Bortezomib, melphalan, prednisone, and thalidomide for relapsed multiple myeloma

Blood - Tập 109 Số 7 - Trang 2767-2772 - 2007
Antonio Palumbo1, Maria Teresa Ambrosini1, Giulia Benevolo2, Patrizia Pregno2, Norbert Pescosta3, Vincenzo Callea4, Clotilde Cangialosi5, Tommaso Caravita6, Fortunato Morabito7, Pellegrino Musto8, Sara Bringhen1, Patrizia Falco1, Ilaria Avonto1, Federica Cavallo1, Mario Boccadoro1
1Divisione di Ematologia dell'Università di Torino, Azienda Ospedaliera (AO) S. Giovanni Battista, Turin, Italy;
2Azienda Sanitaria Ospedaliera Molinette San Giovanni Battista Di Torino
3Divisione di Ematologia, Ospedale Centrale, Bolzano, Italy;
4Divisione di Ematologia, Ospedali Riuniti, Reggio Calabria, Italy;
5Divisione di Ematologia e Trapianto di Midollo Osseo, Azienda Ospedaliera Cervello, Palermo, Italy;
6Cattedra e Divisione di Ematologia, Università Tor Vergata, Ospedale San Eugenio, Rome, Italy;
7Unità Ospedaliera Complessa (UOC) di Ematologia, Azienda Ospedaliera di Cosenza, Cosenza, Italy;
8UOC di Ematologia e Trapianto di Cellule Staminali, Centro di Riferimento Oncologico Regionale (CROB), Rionero in Vulture, Italy

Tóm tắt

AbstractIn multiple myeloma (MM), the addition of thalidomide or bortezomib to the standard oral melphalan/prednisone combination significantly increased response rate and event-free survival. In this multicenter phase 1/2 trial, dosing, safety, and efficacy of the 4-drug combination, bortezomib, melphalan, prednisone, and thalidomide (VMPT) was determined. Bortezomib was administered at 3 dose levels (1.0 mg/m2, 1.3 mg/m2, or 1.6 mg/m2) on days 1, 4, 15, and 22; melphalan was given at a dose of 6 mg/m2 on days 1 through 5 and prednisone at 60 mg/m2 on days 1 through 5. Thalidomide was delivered at 50 mg on days 1 through 35. Each course was repeated every 35 days. The maximum tolerated dose of bortezomib was 1.3 mg/m2. Thirty patients with relapsed or refractory MM were enrolled; 20 patients (67%) achieved a partial response (PR) including 13 patients (43%) who achieved at least a very good PR. Among 14 patients who received VMPT as second-line treatment, the PR rate was 79% and the immunofixation-negative complete response rate 36%. The 1-year progression-free survival was 61%, and the 1-year survival from study entry was 84%. Grade 3 nonhematologic adverse events included infections (5 patients), fatigue (1), vasculitis (1), and peripheral neuropathy (2); no grade 4 toxicities were recorded. Initial results showed that VMPT is an effective salvage therapy with a very high proportion of responses. The incidence of neurotoxicities was unexpectedly low.

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Tài liệu tham khảo

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Thông tin xuất bản

Blood

Tập 109 Số 7

2767-2772

Thông tin tác giả