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ROBUST: A Phase III Study of Lenalidomide Plus R-CHOP Versus Placebo Plus R-CHOP in Previously Untreated Patients With ABC-Type Diffuse Large B-Cell Lymphoma

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Abstract
PURPOSEPatients with the activated B-cell-like (ABC) subtype of diffuse large B-cell lymphoma (DLBCL) historically showed inferior survival with standard rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP). Phase II studies demonstrated that adding the immunomodulatory agent lenalidomide to R-CHOP improved outcomes in ABC-type DLBCL. The goal of the global, phase III ROBUST study was to compare lenalidomide plus R-CHOP (R2-CHOP) with placebo/R-CHOP in previously untreated, ABC-type DLBCL.METHODSHistology and cell-of-origin type were prospectively analyzed by central pathology prior to random assignment and study treatment. Patients with ABC-DLBCL received lenalidomide oral 15 mg/d, days 1-14/21 plus standard R-CHOP21 versus placebo/R-CHOP21 for six cycles. The primary end point was progression-free survival (PFS) per independent central radiology review.RESULTSA total of 570 patients with ABC-DLBCL (n = 285 per arm) were stratified by International Prognostic Index score, age, and bulky disease, and randomly assigned to R2-CHOP or placebo/R-CHOP. Baseline demographics were similar between arms. Most patients completed six cycles of treatment: 74% R2-CHOP and 84% placebo/R-CHOP. The most common grade 3/4 adverse events for R2-CHOP versus placebo/R-CHOP were neutropenia (60% v 48%), anemia (22% v 14%), thrombocytopenia (17% v 11%), and leukopenia (14% v 15%). The primary end point of PFS was not met, with a hazard ratio of 0.85 (95% CI, 0.63 to 1.14) and P = .29; median PFS has not been reached for either arm. PFS trends favoring R2-CHOP over placebo/R-CHOP were seen in patients with higher-risk disease.CONCLUSIONROBUST is the first DLBCL phase III study to integrate biomarker-driven identification of eligible ABC patients. Although the ROBUST trial did not meet the primary end point of PFS in all patients, the safety profile of R2-CHOP was consistent with individual treatments with no new safety signals.
Author(s)
윤덕현Adrian KilcoyneAnna Lia MolinariAnnalisa ChiappellaDavid BeladaDavid W ScottFederica CavalloFrancesco PiazzaGrzegorz S NowakowskiHeidi MocikovaJacqueline RussoJie JinJingshan ZhangJuan Miguel BerguaJun ZhuKazuhito YamamotoKoji IzutsuKoji KatoKrista HudakMuhit OzcanMyron Czu
Issued Date
2021
Type
Article
DOI
10.1200/JCO.20.01366
URI
https://oak.ulsan.ac.kr/handle/2021.oak/8363
https://ulsan-primo.hosted.exlibrisgroup.com/primo-explore/fulldisplay?docid=TN_cdi_proquest_miscellaneous_2493000734&context=PC&vid=ULSAN&lang=ko_KR&search_scope=default_scope&adaptor=primo_central_multiple_fe&tab=default_tab&query=any,contains,ROBUST:%20A%20Phase%20III%20Study%20of%20Lenalidomide%20Plus%20R-CHOP%20Versus%20Placebo%20Plus%20R-CHOP%20in%20Previously%20Untreated%20Patients%20With%20ABC-Type%20Diffuse%20Large%20B-Cell%20Lymphoma&offset=0&pcAvailability=true
Publisher
JOURNAL OF CLINICAL ONCOLOGY
Location
미국
Language
영어
ISSN
0732-183X
Citation Volume
39
Citation Number
12
Citation Start Page
1317
Citation End Page
1317
Appears in Collections:
Medicine > Medicine
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