Evidence map›Paper›PMID 34529768›Full record

Trial reportBlood advances2021

Long-term quality of life of patients with acute promyelocytic leukemia treated with arsenic trioxide vs chemotherapy.

Fabio Efficace, Uwe Platzbecker, Massimo Breccia, Francesco Cottone, Paola Carluccio, Prassede Salutari, Eros Di Bona, Erika Borlenghi, Francesco Autore, Luciano Levato and 15 more

Registry-linked trialOpen access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Blood advances, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03096496 (Long-term Quality of Life Symptom Burden in Acute Promyelocytic Leukemia), which is not on this map. Cited by 9 papers.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed
1.0field-weighted citation impact, top 25% 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.

NCT03096496 unknown statusnot on this map

Long-term Quality of Life Symptom Burden in Acute Promyelocytic Leukemia (APL) Patients Treated With Arsenic Trioxide (ATO) or Standard Chemotherapy

TypeobservationalSponsorGruppo Italiano Malattie EMatologiche dell'AdultoRan2017 to 2022Enrolled161ConditionsAcute Promyelocytic LeukemiaArmsQoL questionnaires
3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 14 citations in OpenAlex.

  1. Article
  2. Review
  3. Article
  4. Observational
  5. Article
  6. Review
  7. Review
  8. Review
  9. Effect of Therapeutically Related Drugs on Coagulation-Anticoagulation Balance in Acute Promyelocytic Leukemia.Clinical and applied thrombosis/hemostasis : official journal of the International Academy of Clinical and Applied Thrombosis/Hemostasis
    Review
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

25 authors at 19 institutions in 2 countries.

