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Pomalidomide Plus Low-Dose Dexamethasone in Relapsed/Refractory Multiple Myeloma Patients: Results of the Real-World "POWERFUL" Study.
Terpos, Evangelos; Repousis, Panagiotis; Lalayanni, Chrysavgi; Hatjiharissi, Evdoxia; Assimakopoulou, Theodora; Vassilopoulos, Georgios; Pouli, Anastasia; Spanoudakis, Emmanouil; Michalis, Eurydiki; Pangalis, Gerassimos; Ntanasis-Stathopoulos, Ioannis; Poziopoulos, Christos; Kyrtsonis, Marie-Christine; Pappa, Vasiliki; Symeonidis, Argiris; Georgopoulos, Christos; Zikos, Panagiotis M; Gavriatopoulou, Maria; Papadaki, Helen A; Dadakaridou, Magdalini; Karvounis-Marolachakis, Kiki; Katodritou, Eirini.
Afiliación
  • Terpos E; Department of Clinical Therapeutics, School of Medicine, National and Kapodistrian University of Athens, Alexandra General Hospital, 11527 Athens, Greece.
  • Repousis P; Department of Hematology, "METAXA" Cancer Hospital of Piraeus, 18537 Athens, Greece.
  • Lalayanni C; Department of Hematology, «G. PAPANIKOLAOU¼ General Hospital of Thessaloniki, 57010 Thessaloniki, Greece.
  • Hatjiharissi E; 1st Department of Internal Medicine, Division of Hematology, AHEPA University General Hospital of Thessaloniki, 54636 Thessaloniki, Greece.
  • Assimakopoulou T; Department of Hematology, "SISMANOGLIO-AMALIA FLEMING" General Hospital of Athens, Marousi, 15126 Athens, Greece.
  • Vassilopoulos G; Department of Hematology, Larissa University Hospital, 41110 Larissa, Greece.
  • Pouli A; Department of Hematology, "AGIOS SAVVAS" Anticancer-Oncology Hospital of Athens, 11522 Athens, Greece.
  • Spanoudakis E; Department of Hematology, University Hospital of Alexandroupolis, 68100 Alexandroupolis, Greece.
  • Michalis E; Department of Hematology, "G. GENNIMATAS" General Hospital of Athens, 11527 Athens, Greece.
  • Pangalis G; Department of Hematology, Athens Medical Center-Psychikon Branch, Psychiko, 11525 Athens, Greece.
  • Ntanasis-Stathopoulos I; Department of Clinical Therapeutics, School of Medicine, National and Kapodistrian University of Athens, Alexandra General Hospital, 11527 Athens, Greece.
  • Poziopoulos C; Department of Hematology, "METROPOLITAN" Athens Private Hospital, N. Faliro, 18547 Athens, Greece.
  • Kyrtsonis MC; First Department of Propaedeutic Internal Medicine, Laikon General Hospital, National and Kapodistrian University of Athens, 11527 Athens, Greece.
  • Pappa V; 2nd Department of Internal Medicine and Research Unit, Hematology Unit, "ATTIKON" University General Hospital of Athens, School of Medicine, National and Kapodistrian University of Athens, Haidari, 12462 Athens, Greece.
  • Symeonidis A; Department of Hematology, University General Hospital of Patras, Rio, 26504 Patras, Greece.
  • Georgopoulos C; Department of Hematology, 424 General Military Hospital of Thessaloniki, 56429 Thessaloniki, Greece.
  • Zikos PM; Department of Hematology, "Agios Andreas" General Hospital of Patras, 26335 Patras, Greece.
  • Gavriatopoulou M; Department of Clinical Therapeutics, School of Medicine, National and Kapodistrian University of Athens, Alexandra General Hospital, 11527 Athens, Greece.
  • Papadaki HA; Department of Hematology, University General Hospital of Heraklion, School of Medicine, University of Crete, 71110 Heraklion, Greece.
  • Dadakaridou M; Department of Hematology, "METAXA" Cancer Hospital of Piraeus, 18537 Athens, Greece.
  • Karvounis-Marolachakis K; Medical Department, Genesis pharma SA, Halandri, 15232 Athens, Greece.
  • Katodritou E; Department of Hematology, "THEAGENIO" Anti-Cancer Hospital of Thessaloniki, 54007 Thessaloniki, Greece.
J Clin Med ; 10(7)2021 Apr 05.
Article en En | MEDLINE | ID: mdl-33916376
The "POWERFUL" multicenter, retrospective, and prospective study investigated the effectiveness of pomalidomide plus low-dose dexamethasone (POM/LoDex) therapy in relapsed/refractory multiple myeloma in routine care in Greece. Ninety-nine eligible adult patients treated with POM/LoDex according to the approved label after having received ≥2 prior therapies, including lenalidomide and bortezomib, were consecutively enrolled between 16 November 2017 and 21 February 2019 in 18 hematology departments. Fifty patients (50.5%) started POM/LoDex as third-line treatment. During the treatment period (median: 8.3 months; range: 0.3-47.6 months), the median POM dose was 4 mg/day, and 31.3% of the patients received additional antimyeloma agents. The overall response rate was 32.3%. During a median follow-up period of 13.8 months (Kaplan-Meier estimate), the median progression-free survival (PFS) was 10.5 months (95% CI: 7.4-14.4). The PFS was not significantly different between patients receiving POM/LoDex in the third versus later line of therapy, nor between patients receiving concomitant antimyeloma therapy versus POM/LoDEx doublet. During the prospective safety data collection period (median: 7.6 months) among patients with prospective follow-up (N = 75), POM-related adverse event incidence rate was 42.7% (serious: 18.7%; grade ≥ 3 hematological POM-related adverse events: 8.0%). Only neutropenia (13.3%) was reported at a frequency ≥10%. In conclusion, in this real-world study, POM/LoDex displayed a long PFS with no new safety signals emerging.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Tipo de estudio: Clinical_trials / Observational_studies / Risk_factors_studies Idioma: En Revista: J Clin Med Año: 2021 Tipo del documento: Article País de afiliación: Grecia Pais de publicación: Suiza

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Tipo de estudio: Clinical_trials / Observational_studies / Risk_factors_studies Idioma: En Revista: J Clin Med Año: 2021 Tipo del documento: Article País de afiliación: Grecia Pais de publicación: Suiza