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Phase II study of R–CVP followed by rituximab maintenance therapy for patients with advanced marginal zone lymphoma: consortium for improving survival of lymphoma (CISL) study

BACKGROUND: The response rate and survival improvement for rituximab, a CD20-targeting monoclonal antibody, have been demonstrated in marginal zone lymphoma (MZL) as monotherapy and in combination with chemotherapeutic regimens, yet relapses still occur despite treatment completion. Thus, extending...

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Autores principales: Oh, Sung Yong, Kim, Won Seog, Kim, Jin Seok, Kim, Seok Jin, Yoon, Dok Hyun, Yang, Deok-Hwan, Lee, Won Sik, Kim, Hyo Jung, Yhim, Ho-Young, Jeong, Seong Hyun, Won, Jong Ho, Lee, Suee, Kong, Jee Hyun, Lim, Sung-Nam, Ji, Jun Ho, Kwon, Kyung A., Lee, Gyeong-Won, Lee, Jae Hoon, Lee, Ho Sup, Shin, Ho-Jin, Suh, Cheolwon
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2019
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6796378/
https://www.ncbi.nlm.nih.gov/pubmed/31619290
http://dx.doi.org/10.1186/s40880-019-0403-7
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author Oh, Sung Yong
Kim, Won Seog
Kim, Jin Seok
Kim, Seok Jin
Yoon, Dok Hyun
Yang, Deok-Hwan
Lee, Won Sik
Kim, Hyo Jung
Yhim, Ho-Young
Jeong, Seong Hyun
Won, Jong Ho
Lee, Suee
Kong, Jee Hyun
Lim, Sung-Nam
Ji, Jun Ho
Kwon, Kyung A.
Lee, Gyeong-Won
Lee, Jae Hoon
Lee, Ho Sup
Shin, Ho-Jin
Suh, Cheolwon
author_facet Oh, Sung Yong
Kim, Won Seog
Kim, Jin Seok
Kim, Seok Jin
Yoon, Dok Hyun
Yang, Deok-Hwan
Lee, Won Sik
Kim, Hyo Jung
Yhim, Ho-Young
Jeong, Seong Hyun
Won, Jong Ho
Lee, Suee
Kong, Jee Hyun
Lim, Sung-Nam
Ji, Jun Ho
Kwon, Kyung A.
Lee, Gyeong-Won
Lee, Jae Hoon
Lee, Ho Sup
Shin, Ho-Jin
Suh, Cheolwon
author_sort Oh, Sung Yong
collection PubMed
description BACKGROUND: The response rate and survival improvement for rituximab, a CD20-targeting monoclonal antibody, have been demonstrated in marginal zone lymphoma (MZL) as monotherapy and in combination with chemotherapeutic regimens, yet relapses still occur despite treatment completion. Thus, extending the period of remission in MZL patients remains an essential goal. This multicenter, single-arm, open-label phase II study evaluated the survival efficacy of 2 years of rituximab-maintenance therapy in patients with stage III–IV CD20-positive MZL who had responded to first-line R–CVP (rituximab, cyclophosphamide, vincristine, and prednisolone). The objective of this study was to determine whether rituximab maintenance following R–CVP warrants further investigation. METHODS: Prior to rituximab-maintenance therapy, patients received 6–8 cycles of first-line R–CVP therapy for stage III–IV MZL. Rituximab (375 mg/m(2)), cyclophosphamide (750 mg/m(2)), and vincristine (1.4 mg/m(2); maximum 2 mg) were administered via an intravenous infusion on day 1 of each 3-week cycle, while oral prednisolone (100 mg) was given on days 1–5 of each 3-week cycle. The patients who achieved complete response (CR), partial response (PR), or stable disease (SD) to R–CVP treatment, were prescribed rituximab-maintenance therapy which was administered intravenously at a dose of 375 mg/m(2) every 8 weeks for up to 12 cycles. The primary endpoint was progression-free survival (PFS). Secondary endpoints were overall survival (OS) and treatment safety. RESULTS: 47 patients were enrolled, of whom, 45 (96%) received rituximab-maintenance treatment. Fifteen (33%) patients had nodal MZL. Following R–CVP first-line therapy, 20 (44%), 22 (49%), and 3 (7%) patients achieved CR, PR, and SD, respectively. After a median follow-up of 38.2 months, their observed 3-year PFS rate was 81%. During the rituximab-maintenance, 6 PR and 1 SD patients achieved CR following the administration of R–CVP. Elevated LDH and the presence of B symptoms were found to be significant prognostic factors for PFS (P = 0.003) and demonstrated a 3-year OS rate of 90%. Rituximab-maintenance therapy was well tolerated, and the common treatment-emergent adverse events were sensory neuropathy (18%), myalgia (13%), fatigue (9%), and neutropenia (9%). CONCLUSION: Rituximab-maintenance therapy following first-line R–CVP demonstrated good PFS in patients with stage III–IV MZL, in addition to a favorable toxicity profile. Trial registration clinicaltrials.gov: NCT01213095
