title: Efficacy and safety of lenalidomide treatment in multiple myeloma (MM) patients--Report of the Polish Myeloma Group.
abstract: The aim of the multi-centre retrospective study was to evaluate the efficacy and safety of lenalidomide (LEN) therapy in patients with resistant or relapsed multiple myeloma (MM) as well as in patients with stable disease (LEN used due to neurological complications). The primary endpoint of this study was an overall response rate (ORR). The secondary endpoints were as follows: time to progression (TTP), overall survival (OS) and the safety of drug use. Data were collected in 19 centres of the Polish Multiple Myeloma Study Group. The study group consisted of 306 subjects: 153 females and 153 males. In 115 patients (38.8%, group A), a resistant myeloma was diagnosed; in 135 (44.1%, group B) a relapse, and in 56 (18.3%, group C) a stable disease were stated. In 92.8% of patients, LEN+DEX combination was used; in remaining group, LEN monotherapy or a combination therapy LEN+bortezomib or LEN+bendamustine and other were used. In the entire study group, ORR was 75.5% (including 12.4% patients achieving complete remission [CR] or stringent CR [sCR]). Median time to progression (TTP) was 20 months. Median overall survival (OS) was 33.3 months. The regression model for "treatment response" was on the borderline of statistical significance (p=0.07), however the number of LEN treatment cycles ≥ 6 (R(2)=17.2%), baseline LDH level (R(2)=1.1%) and no ASCT use (R(2)=1.7%) where the factors most affecting treatment response achievement. The regression model for dependant variable--"overall survival"--was statistically significant (p=0.0000004). Factors with the most impact on OS were as follows: number of LEN cycles treatment ≥ 6 (R(2)=16.7%), treatment response achievement (R(2)=6.9%), β-2-microglobulin (β-2-M) level (R(2)=4.8%), renal function (R(2)=3.0%) and lack of 3/4 grade adverse events (R(2)=1.4%).
  
  
  CONCLUSIONS
  LEN is an effective and safe therapeutic option, even in intensively treated resistant and relapsed MM patients, as well as in patients with stable disease and previous treatment-induced neurological complications. In particular, the number of LEN treatment cycles ≥ 6 was the factor which affected treatment response achievement the most, together with an important impact on OS.
authors.affiliation: Department of Haematology, Blood Neoplasms and Bone Marrow Transplantation, Wroclaw Medical University, Poland. Electronic address: lidiauz@wp.pl.
authors.forename: L
authors.initials: L
authors.lastname: Usnarska-Zubkiewicz
authors.affiliation: Department of Haematology, Blood Neoplasms and Bone Marrow Transplantation, Wroclaw Medical University, Poland.
authors.forename: J
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authors.lastname: Dębski
authors.affiliation: Department of Haematology, Blood Neoplasms and Bone Marrow Transplantation, Wroclaw Medical University, Poland; Department of Physiology, Wroclaw Medical University, Poland.
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authors.initials: A
authors.lastname: Butrym
authors.affiliation: Department of Haematology and Bone Marrow Transplantation, Medical University of Lublin, Poland.
authors.forename: W
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authors.lastname: Legieć
authors.affiliation: Department of Haematology and Bone Marrow Transplantation, Medical University of Lublin, Poland.
authors.forename: M
authors.initials: M
authors.lastname: Hus
authors.affiliation: Department of Haematology and Bone Marrow Transplantation, Medical University of Lublin, Poland.
authors.forename: A
authors.initials: A
authors.lastname: Dmoszyńska
authors.affiliation: Department of Haematology and Bone Marrow Transplantation, Medical University of Silesia, Katowice, Poland.
authors.forename: B
authors.initials: B
authors.lastname: Stella-Hołowiecka
authors.affiliation: Gdynia Oncology Centre, Poland.
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authors.initials: JM
authors.lastname: Zaucha
authors.affiliation: Gdynia Oncology Centre, Poland.
