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

Grzegorz S. Nowakowski, Annalisa Chiappella, Randy D. Gascoyne, David W. Scott, Qingyuan Zhang, Wojciech Jurczak, Muhit Özcan, Xiaonan Hong, Jun Zhu, Jie Jin, David Belada, Juan Miguel Bergua, Francesco Piazza, Heidi Mócikova, Anna Lia Molinari, Dok Hyun Yoon, Federica Cavallo, Monica Tani, Kazuhito Yamamoto, Koji IzutsuKoji Kato, Myron Czuczman, Sarah Hersey, Adrian Kilcoyne, Jacqueline Russo, Krista Hudak, Jingshan Zhang, Steve Wade, Thomas E. Witzig, Umberto Vitolo

研究成果: Contribution to journalArticle査読

7 被引用数 (Scopus)

抄録

PURPOSE: Patients 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. METHODS: Histology 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. RESULTS: A 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. CONCLUSION: ROBUST 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.

本文言語英語
ページ(範囲)1317-1328
ページ数12
ジャーナルJournal of clinical oncology : official journal of the American Society of Clinical Oncology
39
12
DOI
出版ステータス出版済み - 4 20 2021

All Science Journal Classification (ASJC) codes

  • 腫瘍学
  • 癌研究

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