دورية أكاديمية
Phase II study of bortezomib, cyclophosphamide and dexamethasone as induction therapy in multiple myeloma: DSMM XI trial.
العنوان: | Phase II study of bortezomib, cyclophosphamide and dexamethasone as induction therapy in multiple myeloma: DSMM XI trial. |
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المؤلفون: | Einsele H; University Hospital Würzburg, Würzburg, Germany., Engelhardt M; University Hospital Freiburg, Freiburg, Germany., Tapprich C; Janssen-Cilag GmbH, Neuss, Germany., Müller J; Acromion GmbH, Frechen, Germany., Liebisch P; University Hospital Ulm, Ulm, Germany., Langer C; University Hospital Ulm, Ulm, Germany., Kropff M; University Hospital Munster, Munster, Germany., Mügge LO; University Hospital Jena, Jena, Germany., Jung W; University Hospital Gottingen, Gottingen, Germany., Wolf HH; University Hospital Halle, Halle, Germany., Metzner B; Klinikum Oldenburg, University Hospital, Oldenburg, Germany., Hart C; University Hospital Regensburg, Regensburg, Germany., Gramatzki M; University Hospital Schleswig-Holstein, Kiel, Germany., Hertenstein B; Hospital Bremen-Mitte, Bremen, Germany., Pfreundschuh M; University Hospital of Saarlandia, Homburg, Germany., Rösler W; University Hospital Erlangen, Erlangen, Germany., Fischer T; University Hospital Magdeburg, Magdeburg, Germany., Maschmeyer G; Klinikum Ernst von Bergmann, Potsdam, Germany., Kanz L; University Hospital Tübingen, Tübingen, Germany., Hess G; University Medical Centre of the Johannes Gutenberg University Mainz, Mainz, Germany., Jäger E; Northwest Hospital, Frankfurt, Germany., Bentz M; City Hospital Karlsruhe, Karlsruhe, Germany., Dürk HA; St. Mary Hospital Hamm, Hamm, Germany., Salwender H; Asklepios Clinic Altona, Hamburg, Germany., Hebart H; Stauferklinikum Schwäbisch Gmünd, Mutlangen, Germany., Straka C; Schön Klinik Starnberger See, Berg, Germany., Knop S; University Hospital Würzburg, Würzburg, Germany. |
المصدر: | British journal of haematology [Br J Haematol] 2017 Nov; Vol. 179 (4), pp. 586-597. Date of Electronic Publication: 2017 Sep 29. |
نوع المنشور: | Clinical Trial, Phase II; Journal Article; Research Support, Non-U.S. Gov't |
اللغة: | English |
بيانات الدورية: | Publisher: Wiley-Blackwell Country of Publication: England NLM ID: 0372544 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1365-2141 (Electronic) Linking ISSN: 00071048 NLM ISO Abbreviation: Br J Haematol Subsets: MEDLINE |
أسماء مطبوعة: | Publication: Oxford : Wiley-Blackwell Original Publication: Oxford : Blackwell Scientific Publications |
مواضيع طبية MeSH: | Antineoplastic Combined Chemotherapy Protocols/*therapeutic use , Induction Chemotherapy/*methods , Multiple Myeloma/*drug therapy, Adolescent ; Adult ; Antineoplastic Combined Chemotherapy Protocols/adverse effects ; Bortezomib/administration & dosage ; Consolidation Chemotherapy ; Cyclophosphamide/administration & dosage ; Cytogenetics ; Dexamethasone/administration & dosage ; Female ; Humans ; Male ; Middle Aged ; Multiple Myeloma/mortality ; Risk Assessment/methods ; Stem Cell Transplantation ; Survival Analysis ; Transplantation, Autologous ; Young Adult |
مستخلص: | We assessed the safety and efficacy of bortezomib, cyclophosphamide and dexamethasone (VCD) induction therapy in previously untreated multiple myeloma patients. A total of 414 patients received three 21-day cycles of VCD prior to autologous stem-cell transplantation (ASCT). Most common grade ≥3 adverse events were leucopenia (31·4%) and thrombocytopenia (6·8%). The overall response rate (ORR) by investigator-based assessment was 85·4%. Most patients (74%) underwent successful central laboratory-based molecular cytogenetic analysis. No clinically relevant differences in ORR post-induction were seen between patients with or without high-risk cytogenetic abnormalities (86·2% vs. 84·3%). Further follow-up data are available for 113 patients receiving ASCT who were included in a prospective consolidation trial (median follow-up, 55·5 months); median progression-free survival (PFS) was 35·3 months and median overall survival (OS) was not reached. In patients with high-risk versus standard-risk cytogenetics, median PFS was 19·9 vs. 43·6 months (P < 0·0001), and median OS was 54·7 months versus not reached (P = 0·0022). VCD is an effective and tolerable induction regimen; results suggest that VCD induces high response rates independently of cytogenetic risk status, but after long-term follow-up, cytogenetic high risk is associated with markedly reduced PFS and OS post-ASCT. (© 2017 John Wiley & Sons Ltd.) |
فهرسة مساهمة: | Keywords: bortezomib; cyclophosphamide; dexamethasone; induction therapy; multiple myeloma |
المشرفين على المادة: | 69G8BD63PP (Bortezomib) 7S5I7G3JQL (Dexamethasone) 8N3DW7272P (Cyclophosphamide) |
تواريخ الأحداث: | Date Created: 20170930 Date Completed: 20171127 Latest Revision: 20180209 |
رمز التحديث: | 20221213 |
DOI: | 10.1111/bjh.14920 |
PMID: | 28961309 |
قاعدة البيانات: | MEDLINE |
تدمد: | 1365-2141 |
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DOI: | 10.1111/bjh.14920 |