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J.M. Logue et al.
Figure 2. Cellular and humoral immune reconstitution after axicabtagene ciloleucel (axi-cel). Box and whisker plots demonstrating cellular and immune reconstitu- tion following treatment with axi-cel. White blood cells (WC) and neutrophils (N) were measured by complete blood counts with differential at baseline (n=85), day 30 (n=70), day 90 (n=56), day 180 (n=42), day 270 (n=32), and day 360 (n=31). CD3 T cells, CD4 T cells, CD8 T cells, CD56 natural killer cells, and CD19 B cells were measured by flow cytometry at baseline (n=58) and at day 30 (n=34), 90 (n=31), 180 (n=26), 270 (n=20) and 360 (n=19). Also shown are serum mmunoglob- ulin G (IgG) levels at baseline (n=58) and at day 30 (n=34), 90 (n=31), 180 (n=19), 270 (n=17) and 360 (n=17) after treatment with axi-cel. Boxes demonstrate first quartile, median and third quartile values. Whiskers show the data ranges. Dots represent individual patients. P-values are calculated by the Kruskal-Wallis test to assess significant differences in the indicated cell type after axi-cel infusion.
decreased, no patient fell below the minimum titer for a positive test during the follow-up period. In total, 23 of 85 (27.1%) patients required IVIG after axi-cel. 34 of 85 (40·0%) patients required G-CSF due to severe neutrope- nia.
A proportion of patients had bone marrow biopsies done pre-treatment and after axi-cel therapy (Table 3). The median pre-treatment marrow occurred at day -179 (range: -1551 to -7). Before axi-cel, 21.5% of patients had a hypocellular marrow, 60% of patients had a normocel- lular marrow, no patients had dysplasia, 10.8% had mild to moderate fibrosis, and16·9% had a clonal population.
Of marrows with a clonal population, four showed DLBCL, three follicular lymphoma (FL), one marginal zone lymphoma (MZL), one chronic lymphocytic leukemia (CLL), one monoclonal plasma cell proliferation in the setting of monoclonal gammopathy of undeter- mined significance, and one had monoclonal CD5+ B cells. Of these patients, seven went on to have repeat bone mar- row biopsies after treatment with axi-cel, and no patients showed persistence of the clonal population at the time of repeat biopsy. Within the first 100 days after axi-cel, 16 patients had bone marrow biopsies done in the absence of lymphoma progression, occurring at median day 31
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haematologica | 2021; 106(4)