R‐CHOP‐14 versus R‐CHOP‐14/CHASER for upfront autologous transplantation in diffuse large B‐cell lymphoma: JCOG0908 study

Abstract

The efficiency of upfront consolidation with high‐dose chemotherapy/autologous stem‐cell transplantation (HDCT/ASCT) for newly diagnosed high‐risk diffuse large B‐cell lymphoma (DLBCL) may be influenced by induction chemotherapy. To select better induction chemotherapy regimens for HDCT/ASCT, a randomized phase II study was conducted in high‐risk DLBCL patients with age‐adjusted International Prognostic Index (aaIPI) score 2 or 3. As induction chemotherapy, 6 cycles of R‐CHOP‐14 (arm A) or 3 cycles of R‐CHOP‐14 followed by 3 cycles of CHASER (arm B) were planned, and patients who responded proceeded to HDCT with LEED and ASCT. The primary endpoint was 2‐year progression‐free survival (PFS), and the main secondary endpoints included overall survival, overall response rate, and adverse events (AEs). A total of 71 patients were enrolled. With a median follow‐up of 40.3 months, 2‐year PFS in arms A and B were 68.6% (95% confidence interval [CI], 50.5–81.2%) and 66.7% (95% CI, 48.8–79.5%), respectively. Overall survival at 2 years in arms A and B were 74.3% (95% CI, 56.4–85.7%) and 83.3% (95% CI, 66.6–92.1%). Overall response rates were 82.9% in arm A and 69.4% in arm B. During induction chemotherapy, 45.7% and 75.0% of patients in arms A and B, respectively, had grade ≥3 non‐hematologic toxicities. One patient in arm A and 6 in arm B discontinued induction chemotherapy due to AEs. In conclusion, R‐CHOP‐14 showed higher 2‐year PFS and less toxicity compared with R‐CHOP‐14/CHASER in high‐risk DLBCL, suggesting the former to be a more promising induction regimen for further investigations. (UMIN‐CTR, UMIN000003823)