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.
Continue Reading
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.
Reference
- 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]
