Evidence map›Paper›PMID 31436395›Full record

Trial reportCancer medicine2019

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

David I Marks, Ilse van Oostrum, Sabrina Mueller, Verna Welch, Erik Vandendries, Fausto R Loberiza, Sarah Böhme, Yun Su, Matthias Stelljes, Hagop M Kantarjian

Open access · goldAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
In one paragraph

Trial report in Cancer medicine, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
0.9field-weighted citation impact, top 23% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 10 citations in OpenAlex.

  1. Trial
  2. Evaluation of the inpatient use of inotuzumab ozogamicin and creation of appropriate use guidelines.Journal of oncology pharmacy practice : official publication of the International Society of Oncology Pharmacy Practitioners · 2026
    Article
  3. Article
  4. Treatment of Relapsed Acute Lymphocytic Leukemia in Adult Patients.Current treatment options in oncology · 2024
    Review
  5. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors at 8 institutions in 4 countries.

David I MarksBristol Haematology and Oncology Centre, University Hospitals Bristol NHS Foundation Trust, Bristol, UK.
Ilse van OostrumIngress-Health Nederland B.V., Rotterdam, The Netherlands.ORCID 0000-0003-4944-5927
Sabrina MuellerIngress-Health HWM GmbH, Wismar, Germany.
Verna WelchPfizer Global HEOR, New York, NY, USA.
Erik VandendriesPfizer Inc, Cambridge, MA, USA.
Fausto R LoberizaPfizer Inc, Pharma GmbH, Berlin, Germany.
Sarah BöhmePfizer Deutschland GmbH, Berlin, Germany.
Yun SuIndependent, Bridgewater, NJ, USA.
Matthias StelljesUniversitätsklinikum Münster, Münster, Germany.
Hagop M KantarjianUniversity of Texas MD Anderson Cancer Center, Houston, TX, USA.ORCID 0000-0002-1908-3307
Pfizer (Germany) · DEPfizer (United States) · USBridgewater State University · USInholland University of Applied Sciences · NLThe University of Texas MD Anderson Cancer Center · USUniversity Hospital Münster · DEUniversity Hospitals Bristol NHS Foundation Trust · GBWismar University of Applied Sciences · DE

Funding

Pfizer
6 · The paper itself

Abstract

backgroundInotuzumab 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.

methodsAll 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).

resultsOverall, 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).

conclusionsInotuzumab 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.

Indexed as

Antineoplastic Agents, ImmunologicalFemaleHospitalizationHumansInotuzumab OzogamicinMaleMiddle AgedPrecursor Cell Lymphoblastic Leukemia-LymphomaAntineoplastic Agents, ImmunologicalInotuzumab Ozogamicinacute lymphoblastic leukemiachemotherapyhospitalizationinotuzumab ozogamicin

Identifiers

PMID31436395
PMCPMC6792500
OpenAlexW2969231081

What OpenQuestion holds

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LicenceCC BY
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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.