A long-term follow-up of the LYM-3002 study reveals that the VR-CAP regimen (bortezomib, rituximab, cyclophosphamide, doxorubicin, and prednisone) significantly improves overall survival compared to the R-CHOP regimen (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) in patients with previously untreated mantle cell lymphoma (MCL) who are ineligible for bone marrow transplantation. The study, a randomized, open-label, phase 3 trial conducted across 128 clinical centers, highlights the potential of VR-CAP as a superior frontline treatment option.
The LYM-3002 study enrolled 487 patients between May 22, 2008, and December 5, 2011. The final analysis included 268 patients with available data after the primary analysis cutoff date. Patients were randomized to receive either six or eight 21-day cycles of VR-CAP or R-CHOP. After a median follow-up of 82.0 months (IQR 74.1-94.2), the median overall survival was significantly longer in the VR-CAP group at 90.7 months (95% CI 71.4 to not estimable) compared to 55.7 months (95% CI 47.2 to 68.9) in the R-CHOP group (hazard ratio 0.66 [95% CI 0.51-0.85]; p=0.001).
The study's findings indicate a clinically meaningful improvement in survival outcomes for patients treated with VR-CAP. While both regimens have established roles in MCL treatment, the extended survival observed with VR-CAP suggests a potential shift in frontline therapy strategies for transplant-ineligible patients. The manageable safety profile of VR-CAP further supports its consideration as a favorable treatment option.
"The results of the LYM-3002 study provide compelling evidence for the superiority of VR-CAP over R-CHOP in improving overall survival in patients with previously untreated mantle cell lymphoma," the researchers noted. "These findings warrant further investigation and consideration of VR-CAP as a standard frontline treatment option for this patient population."
Regarding safety, three new adverse events were reported since the primary analysis cutoff: one case each of grade 4 lung adenocarcinoma and grade 4 gastric cancer in the VR-CAP group, and one case of grade 2 pneumonia in the R-CHOP group. Progressive disease remained the most common cause of death, affecting 42% of patients in the VR-CAP group and 57% in the R-CHOP group.
