Evaluating Outcomes in Follicular Lymphoma: Standard of Care Versus Clinical Trials

By Julie Gould - Last Updated: January 17, 2025

Researchers at the 2024 American Society of Hematology Annual Meeting said follicular lymphoma (FL) is a biologically diverse disease with no universally established standard of care (SOC) for any treatment line. Although overall survival (OS) for patients with FL is favorable, achieving a cure through SOC is rare, highlighting the importance of clinical trials (CTs) of both initial and subsequent treatment lines. High-risk patients, such as those experiencing disease progression within 24 months (POD24) or transformation to large-cell lymphoma, present additional challenges. Despite these complexities, limited real-world data exist comparing outcomes between SOC and CTs across treatment lines. Researchers investigated the efficacy of SOC and CTs in patients with FL.

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A retrospective cohort study analyzed data from 183 patients with FL treated at MD Anderson Cancer Center between 1989 and 2020, with each receiving at least three lines of therapy. Clinical outcomes, including progression-free survival (PFS), OS, and response rates, were assessed using established criteria. Time-to-event outcomes were calculated using Kaplan-Meier methods. and statistical comparisons were performed using the log-rank test.

Results revealed that in the first-line (1L) setting, 17% of patients were treated in a CT, increasing to 23% in both the second-line (2L) and third-line (3L) settings. Common SOC therapies included rituximab-based regimens such as R-CHOP and bendamustine-rituximab, with lenalidomide-rituximab used more frequently in later lines. Across all lines, complete response rates (CRRs) were similar for SOC and CT groups. For example, CRR was 48% for SOC versus 60% for CTs in 1L and 51% versus 49% in 3L. Median PFS (mPFS) also showed no significant differences between SOC and CTs in 1L and 3L, although SOC demonstrated a significantly longer mPFS than CTs in 2L (12 months vs 8.3 months, P=.001). OS remained comparable across all lines, with no statistically significant differences.

Among high-risk patients with POD24, outcomes mirrored those of the broader cohort. Among these patients, 57% received SOC and 33% participated in a CT. CRR, mPFS, and median OS were equivalent between the two groups. For instance, CRR in 1L was 31% for SOC versus 33% for CTs, with median OS not reached in either group. Transformation rates were similar, further underscoring the comparable effectiveness of SOC and CT.

“These data suggest that patients who utilize CT can have similar response rates and survival to patients who received SOC, providing real world evidence that CTs do not negatively impact outcomes, and therefore can be considered across all lines of therapy,” study authors concluded.

Reference

Akkad N, Ayers A, Balakrishnan K, et al. Treatment patterns and real-world outcomes with clinical trials for patients with follicular lymphoma across lines of therapy. Abstract #4396. Presented at the American Society of Hematology Annual Meeting; December 7-10, 2024; San Diego, California.

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