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spelling pubmed-67963782019-10-22 Phase II study of R–CVP followed by rituximab maintenance therapy for patients with advanced marginal zone lymphoma: consortium for improving survival of lymphoma (CISL) study Oh, Sung Yong Kim, Won Seog Kim, Jin Seok Kim, Seok Jin Yoon, Dok Hyun Yang, Deok-Hwan Lee, Won Sik Kim, Hyo Jung Yhim, Ho-Young Jeong, Seong Hyun Won, Jong Ho Lee, Suee Kong, Jee Hyun Lim, Sung-Nam Ji, Jun Ho Kwon, Kyung A. Lee, Gyeong-Won Lee, Jae Hoon Lee, Ho Sup Shin, Ho-Jin Suh, Cheolwon Cancer Commun (Lond) Original Article BACKGROUND: The response rate and survival improvement for rituximab, a CD20-targeting monoclonal antibody, have been demonstrated in marginal zone lymphoma (MZL) as monotherapy and in combination with chemotherapeutic regimens, yet relapses still occur despite treatment completion. Thus, extending the period of remission in MZL patients remains an essential goal. This multicenter, single-arm, open-label phase II study evaluated the survival efficacy of 2 years of rituximab-maintenance therapy in patients with stage III–IV CD20-positive MZL who had responded to first-line R–CVP (rituximab, cyclophosphamide, vincristine, and prednisolone). The objective of this study was to determine whether rituximab maintenance following R–CVP warrants further investigation. METHODS: Prior to rituximab-maintenance therapy, patients received 6–8 cycles of first-line R–CVP therapy for stage III–IV MZL. Rituximab (375 mg/m(2)), cyclophosphamide (750 mg/m(2)), and vincristine (1.4 mg/m(2); maximum 2 mg) were administered via an intravenous infusion on day 1 of each 3-week cycle, while oral prednisolone (100 mg) was given on days 1–5 of each 3-week cycle. The patients who achieved complete response (CR), partial response (PR), or stable disease (SD) to R–CVP treatment, were prescribed rituximab-maintenance therapy which was administered intravenously at a dose of 375 mg/m(2) every 8 weeks for up to 12 cycles. The primary endpoint was progression-free survival (PFS). Secondary endpoints were overall survival (OS) and treatment safety. RESULTS: 47 patients were enrolled, of whom, 45 (96%) received rituximab-maintenance treatment. Fifteen (33%) patients had nodal MZL. Following R–CVP first-line therapy, 20 (44%), 22 (49%), and 3 (7%) patients achieved CR, PR, and SD, respectively. After a median follow-up of 38.2 months, their observed 3-year PFS rate was 81%. During the rituximab-maintenance, 6 PR and 1 SD patients achieved CR following the administration of R–CVP. Elevated LDH and the presence of B symptoms were found to be significant prognostic factors for PFS (P = 0.003) and demonstrated a 3-year OS rate of 90%. Rituximab-maintenance therapy was well tolerated, and the common treatment-emergent adverse events were sensory neuropathy (18%), myalgia (13%), fatigue (9%), and neutropenia (9%). CONCLUSION: Rituximab-maintenance therapy following first-line R–CVP demonstrated good PFS in patients with stage III–IV MZL, in addition to a favorable toxicity profile. Trial registration clinicaltrials.gov: NCT01213095 BioMed Central 2019-10-16 /pmc/articles/PMC6796378/ /pubmed/31619290 http://dx.doi.org/10.1186/s40880-019-0403-7 Text en © The Author(s) 2019 Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
spellingShingle Original Article
Oh, Sung Yong
Kim, Won Seog
Kim, Jin Seok
Kim, Seok Jin
Yoon, Dok Hyun
Yang, Deok-Hwan
Lee, Won Sik
Kim, Hyo Jung
Yhim, Ho-Young
Jeong, Seong Hyun
Won, Jong Ho
Lee, Suee
Kong, Jee Hyun
Lim, Sung-Nam
Ji, Jun Ho
Kwon, Kyung A.
Lee, Gyeong-Won
Lee, Jae Hoon
Lee, Ho Sup
Shin, Ho-Jin
Suh, Cheolwon
Phase II study of R–CVP followed by rituximab maintenance therapy for patients with advanced marginal zone lymphoma: consortium for improving survival of lymphoma (CISL) study
title Phase II study of R–CVP followed by rituximab maintenance therapy for patients with advanced marginal zone lymphoma: consortium for improving survival of lymphoma (CISL) study
title_full Phase II study of R–CVP followed by rituximab maintenance therapy for patients with advanced marginal zone lymphoma: consortium for improving survival of lymphoma (CISL) study
title_fullStr Phase II study of R–CVP followed by rituximab maintenance therapy for patients with advanced marginal zone lymphoma: consortium for improving survival of lymphoma (CISL) study
title_full_unstemmed Phase II study of R–CVP followed by rituximab maintenance therapy for patients with advanced marginal zone lymphoma: consortium for improving survival of lymphoma (CISL) study
title_short Phase II study of R–CVP followed by rituximab maintenance therapy for patients with advanced marginal zone lymphoma: consortium for improving survival of lymphoma (CISL) study
title_sort phase ii study of r–cvp followed by rituximab maintenance therapy for patients with advanced marginal zone lymphoma: consortium for improving survival of lymphoma (cisl) study
topic Original Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6796378/
https://www.ncbi.nlm.nih.gov/pubmed/31619290
http://dx.doi.org/10.1186/s40880-019-0403-7
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