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Results of a phase 3 study suggest the VR-CAP regimen is more effective but less safe than R-CHOP in patients with newly diagnosed mantle cell lymphoma (MCL).
Patients who received VR-CAP (bortezomib, rituximab, cyclophosphamide, doxorubicin, and prednisone) had superior progression-free survival (PFS) when compared to patients who received R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone).
But VR-CAP was also associated with more adverse events (AEs), particularly hematologic toxicities.
Tadeusz Robak, MD, of the Medical University of Lodz in Poland, and his colleagues reported results from this trial, known as LYM-3002, in NEJM. The study was funded by Janssen Research and Development and Millennium Pharmaceuticals.
LYM-3002 included 487 patients newly diagnosed with MCL who were not eligible for stem cell transplant.
Patients were randomized 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 (similar to the 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 median follow-up was 40 months. The VR-CAP regimen significantly improved PFS, the primary endpoint, when compared to R-CHOP.
According to an independent review committee, there was a 59% improvement in PFS for the VR-CAP arm compared to the R-CHOP arm, with median PFS times of 24.7 months and 14.4 months, respectively (hazard ratio [HR]=0.63, P<0.001).
Study investigators reported a 96% increase in PFS with VR-CAP compared to R-CHOP, with median PFS times of 30.7 months and 16.1 months, respectively (HR=0.51, P<0.001).
Patients in the VR-CAP arm also fared better with regard to some secondary endpoints. The complete response rate was higher in the VR-CAP arm than the R-CHOP arm—53% and 42%, respectively (HR=1.29, P=0.007).
And patients in the VR-CAP arm had a longer median treatment-free interval—40.6 months and 20.5 months, respectively (HR=0.50, P<0.001).
However, there was no significant difference in overall survival between the treatment arms. The median overall survival was not reached in the VR-CAP arm and was 56.3 months in the R-CHOP arm (HR=0.80, P=0.17). The 4-year overall survival rate was 64% and 54%, respectively.
The investigators said VR-CAP was associated with additional, but manageable, toxicity when compared to R-CHOP. Serious AEs were reported in 38% and 30% of patients, respectively. And grade 3 or higher AEs were reported in 93% and 85% of patients, respectively.
Hematologic toxicity was more common in the VR-CAP arm than the R-CHOP arm. This included thrombocytopenia (72% vs 19%), neutropenia (88% vs 74%), anemia (51% vs 37%), leukopenia (50% vs 38%), lymphocytopenia (31% vs 13%), and febrile neutropenia (17% vs 14%).
Treatment discontinuation due to AEs occurred in 8% of patients in the VR-CAP arm and 6% in the R-CHOP arm. On-treatment, drug-related deaths occurred in 2% and 3% of patients, respectively.
It was based on these results that bortezomib was approved for use in patients with newly diagnosed MCL in the Europe Union and the US. 
Results of a phase 3 study suggest the VR-CAP regimen is more effective but less safe than R-CHOP in patients with newly diagnosed mantle cell lymphoma (MCL).
Patients who received VR-CAP (bortezomib, rituximab, cyclophosphamide, doxorubicin, and prednisone) had superior progression-free survival (PFS) when compared to patients who received R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone).
But VR-CAP was also associated with more adverse events (AEs), particularly hematologic toxicities.
Tadeusz Robak, MD, of the Medical University of Lodz in Poland, and his colleagues reported results from this trial, known as LYM-3002, in NEJM. The study was funded by Janssen Research and Development and Millennium Pharmaceuticals.
LYM-3002 included 487 patients newly diagnosed with MCL who were not eligible for stem cell transplant.
Patients were randomized 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 (similar to the 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 median follow-up was 40 months. The VR-CAP regimen significantly improved PFS, the primary endpoint, when compared to R-CHOP.
According to an independent review committee, there was a 59% improvement in PFS for the VR-CAP arm compared to the R-CHOP arm, with median PFS times of 24.7 months and 14.4 months, respectively (hazard ratio [HR]=0.63, P<0.001).
Study investigators reported a 96% increase in PFS with VR-CAP compared to R-CHOP, with median PFS times of 30.7 months and 16.1 months, respectively (HR=0.51, P<0.001).
