R-CHOP Plus Lenalidomide Improves Responses in Patients with Untreated DLBCL

R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) plus lenalidomide improved response rates and survival in patients with transformed, untreated diffuse large B-cell lymphoma (DLBCL), according a study presented at the 2020 ASH Annual Meeting.

“Transformation of low-grade follicular lymphoma (FL) to DLBCL carries a poor prognosis. In retrospective studies, five-year survival of transformed DLBCL treated with R-CHOP without autologous hematopoietic cell transplant is 40% to 60%, underscoring need to improve frontline treatment of transformed DLBCL beyond R-CHOP,” the authors wrote.

The phase II clinical trial included adult patients with transformed DLBCL and either historical or concurrent FL; stage ≥2, measurable disease by positron emission tomography/computed tomography; and adequate organ function. Patients with central nervous system involvement, significant comorbidities, active non-lymphomatous malignancy, life-threatening thromboembolism, and contraindication to aspirin prophylaxis were excluded.

Evaluable patients (n=33; median age, 64 years; range, 24-80 years) received up to six cycles of rituximab 375 mg/m2, cyclophosphamide 750 mg/m2, doxorubicin 50 mg/m2, and vincristine 1.4 mg /m2 on day 1; prednisone 100 mg on days one through five; pegfilgrastim on day two; and lenalidomide 25 mg on days one through 10 of 21-day cycles.

About half of patients (n=18; 54%) were >60 years old. Eighteen patients (54%) were male, and 32 (97%) had Eastern Cooperative Oncology Group performance status score <2. Twenty-three patients (70%) had historical FL, while 10 (30%) had concurrent FL. Twenty-six patients (79%) had advanced stage disease (III/IV).

Median number of extranodal sites were one (range, 0-4 sites). Thirteen patients (39%) had high International Prognostic Index scores (4-5). Almost all patients (n=32; 97%) completed at least two treatment cycles, and 30 patients completed all cycles.

The overall response rate was 97% (n=32), including 29 (88%) complete responses and three partial responses. Twelve-month event-free survival (primary endpoint) was 87.9% (95% confidence interval [CI], 71.8-96.6). Two-year progression-free and overall survival were 84.5% (95% CI, 72.8-98.0) and 96.9% (95% CI, 91-100), respectively.

Four patients discontinued protocol early due to disease progression (n=1), adverse event (AE; n=1), refusal (n=1), and non-compliance (n=1). Thirty patients (91%) experienced grade ≥3 hematologic AEs, including neutropenia (n=27; 82%), thrombocytopenia (n=16; 48%), and anemia (n=7; 21%). About half of patients (n=16; 48%) had grade ≥3 non-hematologic AEs, including eight (24%) with febrile neutropenia. Three deaths occurred due to progressive DLBCL (n=1), acute myeloid leukemia (n=1), and malignant melanoma (n=1).

“This study supports the inclusion of anthracycline-naïve patients with transformed DLBCL in future randomized studies of lenalidomide or other novel immunomodulatory analogues,” the researchers concluded.


Desai SH, Laplant B, Macon WR, et al. Lenalidomide/RCHOP (R2CHOP) Produces High Response Rates and Overall Survival in New, Untreated Diffuse Large B Cell Lymphoma Transformed from Follicular Lymphoma- Results from MC078E. Abstract 1192. Presented at the 62nd American Society of Hematology Annual Meeting & Exposition, December 2-11, 2020.