Fabio EfficaceData Center and Health Outcomes Research Unit, Italian Group for Adult Hematologic Diseases (GIMEMA), Rome, Italy.ORCID 0000-0002-5065-5166
Uwe PlatzbeckerMedical Clinic and Polyclinic I, Hematology and Cellular Therapy, University Hospital Leipzig, Leipzig, Germany.ORCID 0000-0003-1863-3239
Massimo BrecciaHematology, Department of Translational and Precision Medicine, University Sapienza Rome, Roma, Italy.ORCID 0000-0003-1163-6162
Francesco CottoneData Center and Health Outcomes Research Unit, Italian Group for Adult Hematologic Diseases (GIMEMA), Rome, Italy.ORCID 0000-0001-6240-8317
Paola CarluccioHematology and Bone Marrow Transplantation Unit, Department of Emergency and Organ Transplantation, University of Bari, Bari, Italy.
Prassede SalutariHaematology, Pescara Hospital, Pescara, Italy.
Eros Di BonaDivision of Hematology, San Bortolo Hospital, Vicenza, Italy.
Erika BorlenghiHematology, ASST-Spedali Civili, Brescia, Italy.
Francesco AutoreFondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy.ORCID 0000-0002-7868-7469
Luciano LevatoDepartment of Hematology-Oncology, Azienda Ospedaliera Pugliese-Ciaccio, Catanzaro, Italy.ORCID 0000-0003-0032-2977
Olimpia FinizioDivision of Hematology, Cardarelli General Hospital, Naples, Italy.
Valentina ManciniDepartment of Hematology and Oncology, ASST Grande Ospedale Metropolitano Niguarda, Milano, Italy.
Stefano D'ArdiaDivision of Hematology, Department of Oncology, Presidio Molinette, AOU Città della Salute e della Scienza di Torino, Turin, Italy.
Richard F SchlenkDepartment of Internal Medicine V, Heidelberg University Hospital, Heidelberg, Germany.ORCID 0000-0003-2215-2059
Lorella MelilloDivision of Hematology, IRCCS "Casa Sollievo della Sofferenza" Hospital, San Giovanni Rotondo, Italy.
Monica FumagalliHematology, San Gerardo Hospital, Monza, Italy.ORCID 0000-0002-1962-4548
Walter FiedlerUniversity Medical Center Hamburg-Eppendorf, Hamburg, Germany.
Germana BeltramiHematology and Bone Marrow Transplantation Unit, IRCCS Ospedale Policlinico San Martino, Genova, Italy.
Nicola Stefano FracchiollaHematology, Fondazione IRCCS Ca' Granda-Ospedale Maggiore Policlinico, Milano, Italy.
Massimo BernardiHematology and Bone Marrow Transplantation Unit, San Raffaele Scientific, Milano, Italy.ORCID 0000-0002-1334-0851
Paola FaziData Center and Health Outcomes Research Unit, Italian Group for Adult Hematologic Diseases (GIMEMA), Rome, Italy.
Ombretta AnnibaliHematology and Stem Cell Transplantation Unit, Campus Bio-Medico University, Roma, Italy.ORCID 0000-0002-3095-5313
Karin MayerDepartment of Internal Medicine III, University Hospital of Bonn, Bonn, Germany; and.
Maria Teresa VosoDepartment of Biomedicine and Prevention, Università di Roma "Tor Vergata", Rome, Italy.ORCID 0000-0002-6164-4761
Marco VignettiData Center and Health Outcomes Research Unit, Italian Group for Adult Hematologic Diseases (GIMEMA), Rome, Italy.ORCID 0000-0003-1278-604X
Fondazione Gimema Onlus · ITAgostino Gemelli University Polyclinic · ITAzienda Ospedaliera Pugliese Ciaccio · ITAzienda Ospedaliera San Gerardo · ITAzienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia · ITAzienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda · ITAzienda USL di Pescara · ITCasa Sollievo della Sofferenza · ITFondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico · ITGerman Cancer Research Center · DEOspedale Policlinico San Martino · ITOspedale San Bortolo · ITSapienza University of Rome · ITUniversità Campus Bio-Medico · ITUniversität Hamburg · DEUniversity Hospital Bonn · DEUniversity Hospital Leipzig · DEUniversity of Bari Aldo Moro · ITUniversity of Rome Tor Vergata · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The main objective of this study was to compare the long-term health-related quality of life of patients with acute promyelocytic leukemia (APL) treated with all-trans retinoic acid (ATRA) plus arsenic trioxide (ATO) vs ATRA plus standard chemotherapy. Patients previously enrolled in the randomized controlled trial APL0406 were considered eligible for this follow-up study. The following patient-reported outcome measures were used: the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core30 (EORTC QLQ-C30), the EORTC Quality of Life Questionnaire Chemotherapy-Induced Peripheral Neuropathy 20 (QLQ-CIPN20), and the Short Form Health Survey 36 (SF-36). The prevalence of late comorbidities and health problems was also assessed. The clinical significance of differences was evaluated based on predefined thresholds. A total of 161 of 232 potentially eligible patients were analyzed, of whom 83 were treated with ATRA-ATO and 78 were treated with ATRA chemotherapy. The median time since diagnosis of the study sample was 8 years. The 2 largest clinically meaningful differences in the EORTC QLQ-C30 were observed for role functioning (Δ = 8.4; 95% confidence interval [CI], 0.5 to 16.3) and dyspnea (Δ = -8.5; 95% CI, -16.4 to -0.7), favoring patients treated with ATRA-ATO. With regard to the SF-36 results, a clinically relevant better physical component score (Δ = 4.6; 95% CI, 1.3 to 7.8) was observed in patients treated with ATRA-ATO, but this was not the case for the mental component score. The 2 groups showed similar profiles in the scores of the EORTC QLQ-CIPN20 scales and in the prevalence of late comorbidities. Overall, our findings suggest that the greater and more sustained antileukemic efficacy of ATRA-ATO is also associated with better long-term patient-reported outcomes than ATRA chemotherapy. This study was registered at www.clinicaltrials.gov as #NCT03096496.

Indexed as

Leukemia, Promyelocytic, AcuteQuality of LifeAntineoplastic Combined Chemotherapy ProtocolsArsenic TrioxideFollow-Up StudiesHumansTreatment OutcomeArsenic Trioxide

Identifiers

PMID34529768
PMCPMC8579253
OpenAlexW3200378615

What OpenQuestion holds

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Registered trials

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.