Open AccessPS951 MORE OR LESS? IMPACT OF DOSE NUMBER ON OUTCOMES OF PATIENTS WITH ACUTE LYMPHOBLASTIC LEUKEMIA TREATED WITH INOTUZUMAB OZOGAMICIN
Author(s) -
Marks D.I.,
DeAngelo D.J.,
Jabbour E.,
Advani A.,
O’Brien S.,
Wang T.,
Neuhof A.,
Vandendries E.,
Kantarjian H.,
Stock W.,
Stelljes M.,
Cassaday R.
Publication year - 2019
Publication title -
hemasphere
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.677
H-Index - 11
ISSN - 2572-9241
DOI - 10.1097/01.hs9.0000562076.07949.93
Subject(s) - medicine , lymphoblastic leukemia , refractory (planetary science) , complete remission , gastroenterology , adverse effect , chemotherapy , leukemia , physics , astrobiology
Background: In INO‐VATE (NCT01564784), patients with relapsed/refractory acute lymphoblastic leukemia who were treated with inotuzumab ozogamicin (InO) vs standard chemotherapy had significantly greater remission rates and longer overall survival (OS), with more patients proceeding to stem‐cell transplant (SCT). Aims: Here we report outcomes by number of InO cycles (Cyc) received. Methods: Methods are detailed in Kantarjian, NEJM 2016. Outcomes are reported based on number of InO Cyc received (≤3 or >3 Cyc with no SCT and ≤2 or >2 with SCT [consistent with current recommendations]) in patients who achieved complete remission (CR)/CR with incomplete hematologic recovery. Data cutoff: Jan 4, 2017. Results: Among patients who responded but did not proceed to SCT, MRD‐negativity was achieved by 88% of 32 patients receiving >3 Cyc vs 61% of 18 patients receiving ≤3 Cyc ( P = 0.037). Patients who had >3 Cyc had a longer duration of remission (HR 0.35, P = 0.0005) and improved survival outcomes vs those who had ≤3 Cyc ( Table ). The rate of serious adverse events (AE) and the percentage of patients discontinuing treatment due to AEs was numerically lower with >3 Cyc vs ≤3 Cyc. Among patients who responded and proceeded to SCT, the percentage achieving MRD‐negativity (81% vs 69%, P = 0.123) and the duration of remission (HR 1.37, P = 0.848) were similar for those who had >2 Cyc (36 patients) vs ≤2 Cyc (35 patients). Patients with ≤2 Cyc had improved survival outcomes and non‐relapse mortality (NRM) vs those with >2 Cyc ( Table ). 17.1% of patients receiving ≤2 Cyc and 33.3% of patients receiving >2 Cyc developed veno‐occlusive disease ( Table ). Summary/Conclusion: These results are in agreement with current recommendations that patients proceeding to SCT should receive ≤2 Cyc, whereas those not proceeding to SCT may benefit from receiving up to 6 cycles of therapy.