Efficacy and Safety of Rituximab-Bendamustine vs R-CHOP Among Patients With Follicular Lymphoma

Results from a Subset Analysis of the FOLL12 Trial
 

According to the findings from a post hoc analysis of the FOLL12 trial recently published in Hematological Oncology, rituximab-bendamustine (RB) and a rituximab, cyclophosphamide, doxorubicin, and prednisone (R-CHOP) regimen yielded similar efficacy results for treatment of follicular lymphoma (FL). However, the treatments had distinct safety profiles and long-term events among patients with FL. 

Maria E Nizzoli, MD, Azienda Unitа Sanitaria Locale-IRCCS di Reggio Emilia, Reggio Emilia, Italy, and coauthors stated, “The administration of immunochemotherapy followed by rituximab maintenance is the recommended approach for front-line therapy of patients with high tumor burden [follicular lymphoma],” with rituximab-bendamustine and R-CHOP being the preferred immunochemotherapy options. 

The FOLL12 trial found that the standard rituximab maintenance was highly effective after immunochemotherapy. This post hoc study aimed to compare rituximab-bendamustine and R-CHOP outcomes among patients who were enrolled in the FOLL12 trial, which initially only used R-CHOP as immunochemotherapy, but later allowed rituximab-bendamustine as an additional option. 

The FOLL12 trial enrolled 786 patients with FL grade 1 to 3a and high-tumor burden who were randomly assigned to receive standard immunochemotherapy (rituximab-bendamustine or R-CHOP) followed by rituximab maintenance, or immunochemotherapy (rituximab-bendamustine or R-CHOP) followed by a response-adapted approach. 341 patients received rituximab-bendamustine and 445 patients received R-CHOP. 

When comparing the efficacy of rituximab-bendamustine vs R-CHOP in this post hoc analysis, results demonstrated no significant differences in progression-free survival between treatments at a median follow-up of 56 months. Standard rituximab maintenance demonstrated improved progression-free survival compared to response-adaptive management no matter which immunochemotherapy was administered. 

While there were no significant differences in efficacy between rituximab-bendamustine and R-CHOP, there were differences observed in safety measures. Grade 3 to 4 hematologic adverse events occurred more frequently in patients receiving R-CHOP than rituximab-bendamustine, such as neutropenia (43.7% vs. 32.6%). In contrast, a higher incidence of grade 3 to 4 infections and cutaneous events was present in patients receiving rituximab-bendamustine than in R-CHOP (3.2% vs. 1.4%). Rituximab-bendamustine was also associated with a higher occurrence of transformed FL. 

In conclusion, this post hoc analysis of the FOLL12 trial suggests that R-CHOP and rituximab-bendamustine exhibit similar efficacy in treating FL, but have different safety profiles and associated long-term events.

Dr Nizzoli et al concluded that these differences in safety profiles and long-term events indicate “that the treating physician should carefully select the most appropriate chemotherapy regimen for each patient based on patient's individual characteristics, choices, and risk profile.” 

Source:

Nizzoli ME, Manni M, Ghiggi C, et al. Impact of immunochemotherapy with R-bendamustine or R-CHOP for treatment naïve advanced-stage follicular lymphoma: a subset analysis of the FOLL12 trial by Fondazione Italiana Linfomi. Hematol Oncol. 2023; 1- 8. doi: 10.1002/hon.3184