R-ICE versus R-DHAP in relapsed patients with CD20 diffuse large B-cell lymphoma (DLBCL) followed by autologous stem cell transplantation: CORAL study.
C. Gisselbrecht, B. Glass, N. Mounier, D. Gill, D. Linch, M. Trneny, A. Bosly, O. Shpilberg, N. Ketterer, C. Moskowitz, N. Schmitz
Background: Salvage chemotherapy followed by high dose therapy and autologous stem cell transplantation (ASCT) is the standard of treatment for chemosensitive relapses in diffuse large B cell lymphoma. This intergroup trial compared the association rituximab, ifosfamide, etoposide, carboplatinum, R-ICE and rituximab dexamethasone aracytine and cisplatinum R-DHAP.
Methods: DLBCL CD 20+ in first relapse or pts refractory after first line therapy were randomized between R-DHAP and R-ICE. Responding patients received BEAM and ASCT and were randomized between observation or maintenance with rituximab for 1 yr.
Results: Intent to treat analysis was made on the first 396 pts randomized in 11 countries (R ICE:202; R DHAP:194): median age 55 yrs.; 225 relapses >12months, 166 refractory/early relapses; 244 pts with prior exposure to rituximab; Stage 3–4: 240 pts; elevated LDH: 198 pts; secondary IPI 0–1: 226 pts/ 2–3:149 pts. Patients with prior exposure to rituximab had more refractory disease and adverse prognostic factors. The overall response rate was 63%, with
38% complete remission. There was no difference in response rate between R-ICE 63.5% (CI 56–70%) and R-DHAP 62.8% (CI 55–69%), and in mobilization adjusted response rate. ASCT was performed in 206 pts. 90 SAE were reported in the R-ICE arm and 120 in the R-DHAP with 14 deaths. Factors significantly affecting response rate (p<.0001) were: refractory/relapse < 12 months:46 % vs 88 %, secondary IPI >1:52% vs 71% and prior exposure to rituximab:51% vs 83%. There was not significant difference between R-ICE and R-DHAP for 3 yr EFS (26% vs 35% p=0.6) and OS (47% vs 51%, p=0.5). Three yrs EFS was affected by: prior treatment with rituximab, 21% vs none 47% (p<.0001); early relapse <12m 20% vs >12m 45% (p<.0001); secondary IPI
2–3: 18% vs 0–1: 40% (p=.0001). In Cox model, all these parameters were significant (p<.0001) for EFS, PFS and OS but not the treatment arm. Longer follow up is necessary to evaluate the second randomization.
Conclusions: There was no difference between R-ICE and R-DHAP. In pts without adverse prognostic factors a response rate > 80% was observed. However, early relapses/ refractory pts to upfront rituximab-based chemotherapy have a poor response rate and prognosis.
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