TY - JOUR
T1 - Phase 2 Open-Label Study of Bortezomib, Cladribine, and Rituximab in Advanced, Newly Diagnosed, and Relapsed/Refractory Mantle-Cell and Indolent Lymphomas
AU - Puvvada, Soham D.
AU - Guillen-Rodriguez, José
AU - Kumar, Abhijeet
AU - Inclán, Lora
AU - Heard, Kara
AU - Rivera, Xavier I.
AU - Anwer, Faiz
AU - Schatz, Jonathan H.
AU - Mahadevan, Daruka
AU - Persky, Daniel O.
N1 - Publisher Copyright:
© 2017 Elsevier Inc.
PY - 2018/1
Y1 - 2018/1
N2 - The combination of bortezomib, cladribine, and rituximab is novel and effective in mantle-cell and indolent non-Hodgkin lymphomas. Background Mantle-cell lymphoma (MCL) and indolent non-Hodgkin lymphoma (iNHL) are incurable heterogeneous diseases characterized by relapse. There is a need for newer treatments in MCL and iNHL, especially in the relapsed/refractory (R/R) setting. We therefore investigated the novel combination of bortezomib (Velcade), cladribine, and rituximab (VCR) in front-line and R/R settings in MCL and iNHL (NCT00980395). Patients and Methods Eligible patients included adults with biopsy-proven CD20-positive MCL and iNHL who met the criteria for treatment. Rituximab 375 mg/m 2 intravenous (IV) day 1, cladribine 4 mg/m 2 IV days 1 to 5, and bortezomib 1.3 mg/m 2 IV days 1 and 4 were administered every 28 days for 6 cycles. Results Twenty-four patients were enrolled onto the study with a median follow-up of 38.5 months. Median age was 66.5 years, and 46% had MCL. The most common adverse events were hematologic, with febrile neutropenia in 3 patients. Neuropathy was noted in 17% of patients, of which 8% was grade 3 or above. The overall response rate was 92%. For the entire cohort, and for MCL patients, the median progression-free survival and the median overall survival were not reached. The 2-year progression-free survival was 82% for the MCL group and 54% for the iNHL group; it was 80% for treatment-naive patients and 57% for R/R patients. Conclusion VCR is effective in MCL and iNHL. Although hematologic toxicity can be an issue, this study demonstrates a high response rate to a novel combination and provides an alternative option in transplant-ineligible R/R MCL and iNHL.
AB - The combination of bortezomib, cladribine, and rituximab is novel and effective in mantle-cell and indolent non-Hodgkin lymphomas. Background Mantle-cell lymphoma (MCL) and indolent non-Hodgkin lymphoma (iNHL) are incurable heterogeneous diseases characterized by relapse. There is a need for newer treatments in MCL and iNHL, especially in the relapsed/refractory (R/R) setting. We therefore investigated the novel combination of bortezomib (Velcade), cladribine, and rituximab (VCR) in front-line and R/R settings in MCL and iNHL (NCT00980395). Patients and Methods Eligible patients included adults with biopsy-proven CD20-positive MCL and iNHL who met the criteria for treatment. Rituximab 375 mg/m 2 intravenous (IV) day 1, cladribine 4 mg/m 2 IV days 1 to 5, and bortezomib 1.3 mg/m 2 IV days 1 and 4 were administered every 28 days for 6 cycles. Results Twenty-four patients were enrolled onto the study with a median follow-up of 38.5 months. Median age was 66.5 years, and 46% had MCL. The most common adverse events were hematologic, with febrile neutropenia in 3 patients. Neuropathy was noted in 17% of patients, of which 8% was grade 3 or above. The overall response rate was 92%. For the entire cohort, and for MCL patients, the median progression-free survival and the median overall survival were not reached. The 2-year progression-free survival was 82% for the MCL group and 54% for the iNHL group; it was 80% for treatment-naive patients and 57% for R/R patients. Conclusion VCR is effective in MCL and iNHL. Although hematologic toxicity can be an issue, this study demonstrates a high response rate to a novel combination and provides an alternative option in transplant-ineligible R/R MCL and iNHL.
KW - Clinical trial
KW - Non-Hodgkin's lymphoma
KW - Systemic therapy
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U2 - 10.1016/j.clml.2017.09.001
DO - 10.1016/j.clml.2017.09.001
M3 - Article
C2 - 29056470
AN - SCOPUS:85031764536
SN - 2152-2650
VL - 18
SP - 58
EP - 64
JO - Clinical Lymphoma, Myeloma and Leukemia
JF - Clinical Lymphoma, Myeloma and Leukemia
IS - 1
ER -