Abstract
We evaluated the feasibility, safety, and effectiveness of an intense IC regimen including ASCT in pts with untreated MCL up to age 70. Pts with MCL confirmed by central pathology review plus one additional feature (compatible immunophenotype, cyclin D1 over-expression, t(11;14) or Bcl-1/IgH rearrangement) were treated with 2–3 cycles of R-M-augmented CHOP (Rituximab [R] 375 mg/m2 d1, Methotrexate 3000 or 300 mg/m2 d2, CHOP d3 [cyclophosphamide {C} 2 g/m2]) followed by consolidation and stem cell collection with EAR (Etoposide [E] 40 mg/kg continuous d1-4, Cytarabine 2 g/m2 Q12h d1-4, R d6 and d13, and filgrastim 10 mcg/kg/d beginning d14 until completion of stem cell collection). EAR was followed by ASCT using CBV (Carmustine 15 mg/kg d-6, E 60 mg/kg d-4, C 100 mg/kg d-2) followed by R 6 and 7 weeks after ASCT. 69 pts have been enrolled in 36 months.
Patient demographics: median age 57 (38–68); 84% stage IV; 47% serum LDH elevated; 78% bone marrow (+); 5% cerebrospinal fluid (+). To date, 38 pts have completed all therapy, 6 have completed EAR, and10 are still receiving RM-CHOP. Stem cell collection was excellent, with a median CD34+ cell dose of 11.8x106/kg in median1 apheresis. 4 pts were unable to receive the full intended therapy due to adverse events (2 treatment related deaths, 2 early progressions). 5 pts withdrew from study because of personal preference (2), lack of insurance approval (2) or allogeneic stem cell transplant (1). With a median follow-up of 7 months, the projected 2-year progression-free survival is 70±21%. We conclude that intense IC plus ASCT is feasible and safe in pts with MCL up to age 70 with a high percentage of pts able to receive the planned therapy.
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