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Efficacy and safety of prophylactic high-dose MTX in high-risk DLBCL: a treatment intent-based analysis

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Abstract
Despite central nervous system (CNS) relapse occurring in >10% of high-risk diffuse large B-cell lymphoma (DLBCL) patients, the role of CNS-directed prophylaxis is controversial in the absence of randomized controlled trials. In this retrospective study, we aimed to evaluate the safety and efficacy of prophylactic high-dose methotrexate (HD-MTX) on CNS relapse and survival outcomes in 258 newly diagnosed R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone)-treated high-risk DLBCL patients, based on the initial treatment intent (ITT) of the physician on the use of prophylactic HD-MTX. Patients were classified into an ITT HD-MTX group (n = 128) and a non-ITT HD-MTX group (n = 130). The CNS relapse rate was not significantly different between these groups, with 2-year CNS relapse rates of 12.4% and 13.9%, respectively (P = 0.96). Three-year progression-free survival and overall survival rates in the ITT HD-MTX and non-ITT HD-MTX groups were 62.4% vs 64.5% (P = 0.94) and 71.7% vs 71.4% (P = 0.7), respectively. Also, propensity score-matched analyses showed no significant differences in the time-to-CNS-relapse, progression-free survival, or overall survival. The ITT HD-MTX group showed a higher incidence of grade >= 3 oral mucositis and elevated alanine aminotransferase. Prophylactic HD-MTX does not improve CNS relapse rate or survival outcomes in high-risk DLBCL patients, and it is accompanied by increased toxicities.
Author(s)
김경원김신김혜영류진숙박찬식서철원윤덕현이경민이상욱이정복정혜현조형우채은진채희정허주영
Issued Date
2021
Type
Article
Keyword
Clinical Trials and Observations
DOI
10.1182/bloodadvances.2020003947
URI
https://oak.ulsan.ac.kr/handle/2021.oak/7909
https://ulsan-primo.hosted.exlibrisgroup.com/primo-explore/fulldisplay?docid=TN_cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_8095148&context=PC&vid=ULSAN&lang=ko_KR&search_scope=default_scope&adaptor=primo_central_multiple_fe&tab=default_tab&query=any,contains,Efficacy%20and%20safety%20of%20prophylactic%20high-dose%20MTX%20in%20high-risk%20DLBCL:%20a%20treatment%20intent-based%20analysis&sortby=rank&pcAvailability=true
Publisher
BLOOD ADVANCES
Location
미국
Language
영어
ISSN
2473-9529
Citation Volume
5
Citation Number
8
Citation Start Page
2142
Citation End Page
2152
Appears in Collections:
Medicine > Medicine
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