TY - JOUR
T1 - Bortezomib Induction and Maintenance Treatment in Patients With Newly Diagnosed Multiple Myeloma: Results of the Randomized Phase III HOVON-65/GMMG-HD4 Trial
AU - Sonneveld, Pieter
AU - Schmidt-Wolf, IGH
AU - van der Holt, Ronnie
AU - Jarari, L (Laila)
AU - Bertsch, U
AU - Salwender, H
AU - Zweegman, S
AU - Vellenga, E
AU - Broijl, A.
AU - Blau, IW
AU - Weisel, KC
AU - Wittebol, S
AU - Bos, G (Gerard)
AU - Stevens-Kroef, M
AU - Scheid, C
AU - Pfreundschuh, M
AU - Hose, D
AU - Jauch, A
AU - te Velde, H
AU - Raymakers, R
AU - Schaafsma, MR
AU - Kersten, MJ
AU - van Marwijk-Kooy, M
AU - Duehrsen, U
AU - Lindemann, W
AU - Wijermans, PW
AU - Lokhorst, HM
AU - Goldschmidt, HM
PY - 2012
Y1 - 2012
N2 - Purpose We investigated whether bortezomib during induction and maintenance improves survival in newly diagnosed multiple myeloma (MM). Patients and Methods In all, 827 eligible patients with newly diagnosed symptomatic MM were randomly assigned to receive induction therapy with vincristine, doxorubicin, and dexamethasone (VAD) or bortezomib, doxorubicin, and dexamethasone (PAD) followed by high-dose melphalan and autologous stem-cell transplantation. Maintenance consisted of thalidomide 50 mg (VAD) once per day or bortezomib 1.3 mg/m(2) (PAD) once every 2 weeks for 2 years. The primary analysis was progression-free survival (PFS) adjusted for Inter Results Complete response (CR), including near CR, was superior after PAD induction (15% v 31%; P < .001) and bortezomib maintenance (34% v 49%; P < .001). After a median follow-up of 41 months, PFS was superior in the PAD arm (median of 28 months v 35 months; hazard ratio [ HR], 0.75; 95% CI, 0.62 to 0.90; P = .002). In multivariate analysis, overall survival (OS) was better in the PAD arm (HR, 0.77; 95% CI, 0.60 to 1.00; P = .049). In high-risk patients presenting with increased creatinine more than 2 Conclusion Bortezomib during induction and maintenance improves CR and achieves superior PFS and OS.
AB - Purpose We investigated whether bortezomib during induction and maintenance improves survival in newly diagnosed multiple myeloma (MM). Patients and Methods In all, 827 eligible patients with newly diagnosed symptomatic MM were randomly assigned to receive induction therapy with vincristine, doxorubicin, and dexamethasone (VAD) or bortezomib, doxorubicin, and dexamethasone (PAD) followed by high-dose melphalan and autologous stem-cell transplantation. Maintenance consisted of thalidomide 50 mg (VAD) once per day or bortezomib 1.3 mg/m(2) (PAD) once every 2 weeks for 2 years. The primary analysis was progression-free survival (PFS) adjusted for Inter Results Complete response (CR), including near CR, was superior after PAD induction (15% v 31%; P < .001) and bortezomib maintenance (34% v 49%; P < .001). After a median follow-up of 41 months, PFS was superior in the PAD arm (median of 28 months v 35 months; hazard ratio [ HR], 0.75; 95% CI, 0.62 to 0.90; P = .002). In multivariate analysis, overall survival (OS) was better in the PAD arm (HR, 0.77; 95% CI, 0.60 to 1.00; P = .049). In high-risk patients presenting with increased creatinine more than 2 Conclusion Bortezomib during induction and maintenance improves CR and achieves superior PFS and OS.
U2 - 10.1200/JCO.2011.39.6820
DO - 10.1200/JCO.2011.39.6820
M3 - Article
VL - 30
SP - 2946
EP - 2955
JO - Journal of Clinical Oncology
JF - Journal of Clinical Oncology
SN - 0732-183X
IS - 24
ER -