Aim:
To improve progression-free survival (PFS) in MCL using a strategy of incorporating approaches of intensifying induction & intensifying consolidation with high dose chemo radiotherapy (HDT by administering an anthracycline-containing regimen in a dose dense fashion CHOP- or R-CHOP-14) followed by consolidation with ICE HDT/ASCT.
Conclusions:
Researchers concluded that these data provide evidence that dose-dense induction with CHOP-14 or R-CHOP-14 and consolidation with ICE/HDT/ASCT appears to be safe and effective, with minimal acute toxicity Future therapy could incorporate all the successful elements of prior treatment programs with R-CHOP-14, R-ICE, and radioimmunotherapy with high dose chemotherapy conditioning regimen, followed by ASCT.
Official Title
Conditions
Study Type
Phase II
Study Design
46 patients with newly diagnosed MCL underwent HDT/ASCT.Median age was 55 years; 74% were male; 72% had bone marrow involvement, 39% had GI involvement, 7% were in leukemic phase & 91% presented with stage IV disease. Splenomegaly was seen in 35%, B symptoms in 9%, KPS>70 in 93%, elevated LDH in 23%, and blastoid histology in 9%. Treatment:Induction – 4 to 6 cycles of CHOP-14 (43%), R-CHOP-14 (37%), or other doxorubicin-containing regimen (20%). Consolidation was performed with 2-3 cycles of ICE in 53% or R-ICE in 39%. Upfront treatment was well tolerated and permitted adequate stem cell collection and prompt transition to HDT/ASCT. Conditioning regimens were TBI/CY/VP-16 (59%) and BEAM (41%)Involved field radiation therapy was administered to 65%. Post-ASCT rituximab maintenance was given to 39%, with 57% of patients receiving rituximab as part of their treatment.
Further Details
Results:Anthracycline-based induction led to CRu of 44% and ORR of 98%.72% of patients were transplanted in CR, the remaining 28% were in PR. At a median follow-up of 2.5 years (range 0.4-8.0 years) 17% of the patients have died and 24% have had progressive disease. The median OS and PFS have not been reached (lower 95% CI, 5.7 years and 4.4 years, respectively). The 5-year PFS and OS are 58% and 83%, respectively.
Study Start
Eligibility & Criteria
Indication: Newly diagnosed MCL
Total Enrolment
46
Contact Details
Abstract 2072 ASH 2005
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