Clinical data from two studies evaluating the use of lenalidomide (Revlimid?, Celgene International S?rl) with standard R-CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone plus rituximab) chemotherapy, also called R2CHOP, in patients with untreated diffuse large B cell (DLBCL) or grade 3 follicular lymphoma were presented at the 11th International Conference on Malignant Lymphoma (11-ICML) in Lugano, Switzerland.
In a phase I/II study conducted by investigators at the Mayo Clinic, 12 patients received lenalidomide at doses of 15 mg, 20 mg or 25 mg on days 1-10 of each 21-day cycle with standard R-CHOP chemotherapy to determine the maximum tolerated dose (MTD) of lenalidomide. There were no dose-limiting toxicities observed.
In the phase II portion, 32 evaluable patients received 25 mg of lenalidomide on days 1-10 administered with standard R-CHOP chemotherapy (R2CHOP) for up to six cycles. Twenty-eight patients had DLBCL and four patients had grade 3 follicular lymphoma. The age range was 19 to 87 years.
Responses were evaluated using PET/CT. Out of 30 evaluable patients, the overall response rate was 100% and the complete response rate was 83%. Additionally, the 12-month event-free survival for patients in the study (N=32) was 75.1% (95% CI: 60.3-93.7%).
The most common hematological toxicities were grade 3/4 thrombocytopenia (16%/25%) and grade 3/4 neutropenia (13%/75%).
In a similarly designed phase I study conducted by the Fondazione Italiana Linfomi(FIL) in elderly patients with untreated DLBCL, lenalidomide was combined with R-CHOP (LR-CHOP21). Twenty-one patients received lenalidomide at doses of 10 mg, 15 mg, or 20 mg on days 1-14 of each 21-day cycle with standard R-CHOP chemotherapy to determine the maximum tolerated dose (MTD) of lenalidomide. With this particular schedule, lenalidomide at a dose of 15mg was determined to be the MTD. The age range was 61 to 77 years.
Response was evaluated using PET/CT, and of 21 evaluable patients, the overall response rate was 86% and the complete response rate was 76% after 6-cycles of LR-CHOP21.
The most common grade 3 or higher hematological toxicities were neutropenia (28%) and thrombocytopenia (10%), and the most common non-hematologic toxicities greater grade 3 or higher were neuropathy (14%) and infections (14%).
These data are from an investigational study. lenalidomide is not approved as a treatment for patients with DLBCL or follicular grade III lymphoma.
For More Information:
Lenalidomide and R-CHOP in B-cell Lymphoma (R2CHOP-1)
Lenalidomide, Rituximab, and Combination Chemotherapy in Treating Patients With Newly Diagnosed Stage II, Stage III, or Stage IV Diffuse Large Cell or Follicular B-Cell Lymphoma.