LAUSR

*Was employed by DRG Abacus at the time of analysis **Was employed by F. Hoffmann-La Roche Ltd at the time of the analysis Background: Despite improvements in DLBCL treatment, outcomes for patients with R/R DLBCL remain poor. This systematic literature review (SLR) aimed to summarise current clinical evidence for treatment of patients with stem-cell transplant (SCT) ineligible R/R DLBCL. A secondary objective was to assess the possibility of completing an indirect treatment comparison (ITC) or network meta-analysis (NMA). Methods: Databases were searched in September 2018 (Embase, MEDLINE, The Cochrane Library) and November 2018 (ASH 2018 abstracts). Only studies of patients with SCT-ineligible R/R DLBCL were included, per pre-defined eligibility criteria. Identified studies were evaluated in a network-building exercise to identify whether a connected network of evidence could be constructed. To explore a broader evidence base, evidence not meeting the study criteria was evaluated in a post-hoc network-building exercise. Results: The SLR identified 36 studies of patients with R/R DLBCL (90 publications); of these, 19 studies (53 publications) met the eligibility criteria. Six of the 19 studies were randomised controlled trials (RCTs [Figure]), and 13 were prospective, observational or single-arm trials. A further three RCTs not meeting the eligibility criteria were identified (Figure). Thirteen included studies had a sample size <60. Across studies, baseline median patient ages ranged from 54–74 years; the proportion of patients with AnnArbor stage III–IV disease ranged from 48%–90%; three studies had >65% male patients. All studies reported objective and complete response rates; additional endpoints included median progression-free survival (PFS; 11 studies, range 2.6–17.1 months), overall survival (OS; 11 studies, range 5–22.2 months), safety, and discontinuation. The IWG 1999-NHL guidelines were used by 10/19 studies. As response criteria and PFS definitions varied between studies, cross-study comparisons were limited. Construction of a connected network of evidence was not possible using data from RCTs or the broader post-hocanalysis (Figure). Thus, conducting an NMA was deemed unfeasible. Conclusions: This SLR provides a summary of currently published evidence on treatments for patients with R/R DLBCL. Only nine of 36 identified studies were RCTs, preventing completion of an ITC or NMA. This SLR highlights the paucity of published RCTs to establish the comparative efficacy of R/R DLBCL treatments, and demonstrates a lack of standard of care in this setting. Figure: Network-building analysis of evidence in 9 RCTs Treatments: BR=bendamustine, rituximab; DHAP=dexamethasone, cytarabine, cisplatin; ESHAP=etoposide, methylprednisolone, cytarabine, cisplatin; GDP=cisplatin, dexamethasone, gemcitabine; ICE=ifosfamide, carboplatin, etoposide;R=rituximab. Single-arm studies not shown. Blue lines: RCTs meeting the SLR criteria (SCT ineligible) Red lines: RCTs not meeting the SLR criteria This abstract was previously submitted to EHA 2019.