A long-term post-hoc analysis of the FOLL05 trial (ClinicalTrials.gov Identifier: NCT00774826) confirmed that rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) or rituximab plus cyclophosphamide, vincristine, and prednisone (R-CVP) resulted in favorable outcomes compared with rituximab plus fludarabine and mitoxantrone (R-FM) among patients with advanced-stage symptomatic follicular lymphoma (FL).
The previous analysis demonstrated that R-CHOP and R-CVP were superior to R-FM, though R-CHOP was associated with less toxicity than R-CVP after a median of 34 months of follow-up. The purpose of this post hoc analysis was to determine the long-term efficacy and safety of the 3 regimens after a median of 84 months of follow-up.
The open-label, multicenter, phase 3 FOLL05 trial included untreated patients with grade 1, 2, or 3a and Ann Arbor stage II to IV disease. This analysis included 504 evaluable patients.
The overall rates of progression-free survival (PFS) were similar among the arms. When, however, PFS was adjusted by the FL International Prognostic Index 2, R-CHOP resulted in a significant improvement in PFS compared with R-CVP (hazard ratio [HR], 0.73; 95% CI, 0.54-0.98; P = .037) and R-FM (HR, 0.67; 95% CI, 0.50-0.91; P = .009).
Time to treatment failure (TTF) was longer with R-CHOP (45%; HR, 0.73; 95% CI, 0.55-0.98; P = .033) and R-CVP (49%; HR, 0.70; 95% CI, 0.52-0.93; P = .016) compared with R-FM.
There was no significant difference in overall survival among the 3 arms, with an 8-year rate of 83% (95% CI, 79%-87%).
Secondary malignancies occurred in 9.4% of patients overall, with the highest proportion occurring in the R-CHOP arm (12%; 95% CI, 7.7%-18.7%) followed by the R-FM (9.6%; 95% CI, 6.0%-15.2%) and the R-CVP (6.2%; 95% CI, 2.5%-14.8%) arms.
The authors wrote that “[i]f the initial aim is to maximize treatment activity and increase the chance of durable disease control, R-CHOP should be the preferred option.” They added, however, that R-CVP is also a good option, particularly among patients whose goal for therapy is tolerability.
- Luminari S, Ferrari A, Manni M, et al. Long-term results of the FOLL05 trial comparing R-CVP versus R-CHOP versus R-FM for the initial treatment of patients with advanced-stage symptomatic follicular lymphoma. J Clin Oncol. 2017 Nov 2. doi: 10.1200/JCO.2017.74.1652 [Epub ahead of print]