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ROBUST Study: R-CHOP With or Without Lenalidomide in ABC-Type DLBCL
The phase 3 ROBUST trial showed that adding lenalidomide to rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) did not improve progression-free survival (PFS) in patients with diffuse large B-cell lymphoma (DLBCL) who had activated B-cell-like (ABC) disease. The study was published in the Journal of Clinical Oncology (2021 Feb 23. Epub ahead of print).
The study aimed to compare the use of lenalidomide to R-CHOP to placebo plus R-CHOP for the treatment of patients with ABC subtype of DLBCL and found it failed to meet its primary end point.
Historically, patients with the ABC subtype of DLBCL show inferior survival when treated with standard R-CHOP, Grzegorz S. Nowakowski, MD, Division of Hematology, Mayo Clinic, Rochester, Minnesota, and colleagues said.
Between February 17, 2015 and August 3, 2017, 570 patients were identified with CD20+, ABC-type DLBCL (n = 285 per arm) and were randomly assigned to R2-CHOP or control placebo/R-CHOP. Most patients complexed 6 treatment cycles: 74% R2-CHOP and 84% placebo/R-CHOP.
The most common adverse events (grade 3/4) for R2-CHOP versus placebo/R-CHOP were neutropenia (60%, 48% respectively), anemia (22%, 14%), thrombocytopenia (17%, 11%), and leukopenia (14%, 15%).
The primary end point of progression-free survival (PFS) was not met (hazard ratio [HR] 0.85, 95% CI, 0.63-1.14, p=.29), although response rates were very high (91% overall response rate) in both arms. The median PFS for both was also not met. PFS trends favoring R2-CHOP over placebo/R-CHOP were seen in patients with higher-risk disease.
“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,” said Dr Nowakowski et al.—Emily Bader
