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Thalidomide and dex...
Thalidomide and dexamethasone vs. bortezomib and dexamethasone for melphalan refractory myeloma: a randomized study.
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- Hjorth, Martin (author)
- Department of Medicine, Lidköping Hospital, Lidköping, Sweden,Nordic Myeloma Study Group (NMSG)
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- Hjertner, Øyvind (author)
- Department of Hematology, St Olavs University Hospital, and Department of Cancer Research and Molecular Medicine, Norwegian University of Science and Technology, Trondheim, Norway,Nordic Myeloma Study Group (NMSG)
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- Knudsen, Lene Meldgaard (author)
- Department of Hematology, Odense University Hospital, Odense, Denmark,Nordic Myeloma Study Group (NMSG)
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- Gulbrandsen, Nina (author)
- Department of Hematology and Faculty Division, Ullevål University Hospital, Oslo, Norway,Nordic Myeloma Study Group (NMSG)
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- Holmberg, Erik, 1951 (author)
- Gothenburg University,Göteborgs universitet,Institutionen för kliniska vetenskaper, Avdelningen för onkologi,Institute of Clinical Sciences, Department of Oncology,Department of Oncology, Institute of Clinical Sciences, Sahlgrenska Academy at University of Gothenburg, Gothenburg, Sweden,Nordic Myeloma Study Group (NMSG)
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- Pedersen, Per Trøllund (author)
- Department of Hematology, Odense University Hospital, Odense, Denmark and Department of Hematology, Esbjerg Hospital, Esbjerg,Nordic Myeloma Study Group (NMSG)
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- Andersen, Niels Frost (author)
- Department of Hematology, Aarhus University Hospital, Aarhus, Denmark,Nordic Myeloma Study Group (NMSG)
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- Andréasson, Björn (author)
- Hematology Section, Department of Medicine, NU Health Organization, Uddevalla,Nordic Myeloma Study Group (NMSG)
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- Billström, Rolf (author)
- Department of Medicine, Skövde Hospital/KSS, Skövde,Nordic Myeloma Study Group (NMSG)
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- Carlson, Kristina (author)
- Uppsala universitet,Hematologi
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- Carlsson, Margaretha S (author)
- Department of Medicine, Växjö Hospital, Växjö,Nordic Myeloma Study Group (NMSG)
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- Flogegård, Max (author)
- Department of Medicine, Falun Hospital, Falun,Nordic Myeloma Study Group (NMSG)
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- Forsberg, Karin (author)
- Umeå universitet,Onkologi,Nordic Myeloma Study Group (NMSG)
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- Gimsing, Peter (author)
- Department of Hematology, Rigshospitalet and University of Copenhagen, Copenhagen, Denmark,Nordic Myeloma Study Group (NMSG)
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- Karlsson, Torbjorn (author)
- Uppsala universitet,Hematologi
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- Linder, Olle (author)
- Department of Hematology, Örebro University Hospital, Örebro,Nordic Myeloma Study Group (NMSG)
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- Nahi, Hareth (author)
- Karolinska Institutet
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- Othzén, Annika (author)
- Department of Medicine, Gävle Hospital, Gävle,Nordic Myeloma Study Group (NMSG)
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- Swedin, Agneta (author)
- Department of Hematology, Skane University Hospital, Lund, Sweden,Nordic Myeloma Study Group (NMSG)
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Hjertner, O (author)
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(creator_code:org_t)
- 2012-03-30
- 2012
- English.
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In: European journal of haematology. - : Wiley. - 0902-4441 .- 1600-0609. ; 88:6, s. 485-496
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Abstract
Subject headings
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- Objectives: Thalidomide and bortezomib have been frequently used for second-line therapy in patients with myeloma relapsing after or refractory to initial melphalan-based treatment, but no randomized trials have been published comparing these two treatment alternatives. Methods: Thalidomide- and bortezomib-naïve patients with melphalan refractory myeloma were randomly assigned to low-dose thalidomide + dexamethasone (Thal-Dex) or bortezomib + dexamethasone (Bort-Dex). At progression on either therapy, the patients were offered crossover to the alternative drug combination. An estimated 300 patients would be needed for the trial to detect a 50% difference in median PFS between the treatment arms. Results: After inclusion of 131 patients, the trial was prematurely closed because of low accrual. Sixty-seven patients were randomized to Thal-Dex and 64 to Bort-Dex. Progression-free survival was similar (median, 9.0 months for Thal-Dex and 7.2 for Bort-Dex). Response rate was similar (55% for Thal-Dex and 63% for Bort-Dex), but time to response was shorter (P < 0.05) and the VGPR rate higher (P < 0.01) for Bort-Dex. Time-to-other treatment after crossover was similar (median, 13.2 months for Thal-Dex and 11.2 months for Bort-Dex), as was overall survival (22.8 months for Thal-Dex and 19.0 for Bort-Dex). Venous thromboembolism was seen in seven patients and cerebrovascular events in four patients in the Thal-Dex group. Severe neuropathy, reactivation of herpes virus infections, and mental depression were more frequently observed in the Bort-Dex group. In the quality-of-life analysis, no difference was noted for physical function, pain, and global quality of life. Fatigue and sleep disturbances were significantly more prevalent in the Bort-Dex group. Conclusions: Thalidomide (50–100 mg daily) in combination with dexamethasone seems to have an efficacy comparable with that of bortezomib and dexamethasone in melphalan refractory myeloma. However, the statistical strength of the results in this study is limited by the low number of included patients.
Subject headings
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Cancer och onkologi (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Cancer and Oncology (hsv//eng)
Keyword
- Adult
- Aged
- Aged
- 80 and over
- Antineoplastic Combined Chemotherapy Protocols
- administration & dosage
- adverse effects
- Boronic Acids
- administration & dosage
- Cross-Over Studies
- Dexamethasone
- administration & dosage
- Disease-Free Survival
- Drug Resistance
- Neoplasm
- Female
- Humans
- Male
- Melphalan
- therapeutic use
- Middle Aged
- Multiple Myeloma
- drug therapy
- Pyrazines
- administration & dosage
- Quality of Life
- Recurrence
- Thalidomide
- administration & dosage
- multiple myeloma
Publication and Content Type
- vet (subject category)
- art (subject category)
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- By the author/editor
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Hjorth, Martin
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Hjertner, Øyvind
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Knudsen, Lene Me ...
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Gulbrandsen, Nin ...
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Holmberg, Erik, ...
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Pedersen, Per Tr ...
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Andersen, Niels ...
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Andréasson, Björ ...
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Billström, Rolf
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Carlson, Kristin ...
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Carlsson, Margar ...
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Flogegård, Max
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Forsberg, Karin
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Gimsing, Peter
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Karlsson, Torbjo ...
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Linder, Olle
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Nahi, Hareth
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Othzén, Annika
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Swedin, Agneta
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Hjertner, O
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- About the subject
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- MEDICAL AND HEALTH SCIENCES
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MEDICAL AND HEAL ...
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and Clinical Medicin ...
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and Cancer and Oncol ...
- Articles in the publication
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European journal ...
- By the university
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University of Gothenburg
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Umeå University
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Karolinska Institutet
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Uppsala University