A1 Vertaisarvioitu alkuperäisartikkeli tieteellisessä lehdessä
Bortezomib consolidation after autologous stem cell transplantation in multiple myeloma – a Nordic Myeloma Study Group randomized phase 3 trial
Alaotsikko: a Nordic Myeloma Study Group randomized phase 3 trial
Tekijät: Mellqvist UH, Gimsing P, Hjertner O, Lenhoff S, Laane E, Remes K, Steingrimsdottir H, Abildgaard N, Ahlberg L, Blimark C, Dahl IM, Forsberg K, Gedde-Dahl T, Gregersen H, Gruber A, Guldbrandsen N, Haukas E, Carlson K, Kvam AK, Nahi H, Lindas R, Andersen NF, Turesson I, Waage A, Westin J, for the Nordic Myeloma Study Group
Kustantaja: AMER SOC HEMATOLOGY
Julkaisuvuosi: 2013
Journal: Blood
Tietokannassa oleva lehden nimi: BLOOD
Lehden akronyymi: BLOOD
Numero sarjassa: 23
Vuosikerta: 121
Numero: 23
Aloitussivu: 4647
Lopetussivu: 4654
Sivujen määrä: 8
ISSN: 0006-4971
DOI: https://doi.org/10.1182/blood-2012-11-464503
The Nordic Myeloma Study Group conducted an open randomized trial to compare bortezomib as consolidation therapy given after high-dose therapy and autologous stem cell transplantation (ASCT) with no consolidation in bortezomib-naive patients with newly diagnosed multiple myeloma. Overall, 370 patients were centrally randomly assigned 3 months after ASCT to receive 20 doses of bortezomib given during 21 weeks or no consolidation. The hypothesis was that consolidation therapy would prolong progression-free survival (PFS). The PFS after randomization was 27 months for the bortezomib group compared with 20 months for the control group (P = .05). Fifty-one of 90 patients in the treatment group compared with 32 of 90 controls improved their response after randomization (P = .007). No difference in overall survival was seen. Fatigue was reported more commonly by the bortezomib-treated patients in self-reported quality-of-life (QOL) questionnaires, whereas no other major differences in QOL were recorded between the groups. Consolidation therapy seemed to be beneficial for patients not achieving at least a very good partial response (VGPR) but not for patients in the >= VGPR category at randomization. Consolidation with bortezomib after ASCT in bortezomib-naive patients improves PFS without interfering with QOL. This trial was registered at www.clinicaltrials.gov as #NCT00417911.
