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Bortezomib Inductionand MaintenanceTreatment in PatientsWith Newly DiagnosedMultiple Myeloma:Results of theRandomized Phase IIIHOVON-65/ GMMG-HD4Trial Pieter SonneveldIngo Schmidt‐WolfBronno van der Holt2012 год

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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Аннотация: We investigated whether bortezomib during induction and maintenance improves survival in newly diagnosed multiple myeloma (MM).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 International Staging System (ISS) stage.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).Bortezomib during induction and maintenance improves CR and achieves superior PFS and OS.
Год издания: 2012
Авторы: Pieter Sonneveld, Ingo Schmidt‐Wolf, Bronno van der Holt, Laila el Jarari, Uta Bertsch, Hans Salwender, Sonja Zweegman, Edo Vellenga, Annemiek Broyl, Igor Wolfgang Blau, Katja Weisel, Shulamiet Wittebol, Gerard M.J. Bos, Marian Stevens‐Kroef, Christof Scheid, Michael Pfreundschuh, Dirk Hose, Anna Jauch, Helgi van der Velde, Reinier Raymakers, M Schaafsma, Marie José Kersten, Marinus van Marwijk-Kooy, Ulrich Duehrsen, Walter Lindemann, Pierre W. Wijermans, Henk M. Lokhorst, Hartmut Goldschmidt
Издательство: Lippincott Williams & Wilkins
Источник: Journal of Clinical Oncology
Ключевые слова: Multiple Myeloma Research and Treatments, Protein Degradation and Inhibitors, Peptidase Inhibition and Analysis
Другие ссылки: Journal of Clinical Oncology (HTML)
EUR Research Repository (Erasmus University Rotterdam) (HTML)
EUR Research Repository (Erasmus University Rotterdam) (PDF)
EUR Research Repository (Erasmus University Rotterdam) (HTML)
EUR Research Repository (Erasmus University Rotterdam) (PDF)
EUR Research Repository (Erasmus University Rotterdam) (HTML)
PubMed (HTML)