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authors.initials: J
authors.lastname: Januszczyk
authors.affiliation: Department of Haematology, District Hospital in Torun, Poland.
authors.forename: M
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authors.lastname: Rymko
authors.affiliation: Department of Haematology, Oncology and Internal Medicine, Warsaw Medical University, Poland.
authors.forename: T
authors.initials: T
authors.lastname: Torosian
authors.affiliation: Department of Haematology, Oncology and Internal Medicine, Warsaw Medical University, Poland.
authors.forename: G
authors.initials: G
authors.lastname: Charliński
authors.affiliation: Department of Haematology, Institute of Haematology and Blood Transfusion, Warsaw, Poland; Centre of Postgraduate Medical Education, Warsaw, Poland.
authors.forename: E
authors.initials: E
authors.lastname: Lech-Marańda
authors.affiliation: Department of Haematology, Institute of Haematology and Blood Transfusion, Warsaw, Poland.
authors.forename: A
authors.initials: A
authors.lastname: Malenda
authors.affiliation: Department of Haematology, Collegium Medicum at the Jagiellonian University, Cracow, Poland.
authors.forename: A
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authors.lastname: Jurczyszyn
authors.affiliation: Department of Haematology, Medical University of Lodz, Poland.
authors.forename: H
authors.initials: H
authors.lastname: Urbańska-Ryś
authors.affiliation: Department of Lymphoproliferative Diseases, Maria Sklodowska-Curie Memorial Institute and Oncology Centre, Warsaw, Poland.
authors.forename: A
authors.initials: A
authors.lastname: Druzd-Sitek
authors.affiliation: Department of Haematology and Neoplasmatic Diseases of Haematopoiesis, Bydgoszcz, Poland.
authors.forename: D
authors.initials: D
authors.lastname: Błońska
authors.affiliation: Department of Clinical Oncology and Haematology, District Hospital in Suwalki, Poland.
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authors.lastname: Urbanowicz
authors.affiliation: Department of Haematology, District Specialist Hospital in Legnica, Poland.
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authors.lastname: Hołojda
authors.affiliation: Department of Haematology and Haematooncology, District Hospital in Opole, Poland.
authors.forename: J
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authors.lastname: Pogrzeba
authors.affiliation: Department of Internal Diseases and Haematology, Military Institute of Medicine, Central Clinical Hospital of the Ministry of National Defence, Warsaw, Poland.
authors.forename: P
authors.initials: P
authors.lastname: Rzepecki
authors.affiliation: Department of Internal Diseases and Haematology, Military Institute of Medicine, Central Clinical Hospital of the Ministry of National Defence, Warsaw, Poland.
authors.forename: J
authors.initials: J
authors.lastname: Hałka
authors.affiliation: Department of Internal Diseases and Haematology, Military Institute of Medicine, Central Clinical Hospital of the Ministry of National Defence, Warsaw, Poland.
authors.forename: E
authors.initials: E
authors.lastname: Subocz
authors.affiliation: Department of Haematology, Pomeranian Medical University, Szczecin, Poland.
authors.forename: R
authors.initials: R
authors.lastname: Becht
authors.affiliation: Department of Haematology, Pomeranian Medical University, Szczecin, Poland.
authors.forename: B
authors.initials: B
authors.lastname: Zdziarska
authors.affiliation: Department of Haematology and Bone Marrow Transplantation, Poznan University of Medical Sciences, Poland.
authors.forename: D
authors.initials: D
authors.lastname: Dytfeld
authors.affiliation: Department of Haematology and Bone Marrow Transplantation, Poznan University of Medical Sciences, Poland.
authors.forename: A
authors.initials: A
authors.lastname: Nowicki
authors.affiliation: Department of Haematology, University Clinical Hospital of Białystok, Poland.
authors.forename: Ł
authors.initials: Ł
authors.lastname: Bołkun
authors.affiliation: Department of Haematology, University Clinical Hospital of Białystok, Poland.
authors.forename: J
authors.initials: J
authors.lastname: Kłoczko
authors.affiliation: Ministry of the Interior Hospital in Olsztyn with Warmia and Masuria Oncology Center, Poland.
authors.forename: W
authors.initials: W
authors.lastname: Knopińska-Posłuszny
authors.affiliation: Department of Endocrinology and Diabetology for Children and Adolescents, Wroclaw Medical University, Poland.
authors.forename: A
authors.initials: A
authors.lastname: Zubkiewicz-Kucharska
authors.affiliation: Department of Haematology, Blood Neoplasms and Bone Marrow Transplantation, Wroclaw Medical University, Poland.
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mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D018450:Disease Progression; D005260:Female; D006801:Humans; D007155:Immunologic Factors / Q000009:adverse effects / Q000627:therapeutic use*; D000077269:Lenalidomide; D008297:Male; D008875:Middle Aged; D009101:Multiple Myeloma / Q000188:drug therapy* / Q000473:pathology; D013792:Thalidomide / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use
chemical_list: D007155:Immunologic Factors; D013792:Thalidomide; D000077269:Lenalidomide
keywords: Efficacy; Lenalidomide; Multiple myeloma; Safety