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Consolidation therapy with low-dose thalidomide and prednisolone prolongs the survival of multiple myeloma patients undergoing a single autologous stem-cell transplantation procedure.
J Clin Oncol. 2009 Apr 10; 27(11):1788-93.JC

Abstract

PURPOSE

Thalidomide is effective in the treatment of newly diagnosed and relapsed/refractory multiple myeloma (MM). However, the role of thalidomide in the post-autologous stem cell transplantation (ASCT) context remains unclear. This study assessed whether the addition of thalidomide consolidation following ASCT would improve the durability of responses achieved and overall survival.

PATIENTS AND METHODS

Between January 2002 and March 2005, 269 patients with newly diagnosed MM who achieved disease stabilization or better with conventional induction chemotherapy received a single high-dose melphalan conditioned ASCT. Post-ASCT, 129 patients were randomly assigned to receive indefinite prednisolone maintenance therapy (control group) and 114 to receive the same in addition to 12 months of thalidomide consolidation (thalidomide group). The primary study end points were progression-free survival (PFS) and overall survival (OS). The secondary end point was tolerability.

RESULTS

After a median follow-up of 3 years, the postrandomization 3-year PFS rates were 42% and 23% (P < .001; hazard ratio [HR], 0.5; 95% CI, 0.35 to 0.71) and the OS rates were 86% and 75% (P = .004; HR, 0.41; 95% CI, 0.22 to 0.76) in the thalidomide and control groups, respectively. There was no difference in survival between groups 12 months after disease progression (79% v 77%; P = .237). Neurological toxicities were more common in the thalidomide arm but there were no differences between arms for thromboembolic events.

CONCLUSION

Consolidation therapy with 12 months of thalidomide combined with prednisolone prolongs survival when used after a single high-dose therapy supported ASCT in patients with newly diagnosed MM. Furthermore, thalidomide consolidation therapy did not adversely impact on survival in the subsequent salvage setting.

Authors+Show Affiliations

Malignant Haematology and Stem Cell Transplantation Service, Alfred Hospital, Melbourne, Victoria, Australia. aspencer@netspace.net.auNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

19273705

Citation

Spencer, Andrew, et al. "Consolidation Therapy With Low-dose Thalidomide and Prednisolone Prolongs the Survival of Multiple Myeloma Patients Undergoing a Single Autologous Stem-cell Transplantation Procedure." Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology, vol. 27, no. 11, 2009, pp. 1788-93.
Spencer A, Prince HM, Roberts AW, et al. Consolidation therapy with low-dose thalidomide and prednisolone prolongs the survival of multiple myeloma patients undergoing a single autologous stem-cell transplantation procedure. J Clin Oncol. 2009;27(11):1788-93.
Spencer, A., Prince, H. M., Roberts, A. W., Prosser, I. W., Bradstock, K. F., Coyle, L., Gill, D. S., Horvath, N., Reynolds, J., & Kennedy, N. (2009). Consolidation therapy with low-dose thalidomide and prednisolone prolongs the survival of multiple myeloma patients undergoing a single autologous stem-cell transplantation procedure. Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology, 27(11), 1788-93. https://doi.org/10.1200/JCO.2008.18.8573
Spencer A, et al. Consolidation Therapy With Low-dose Thalidomide and Prednisolone Prolongs the Survival of Multiple Myeloma Patients Undergoing a Single Autologous Stem-cell Transplantation Procedure. J Clin Oncol. 2009 Apr 10;27(11):1788-93. PubMed PMID: 19273705.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Consolidation therapy with low-dose thalidomide and prednisolone prolongs the survival of multiple myeloma patients undergoing a single autologous stem-cell transplantation procedure. AU - Spencer,Andrew, AU - Prince,H Miles, AU - Roberts,Andrew W, AU - Prosser,Ian W, AU - Bradstock,Kenneth F, AU - Coyle,Luke, AU - Gill,Devinder S, AU - Horvath,Noemi, AU - Reynolds,John, AU - Kennedy,Nola, Y1 - 2009/03/09/ PY - 2009/3/11/entrez PY - 2009/3/11/pubmed PY - 2009/5/8/medline SP - 1788 EP - 93 JF - Journal of clinical oncology : official journal of the American Society of Clinical Oncology JO - J Clin Oncol VL - 27 IS - 11 N2 - PURPOSE: Thalidomide is effective in the treatment of newly diagnosed and relapsed/refractory multiple myeloma (MM). However, the role of thalidomide in the post-autologous stem cell transplantation (ASCT) context remains unclear. This study assessed whether the addition of thalidomide consolidation following ASCT would improve the durability of responses achieved and overall survival. PATIENTS AND METHODS: Between January 2002 and March 2005, 269 patients with newly diagnosed MM who achieved disease stabilization or better with conventional induction chemotherapy received a single high-dose melphalan conditioned ASCT. Post-ASCT, 129 patients were randomly assigned to receive indefinite prednisolone maintenance therapy (control group) and 114 to receive the same in addition to 12 months of thalidomide consolidation (thalidomide group). The primary study end points were progression-free survival (PFS) and overall survival (OS). The secondary end point was tolerability. RESULTS: After a median follow-up of 3 years, the postrandomization 3-year PFS rates were 42% and 23% (P < .001; hazard ratio [HR], 0.5; 95% CI, 0.35 to 0.71) and the OS rates were 86% and 75% (P = .004; HR, 0.41; 95% CI, 0.22 to 0.76) in the thalidomide and control groups, respectively. There was no difference in survival between groups 12 months after disease progression (79% v 77%; P = .237). Neurological toxicities were more common in the thalidomide arm but there were no differences between arms for thromboembolic events. CONCLUSION: Consolidation therapy with 12 months of thalidomide combined with prednisolone prolongs survival when used after a single high-dose therapy supported ASCT in patients with newly diagnosed MM. Furthermore, thalidomide consolidation therapy did not adversely impact on survival in the subsequent salvage setting. SN - 1527-7755 UR - https://www.unboundmedicine.com/medline/citation/19273705/Consolidation_therapy_with_low_dose_thalidomide_and_prednisolone_prolongs_the_survival_of_multiple_myeloma_patients_undergoing_a_single_autologous_stem_cell_transplantation_procedure_ L2 - https://ascopubs.org/doi/10.1200/JCO.2008.18.8573?url_ver=Z39.88-2003&amp;rfr_id=ori:rid:crossref.org&amp;rfr_dat=cr_pub=pubmed DB - PRIME DP - Unbound Medicine ER -