Outcome with lenalidomide plus dexamethasone followed by early autologous stem cell transplantation in patients with newly diagnosed multiple myeloma on the ECOG-ACRIN E4A03 randomized clinical trial: Long-term follow-up

N. Biran, S. Jacobus, D. H. Vesole, N. S. Callander, R. Fonseca, M. E. Williams, Rafat Abonour, M. S. Katz, S. V. Rajkumar, P. R. Greipp, D. S. Siegel

Research output: Contribution to journalArticle

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Abstract

In Eastern Cooperative Oncology Group-ACRIN E4A03, on completion of four cycles of therapy, newly diagnosed multiple myeloma patients had the option of proceeding to autologous peripheral blood stem cell transplant (ASCT) or continuing on their assigned therapy lenalidomide plus low-dose dexamethasone (Ld) or lenalidomide plus high-dose dexamethasone (LD). This landmark analysis compared the outcome of 431 patients surviving their first four cycles of therapy pursuing early ASCT to those continuing on their assigned therapy. Survival distributions were estimated using the Kaplan-Meier method and compared with log-rank test. Ninety patients (21%) opted for early ASCT. The 1-, 2-, 3-, 4-and 5-year survival probability estimates were higher for early ASCT versus no early ASCT at 99, 93, 91, 85 and 80% versus 94, 84, 75, 65 and 57%, respectively. The median overall survival (OS) in the early versus no early ASCT group was not reached (NR) versus 5.78 years. In patients <65 years of age, median OS in the early versus no early ASCT groups was NR in both, hazard ratio 0.79, 95% confidence interval: (0.50, 0.25). In patients ≥65 years of age, median OS in the early versus no early ASCT was NR versus 5.11 years. ASCT dropped out of statistical significance (P=0.080). Patients opting for ASCT after induction Ld/LD had a higher survival probability and improvement in OS regardless of dexamethasone dose density.

Original languageEnglish (US)
Article numbere466
JournalBlood Cancer Journal
Volume6
Issue number9
DOIs
StatePublished - Sep 2 2016

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Stem Cell Transplantation
Multiple Myeloma
Dexamethasone
Randomized Controlled Trials
Transplants
Survival
Peripheral Blood Stem Cells
lenalidomide
Therapeutics
Confidence Intervals

ASJC Scopus subject areas

  • Oncology
  • Hematology

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Outcome with lenalidomide plus dexamethasone followed by early autologous stem cell transplantation in patients with newly diagnosed multiple myeloma on the ECOG-ACRIN E4A03 randomized clinical trial : Long-term follow-up. / Biran, N.; Jacobus, S.; Vesole, D. H.; Callander, N. S.; Fonseca, R.; Williams, M. E.; Abonour, Rafat; Katz, M. S.; Rajkumar, S. V.; Greipp, P. R.; Siegel, D. S.

In: Blood Cancer Journal, Vol. 6, No. 9, e466, 02.09.2016.

Research output: Contribution to journalArticle

Biran, N. ; Jacobus, S. ; Vesole, D. H. ; Callander, N. S. ; Fonseca, R. ; Williams, M. E. ; Abonour, Rafat ; Katz, M. S. ; Rajkumar, S. V. ; Greipp, P. R. ; Siegel, D. S. / Outcome with lenalidomide plus dexamethasone followed by early autologous stem cell transplantation in patients with newly diagnosed multiple myeloma on the ECOG-ACRIN E4A03 randomized clinical trial : Long-term follow-up. In: Blood Cancer Journal. 2016 ; Vol. 6, No. 9.
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abstract = "In Eastern Cooperative Oncology Group-ACRIN E4A03, on completion of four cycles of therapy, newly diagnosed multiple myeloma patients had the option of proceeding to autologous peripheral blood stem cell transplant (ASCT) or continuing on their assigned therapy lenalidomide plus low-dose dexamethasone (Ld) or lenalidomide plus high-dose dexamethasone (LD). This landmark analysis compared the outcome of 431 patients surviving their first four cycles of therapy pursuing early ASCT to those continuing on their assigned therapy. Survival distributions were estimated using the Kaplan-Meier method and compared with log-rank test. Ninety patients (21{\%}) opted for early ASCT. The 1-, 2-, 3-, 4-and 5-year survival probability estimates were higher for early ASCT versus no early ASCT at 99, 93, 91, 85 and 80{\%} versus 94, 84, 75, 65 and 57{\%}, respectively. The median overall survival (OS) in the early versus no early ASCT group was not reached (NR) versus 5.78 years. In patients <65 years of age, median OS in the early versus no early ASCT groups was NR in both, hazard ratio 0.79, 95{\%} confidence interval: (0.50, 0.25). In patients ≥65 years of age, median OS in the early versus no early ASCT was NR versus 5.11 years. ASCT dropped out of statistical significance (P=0.080). Patients opting for ASCT after induction Ld/LD had a higher survival probability and improvement in OS regardless of dexamethasone dose density.",
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