CHOP and DHAP plus rituximab followed by autologous stem cell transplantation (ASCT) in mantle cell lymphoma (MCL): a phase II study from the GELA
Mené sur 60 patients d'âge inférieur à 66 ans et atteints d'un lymphome à cellules du manteau, cet essai français de phase II évalue l'efficacité d'un protocole d'induction à base de cytarabine et rituximab avant une greffe autologue de cellules souches
Treatment of mantle cell lymphoma (MCL) in younger patients remains a challenge. We report results of a phase II trial using Cytarabine and Rituximab (R) as induction regimen before autologous stem cell transplantation (ASCT). Patients under 66y with stage III-IV, MCL were included. Treatment consisted in three courses of CHOP21 with Rituximab at the third one and three R-DHAP. Responding patients were eligible for ASCT with TAM6 or BEAM. Sixty patients were included. Median age was 57 years. Characteristics of patients were: BM involvement 85%, leukemic disease 48%, gastrointestinal involvement 52%, PS>1 6%, LDH>1N 38%, MIPI (low 55%, intermediate 38%, high 13%). ORR was 93% after (R)-CHOP and 95% after R-DHAP. Whereas CR was uncommon after (R)-CHOP (12%), high proportion of patients (57%) was in CR after R-DHAP. With median follow-up of 67 months, median EFS is 83 months and median OS is not reached. Five-year OS is 75%. Comparison with previous study without Rituximab (Lefrere et al., Haematologica 2007) shows improvement of outcome (median EFS: 51 versus 83 months). No toxic death or unexpected toxicities were observed. This study confirms that induction with Rituximab and Cytarabine-based regimens are safe and effective in MCL patients. This regimen is currently compared with R-CHOP21 induction in a multicentric European protocol.
Blood 2012