Comparative Effectiveness Study Supports Combination Regimen for B-Cell Malignancy

11/09/17

A long-term post-hoc analysis compared the effects of three therapy regimens for the initial treatment of patients with a type of advanced-stage B-cell malignancy, published in the Journal of Clinical Oncology (online November 2, 2017; doi:10.1200/JCO.2017.74.1652).

The FOLL05 trial compared the effects of rituximab plus cyclophosphamide, vincristine, and prednisone (R-CVP) with rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) and rituximab plus fludarabine and mitoxantrone (R-FM) regimens without maintenance as initial therapies for patients with advanced-stage follicular lymphoma. Results of the study showed a superior 3-year time to treatment failure with R-CHOP and R-FM versus R-CVP, and R-CHOP to have a better risk-benefit ratio in regard to toxicity than R-FM.

A group of Italian researchers conducted a post-hoc analysis of this trial after a median follow-up of 7 years to determine the long-term efficacy and safety of the three regimens. Among the 534 patients enrolled in the trial, 504 were deemed evaluable.

Researchers reported that the 8-year time to treatment failure and progression-free survival (PFS) rates were 44% (95% CI, 39%-49%) and 48% (95% CI, 43%-53%), respectively, for the evaluable patients. However, when PFS was adjusted by the follicular lymphoma International Prognostic Index 2, results were less similar; R-CHOP resulted in a significant improvement in PFS compared with R-CVP (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).

Additionally, time to treatment failure was reportedly longer for patients receiving 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. No significant difference was observed in overall survival among the three treatment arms, with an 8-year rate of 83% (95% CI, 79%-87%).

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A higher risk of dying as a result of causes unrelated to follicular lymphoma progression was noted for patients receiving R-FM compared with those receiving R-CVP.

Authors of the study concluded that R-CHOP should be the preferred option for patients with advanced-stage follicular lymphoma “if the initial aim is to maximize treatment activity and increase the chance of durable disease control.” Furthermore, they acknowledged that R-CVP is a plausible option for those patients prioritizing tolerability.—Zachary Bessette