A Retrospective Cohort Study of Treatment Outcomes of Adult Patients With Relapsed or Refractory Follicular Lymphoma (ReCORD-FL)

Abstract

This study (ReCORD-FL) sought to construct a historical control cohort to augment single-arm trials in relapsed/refractory follicular lymphoma (r/r FL). A retrospective study in 10 centers across North America and Europe was conducted. Adults with grade 1-3A FL were required to be r/r after ≥2 therapy lines including an anti-CD20 and an alkylator. After first becoming r/r, patients were required to initiate ≥1 additional therapy line, which defined the study index date. Endpoints were observed from start of each therapy line (including index line) until death, last follow-up, or December 31, 2020. Endpoints were complete response (CR) rate, overall response rate (ORR), time to next treatment or death (TNT-D), event-free survival (EFS), and overall survival (OS). One hundred eighty-seven patients were identified. Most patients' (80.2%) index therapy occurred in third line (3L) (range, 3L-6L). Median follow-up from FL diagnosis was 9 years (range, 1-21 years). CR and ORR to the index therapy were 39.0% and 70.6%, respectively. Median (95% confidence interval) EFS from index was 14.6 (11.0-18.0) months; median OS from index was 10.6 years. Outcomes worsened across successive treatment lines and for patients who were double refractory (r/r to both an anti-CD20 monoclonal antibody and an alkylator) or POD24 (progressed ≤24 months after front-line anti-CD20) at index. Findings demonstrate the unmet need of FL patients with multiply relapsed, double refractory, or POD24 disease. Based on robustness of the historical data collected and comparability with a previous study (SCHOLAR-5), ReCORD-FL presents a valuable source of control data for comparative studies in r/r FL.

Treatment patterns and outcomes in relapsed/refractory follicular lymphoma: results from the international SCHOLAR-5 study

“…The general alignment of results from SCHOLAR-5, conducted in the US and Europe, to those from the literature (US, 5,6 Europe, 23 and Japan 21 ), suggest that OS and PFS results in r/r FL patients are similar across these regions. In addition, the inverse relationship between length of overall survival and number of LoTs (i.e., shorter survival at higher LoTs) in SCHOLAR-5 is consistent with the trends documented in previously reported cohort studies.…”

“…The similarity in results between the SCHOLAR-5 and patient cohorts going back to the early 2000s suggests that contemporary treatments (those approved in the 2014-2020 study period) may not offer as significantly improved outcomes over treatments available prior to the introduction of idelalisib. The general alignment of results from SCHOLAR-5, conducted in the US and Europe, to those from the literature (US, 5 , 6 Europe, 23 and Japan 21 ), suggest that OS and PFS results in r/r FL patients are similar across these regions. In addition, the inverse relationship between length of overall survival and number of LoT (i.e., shorter survival at higher LoT) in SCHOLAR-5 is consistent with the trends docu mented in previously reported cohort studies.…”

“…The MSK flow diagram also provides insights into the modest resulting sample size for SCHOLAR-5, which is consistent with that reported in other related or similar studies. A similarly modest patient population was also observed in the recently published RECORD-FL control cohort, 23 where 143 patients initiating 3rd LoT or higher as far back as 2000 were included. In a sub-group analysis that matched the SCHOLAR-5 study period, only 60 initiated 3rd LoT or higher.…”

“…5,6,21 Two additional multicenter cohort studies were conducted at approximately the same time as SCHOLAR-5, namely the ReCORD-FL and LEO CReWE cohorts. 22,23 There were similarities across all of the patient cohorts. The complete response observed in SCHOLAR-5, 43.9% and 27.1% at 3 rd and 4 th LoT respectively, are comparable to those published for the Japanese cohort (42.1% and 23.8% at 3 rd and 4 th LoT, respectively), 21 for ReCORD-FL (37.4% and 32.0% at 3 rd and 4 th LoT, respectively), and for LEO CReWE (45% at 3 rd LoT).…”

A 24-month updated analysis of the comparative effectiveness of ZUMA-5 (axi-cel) vs. SCHOLAR-5 external control in relapsed/refractory follicular lymphoma

“…For example, the rate of survival and durability of response both decrease with each subsequent LoT among patients who fail multiple LoTs [ 5 – 7 ]. The majority of these studies report a median progression-free survival (PFS) [ 5 , 6 ] or event-free survival (EFS) [ 8 ] of 11 ± 2 months, whilst the LEO-CReWE cohort had a median PFS of 17 months [ 9 ]. These studies also highlight a high degree of heterogeneity in the choice of treatments for r/r FL patients beyond the second LoT [ 6 , 9 ].…”