دورية أكاديمية
Extended follow-up of a phase 2 trial of bortezomib alone and in combination with dexamethasone for the frontline treatment of multiple myeloma.
العنوان: | Extended follow-up of a phase 2 trial of bortezomib alone and in combination with dexamethasone for the frontline treatment of multiple myeloma. |
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المؤلفون: | Jagannath S; St. Vincent's Comprehensive Cancer Center, New York, NY 10011, USA. sjagannath@aptiumoncology.com, Durie BG, Wolf JL, Camacho ES, Irwin D, Lutzky J, McKinley M, Potts P, Gabayan AE, Mazumder A, Crowley J, Vescio R |
المصدر: | British journal of haematology [Br J Haematol] 2009 Sep; Vol. 146 (6), pp. 619-26. Date of Electronic Publication: 2009 Jul 20. |
نوع المنشور: | Clinical Trial, Phase II; Journal Article; Multicenter Study; 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 Agents/*therapeutic use , Boronic Acids/*therapeutic use , Dexamethasone/*therapeutic use , Multiple Myeloma/*drug therapy , Pyrazines/*therapeutic use, Adult ; Aged ; Aged, 80 and over ; Antineoplastic Agents/adverse effects ; Boronic Acids/adverse effects ; Bortezomib ; Dexamethasone/adverse effects ; Drug Therapy, Combination ; Female ; Follow-Up Studies ; Humans ; Male ; Middle Aged ; Multiple Myeloma/mortality ; Pyrazines/adverse effects ; Stem Cell Transplantation ; Survival Analysis ; Treatment Outcome |
مستخلص: | High-quality response to multiple myeloma (MM) therapy can be predictive for improved outcomes. Novel agents may improve the depth of responses and therefore prolong survival. We report on the extended follow-up of a phase II study in frontline MM of bortezomib alone and in combination with dexamethasone. Forty-nine previously untreated, symptomatic MM patients received bortezomib 1.3 mg/m(2), days 1, 4, 8, 11, for up to six 3-week cycles. High-dose dexamethasone was added for patients not reaching either a partial response after cycle 2 or a complete response (CR) after cycle 4. The overall response rate in 48 evaluable patients was 90%, with 42% achieving at least a very good partial response, of which 19% were CR/near CR. Thirty-six patients received high-dose dexamethasone with 28 (77%) showing improved response. Twenty-seven patients have undergone successful stem-cell transplantation (SCT). After median follow-up of 49 months, 15 patients have died; median overall survival has still not been reached, with an estimated survival at 4 years of 67%. Overall survival with and without SCT was not different (P = 0.54). Grade 3/4 adverse events included neutropenia (10%), sensory neuropathy (6% grade 3), neuropathic pain (4% grade 3), and diarrhoea (4% grade 3). Bortezomib +/- dexamethasone is an effective and well-tolerated induction regimen for the frontline treatment of MM. |
المشرفين على المادة: | 0 (Antineoplastic Agents) 0 (Boronic Acids) 0 (Pyrazines) 69G8BD63PP (Bortezomib) 7S5I7G3JQL (Dexamethasone) |
تواريخ الأحداث: | Date Created: 20090723 Date Completed: 20100222 Latest Revision: 20151119 |
رمز التحديث: | 20240628 |
DOI: | 10.1111/j.1365-2141.2009.07803.x |
PMID: | 19622094 |
قاعدة البيانات: | MEDLINE |
تدمد: | 1365-2141 |
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DOI: | 10.1111/j.1365-2141.2009.07803.x |