دورية أكاديمية
Bortezomib consolidation following autologous transplant in younger and older patients with newly diagnosed multiple myeloma in two phase III trials.
| العنوان: | Bortezomib consolidation following autologous transplant in younger and older patients with newly diagnosed multiple myeloma in two phase III trials. |
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| المؤلفون: | Straka C; 1. Medizinische Klinik, München Klinik Schwabing, München, Germany., Knop S; Medizinische Klinik und Poliklinik II, Julius Maximilians Universität Würzburg, Würzburg, Germany., Vogel M; Janssen-Cilag GmbH, Neuss, Germany., Müller J; Acromion GmbH, Frechen, Germany., Kropff M; Universitätsklinikum Münster, Münster, Germany., Metzner B; Universitätsklinik für Innere Medizin - Onkologie und Hämatologie, Klinikum Oldenburg, Oldenburg, Germany., Langer C; Zentrum für Innere Medizin Universitätsklinikum Ulm, Ulm, Germany., Sayer H; Klinik für Innere Medizin II [Hämatologie/Onkologie], Universitätsklinikum Jena, Jena, Germany., Jung W; Onkologie Universitätsmedizin Göttingen, Göttingen, Germany., Dürk HA; St. Marien Hospital Hamm Knappenstraße, Hamm, Germany., Salwender H; Asklepios Klinik Altona, Hamburg, Germany., Wandt H; Medizinische Klinik 5, Paracelsus Medizinische Privatuniversität Nürnberg, Nürnberg, Germany., Bassermann F; Klinikum rechts der Isar, III. Medizinische Klinik, Technische Universität München, München, Germany., Gramatzki M; Universitätsklinikum Schleswig-Holstein, Kiel, Germany., Rösler W; Universitätsklinkum Erlangen, Erlangen, Germany., Wolf HH; University Hospital Halle, Halle (Saale), Germany., Brugger W; Schwarzwald-Baar Klinikum, Villingen-Schwenningen, Germany., Fischer T; Otto-von-Guericke University, Magdeburg, Germany., Liebisch P; Zentrum für Innere Medizin Universitätsklinikum Ulm, Ulm, Germany., Engelhardt M; Faculty of Medicine, University of Freiburg, Freiburg, Germany., Einsele H; Medizinische Klinik und Poliklinik II, Julius Maximilians Universität Würzburg, Würzburg, Germany. |
| المصدر: | European journal of haematology [Eur J Haematol] 2019 Sep; Vol. 103 (3), pp. 255-267. Date of Electronic Publication: 2019 Jul 19. |
| نوع المنشور: | Clinical Trial, Phase III; Journal Article; Randomized Controlled Trial |
| اللغة: | English |
| بيانات الدورية: | Publisher: Blackwell Country of Publication: England NLM ID: 8703985 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1600-0609 (Electronic) Linking ISSN: 09024441 NLM ISO Abbreviation: Eur J Haematol Subsets: MEDLINE |
| أسماء مطبوعة: | Publication: <2005->: Oxford : Blackwell Original Publication: Copenhagen : Munksgaard, c1987- |
| مواضيع طبية MeSH: | Hematopoietic Stem Cell Transplantation*/adverse effects , Hematopoietic Stem Cell Transplantation*/methods, Antineoplastic Agents/*therapeutic use , Bortezomib/*therapeutic use , Multiple Myeloma/*therapy, Adolescent ; Adult ; Aged ; Aged, 80 and over ; Antineoplastic Agents/administration & dosage ; Antineoplastic Agents/adverse effects ; Bortezomib/administration & dosage ; Bortezomib/adverse effects ; Combined Modality Therapy ; Consolidation Chemotherapy ; Female ; Humans ; Male ; Middle Aged ; Multiple Myeloma/diagnosis ; Multiple Myeloma/mortality ; Neoplasm Staging ; Prognosis ; Survival Analysis ; Transplantation, Autologous ; Treatment Outcome ; Young Adult |
| مستخلص: | Objective: A post hoc analysis of two phase III trials was carried out to explore the influence of age and treatment factors on the effect of bortezomib consolidation on progression-free survival (PFS) post autologous stem cell transplantation (ASCT). Methods: Patients with newly diagnosed multiple myeloma were assigned to one of two trials (ClinicalTrials.gov IDs: NCT00416273, NCT00416208), which were conducted in parallel, based on age (18-60 or 61-75 years, respectively). Following induction and ASCT, patients were randomized 1:1 to four 35-day cycles of bortezomib consolidation (1.6 mg/m 2 IV on days 1, 8, 15, 22) or observation only. Results: Median PFS with bortezomib consolidation vs observation was 33.6 vs 29.0 months (P = 0.3599) in patients aged 18-60 years (n = 202), and 33.4 vs 26.4 months (P = 0.0073) in patients aged 61-75 years (n = 155), respectively. Bortezomib consolidation post-ASCT appeared to equalize outcomes between older and younger patients who received prior treatment of differing intensity. This suggests that the effect of consolidation may be relative and may depend on the composition and intensity of induction and high-dose therapy. Conclusion: Older patients receiving less intensive prior treatment could experience a larger PFS benefit from bortezomib consolidation. (© 2019 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.) |
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| معلومات مُعتمدة: | Millennium Pharmaceuticals Inc; Janssen-Cilag GmbH |
| فهرسة مساهمة: | Keywords: bortezomib; consolidation; newly diagnosed multiple myeloma; phase 3; post hoc analysis |
| سلسلة جزيئية: | ClinicalTrials.gov NCT00416273; NCT00416208 |
| المشرفين على المادة: | 0 (Antineoplastic Agents) 69G8BD63PP (Bortezomib) |
| تواريخ الأحداث: | Date Created: 20190625 Date Completed: 20200124 Latest Revision: 20200124 |
| رمز التحديث: | 20240628 |
| DOI: | 10.1111/ejh.13281 |
| PMID: | 31231828 |
| قاعدة البيانات: | MEDLINE |
Full Text Finder | تدمد: | 1600-0609 |
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| DOI: | 10.1111/ejh.13281 |