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- Title
ALL-056: Outcome of Relapsed or Refractory Acute B-Lymphoblastic Leukemia Patients with Extramedullary Disease Receiving Inotuzumab Ozogamicin.
- Authors
Kayser, Sabine; Sartor, Chiara; Panitz, Nydia; Fante, Matthias; Lutz, Christoph; Wolff, Daniel; Ho, Anthony; Papayannidis, Cristina
- Abstract
Extramedullary involvement of B-cell acute lymphoblastic leukemia (EM-ALL) is a rare occurrence, characterized by dismal outcomes and without a defined and shared therapeutic approach. To evaluate outcomes after Inotuzumab Ozogamicin (InO) treatment in a series of relapsed/refractory (r/r) EM-ALL patients (pts). Retrospective analysis of 17 CD22+ pts treated between 2015 and 2020 within a compassionate use program (n=7) or in-label (n=10). Patients treated in an outpatient setting or during hospitalization based on clinical conditions. No selection procedures applied. InO was administered at the approved dose. EM disease was assessed by CT or PET-CT before and after InO therapy. Up to 6 InO cycles (≤2 cycles, n=11; 3–4cycles, n=4; 5–6 cycles, n=2) were administered. Response rates (complete response, CR, or partial response, PR) after InO and overall survival (OS). EM disease localization included lymph nodes (total, n=9), bones (n=4), kidney (n=1), peripheral nerves (n=1), pancreas and bone (n=1), and ovary (n=1). At the time of r/r EM-ALL, median WBC and PLT counts were 4.9/nl (range, 0.7–10.3/nl) and 94.5/nl (range, 11–515/nl), respectively. ECOG was ≤2 in all pts. Two pts displayed a t(9;22). CR after the first InO cycle was achieved in 7 pts (41%), 7 pts had a PR (41%), 1 (6%) had stable disease (SD), and 1 patient (6%) died at day 11 of the first cycle. After 2 InO cycles, ORR was 94% (n=16), including CR in 9 pts (56%) and PR in 6 (38%). Median follow-up was 12.1 months (range, 0.4–44.9 months) and median OS 11.9 months (95%>CI, 8–20 months). One-year and two-years OS rates were 50% (95%>CI, 25–71%) and 23% (95%>CI, 6–46%), respectively. Age above 60 years had no impact on OS (p=0.48). Seven pts proceeded to allo-SCT, receiving ≤2 cycles (4 pts) and ≤4 cycles (3 pts). No VOD occurred. Relapse/progressive disease occurred in nine pts. Cumulative incidence of relapse after 12 months was 38%. InO is an effective approach and a successful bridge-to-transplant strategy in patients with r/r EM-ALL.
- Publication
Clinical Lymphoma, Myeloma & Leukemia, 2021, Vol 21, pS265
- ISSN
2152-2650
- Publication type
Article
- DOI
10.1016/S2152-2650(21)01646-3