Bortezomib before and after high-dose therapy in myeloma: long-term results from the phase III HOVON-65/GMMG-HD4 trial
Goldschmidt, H; Lokhorst, H M; Mai, E K; van der Holt, B; Blau, I W; Zweegman, S; Weisel, K C; Vellenga, E; Pfreundschuh, M; Kersten, M J; Scheid, C; Croockewit, S; Raymakers, R; Hose, D; Potamianou, A; Jauch, A; Hillengass, J; Stevens-Kroef, M; Raab, M S; Broijl, A; Lindemann, H W; Bos, G M J; Brossart, P; van Marwijk Kooy, M; Ypma, P; Duehrsen, U; Schaafsma, R M; Bertsch, U; Hielscher, T; Jarari, Le; Salwender, H J; Sonneveld, P
(2018) Leukemia, volume 32, issue 2, pp. 383 - 390
(Article)
Abstract
The Dutch-Belgian Cooperative Trial Group for Hematology Oncology Group-65/German-speaking Myeloma Multicenter Group-HD4 (HOVON-65/GMMG-HD4) phase III trial compared bortezomib (BTZ) before and after high-dose melphalan and autologous stem cell transplantation (HDM, PAD arm) compared with classical cytotoxic agents prior and thalidomide after HDM (VAD arm) in multiple myeloma (MM) patients aged
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18-65 years. Here, the long-term follow-up and data on second primary malignancies (SPM) are presented. After a median follow-up of 96 months, progression-free survival (censored at allogeneic transplantation, PFS) remained significantly prolonged in the PAD versus VAD arm (hazard ratio (HR)=0.76, 95% confidence interval (95% CI) of 0.65-0.89, P=0.001). Overall survival (OS) was similar in the PAD versus VAD arm (HR=0.89, 95% CI: 0.74-1.08, P=0.24). The incidence of SPM were similar between the two arms (7% each, P=0.73). The negative prognostic effects of the cytogenetic aberration deletion 17p13 (clone size ⩾10%) and renal impairment at baseline (serum creatinine >2 mg dl-1) on PFS and OS remained abrogated in the PAD but not VAD arm. OS from first relapse/progression was similar between the study arms (HR=1.02, P=0.85). In conclusion, the survival benefit with BTZ induction/maintenance compared with classical cytotoxic agents and thalidomide maintenance is maintained without an increased risk of SPM.
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Keywords: Hematology, Oncology, Cancer Research
ISSN: 0887-6924
Publisher: Nature Publishing Group
Note: Publisher Copyright: © 2018 Macmillan Publishers Limited, part of Springer Nature.
(Peer reviewed)