Evidence map›Paper›PMID 30307611›Full record

Trial reportCancer2018

Chemoimmunotherapy with inotuzumab ozogamicin combined with mini-hyper-CVD, with or without blinatumomab, is highly effective in patients with Philadelphia chromosome-negative acute lymphoblastic leukemia in first salvage.

Elias Jabbour, Koji Sasaki, Farhad Ravandi, Xuelin Huang, Nicholas J Short, Maria Khouri, Partow Kebriaei, Jan Burger, Joseph Khoury, Jeffrey Jorgensen and 10 more

Open access · bronzeAbstract readClinical Trial, Phase II
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Cancer, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 59 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
59citing papers in PubMed, 2 pooled it
13.8field-weighted citation impact, top 1% 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

59 citing papers in PubMed, 2 syntheses or guidelines pooled it, 109 citations in OpenAlex.

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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

20 authors at 2 institutions in 1 country.

Elias JabbourDepartment of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, Texas.ORCID 0000-0003-4465-6119
Koji SasakiDepartment of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, Texas.ORCID 0000-0002-9140-0610
Farhad RavandiDepartment of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, Texas.
Xuelin HuangDepartment of Biostatistics, The University of Texas MD Anderson Cancer Center, Houston, Texas.
Nicholas J ShortDepartment of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, Texas.
Maria KhouriDepartment of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, Texas.
Partow KebriaeiDepartment of Stem Cell Transplantation and Cellular Therapy, The University of Texas MD Anderson Cancer Center, Houston, Texas.
Jan BurgerDepartment of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, Texas.
Joseph KhouryDepartment of Hematopathology, The University of Texas MD Anderson Cancer Center, Houston, Texas.
Jeffrey JorgensenDepartment of Hematopathology, The University of Texas MD Anderson Cancer Center, Houston, Texas.
Nitin JainDepartment of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, Texas.
Marina KonoplevaDepartment of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, Texas.
Guillermo Garcia-ManeroDepartment of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, Texas.
Tapan KadiaDepartment of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, Texas.ORCID 0000-0002-9892-9832
Jorge CortesDepartment of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, Texas.
Jovitta JacobDepartment of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, Texas.
Kathryn MontalbanoDepartment of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, Texas.
Rebecca GarrisDepartment of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, Texas.
Susan O'BrienChao Family Comprehensive Cancer Center, University of California Irvine, Orange, California.
Hagop M KantarjianDepartment of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, Texas.ORCID 0000-0002-1908-3307
The University of Texas MD Anderson Cancer Center · USUniversity of California, Irvine · US

Funding

Tumor Evolution and Metastasis ProgramP30CA016672 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI Fabien Delerue · 1985 to 2026
$290.8M
Paul Calabresi Clinical Oncology AwardK12CA088084 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI David S. Hong, Scott Kopetz · 2000 to 2026
$14.0M
NCI NIH HHS K12 CA088084NCI NIH HHS P30 CA016672
6 · The paper itself

Abstract

backgroundThe outcomes of patients with relapsed or refractory (R-R) acute lymphoblastic leukemia (ALL) are poor. Inotuzumab ozogamicin and blinatumomab have single-agent activity in R-R ALL. Their addition to low-intensity chemotherapy may further improve the outcomes of patients with ALL in their first relapse.

methodsThe chemotherapy was lower in intensity than conventional hyperfractionated cyclophosphamide, vincristine, adriamycin, and dexamethasone and was called mini-hyperfractionated cyclophosphamide, vincristine, and dexamethasone (or mini-HCVD). Inotuzumab was given on day 3 of each of the first 4 cycles at 1.8 to 1.3 mg/m

resultsForty-eight patients with Philadelphia chromosome-negative ALL with a median age of 39 years were treated during their first relapse. Overall, 44 patients (92%) responded, with 35 of them (73%) achieving a complete response. The overall minimal residual disease negativity rate among the responders was 93%. Twenty-four patients (50%) underwent allogeneic stem cell transplantation (ASCT). Veno-occlusive disease of any grade occurred in 5 patients (10%). With a median follow-up of 31 months, the median progression-free survival (PFS) and the median overall survival (OS) were 11 and 25 months, respectively. The 2-year PFS and OS rates were 42% and 54%, respectively. Of the 24 patients (50%) who underwent ASCT, 14 patients were alive at the last follow-up (13 [54%] in remission). Of the remaining 20 responding patients who did not undergo subsequent ASCT, 6 (30%) remained in remission at the last follow-up. According to propensity score matching, the combination of mini-HCVD and inotuzumab with or without blinatumomab conferred better outcomes than intensive salvage chemotherapy or inotuzumab alone.

conclusionsThe combination of inotuzumab and low-intensity mini-HCVD chemotherapy with or without blinatumomab shows encouraging results in patients with ALL in first salvage.

Indexed as

AdolescentAdultAgedAged, 80 and overAntibodies, BispecificAntibodies, Monoclonal, HumanizedAntineoplastic Agents, ImmunologicalAntineoplastic Combined Chemotherapy ProtocolsCyclophosphamideDexamethasoneDose-Response Relationship, DrugDrug Administration ScheduleDrug Resistance, NeoplasmFemaleHumansImmunotherapyAntibodies, BispecificAntibodies, Monoclonal, HumanizedAntineoplastic Agents, ImmunologicalblinatumomabCyclophosphamideDexamethasoneInotuzumab OzogamicinRituximabVincristineacute lymphoblastic leukemia (ALL)first relapseinotuzumab ozogamicinsalvage

Identifiers

PMID30307611
PMCPMC6515924
OpenAlexW2896845000

What OpenQuestion holds

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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.