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Bortezomib induction and maintenance treatment in patients with newly diagnosed multiple myeloma: results of the randomized phase III HOVON-65/ GMMG-HD4 trial

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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, doxor...

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Hauptverfasser: Sonneveld, Pieter (VerfasserIn) , Bertsch, Uta (VerfasserIn) , Hose, Dirk (VerfasserIn) , Jauch, Anna (VerfasserIn) , Goldschmidt, Hartmut (VerfasserIn)
Dokumenttyp: Article (Journal)
Sprache:Englisch
Veröffentlicht: July 16, 2012
In: Journal of clinical oncology
Year: 2012, Jahrgang: 30, Heft: 24, Pages: 2946-2955
ISSN:1527-7755
DOI:10.1200/JCO.2011.39.6820
Online-Zugang:Verlag, Volltext: http://dx.doi.org/10.1200/JCO.2011.39.6820
Verlag, Volltext: http://ascopubs.org/doi/10.1200/JCO.2011.39.6820
Volltext
Verfasserangaben:Pieter Sonneveld, Ingo G.H. Schmidt-Wolf, Bronno van der Holt, Laila el Jarari, Uta Bertsch, Hans Salwender, Sonja Zweegman, Edo Vellenga, Annemiek Broyl, Igor W. Blau, Katja C. Weisel, Shulamiet Wittebol, Gerard M.J. Bos, Marian Stevens-Kroef, Christof Scheid, Michael Pfreundschuh, Dirk Hose, Anna Jauch, Helgi van der Velde, Reinier Raymakers, Martijn R. Schaafsma, Marie-Jose Kersten, Marinus van Marwijk-Kooy, Ulrich Duehrsen, Walter Lindemann, Pierre W. Wijermans, Henk M. Lokhorst, and Hartmut M. Goldschmidt
Beschreibung
Zusammenfassung: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/m2 (PAD) once every 2 weeks for 2 years. The primary analysis was progression-free survival (PFS) adjusted for International Staging System (ISS) stage. 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 mg/dL, bortezomib significantly improved PFS from a median of 13 months to 30 months (HR, 0.45; 95% CI, 0.26 to 0.78; P = .004) and OS from a median of 21 months to 54 months (HR, 0.33; 95% CI, 0.16 to 0.65; P < .001). A benefit was also observed in patients with deletion 17p13 (median PFS, 12 v 22 months; HR, 0.47; 95% CI, 0.26 to 0.86; P = .01; median OS, 24 months v not reached at 54 months; HR, 0.36; 95% CI, 0.18 to 0.74; P = .003). Conclusion: Bortezomib during induction and maintenance improves CR and achieves superior PFS and OS.
Beschreibung:Published ahead of print at July 16, 2012
Gesehen am 31.07.2018
Beschreibung:Online Resource
ISSN:1527-7755
DOI:10.1200/JCO.2011.39.6820

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