Originally published as JCO Early Release 10.1200/JCO.2009.22.7389 on August 31 2009

This Article Full Text Full Text (PDF) Purchase Article View Shopping Cart Alert me when this article is cited Alert me if a correction is posted Services Email this article to a colleague Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Save to my personal folders Download to citation manager Rights & Permissions Google Scholar Articles by Cavo, M. Articles by Baccarani, M. PubMed PubMed Citation Articles by Cavo, M. Articles by Baccarani, M. Social Bookmarking                            What's this?

Short-Term Thalidomide Incorporated Into Double Autologous Stem-Cell Transplantation Improves Outcomes in Comparison With Double Autotransplantation for Multiple Myeloma

From the Dipartimento di Ematologia e Scienze Oncologiche "Seràgnoli," Istituto di Ematologia "Seràgnoli," Università di Bologna; Ematologia, Università di Catania; Ematologia, Università di Udine; Ematologia, Taranto; Ematologia, Avellino; Ematologia, Cagliari; Ematologia, Nocera Inferiore; Ematologia, Ascoli Piceno; Ematologia, Università di Ancona; Ematologia, Treviso; and Ematologia, Università di Genova, Italy.

Corresponding author: Michele Cavo, MD, Istituto di Ematologia "Seràgnoli," via Massarenti 9, 40138, Bologna, Italy; e-mail: michele.cavo{at}unibo.it.

Purpose To assess potential benefits with thalidomide incorporated into double autologous stem-cell transplantation (ASCT) for younger patients with newly diagnosed multiple myeloma (MM).

Patients and Methods One hundred thirty-five patients who received thalidomide from induction until the second ASCT were retrospectively analyzed in comparison with an equal number of pair mates treated with double ASCT not including thalidomide.

Results On an intention-to-treat basis, the addition of thalidomide to double ASCT effected a significant improvement in the rate (68% v 49%; P = .001) and duration (62% v 33% at 4 years; P < .001) of at least very good partial response (VGPR), time to progression (TTP; 61% v 41% at 4 years; P < .001) and progression-free survival (PFS; 51% v 31% at 4 years; P = .001). A trend was also noted for extended overall survival (OS) among thalidomide-treated patients (69% at 5 years v 53% for the control group), although the difference between the two groups was not statistically significant (P = .07). Benefits with thalidomide in increasing the rate of VGPR or better response, TTP, and PFS were confirmed in a multivariate analysis. Median OS after relapse was 24 months for patients receiving thalidomide added to double ASCT and 25 months for the control group. Overall, 17% of patients discontinued thalidomide, including 8% because of drug-related adverse events.

Conclusion In comparison with double ASCT, the addition of first-line thalidomide to double ASCT improved clinical outcomes. Short-term thalidomide was generally well tolerated and had no adverse impact on postrelapse survival.

Supported in part by Università di Bologna, Ricerca Fondamentale Orientata (M.C.), Fondazione Carisbo, and BolognAIL.

Written on behalf of Bologna 96 and Bologna 2002 clinical study groups.

A list of additional investigators who participated in Bologna 96 and Bologna 2002 studies is reported in the online-only Appendix.

Authors' disclosures of potential conflicts of interest and author contributions are found at the end of this article.

Clinical trial information can be found for the following: NCT00378222 [ClinicalTrials.gov] .

CiteULike    Complore    Connotea    Del.icio.us    Digg    Facebook    Reddit    Technorati    Twitter    What's this?