Adult patients with multiple myeloma who receive a high-dose chemotherapy regimen plus autologous stem-cell transplantation improve their median progression-free survival (PFS) by 14 months compared with patients who receive chemotherapy alone, according to a study published in the New England Journal of Medicine (April 6, 2017;376:1311-1320).
High-dose chemotherapy plus autologous stem-cell transplantation is regarded as the standard of care for patients with newly diagnosed multiple myeloma aged 65 years or younger. However, promising data in recent years on the use of combination therapy with lenalidomide, bortezomib, and dexamethasone for patients with such disease have challenged conceptions about the optimal utilization of transplantation.
Michel Attal, Institut Universitaire du Cancer de Toulouse-Oncopole (France), and colleagues conducted a study to analyze the effects of transplantation after induction therapy for adult patients with multiple myeloma. Researchers randomly assigned 700 patients to receive induction therapy with 3 cycles of lenalidomide, bortezomib, and dexamethasone and then consolidation therapy with either 5 additional combination cycles or high-dose melphalan plus transplantation followed by 2 additional combination cycles. Patients in both groups received maintenance therapy with lenalidomide for an additional year. The primary endpoint was PFS.
Results of the study showed that median PFS was significantly longer in the transplantation cohort compared with the chemotherapy alone cohort (50 months vs 36 months; HR, 0.65; P < .001). Patients in the transplantation cohort also demonstrated a higher percentage of complete response (59% vs 48%, P = .03) and a higher percentage of minimal residual disease not detected (79% vs 65%, P < .001).
Researchers noted that overall survival after 4 years did not differ significantly between cohorts (81% vs 82%, respectively), nor were there any differences observed in the rates of treatment-related deaths, secondary primary cancers, thromboembolic events, and peripheral neuropathy.
Despite survival outcomes being better in the transplantation cohort, these patients also exhibited higher rates of grade 3 or 4 adverse events, including neutropenia (92% vs 47%), gastrointestinal disorders (28% vs 7%), and infections (20% vs 9%), leading Michel Attal to recommend that “benefit must be weighed against the increased risk of toxic effects associated with high-dose chemotherapy plus transplantation” in a press release (April 12, 2017). – Zachary Bessette