In transplant-ineligible patients with previously untreated mantle cell lymphoma, frontline bortezomib plus rituximab, cyclophosphamide, doxorubicin, and prednisone (VR-CAP) showed better survival compared with rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP).1 The results of LYM-3002, a randomized phase 3 clinical trial (ClinicalTrials.org Identifier: NCT00722137), were reported online October 19, 2018, in The Lancet Oncology.
A total of 487 participants were enrolled in the LYM-3002 trial between 2008 and 2011 across 128 centers in 28 countries. Eligible participants had treatment-naive stage II to stage IV mantle cell lymphoma and were ineligible for bone marrow transplantation. Patients were randomized in a 1:1 fashion to receive either 6 or 8 cycles (cycles of 21 days each) of VR-CAP or R-CHOP.
For the follow-up analysis, 268 participants were included (140 participants from the VR-CAP arm and 128 from the R-CHOP arm). At a median follow-up of 82 months, participants who received VR-CAP had a nearly 35-month longer median overall survival than those who received R-CHOP (90.7 months vs 55.7 months; hazard ration [HR] = 0.66; P = .001). In the VR-CAP arm, 42% of participants (103 of 243) had died by the time of analysis, whereas 57% (138 of 244) in the R-CHOP arm had died.
As for safety, 3 new adverse events were seen. In the R-CHOP arm, 1 patient had grade 2 pneumonia. In the VR-CAP arm, 1 patient had grade 4 lung adenocarcinoma and 1 patient had grade 4 gastric cancer.
“This follow-up study showed that replacement of vincristine with bortezomib in the R-CHOP regimen (ie, VR-CAP) significantly improved median overall survival in previously untreated patients with mantle cell lymphoma,” the study authors wrote. “Our results support further assessment of VR-CAP in patients with previously untreated mantle cell lymphoma.”
Disclosure: This study was funded by Janssen Research & Development. For a full list of disclosures, please refer to the original study.
- Robak T, Jin J, Pylypenko H, et al. Frontline bortezomib, rituximab, cyclophosphamide, doxorubicin, and prednisone (VR-CAP) versus rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) in transplantation-ineligible patients with newly diagnosed mantle cell lymphoma: final overall survival results of a randomised, open-label, phase 3 study [published online October 19, 2018]. Lancet Oncol. doi: 10.1016/S1470-2045(18)30685-5