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Göteborgs universitets publikationer

Thalidomide and dexamethasone vs. bortezomib and dexamethasone for melphalan refractory myeloma: a randomized study.

Författare och institution:
Martin Hjorth (-); Øyvind Hjertner (-); Lene Meldgaard Knudsen (-); Nina Gulbrandsen (-); Erik Holmberg (Institutionen för kliniska vetenskaper, sektionen för onkologi, radiofysik, radiologi och urologi, Avdelningen för onkologi); Per Trøllund Pedersen (-); Niels Frost Andersen (-); Björn Andréasson (-); Rolf Billström (-); Kristina Carlson (-); Margaretha S Carlsson (-); Max Flogegård (-); Karin Forsberg (-); Peter Gimsing (-); Torbjörn Karlsson (-); Olle Linder (-); Hareth Nahi (-); Annika Othzén (-); Agneta Swedin (-)
Publicerad i:
European journal of haematology, 88 ( 6 ) s. 485-496
Artikel, övrig vetenskaplig
Sammanfattning (abstract):
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.
Ämne (baseras på Högskoleverkets indelning av forskningsämnen):
Klinisk medicin ->
Cancer och onkologi
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
Postens nummer:
Posten skapad:
2012-07-27 10:25
Posten ändrad:
2012-08-29 10:03

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