Page 68 - Haematologica Vol. 107 - September 2022

ARTICLE - Outcome of r/r B-ALL with extramedullary disease S. Kayser et al.
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Figure 1. Whole body 18-fluorodeoxyglucose positron emission tomography-computed tomography. (A) Before the start of treat- ment with inotuzumab ozogamicin (B) After one cycle of inotuzumab ozogamicin, showing partial remission.
Figure 2. Contrast-enhanced imaging by positron emission tomography-computed tomography (axial slice). (A) Before the start of treatment with inotuzumab ozogamicin. (B) After one cycle of inotuzumab ozogamicin, showing complete remission.
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with PR after the first cycle maintained the PR.
Patients, who achieved at least a PR after two INO cycles and did not proceed to allogeneic HSCT, could continue with INO for up to six cycles.
Survival
The median follow-up was 29 months (95% CI: 21 months - not reached) and the median OS was 12.8 months (95% CI: 9.9-16.2 months) (Figure 3). One-year and 2-years OS and relapse-free survival rates were 53% (95% CI: 37-76%) and 47% (95% CI: 25-88%) and 18% (95% CI: 8-43%) and 23% (95% CI: 7-75%), respectively (Figure 4). In Cox regres- sion analysis age as a continuous variable had no impact on OS (P=0.83). This was also true when using 60 years as cut-off (P=0.2). Twelve patients went on to allogeneic HSCT (CR, n=6; PR, n=3; progressive disease, n=3). Prior to allogeneic HSCT, eight patients received two or fewer cycles of INO and four patients received three or four INO cycles. The influence of allogeneic HSCT assessed as a
time-dependent co-variable as post-remission therapy on OS is illustrated by a Simon Makuch plot (Figure 5). The Mantel-Byar test revealed no impact on OS (P=0.19) for patients proceeding to allogeneic HSCT as compared to consolidation with INO. A multivariable Andersen-Gill model including prior allogeneic HSCT before INO treat- ment, age at initial diagnosis and allogeneic HSCT after INO as a time-dependent variable did not show any sig- nificant impact of any of these variables on OS.
In patients achieving a CR after INO treatment (n=17), the median OS was 16.2 months. There was no difference in OS (P=0.08) or relapse-free survival (P=0.2) according to whether patients had EMD manifestations only as com- pared to EMD and bone marrow involvement.
Of the 26 patients in CR/PR after INO treatment, ten re- lapsed (38%; after allogeneic HSCT, n=3); of those, all ex- cept one succumbed to their disease. Two patients died in remission (sepsis, VOD/SOS/multi-organ failure, n=1; each); both had undergone allogeneic HSCT before INO
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