Phase II study of bortezomib-dexamethasone alone or with added cyclophosphamide or lenalidomide for sub-optimal response as second-line treatment for patients with multiple myeloma
| Autor: | Esther Broer, Catherine Couturier, Ralf Angermund, Meral Beksac, Meletios A. Dimopoulos, Lotfi Benboubker, Thierry Facon, Nathalie Allietta, Huw Roddie, Marie-Andrée Mazier |
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| Rok vydání: | 2013 |
| Předmět: |
Adult
Male medicine.medical_specialty Cyclophosphamide Urology Phases of clinical research Kaplan-Meier Estimate Dexamethasone Bortezomib Median follow-up Antineoplastic Combined Chemotherapy Protocols medicine Humans Prospective Studies Lenalidomide Multiple myeloma Aged Aged 80 and over business.industry Hematology Middle Aged medicine.disease Boronic Acids Thalidomide Surgery Treatment Outcome Pyrazines Female Original Articles and Brief Reports Multiple Myeloma business medicine.drug |
| Zdroj: | Haematologica. 98:1264-1272 |
| ISSN: | 1592-8721 0390-6078 |
| DOI: | 10.3324/haematol.2013.084376 |
| Popis: | This phase II study is the first prospective evaluation of bortezomib-dexamethasone as second-line therapy for relapsed/refractory multiple myeloma. A total of 163 patients were enrolled to receive four cycles of bortezomib-dexamethasone. Patients were investigator-assessed for response at cycle 5 Day 1, then treated as follows: responding patients received another four cycles of bortezomib-dexamethasone, while patients with stable disease were subsequently randomized to sequential treatment with a further four cycles of bortezomib-dexamethasone alone or with added cyclophosphamide or lenalidomide. The primary end point was response to sequential therapy; however, this could not be evaluated because investigator-assessed response rates to bortezomib-dexamethasone after four cycles were high, and an insufficient number of patients were randomized to sequential treatment per protocol. Among all 163 patients, validated best confirmed response rate was 66%, including 37% complete/very good partial responses; median response duration was 9.7 months. After a median follow up of 16.9 months, median time to progression and progression-free survival were 9.5 and 8.6 months, respectively; estimated 1-year overall survival was 81%. Median glomerular filtration rate improved from baseline during treatment. Among 58 patients with baseline glomerular filtration rate below 50 mL/min, 24 had renal responses. Grade 3/4 adverse events included: thrombocytopenia (17%), anemia (10%), constipation (6%), peripheral sensory neuropathy (5%), and polyneuropathy (5%). Overall, 57% of neuropathy events improved/resolved; median time to improvement was 2.1 months. These findings suggest bortezomib-dexamethasone represents an active, feasible second-line treatment option for patients with relapsed/refractory myeloma. |
| Databáze: | OpenAIRE |
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