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Randomized Controlled Trial
. 2010 Sep;95(9):1548-54.
doi: 10.3324/haematol.2009.020586. Epub 2010 Apr 23.

Thalidomide maintenance treatment increases progression-free but not overall survival in elderly patients with myeloma

Heinz Ludwig  1 , Zdenek Adam, Elena Tóthová, Roman Hajek, Boris Labar, Miklós Egyed, Ivan Spicka, Heinz Gisslinger, Johannes Drach, Ingrid Kuhn, Axel Hinke, Niklas Zojer
Affiliations
Randomized Controlled Trial

Thalidomide maintenance treatment increases progression-free but not overall survival in elderly patients with myeloma

Heinz Ludwig et al. Haematologica. 2010 Sep.

Abstract

Background: Thalidomide maintenance therapy after stem cell transplantation resulted in increased progression-free survival and overall survival in a few trials, but its role in non-transplant eligible patients with multiple myeloma remains unclear. This study assessed the impact of thalidomide-interferon in comparison to interferon maintenance therapy in elderly patients with multiple myeloma.

Design and methods: Of 289 elderly patients with multiple myeloma who were randomized to thalidomide-dexamethasone or melphalan-prednisolone induction therapy, 137 finally completed 9 cycles of induction therapy with stable disease or better and thereby qualified for maintenance treatment. Of these, 128 have been randomized to either thalidomide-interferon or interferon alone. Primary study endpoints were progression-free survival and response rates; secondary endpoints were overall survival, toxicity and quality of life.

Results: Thalidomide-interferon maintenance therapy led to a significantly longer progression-free survival compared to interferon (27.7 vs. 13.2 months, P=0.0068), but overall survival was similar in both groups (52.6 vs. 51.4 months, P=0.81) and did not differ between patients aged 75 years or older, or younger patients (P=0.39). Survival after disease progression tended to be shorter in patients on thalidomide-interferon maintenance therapy (P=0.056). Progression-free survival and overall survival tended to be shorter in patients with adverse cytogenetic (FISH) findings compared to the standard risk group but differences were not significant (P=0.084 and P=0.082, respectively). Patients on thalidomide-interferon presented with more neuropathy (P=0.0015), constipation (P=0.0004), skin toxicity (P=0.0041) and elevated creatinine (P=0.026).

Conclusions: Thalidomide plus interferon maintenance therapy increased progression-free survival but not overall survival and was associated with slightly more toxicity than maintenance with interferon alone. (ClinicalTrials.gov Identifier: NCT00205751).

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Figures

Figure 1.
Figure 1.
Study flow chart.
Figure 2.
Figure 2.
(A) Time on maintenance therapy. (B) Progression-free survival by treatment arm. (C) Time to progression on treatment arm and induction group. (D) Overall survival by treatment arm. (E) Overall survival on treatment arm and induction group. (F) Overall survival by age group.
Figure 3.
Figure 3.
(A) Survival after progressive disease on maintenance. (B) Survival after end of maintenance therapy. (C) Progression-free survival by cytogenetic findings. (D) Overall survival by cytogenetic risk groups.
See this image and copyright information in PMC

References

    1. Wisløff F, Hjorth M. Health-related quality of life assessed before and during chemotherapy predicts for survival in multiple myeloma. Nordic Myeloma Study Group. Br J Haematol. 1997;97(1):29–37. - PubMed
    1. Quach H, Mileshkin L, Seymour JF, Milner A, Ritchie D, Harrison S, et al. Predicting durable remissions following thalidomide therapy for relapsed myeloma. Leuk Lymphoma. 2009;50(2):223–9. - PubMed
    1. Belch A, Shelley W, Bergsagel D, Wilson K, Klimo P, White D, et al. A randomized trial of maintenance versus no maintenance melphalan and prednisone in responding multiple myeloma patients. Br J Cancer. 1988;57(1):94–9. - PMC - PubMed
    1. Berenson JR, Crowley JJ, Grogan TM, Zangmeister J, Briggs AD, Mills GM, et al. Maintenance therapy with alternate-day prednisone improves survival in multiple myeloma patients. Blood. 2002;99(9):3163–8. - PubMed
    1. Shustik C, Belch A, Robinson S, Rubin SH, Dolan SP, Kovacs MJ, et al. A randomised comparison of melphalan with prednisone or dexamethasone as induction therapy and dexamethasone or observation as maintenance therapy in multiple myeloma: NCIC CTG MY.7. Br J Haematol. 2007;136(2):203–11. - PubMed

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