BACKGROUND:
The proteasome inhibitor bortezomib was initially approved for the treatment of relapsed mantle-cell lymphoma. We investigated whether substituting bortezomib for vincristine in frontline therapy with R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) could improve outcomes in patients with newly diagnosed mantle-cell lymphoma.
METHODS:
In this phase 3 trial, we randomly assigned 487 adults with newly diagnosed mantle-cell lymphoma who were ineligible or not considered for stem-cell transplantation to receive six to eight 21-day cycles of R-CHOP intravenously on day 1 (with prednisone administered orally on days 1 to 5) or VR-CAP (R-CHOP regimen, but replacing vincristine with bortezomib at a dose of 1.3 mg per square meter of body-surface area on days 1, 4, 8, and 11). The primary end point was progression-free survival.
RESULTS:
After a median follow-up of 40 months, median progression-free survival (according to independent radiologic review) was 14.4 months in the R-CHOP group versus 24.7 months in the VR-CAP group (hazard ratio favoring the VR-CAP group, 0.63; P<0 .001="" 0.51="" 16.1="" 30.7="" 4-year="" 40.6="" 42.1="" 53="" 59="" 64="" 96="" a="" abstracttext="" and="" assessment="" basis="" complete="" consistently="" duration="" durations="" end="" group.="" group="" hazard="" higher="" improved="" improvement="" in="" including="" interval="" investigator="" median="" months="" neutropenia="" of="" on="" overall="" p="" points="" progression-free="" rate="" rates="" ratio="" relative="" respectively="" response="" secondary="" survival="" the="" thrombocytopenia="" treatment-free="" vr-cap="" vs.="" were="">
CONCLUSIONS:
VR-CAP was more effective than R-CHOP in patients with newly diagnosed mantle-cell lymphoma but at the cost of increased hematologic toxicity. (Funded by Janssen Research and Development and Millennium Pharmaceuticals; LYM-3002 ClinicalTrials.gov number,
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