ABSTRACT
Background: Maintenance in FL patients (pts) improves progression free survival (PFS). SARS-Cov2 pandemic posed unique challenges for immunocompromised pts. Aims: The aim is to evaluate the outcome of FL pts in maintenance with antiCD20-MoAb during SARS-Cov2 pandemic and how suspension of therapy affected lymphoma outcome and the risk of SARS-Cov2 infection and its morbidity and mortality. Methods: This is an observational, multicenter, retrospective and prospective study. Results: A total of 420 from 18 Italian Hematological Centers were included in the analysis. Median age was 62 years old (range 27-91 years), 216 pts (51%) were male. Main clinical characteristics of the population were: histological grade 1-2 vs 3A in 288 (69%) vs 109 (26%), while not valuable in 23 (5%) pts;limited I-II vs advanced III-IV stage in 57 (14%) vs 361 (86%) pts, not reported in 2 cases. FLIPI score was low vs intermediate vs high in 71 (17%) vs 151 (36%) vs 192 (46%) patients, respectively, not valuable in 6 cases. All 420 patients included were in maintenance treatment with antiCD20 MoAb at the time of the onset of SARS-Cov2 pandemic (March 2020): 333 (79%) pts were receiving maintenance after a first line, while 87 (21%) after a second line. 342 (81%) pts were receiving Rituximab, while 75 (18%) Obinutuzumab, 3 patients did not start the planned maintenance because of pandemic spread. Status of disease after induction was complete remission (CR) in 374 (89%), partial response (PR) in 41 (10%), progressive disease (PD) in 1, not evaluated in 4 pts, respectively. At the end of maintenance was CR in 265 (63%), PR in 19 (4%), stable disease (SD) in one and PD in 14 (3%) patients, respectively, maintenance is stiil ongoing in 121 (29%) pts. Because of SARS-Cov2 pandemic from March 2020 consequences on maintenance treatment were: temporary suspension in 122 (29%), definitively interruption in123 (29%), no modification in 175 (42%) of pts, respectively. Median number of maintenance treatment administered at the time of SARS-Cov2 pandemic onset was 2 (range 1-12), median number of courses administered at the time of analysis was 8 (range 0-12), in patients who modified treatment because of pandemic median number of performed courses was 7 (range 0-11) and median number of lost cycles were 2 (range 1-12). Pts were divided into two groups according to type of approach to maintenance during pandemic: pts who interrupted maintenance (temporary or definitively): groups A (245 (58%) pts) vs pts who did not modified maintenance: group B (175 (42%) pts). No differences in clinical characteristics, type of therapy and response were observed between the two groups. 29(7%) relapses were observed: 16 (7%) vs 13 (7%) in group A vs B, respectively. 70 (17%) pts experienced SARS-Cov2 positivity: 47 (19%) vs 23 (13%) in group A vs B, respectively. 53 (76%) pts had symptomatic COVID syndrome and 43 (61%) were hospitalized, with no differences between the two groups. Anti-SARS-Cov2 vaccine was administered in 349 patients, serology assessment was done in 46% of cases, showing 21 (13%) reactive vs 138 (87%) not reactive pts, with no differences between the two groups. 21 (30%) pts died because of COVID: 9 (19%) vs 12 (52%) in groups A vs B, respectively. Summary/Conclusion: Suspension of maintenance treatment during SARS-Cov2 pandemic did not show a protection in terms of SARS-Cov2 positivity and morbidity. A trend in lower mortality is suggested. No differences in terms of relapse rate were observed, but longer follow up is needed.
ABSTRACT
Background: Maintenance in FL patients (pts) improves progression free survival (PFS). SARS-Cov2 pandemic posed unique challenges for immunocompromised pts. Methods: This is an observational, multicenter, retrospective and prospective study. The aim is to evaluate the outcome of FL pts in maintenance with antiCD20-MoAb during SARS-Cov2 pandemic and how suspension of therapy affected lymphoma outcome and the risk of SARS-Cov2 infection and its morbidity and mortality. Results: 420 pts from 18 Italian Centers were included. Median age was 62 years old (range 27-91), 216 pts (51%) were male. Main clinical characteristics were: histological grade 1-2 vs 3A vs not valuable in 288 (69%) vs 109 (26%) vs 23 (5%), respectively;advanced stage in 361 (86%), high FLIPI score in 192 (46%) pts. All 420 pts were in antiCD20-MoAb maintenance at the time of SARS-Cov2 pandemic onset (March 2020): 333 (79%) were receiving maintenance after a first line, while 87 (21%) after a second line. 342 (81%) pts were receiving Rituximab, while 75 (18%) Obinutuzumab, 3 pts did not start the planned maintenance. Status of disease after induction was complete remission (CR) in 374 (89%), partial response (PR) in 41 (10%), progressive disease (PD) in 1, not evaluated in 4 patients, respectively. At the end of maintenance was CR in 265 (63%), PR in 19 (4%), stable disease (SD) in one and PD in 14 (3%) pts, maintenance is ongoing in 121 (29%) pts. Because of SARS-Cov2 pandemic maintenance treatment was temporary suspended in 122 (29%), definitively interrupted in123 (29%), not changed in 175 (42%). Median number of maintenance treatment administered at March 2020 was 2 (range 1-12), in pts who modified treatment median number of performed vs lost courses was 7 (range 0-11) vs 2 (range 1-12). Patients were divided into two groups according to the approach to maintenance during pandemic: pts who interrupted maintenance (temporary or definitively): groups A (245 (58%) cases) vs pts who did not modified maintenance: group B (175 (42%)). No differences in clinical characteristics, type of therapy and response were observed between the two groups. 29(7%) relapses were observed: 16 (7%) vs 13 (7%) in group A vs B. 70 (17%) pts experienced SARS-Cov2 positivity: 47 (19%) vs 23 (13%) in group A vs B. 53 (76%) pts had symptomatic COVID and 43 (61%) were hospitalized, with no differences between the two groups. Anti-SARS-Cov2 vaccine was administered in 349 patients, serology assessment was done in 46% of cases, showing 21 (13%) reactive vs 138 (87%) not reactive patients, with no differences between the two groups. 21 (30%) pts died because of COVID: 9 (19%) vs 12 (52%) in groups A vs B. Conclusions: Suspension of maintenance during SARS-Cov2 pandemic did not show a protection in terms of SARS-Cov2 positivity and morbidity. A trend in lower mortality is suggested. No differences in terms of relapse rate were observed, but longer follow up is needed.