TY - JOUR
T1 - Burden of hospitalization in acute lymphoblastic leukemia patients treated with Inotuzumab Ozogamicin versus standard chemotherapy treatment
AU - Marks, David I.
AU - van Oostrum, Ilse
AU - Mueller, Sabrina
AU - Welch, Verna
AU - Vandendries, Erik
AU - Loberiza, Fausto R.
AU - Böhme, Sarah
AU - Su, Yun
AU - Stelljes, Matthias
AU - Kantarjian, Hagop M.
N1 - Publisher Copyright:
© 2019 The Authors. Cancer Medicine published by John Wiley & Sons Ltd.
PY - 2019/10/1
Y1 - 2019/10/1
N2 - Background: Inotuzumab Ozogamicin (INO), has demonstrated an improvement in overall survival, high rate of complete remission, favorable patient-reported outcomes, and manageable safety profile vs standard of care (SoC; intensive chemotherapy) for relapsed/refractory (R/R) acute lymphoblastic leukemia (ALL) in the phase 3 INO-VATE trial. With a one-hour weekly dosing schedule, INO might be associated with lower healthcare system burden. This study analyses hospitalizations for INO vs SoC. Methods: All patients receiving study treatment in the INO-VATE trial were included. The days hospitalized during study treatment was calculated. Due to different treatment durations for INO and SoC (median of 3 vs 1 cycles), number of hospital days was mainly reported per observed patient month. Hospital days per patient month were analyzed for different treatment cycles, subgroups, and main reasons for hospitalization. Differences between treatments were analyzed by the incidence rate ratio (IRR). Results: Overall, 82.9% and 94.4% INO and SoC patients experienced at least one hospitalization. The mean hospitalization days per patient month was 7.6 and 18.4 days for INO and SoC (IRR = 0.413, P <.001), which corresponds to patients spending 25.0% and 60.5% of their treatment time in a hospital. Main hospitalization reasons were R/R ALL treatment (5.2 (INO) vs 14.0 (SoC) days, IRR = 0.368, P <.001), treatment toxicities (1.4 vs 2.8 days, IRR = 0.516, P <.001) or other reasons (1.0 vs 1.6 days, IRR 0.629, P <.001). Conclusions: Inotuzumab Ozogamicin treatment in R/R ALL is associated with a lower hospitalization burden compared with SoC. It is likely this lower burden has a favorable impact on healthcare budgets and cost-effectiveness considerations.
AB - Background: Inotuzumab Ozogamicin (INO), has demonstrated an improvement in overall survival, high rate of complete remission, favorable patient-reported outcomes, and manageable safety profile vs standard of care (SoC; intensive chemotherapy) for relapsed/refractory (R/R) acute lymphoblastic leukemia (ALL) in the phase 3 INO-VATE trial. With a one-hour weekly dosing schedule, INO might be associated with lower healthcare system burden. This study analyses hospitalizations for INO vs SoC. Methods: All patients receiving study treatment in the INO-VATE trial were included. The days hospitalized during study treatment was calculated. Due to different treatment durations for INO and SoC (median of 3 vs 1 cycles), number of hospital days was mainly reported per observed patient month. Hospital days per patient month were analyzed for different treatment cycles, subgroups, and main reasons for hospitalization. Differences between treatments were analyzed by the incidence rate ratio (IRR). Results: Overall, 82.9% and 94.4% INO and SoC patients experienced at least one hospitalization. The mean hospitalization days per patient month was 7.6 and 18.4 days for INO and SoC (IRR = 0.413, P <.001), which corresponds to patients spending 25.0% and 60.5% of their treatment time in a hospital. Main hospitalization reasons were R/R ALL treatment (5.2 (INO) vs 14.0 (SoC) days, IRR = 0.368, P <.001), treatment toxicities (1.4 vs 2.8 days, IRR = 0.516, P <.001) or other reasons (1.0 vs 1.6 days, IRR 0.629, P <.001). Conclusions: Inotuzumab Ozogamicin treatment in R/R ALL is associated with a lower hospitalization burden compared with SoC. It is likely this lower burden has a favorable impact on healthcare budgets and cost-effectiveness considerations.
KW - acute lymphoblastic leukemia
KW - chemotherapy
KW - hospitalization
KW - inotuzumab ozogamicin
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U2 - 10.1002/cam4.2480
DO - 10.1002/cam4.2480
M3 - Article
C2 - 31436395
AN - SCOPUS:85070912692
SN - 2045-7634
VL - 8
SP - 5959
EP - 5968
JO - Cancer medicine
JF - Cancer medicine
IS - 13
ER -