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Blood, 15 January 2008, Vol. 111, No. 2, pp. 537-543.
Prepublished online as a Blood First Edition Paper on October 30, 2007; DOI 10.1182/blood-2007-08-108415.
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Submitted August 23, 2007
Accepted September 24, 2007
Rituximab improves the treatment results of DHAP-VIM-DHAP and ASCT in relapsed/progressive aggressive CD20+ NHL. A prospective randomized HOVON trial
Edo Vellenga*, Wim L.J. van Putten, Mars B. van 't Veer, Josee M. Zijlstra, Willem E. Fibbe, Marinus H.J. van Oers, Leo F. Verdonck, Pierre W. Wijermans, Gustaaf W van Imhoff, Pieternella J. Lugtenburg, and Peter C. Huijgens
Hematology, University of Groningen and University Medical Center Groningen, Groningen, Netherlands
Hovon Data Center, Erasmus MC, Rotterdam, Netherlands
Hematology, Erasmus MC/lok. Daniel Rotterdam, Rotterdam, Netherlands
Hematology, VUMC, Amsterdam, Netherlands
Hematology, LUMC, Leiden, Netherlands
Hematology, AMC, Amsterdam, Netherlands
Hematology, University Medical Center Utrecht, Utrecht, Netherlands
Hematology, Leyenburg Hospital, The Hague, Netherlands
Hematology, Erasmus MC, Rotterdam, Netherlands
* Corresponding author; email: e.vellenga{at}int.umcg.nl.
We evaluated the role of Rituximab during remission induction chemotherapy in relapsed aggressive CD20+ Non-Hodgkin Lymphoma (NHL). A total of 239 patients were included of which 225 were evaluable for analysis. Randomized to DHAP-VIM-DHAP chemotherapy with (R)Rituximab (R-DHAP arm) were 119 patients (113 evaluable) and to chemotherapy without Rituximab (DHAP arm) 120 patients (112 evaluable). Patients in complete remission (CR) and partial remission (PR) after 2-chemotherapy courses were eligible for ASCT.
After the 2nd chemotherapy cycle, 75% of the patients in the R-DHAP arm had responsive disease (CR or PR) vs 54% in the DHAP arm (p=.01). With a median follow-up of 24 months there was a significant difference in failure free survival (FFS24) (50% vs 24% vs, p<.001), and progression free survival (PFS24, 52% vs 31% p<.002) in favor of the R-DHAP arm. Cox-regression analysis demonstrated a significant effect of Rituximab treatment on FFS24 (HR 0.41) (95%CI 0.29-0.57) vs 0.51 (0.37-0.70) and overall-survival (OS24) (HR 0.60 (0.41-0.89) vs 0.76 (0.52-1.10) when adjusted for the variables: time since upfront treatment, age, WHO performance status and sAAIPI. These results demonstrate an improved FFS and PFS for relapsed aggressive B-NHL, if Rituximab is added to the re-induction chemotherapy regimen.
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