Lenalidomide in combination with R-CHOP produces high response rates and progression-free survival in new, untreated diffuse large B-cell lymphoma transformed from follicular lymphoma: results from the Phase 2 MC078E study.
Sanjal H DesaiBetsy LaPlantWilliam R MaconRebecca L KingYucai WangDavid J InwardsIvana MicallefPatrick B JohnstonLuis F PorrataStephen M AnsellThomas M HabermannThomas E WitzigGrzegorz S NowakowskiPublished in: Blood cancer journal (2021)
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.
Keyphrases
- diffuse large b cell lymphoma
- free survival
- clinical trial
- newly diagnosed
- epstein barr virus
- phase ii
- end stage renal disease
- locally advanced
- multiple myeloma
- open label
- stem cell transplantation
- ejection fraction
- chronic kidney disease
- peritoneal dialysis
- prognostic factors
- low dose
- high dose
- randomized controlled trial
- rectal cancer
- adipose tissue
- acute myeloid leukemia
- radiation therapy
- skeletal muscle
- insulin resistance
- cancer therapy