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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.
- Source :
-
Blood cancer journal [Blood Cancer J] 2016 Sep 02; Vol. 6 (9), pp. e466. Date of Electronic Publication: 2016 Sep 02. - Publication Year :
- 2016
-
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.<br />Competing Interests: NB, Celgene speaker's bureau; DHV, Celgene speaker's bureau; MEW, Celgene clinical research funding and consulting fees; RF, Celgene consulting fees; DSS, Celgene consulting fees and speaker's bureau. All other authors declare no conflict of interest.
- Subjects :
- Aged
Antineoplastic Combined Chemotherapy Protocols adverse effects
Biomarkers
Clinical Trials, Phase III as Topic
Combined Modality Therapy
Dexamethasone administration & dosage
Follow-Up Studies
Humans
Lenalidomide
Middle Aged
Multiple Myeloma diagnosis
Multiple Myeloma mortality
Neoplasm Staging
Proportional Hazards Models
Randomized Controlled Trials as Topic
Thalidomide administration & dosage
Thalidomide analogs & derivatives
Transplantation, Autologous
Treatment Outcome
Antineoplastic Combined Chemotherapy Protocols therapeutic use
Hematopoietic Stem Cell Transplantation
Multiple Myeloma therapy
Subjects
Details
- Language :
- English
- ISSN :
- 2044-5385
- Volume :
- 6
- Issue :
- 9
- Database :
- MEDLINE
- Journal :
- Blood cancer journal
- Publication Type :
- Academic Journal
- Accession number :
- 27588519
- Full Text :
- https://doi.org/10.1038/bcj.2016.68