Background. The introduction of new agents has improved the prognosis of follicular lymphoma (FL). Unfortunately, COVID‐19 pandemic may have affected disease management.
Objective. The non‐interventional, retrospective/prospective URBAN study is aimed to evaluate effectiveness and safety of Obinutuzumab‐based treatment in real‐life practice of patients with untreated advanced FL with FLIPI≥2. The study is ongoing in 46 sites in Italy. The objective of this interim analysis is to evaluate patient characteristics, potential changes in the management due to COVID‐19 pandemic, preliminary efficacy at the end of induction (EOI) and safety data collected about 1 year after the first patient enrolled.
Methods. Participants should have received at least 2 cycles of Obinutuzumab‐chemotherapy induction before the enrollment (retrospective part of the study). The study, launched in Sep‐2019 includes 6‐8 induction courses, 2‐year maintenance with Obinutuzumab monotherapy, and 1‐year follow‐up period after the last Obinutuzumab administration. Two time periods have been analyzed: pre‐COVID‐19 phase (until 24‐Feb‐2020) and COVID‐19 phase (25‐Feb‐2020 to 09‐Oct‐2020; clinical cut‐off date).
Results. Overall, 266 patients (median age 61 years, 56% females) were enrolled: 186 patients began the treatment pre‐COVID‐19 (pre‐C group) and 80 patients during COVID‐19 (C group).
Among the trends, not statistically significant, from this analysis, more patients in the C group vs pre‐C group initiated treatment with B‐symptoms (26.2% vs 19.4%; p = 0.357) and more advanced (III‐IV) disease stage (95% vs 90.9%; p = 0.605).
Fewer patients in the C group than in the pre‐C one (41.2% vs 48.9%; p = 0.309) received bendamustine, resulting in reversed rates for CHOP adoption (55% in C and 44.1% in pre‐C; p = 0.133).
As to safety, in the retrospective part of the study neutropenia occurred in 22.9% of patients, infusion‐related reactions in 12.8%, thrombocytopenia in 9.4%, and infections in 7.5%. In the prospective part they were 17.7%, 0.8%, 2.3%, and 8.6%, respectively. One patient had a grade 3 COVID‐19 infection, which required treatment withdrawal. No data is yet mature about possible changes in maintenance strategies due to COVID‐19.
Preliminary efficacy data, available for 164 patients at EOI, show that 134 patients (81.7%) achieved a PET‐CT CR (confirmed by BM evaluation for 46/73 patients positive at baseline), and 25 (15.2%) a PR.
Conclusions. The interim analysis of the URBAN study shows that Obinutuzumab‐based treatment is associated with a good safety and efficacy profile. Furthermore, the observed trends might suggest that during pandemic the adoption of a watch‐and‐wait strategy is wider and the use of bendamustine reduced, possibly due to concerns on more severe and prolonged induced lymphodepletion; therefore COVID‐19 might have influenced the clinical approach to the treatment of FL patients.
The research was funded by: Roche Spa, Monza, Italy
Keywords: Indolent non‐Hodgkin lymphoma
Conflicts of interests pertinent to the abstract
C. Piparo
Employment or leadership position: Roche employee
E. Guardalben
Employment or leadership position: Roche employee