Autologous stem cell transplantation from 2011 to 2022 in Japanese patients aged ≥ 65 years with relapsed or refractory diffuse large B-cell lymphoma

High-dose chemotherapy with autologous stem cell transplantation (ASCT) is an option for patients aged >= 65 years with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL). Few data are available to select patients suitable for chimeric antigen receptor T-cell (CAR-T) therapy or bispecific antibodies. We retrospectively analyzed the risk factors for poor outcomes for 451 Japanese patients aged >= 65 years with R/R DLBCL who received ASCT at either second complete remission or first partial remission (n = 336 and 115, respectively) between 2011 and 2022. CAR-T became commercially available in Japan in March 2019, and the annual number of ASCTs for older patients with R/R DLBCL increased significantly until 2018. However, the number of ASCT cases plateaued in 2018. Multivariate Cox regression analysis identified <= 24 months from diagnosis to ASCT (hazard ratio [HR], 1.497) and performance status > 0 at ASCT (HR, 1.460) as independent predictors of overall survival (OS) and an association with late recurrence. The 3-year OS rates were 73.4% (95% confidence interval [CI], 65.8%-79.6%) in patients with > 24 months from diagnosis to ASCT and 58.6% (95% CI, 51.2%-65.2%) in those with <= 24 months from diagnosis to ASCT. The 3-year OS rates were 69.4% (95% CI, 62.5%-75.2%) in patients with performance status (PS) = 0 and 60.6% (95% CI, 62.5%-70.4%) in those with PS > 0. CAR-T therapy or bispecific antibodies may be used initially instead of ASCT for early relapsed and refractory patients. However, ASCT remains beneficial for older chemo-sensitive patients with late recurrence and good performance status.