Bortezomib induction and maintenance treatment in patients with newly diagnosed multiple myeloma

• Verfasst von: Sonneveld, Pieter [VerfasserIn]
• Verfasst von: Bertsch, Uta [VerfasserIn]
• Verfasst von: Hose, Dirk [VerfasserIn]
• Verfasst von: Jauch, Anna [VerfasserIn]
• Verfasst von: Goldschmidt, Hartmut [VerfasserIn]
• Titel: Bortezomib induction and maintenance treatment in patients with newly diagnosed multiple myeloma
• Titelzusatz: results of the randomized phase III HOVON-65/ GMMG-HD4 trial
• Verf.angabe: 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
• E-Jahr: 2012
• Jahr: July 16, 2012
• Umfang: 10 S.
• Fussnoten: Published ahead of print at July 16, 2012 ; Gesehen am 31.07.2018
• Titel Quelle: Enthalten in: Journal of clinical oncology
• Ort Quelle: Alexandria, Va. : American Society of Clinical Oncology, 1983
• Jahr Quelle: 2012
• Band/Heft Quelle: 30(2012), 24, Seite 2946-2955
• ISSN Quelle: 1527-7755
• DOI: doi:10.1200/JCO.2011.39.6820
• Datenträger: Online-Ressource
• Sprache: eng
• Bibliogr. Hinweis: Erscheint auch als : Druck-Ausgabe: Bortezomib induction and maintenance treatment in patients with newly diagnosed multiple myeloma. - 2012
• K10plus-PPN: 1578101549

Abstract

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.