Patients in the VR-CAP arm also fared better with regard to some secondary endpoints. The complete response rate was higher in the VR-CAP arm than the R-CHOP arm—53% and 42%, respectively (HR=1.29, P=0.007).
And patients in the VR-CAP arm had a longer median treatment-free interval—40.6 months and 20.5 months, respectively (HR=0.50, P<0.001).
However, there was no significant difference in overall survival between the treatment arms. The median overall survival was not reached in the VR-CAP arm and was 56.3 months in the R-CHOP arm (HR=0.80, P=0.17). The 4-year overall survival rate was 64% and 54%, respectively.
The investigators said VR-CAP was associated with additional, but manageable, toxicity when compared to R-CHOP. Serious AEs were reported in 38% and 30% of patients, respectively. And grade 3 or higher AEs were reported in 93% and 85% of patients, respectively.
Hematologic toxicity was more common in the VR-CAP arm than the R-CHOP arm. This included thrombocytopenia (72% vs 19%), neutropenia (88% vs 74%), anemia (51% vs 37%), leukopenia (50% vs 38%), lymphocytopenia (31% vs 13%), and febrile neutropenia (17% vs 14%).
Treatment discontinuation due to AEs occurred in 8% of patients in the VR-CAP arm and 6% in the R-CHOP arm. On-treatment, drug-related deaths occurred in 2% and 3% of patients, respectively.
It was based on these results that bortezomib was approved for use in patients with newly diagnosed MCL in the Europe Union and the US.
Results of a phase 3 study suggest the VR-CAP regimen is more effective but less safe than R-CHOP in patients with newly diagnosed mantle cell lymphoma (MCL).
Patients who received VR-CAP (bortezomib, rituximab, cyclophosphamide, doxorubicin, and prednisone) had superior progression-free survival (PFS) when compared to patients who received R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone).
But VR-CAP was also associated with more adverse events (AEs), particularly hematologic toxicities.
Tadeusz Robak, MD, of the Medical University of Lodz in Poland, and his colleagues reported results from this trial, known as LYM-3002, in NEJM. The study was funded by Janssen Research and Development and Millennium Pharmaceuticals.
LYM-3002 included 487 patients newly diagnosed with MCL who were not eligible for stem cell transplant.
Patients were randomized 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 (similar to the 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 median follow-up was 40 months. The VR-CAP regimen significantly improved PFS, the primary endpoint, when compared to R-CHOP.
According to an independent review committee, there was a 59% improvement in PFS for the VR-CAP arm compared to the R-CHOP arm, with median PFS times of 24.7 months and 14.4 months, respectively (hazard ratio [HR]=0.63, P<0.001).
Study investigators reported a 96% increase in PFS with VR-CAP compared to R-CHOP, with median PFS times of 30.7 months and 16.1 months, respectively (HR=0.51, P<0.001).
Patients in the VR-CAP arm also fared better with regard to some secondary endpoints. The complete response rate was higher in the VR-CAP arm than the R-CHOP arm—53% and 42%, respectively (HR=1.29, P=0.007).
And patients in the VR-CAP arm had a longer median treatment-free interval—40.6 months and 20.5 months, respectively (HR=0.50, P<0.001).
However, there was no significant difference in overall survival between the treatment arms. The median overall survival was not reached in the VR-CAP arm and was 56.3 months in the R-CHOP arm (HR=0.80, P=0.17). The 4-year overall survival rate was 64% and 54%, respectively.
The investigators said VR-CAP was associated with additional, but manageable, toxicity when compared to R-CHOP. Serious AEs were reported in 38% and 30% of patients, respectively. And grade 3 or higher AEs were reported in 93% and 85% of patients, respectively.
Hematologic toxicity was more common in the VR-CAP arm than the R-CHOP arm. This included thrombocytopenia (72% vs 19%), neutropenia (88% vs 74%), anemia (51% vs 37%), leukopenia (50% vs 38%), lymphocytopenia (31% vs 13%), and febrile neutropenia (17% vs 14%).
Treatment discontinuation due to AEs occurred in 8% of patients in the VR-CAP arm and 6% in the R-CHOP arm. On-treatment, drug-related deaths occurred in 2% and 3% of patients, respectively.
It was based on these results that bortezomib was approved for use in patients with newly diagnosed MCL in the Europe Union and the US.