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Burden of hospitalization in acute lymphoblastic leukemia patients treated with Inotuzumab Ozogamicin versus standard chemotherapy treatment

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 leukem...

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Autores principales: Marks, David I., van Oostrum, Ilse, Mueller, Sabrina, Welch, Verna, Vandendries, Erik, Loberiza, Fausto R., Böhme, Sarah, Su, Yun, Stelljes, Matthias, Kantarjian, Hagop M.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2019
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6792500/
https://www.ncbi.nlm.nih.gov/pubmed/31436395
http://dx.doi.org/10.1002/cam4.2480
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author Marks, David I.
van Oostrum, Ilse
Mueller, Sabrina
Welch, Verna
Vandendries, Erik
Loberiza, Fausto R.
Böhme, Sarah
Su, Yun
Stelljes, Matthias
Kantarjian, Hagop M.
author_facet Marks, David I.
van Oostrum, Ilse
Mueller, Sabrina
Welch, Verna
Vandendries, Erik
Loberiza, Fausto R.
Böhme, Sarah
Su, Yun
Stelljes, Matthias
Kantarjian, Hagop M.
author_sort Marks, David I.
collection PubMed
description 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.
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spelling pubmed-67925002019-10-21 Burden of hospitalization in acute lymphoblastic leukemia patients treated with Inotuzumab Ozogamicin versus standard chemotherapy treatment Marks, David I. van Oostrum, Ilse Mueller, Sabrina Welch, Verna Vandendries, Erik Loberiza, Fausto R. Böhme, Sarah Su, Yun Stelljes, Matthias Kantarjian, Hagop M. Cancer Med Clinical Cancer Research 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. John Wiley and Sons Inc. 2019-08-22 /pmc/articles/PMC6792500/ /pubmed/31436395 http://dx.doi.org/10.1002/cam4.2480 Text en © 2019 The Authors. Cancer Medicine published by John Wiley & Sons Ltd. This is an open access article under the terms of the http://creativecommons.org/licenses/by/4.0/ License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited.
spellingShingle Clinical Cancer Research
Marks, David I.
van Oostrum, Ilse
Mueller, Sabrina
Welch, Verna
Vandendries, Erik
Loberiza, Fausto R.
Böhme, Sarah
Su, Yun
Stelljes, Matthias
Kantarjian, Hagop M.
Burden of hospitalization in acute lymphoblastic leukemia patients treated with Inotuzumab Ozogamicin versus standard chemotherapy treatment
title Burden of hospitalization in acute lymphoblastic leukemia patients treated with Inotuzumab Ozogamicin versus standard chemotherapy treatment
title_full Burden of hospitalization in acute lymphoblastic leukemia patients treated with Inotuzumab Ozogamicin versus standard chemotherapy treatment
title_fullStr Burden of hospitalization in acute lymphoblastic leukemia patients treated with Inotuzumab Ozogamicin versus standard chemotherapy treatment
title_full_unstemmed Burden of hospitalization in acute lymphoblastic leukemia patients treated with Inotuzumab Ozogamicin versus standard chemotherapy treatment
title_short Burden of hospitalization in acute lymphoblastic leukemia patients treated with Inotuzumab Ozogamicin versus standard chemotherapy treatment
title_sort burden of hospitalization in acute lymphoblastic leukemia patients treated with inotuzumab ozogamicin versus standard chemotherapy treatment
topic Clinical Cancer Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6792500/
https://www.ncbi.nlm.nih.gov/pubmed/31436395
http://dx.doi.org/10.1002/cam4.2480
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