摘要

The proteasome inhibitor, bortezomib, potentially increases cell sensitivity to chemotherapy. This study was performed to determine the overall response rate (ORR), overall survival (OS), progression-free survival (PFS) and toxicity of CHOP (cyclophosphamide, doxorubicin, vincristine and prednisolone) compared to CHOP + bortezomib chemotherapy in mantle cell lymphoma (MCL) patients at first relapse. Forty-six patients were randomly assigned to standard dose CHOP +/- bortezomib 16mg/m(2) given on a 21-d cycle for up to eight cycles of treatment. Median age was 71years (CHOP arm) and 69years (CHOP-bortezomib arm). Median Eastern Cooperative Oncology Group performance status was 1 (CHOP) and 0 (CHOP-bortezomib) with 65% and 52%, respectively, having a disease stage of IV. ORR was 478% (CHOP) and 826% (CHOP-bortezomib). Complete response rate was 217% (CHOP) vs. 348% (CHOP-bortezomib); partial response rate was 261% (CHOP) vs. 478% (CHOP-bortezomib). Median OS was 118months (CHOP) and 356months (CHOP-bortezomib) (P=001, Hazard ratio [HR] 037 [95% confidence interval (CI) 016-083)] and there was a non-significant improvement in PFS: 81months (CHOP) and 165months (CHOP-bortezomib) [P=012, HR 060 (95% CI 031-115)]. Severe (grade 3) sensory neuropathy was similar in both arms (43% CHOP vs. 65% CHOP-bortezomib). We conclude that the addition of bortezomib to CHOP chemotherapy for relapsed MCL significantly improves outcome with a manageable increase in toxicity.

  • 出版日期2015-1