In an analysis reported in The Lancet Oncology by Robak et al, bortezomib, rituximab [Rituxan], cyclophosphamide, doxorubicin, and prednisone (VR-CAP) significantly prolonged overall survival vs rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) in a phase III trial (LYM-3002) in transplantation-ineligible patients with newly diagnosed mantle cell lymphoma. The primary analysis from the study showed a significant improvement in progression-free survival with VR-CAP.
In the open-label trial, 487 patients with stage II to IV disease from 128 sites in 28 countries in Asia, Europe, North America, and South America were randomly assigned between May 2008 and December 2011 to receive six or eight 21-day cycles of VR-CAP (rituximab at 375 mg/m², cyclophosphamide at 750 mg/m², doxorubicin at 50 mg/m², and bortezomib at 1.3 mg/m² plus oral prednisone 100 mg/m²) or R-CHOP (vincristine at 1.4 mg/m² [2 mg maximum], rituximab at 375 mg/m², cyclophosphamide at 750 mg/m², and doxorubicin at 50 mg/m² plus oral prednisone at 100 mg/m²).
The current analysis includes 268 patients (follow-up analysis set), 140 in the VR-CAP group and 128 in the R-CHOP group, with data available after the primary analysis clinical cutoff date in December 2013.
Median follow-up was 82.0 months among surviving patients in the follow-up analysis set. Median overall survival was 90.7 months in the VR-CAP group vs 55.7 months in the R-CHOP group (hazard ratio = 0.66, P =.001). In the entire population, death occurred in 103 (42%) of 243 patients in the VR-CAP group and in 138 (57%) of 244 in the R-CHOP group, with progressive disease as the most common cause.
Among all patients, 43% of the VR-CAP group and 62% of the R-CHOP group received subsequent therapies. Of these, 77% and 81% received antineoplastic therapy, with 53% and 59% receiving rituximab as second-line therapy.
Fatal Adverse Events
Adverse events leading to death were infections and infestations (3%) and respiratory, thoracic, and mediastinal disorders (2%) in the VR-CAP group and cardiac disorders (2%), infections and infestations (2%), and respiratory, thoracic, and mediastinal disorders (3%) in the R-CHOP group. Death from treatment-related adverse events occurred in 4% of each group.
The investigators concluded, “Compared with R-CHOP, VR-CAP was associated with significantly longer survival, and had a manageable and expected safety profile. Our results support further assessment of VR-CAP in patients with previously untreated mantle cell lymphoma.”
The study was funded by Janssen Research & Development.
Tadeusz Robak, MD, of Copernicus Memorial Hospital, Medical University of Lodz, Poland, is the corresponding author for The Lancet Oncology article.
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