Efficacy and safety of frontline rituximab, cyclophosphamide, doxorubicin and prednisone plus bortezomib (VR-CAP) or vincristine (R-CHOP) in a subset of newly diagnosed mantle cell lymphoma patients medically eligible for transplantation in the randomized, phase 3 LYM-3002 study.

Drach, Johannes;Huang, Huiqiang;Samoilova, Olga;Belch, Andrew;Cavalli, Franco;et.al.
(2018) Leukemia and Lymphoma — Vol. 59, n° 4, p. 896-903 (2018)

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Authors
  • Drach, Johannes
    Author
  • Huang, Huiqiang
    Author
  • Samoilova, Olga
    Author
  • Belch, Andrew
    Author
  • Bosly, AndréUCLouvain
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  • Cavalli, Franco
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Abstract
This post-hoc subanalysis of the LYM-3002 phase 3 study assessed the efficacy and safety of substituting vincristine in rituximab, cyclophosphamide, doxorubicin and prednisone (R-CHOP; n = 42) for bortezomib (VR-CAP; n = 38) in a subgroup of 80 mantle cell lymphoma (MCL) patients aged <60 years who did not receive stem cell transplantation (SCT) despite medical eligibility. Complete response (CR)/unconfirmed CR (CRu) rates were 67 vs. 39% (odds ratio 3.69 [95% CI(confidence interval): 1.31, 10.41]; p = .012). After 40 months median follow-up, median progression-free survival by independent radiology committee with VR-CAP vs. R-CHOP was 32.6 vs. 12.0 months (hazard ratio (HR) 0.59 [95% CI: 0.31, 1.13]; p = .108); median overall survival was not reached vs. 47.3 months (HR 0.81 [95% CI: 0.33, 1.96]; p = .634). Adverse events included neutropenia (92/76%), thrombocytopenia (70/10%) and leukopenia (65/50%). VR-CAP represents a potential alternative to R-CHOP in combined and/or alternating regimens for younger, SCT-eligible MCL patients.
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Drach, J., Huang, H., Samoilova, O., Belch, A., Farber, C., Bosly, A., Novak, J., Zaucha, J., Dascalescu, A., Bunworasate, U., Masliak, Z., Vilchevskaya, K., Robak, T., Pei, L., Rooney, B., van de Velde, H., & Cavalli, F. (2018). Efficacy and safety of frontline rituximab, cyclophosphamide, doxorubicin and prednisone plus bortezomib (VR-CAP) or vincristine (R-CHOP) in a subset of newly diagnosed mantle cell lymphoma patients medically eligible for transplantation in the randomized, phase 3 LYM-3002 study. Leukemia and Lymphoma, 59(4), 896-903. https://doi.org/10.1080/10428194.2017.1365855 (Original work published 2018)