Abstract
Diffuse large B-cell lymphoma (DLBCL), either concurrent with or transformed from follicular lymphoma (FL) is often excluded from clinical trials. Lenalidomide has response rates of 45% in relapsed transformed DLBCL. Herein we present an analysis of MC078E, a phase II clinical trial testing lenalidomide plus R-CHOP (R2CHOP) for patients with untreated transformed/concurrent DLBCL (NCT00670358). Adult patients with transformed or concurrent DLBCL were included. Patients received six cycles of rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone (R-CHOP) with lenalidomide 25 mg days 1–10 of each cycle. The primary outcome was progression-free survival (PFS) at 24 months. Secondary outcomes were response rates, event-free survival (EFS), and overall survival (OS). Thirty-nine patients were accrued from August 5, 2013 to July 28, 2020 and 33 were eligible by central pathology review. The median age was 64 (24–80) years, 18 (54%) were male, 25 (76%) were concurrent and 8 (24%) were transformed DLBCL. The PFS, EFS, and OS rates at 24 months were 84.4% (CI95: 67.2–94.7%), 84.5% (CI95: 72.9–98%), and 97.0% (CI95: 91.3–100%), respectively. R2CHOP is effective in concurrent and transformed DLBCL. The study supports the inclusion of anthracycline-naive transformed and concurrent DLBCL in future clinical trials of novel immunomodulatory analogues.
Highlights
Histological transformation of follicular lymphoma (FL) to diffuse large B-cell lymphoma (DLBCL) has a poor prognosis [1, 2]
Key exclusion criteria were central nervous system (CNS) involvement, pregnancy, and lactation, the inability of patients of childbearing age to employ adequate contraception, significant cardiac, renal, or liver dysfunction, presence of active malignancy other than DLBCL and FL, history of life-threatening venous thromboembolism, inability to take aspirin, lovenox or warfarin prophylaxis, presence of HIV infection and RESULTS Baseline characteristics Thirty-nine patients were accrued from August 5, 2013 to November 11, 2019 and 33 patients were eligible for study after central pathology review (Fig. 1)
The study was conducted according to the declaration of Helsinki, approved by the Mayo Clinic institutional review board (IRB), and registered at clinicalTrial.gov (NCT00670358)
Summary
Histological transformation of follicular lymphoma (FL) to diffuse large B-cell lymphoma (DLBCL) has a poor prognosis [1, 2]. Patients with indolent lymphoma treated with anthracycline therapy prior to transformation had a worse outcome [5]. These features highlight that transformed DLBCL is a biologically distinct disease. DLBCL concurrent with indolent FL has similar outcomes to de novo DLBCL but differs in the pattern of relapse with frequent relapse of FL [9]. It is unknown whether concurrent DLBCL represents an early transformation of the indolent lymphoma component or co-development of two independent lymphomas. In clinical trials evaluating novel therapeutics, concurrent and transformed DLBCL patients are either in the minority or excluded
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