title: 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.
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.
authors: Hackensack University Medical Center, John Theurer Cancer Center, Hackensack, NJ, USA.
authors: N
authors: N
authors: Biran
authors: Biostatistics and Computational Biology, Dana Farber Cancer Institute, Boston, MA, USA.
authors: S
authors: S
authors: Jacobus
authors: Hackensack University Medical Center, John Theurer Cancer Center at Hackensack UMC, Hackensack, NJ, USA.
authors: D H
authors: DH
authors: Vesole
authors: University of Wisconsin Carbone Cancer Center, Madison, WI, USA.
authors: N S
authors: NS
authors: Callander
authors: Lombardi Cancer Center, Mayo Clinic, Scottsdale, AZ Georgetown University, Washington, DC, USA.
authors: R
authors: R
authors: Fonseca
authors: Division of Hematology/Oncology, University of Virginia Cancer Center, Charlottesville, VA, USA.
authors: M E
authors: ME
authors: Williams
authors: Department of Hematology/Oncology, Indiana University School of Medicine, Indianapolis, IN, USA.
authors: R
authors: R
authors: Abonour
authors: International Myeloma Foundation, Los Angeles, CA, USA.
authors: M S
authors: MS
authors: Katz
authors: Division of Hematology, Mayo Clinic, Rochester, MN, USA.
authors: S V
authors: SV
authors: Rajkumar
authors: Mayo Clinic, Rochester, MN, USA.
authors: P R
authors: PR
authors: Greipp
authors: Hackensack University Medical Center, John Theurer Cancer Center, Hackensack, NJ, USA.
authors: D S
authors: DS
authors: Siegel
mesh_terms: D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D015415:Biomarkers; D017326:Clinical Trials, Phase III as Topic; D003131:Combined Modality Therapy; D003907:Dexamethasone / Q000008:administration & dosage; D005500:Follow-Up Studies; D018380:Hematopoietic Stem Cell Transplantation; D006801:Humans; D000077269:Lenalidomide; D008875:Middle Aged; D009101:Multiple Myeloma / Q000175:diagnosis / Q000401:mortality / Q000628:therapy*; D009367:Neoplasm Staging; D016016:Proportional Hazards Models; D016032:Randomized Controlled Trials as Topic; D013792:Thalidomide / Q000008:administration & dosage / Q000031:analogs & derivatives; D014182:Transplantation, Autologous; D016896:Treatment Outcome
chemical_list: D015415:Biomarkers; D013792:Thalidomide; D003907:Dexamethasone; D000077269:Lenalidomide