Double Versus Single Autologous Stem Cell Transplantation in Multiple Myeloma
In a phase III trial, double autologous stem cell transplantation (ASCT-2) in patients with newly diagnosed multiple myeloma was associated with significantly improved progression-free and overall survival compared with single ASCT (ASCT-1). The analysis was part of a larger study, EMN02/HO95.
Randomization to ASCT-2 versus ASCT-1 predicted superior prolonged progression-free and overall survival for the complete patient population. And, “ASCT-2 overcame the adverse prognosis conferred by high-risk-cyto-3 [high-risk cytogenetic profile defined by t(4;14) ± t(14;16) ± del(17p) positivity] ,” noted lead author Michele Cavo, MD, of the Bologna University School of Medicine, Italy, in a presentation at the 2017 American Society of Hematology (ASH) Annual Meeting & Exposition (Abstract 401).
A subset of 618 newly diagnosed patients aged ≤ 65 years, being treated at centers with an ASCT-2 policy, received 3 to 4 cycles of bortezomib, cyclophosphamide, and dexamethasone induction therapy. Then, 203 were randomized to no ASCT (just standard-dose intensification treatment with bortezomib, melphalan, and prednisone); 208, to ASCT-1; and 207, to ASCT-2.
Each arm had the same percentage of patients defined as high-risk by International Staging System (stage III; 19% vs. 19%). The cytogenic profiles of 80% and 86% of the patients in ASCT-1 and ASCT-2, respectively, could be determined; of them, 26% and 21% of the ASCT-1 and ASCT-2 patients, respectively, were high-risk-cyto-3.
In the ASCT-1 arm, 3-year progression-free survival was 43% for high-risk patients carrying or lacking del(17p) and 67% for the standard-risk patients. In the ASCT-2 arm, the comparable percentages were 72% and 73%.