Efficacy of low-dose thalidomide and dexamethasone as first salvage regimen in multiple myeloma

Antonio Palumbo, Alessandra Bertola, Patrizia Falco, Rosalba Rosato, Federica Cavallo, Luisa Giaccone, Sara Bringhen, Pellegrino Musto, Patrizia Pregno, Tommaso Caravita, Giovannino Ciccone, Mario Boccadoro

Research output: Contribution to journalArticlepeer-review

Abstract

Purpose: The efficacy of low-dose thalidomide (THAL) plus dexamethasone (DEX) has been evaluated in myeloma. The clinical outcome of patients treated with THAL-DEX was compared with that of a control group treated with conventional chemotherapy (CC). Experimental design: A total of 120 relapsed/refractory patients to one (52%), or two or more (48%) lines of chemotherapy were treated with THAL 100mg/day (continuous) and DEX 40 mg (days 1-4 of each month). Their clinical outcome was compared to a control group of 120 patients frequency matched for serum β2-microglobulin levels and Durie and Salmon clinical stage. Clinical characteristics were homogeneous in the two groups. Results: In patients treated after one line of chemotherapy, THAL-DEX significantly improved outcome. Median progression-free survival (PFS) was superior in THAL-DEX group versus CC group (17 months versus 11 months, P = 0.0024). The median survival for THAL-DEX patients has not to been reached, but the probabilities of survival at 3 years were 60% after THAL-DEX and 26% after CC (P = 0.0016). The clinical outcome of patients receiving THAL-DEX or CC after two or more lines of chemotherapy, was similar. In the THAL-DEX group, the median PFS was 11 months compared to 9 months in the CC group (P = NS). No differences in overall survival (OS) were observed (median OS 19 months for both THAL-DEX and CC). Conclusions: As first salvage regimen, THAL-DEX was superior to CC, as second or third salvage regimen, it was equivalent to CC. THAL-DEX is not myelotoxic. It postpones the delivery of effective salvage chemotherapy. This might explain the survival benefit.

Original languageEnglish
Pages (from-to)318-324
Number of pages7
JournalHematology Journal
Volume5
Issue number4
DOIs
Publication statusPublished - 2004

Keywords

  • Clinical trial
  • Plasma cell dyscrasia
  • Salvage therapy

ASJC Scopus subject areas

  • Hematology

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