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
Year: 2019
Type: article
Study design: Clinical Trial
Abstract: 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
Source: 癌症：英文版
Authors: Sung Yong Oh, Won Seog Kim, Jin Seok Kim, Seok Jin Kim, Dok Hyun Yoon, Deok‐Hwan Yang, Won Sik Lee, Hyo Jung Kim, Ho‐Young Yhim, Seong Hyun Jeong, Jong Ho Won, Suee Lee, Jee Hyun Kong, Sung‐Nam Lim, Jun Ho Ji, Kyung A. Kwon, Gyeong‐Won Lee, Jae Hoon Lee, Ho Sup Lee, Ho‐Jin Shin, Cheolwon Suh
Institutions: Dong-A University Hospital, Samsung Medical Center, Sungkyunkwan University, Yonsei University, Yonsei University Health System, Asan Medical Center, University of Ulsan, Chonnam National University Hwasun Hospital, Inje University, Inje University Busan Paik Hospital, Hallym University Sacred Heart Hospital, Jeonbuk National University Hospital, Ajou University, Soonchunhyang University, Soonchunhyang University Hospital Seoul, Wonju Severance Christian Hospital, Inje University Haeundae Paik Hospital, Samsung Changwon Hospital, Dongnam Institute of Radiological & Medical Sciences, Gyeongsang National University, Gyeongsang National University Hospital, Gachon University Gil Medical Center, Kosin University Gospel Hospital, Kosin University, Pusan National University Hospital, Pusan National University
Language: English
Subfield: Pathology and Forensic Medicine
Field: Medicine
Domain: Health Sciences
Open Access status: gold
Estimated APC paid: $1,732
Funder: Dong-A University
OpenAlex ID: W2980850779