeutic Department of Internal Medicine, National and Kapodistrian University of Athens, Laikon General Hospital, 115 27 Athens, Greece.
²⁰ Hematology and Thalassemia Unit, General Hospital of Kalamata, 241 00 Antikalamos, Greece.
²¹ Department of Hematology, Venizeleion Hospital, 714 09 Heraklion, Greece.
²² Department of Hematology, Metaxa Anti-Cancer Hospital, 185 37 Piraeu, Greece.
²³ Department of Hematology, Alexandra General Hospital, 115 28 Athens, Greece.
²⁴ Second Department of Internal Medicine, Hippokration Hospital, Aristotle University, 541 24 Thessaloniki, Greece.
²⁵ First Propedeutic Department of Internal Medicine, AHEPA University Hospital, 546 36 Thessaloniki, Greece.
²⁶ Department of Hematology, Athens Medical Center, 151 25 Athens, Greece.
²⁷ Department of Hematology, Army Share Fund Hospital "NIMTS", 115 24 Athens, Greece.
²⁸ Department of Clinical Therapeutics, National & Kapodistrian University of Athens, School of Medicine, Alexandra Hospital, 106 79 Athens, Greece.
²⁹ Department of Hematology, University of Thessaly, School of Medicine, 413 34 Larissa, Greece.

PMID: 40361316
PMCID: PMC12071050
DOI: 10.3390/cancers17091388

Abstract

Background-Objectives: Although considered standard of care for patients with low-/intermediate-1 risk MDS and isolated del(5q), lenalidomide is not widely used in patients exhibiting additional cytogenetic abnormalities, on top of del(5)q. The aim of this study was to provide real-world evidence for the efficacy of lenalidomide in patients with del(5q), with or without additional cytogenetic abnormalities. Methods: Patients with MDS exhibiting del(5q) in the Greek National Myelodysplastic Syndromes Registry were analyzed if they had received at least one lenalidomide dose and detailed response assessment/follow-up was available. Results: Among 238 patients analyzed, 153 (64.3%) had del(5q) syndrome (Group-I), 34 (14.3%) had an isolated del(5q) abnormality but were not 5q- syndrome (Group-II), 26 (10.9%) had del(5q) plus only one additional cytogenetic abnormality (Group-III), and 25 (10.5%) had del(5q) plus >1 additional abnormality (Group-IV). Among 218 (91.6%) evaluable patients, a major response was achieved by 146 (67.0%) patients, 114/146 (78.1%) in Group-I, 18/31 (58.1%) in Group-II, 10/20 (50.0%) in Group-III, and 4/21 (19.0%) in Group-IV. Overall, hematological response was seen in 177/218 (81.2%) patients, even among those with an excess of bone marrow blasts/frank acute myeloid leukemia. Duration of response was comparable between the four patient groups. A complete cytogenetic response was achieved by 38.0% overall, more commonly in Group-I (42.3%) and -III (35.7%). Transfusion-independent patients and those with a higher MCV or lower marrow blast cells at baseline had a higher probability of achieving a major response. With multivariate analysis, factors associated with overall survival were age, performance status, transfusion dependence, and marrow blast cell percentage at treatment start, as well as time from initial diagnosis to lenalidomide start. Conclusions: Lenalidomide was highly effective in patients with the del(5)q syndrome and also in those with isolated del(5)q, other than del(5)q syndrome, or those exhibiting del(5)q plus only one additional cytogenetic abnormality, not affecting chromosome 7.

Keywords: del(5)q; lenalidomide; myelodysplastic syndromes; prognosis; real-world-data; treatment.

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Conflict of interest statement

Since this study represents an analysis of Registry data regarding real-world experience from the use of an approved drug the authors had not designed any prospective analysis at the time of administration of lenalidomide. Thus, all the authors declare that they have no conflicts of interest, related to this retrospective study. Moreover, there is no intervention by any pharmaceutical company or at any aspect facilitation or financial support in data retrieving and processing and in manuscript preparation, related to this study.

Figures

**Figure 1**
Overall survival probability in (A) the whole patient population and (B) Groups I, combined (II + III), and IV, according to patient group. CI, confidence interval; OS, overall survival.

**Figure 2**
Overall survival probability in (A) all evaluable patients and (B) Only patients with Del(5q) syndrome (Group I), according to response type. CI, confidence interval; Del(5q), deletion of chromosome 5q; MR, major response; MiR: minor response; NR, no response; OS, overall survival.

See this image and copyright information in PMC

References

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Lenalidomide Efficacy in Patients with MDS and Del-5q: Real-World Data from the Hellenic (Greek) National Myelodysplastic & Hypoplastic Syndromes Registry (EAKMYS)

Affiliations

Lenalidomide Efficacy in Patients with MDS and Del-5q: Real-World Data from the Hellenic (Greek) National Myelodysplastic & Hypoplastic Syndromes Registry (EAKMYS)

Authors

Affiliations

Abstract

Conflict of interest statement

Figures

References

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Full Text Sources

Research Materials

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