Evidence map›Paper›PMID 33483613›Full record

Trial reportLeukemia2021

Long-term outcome of imatinib 400 mg compared to imatinib 600 mg or imatinib 400 mg daily in combination with cytarabine or pegylated interferon alpha 2a for chronic myeloid leukaemia: results from the French SPIRIT phase III randomised trial.

Francois Guilhot, Françoise Rigal-Huguet, Joëlle Guilhot, Agnès-Paule Guerci-Bresler, Frédéric Maloisel, Delphine Rea, Valérie Coiteux, Martine Gardembas, Christian Berthou, Anne Vekhoff and 46 more

Abstract readClinical Trial, Phase IIIComparative StudyMulticenter Study
PubMed Publisher
In one paragraph

Trial report in Leukemia, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed, 1 pooled it
2.9field-weighted citation impact, top 9% 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

15 citing papers in PubMed, 1 synthesis or guideline pooled it, 27 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

56 authors at 20 institutions in 1 country.

Francois GuilhotINSERM CIC 1402, CHU, Poitiers, France. fr.guilhot@wanadoo.fr.ORCID http://orcid.org/0000-0001-7222-487X
Françoise Rigal-HuguetClinical Hematology Department, I.U.C.T.O., CHU, Toulouse, France.
Joëlle GuilhotINSERM CIC 1402, CHU, Poitiers, France.
Agnès-Paule Guerci-BreslerClinical Hematology Department, CHRU Brabois, Vandoeuvre-les-Nancy, France.
Frédéric MaloiselHematology Department, Clinique Sainte Anne, Strasbourg, France.
Delphine ReaDepartment of Hematology, Hopital Saint-Louis, APHP, Paris, France.
Valérie CoiteuxClinical Hematology Department, Hospital Claude Huriez, CHRU, Lille, France.
Martine GardembasDepartment of Hematology, CHU, Angers, France.
Christian BerthouDepartment of Hematology, Brest University Hospital, Brest, France.
Anne VekhoffClinical Hematology Department, Hospital St Antoine, APHP. Sorbonne Université, Paris, France.
Eric JourdanHématologie Clinique, Institut de Cancérologie du Gard, CHU de Nîmes, Nîmes, France.
Marc BergerHematologie Biologique, CHU Estaing, Clermont Ferrand, France.
Loïc FouillardClinical Hematology, CH Orleans, Orleans, France.
Magda AlexisHématologie et Thérapie Cellulaire, Grand Hôpital de l'EST Francilien, Meaux, France.
Laurence LegrosDepartment of Haematology, Hopital Paul Brousse, AP-HP, INSERM UMRS-MD1197, Villejuif, France.
Philippe RousselotHematology Department, Division of Innovative Therapies, Centre Hospitalier de Versailles, Versailles and Université Paris-Saclay, Inserm, CEA, Center for Immunology of Viral, Auto-immune, Hematological and Bacterial Diseases (IMVA-HB/IDMIT), Fontenay-aux-Roses & Le Kremlin-Bicêtre, France.
Alain DelmerClinical Hematology Department, CHU, Reims, France.ORCID http://orcid.org/0000-0002-1430-2574
Pascal LenainClinical Hematology Department, Centre Henri Becquerel, Rouen, France.
Martine Escoffre BarbeClinical Hematology Department, CHU Pontchaillou, Rennes, France.
Emmanuel GyanHematology and Cell Therapy Department, University of Tours, Tours, France.ORCID http://orcid.org/0000-0002-7651-9189
Claude-Eric BulaboisHematologie Soins Intensifs, CHU Grenoble Alpes, Grenoble, France.
Viviane DubruilleClinical Hematology Department, CHU Hotel Dieu, Nantes, France.
Bertrand JolyHématologie Clinique, CH Sud Francilien, Corbeil-Essonnes, France.ORCID http://orcid.org/0000-0002-4136-9002
Bertrand PolletHématologie Clinique, CH Boulogne sur mer, Boulogne sur mer, France.
Pascale Cony-MakhoulHematology Department, CH Annecy-Genevois, Epagny Metz-Tessy, Pringy, France.
Hyacinthe Johnson-AnsahInstitut d'Hématologie de Basse Normandie (IHBN), CHU Côte de Nacre, Caen, France.
Melanie MercierService d'Dématologie Médecine Interne Maladies Infectieuses, Centre Hospitalier Bretagne Atlantique Vannes, Vannes, France.
Denis CaillotHématologie Clinique, CHU Dijon Bourgogne, Dijon, France.
Aude CharbonnierClinical Hematology Department, Institut Paoli Calmettes, Marseille, France.
Jean-Jacques KiladjianInserm CIC 1427, Université de Paris, Paris, France.
Jacques ChapiroService Hématologie Clinique, Hopitaux Civiles de Colmar, Colmar, France.
Amélie PenotService Hématologie et Thérapie Cellulaire, CHU Limoges, Limoges, France.
Véronique DorvauxHématologie Clinique, CHR Metz-Thionville, Metz, France.
Iona VaidaHématologie Clinique, Centre Hospitalier René-Dubois, Cergy-Pontoise, France.
Alberto SantagostinoHématologie Clinique, CH, Troyes, France.
Lydia RoyClinical Hematology Department, Hop Henri Mondor, APHP, UPEC, Créteil, France.
Hacene ZerazhiService Oncologie Médicale et Hématologie Clinique, Centre Hospitalier Henri Duffaut, Avignon, France.
Eric DeconinckService d'Hématologie, CHRU Besançon, Besançon, France.ORCID http://orcid.org/0000-0002-6006-8088
Herve MaisonneuveOncologie Médicale, CHD Vendée, La Roche Sur Yon, France.
Isabelle PlantierHématologie Clinique CH Roubaix, Roubaix, France.
Delphine LebonService d'Hématologie Clinique CHU Amiens-Picardie, Amiens-Picardie, France.
Yazid ArkamService d'Hématologie GHR Mulhouse, Mulhouse, France.
Nathalie CambierHématologie Clinique, CH Valenciennes, Valenciennes, France.
Kamel GhomariService d'Hématologie-Oncologie CH Beauvais, Beauvais, France.
Jean-Michel MicleaService Hémato-oncologie CH Chartres, Chartres, France.
Sylvie GlaisnerService d'Hématologie Institut Curie, St Cloud, France.
Jean-Michel CayuelaService d'Hématologie Moléculaire, Hôpital St Louis, APHP, Paris, France.
Jean-Claude ChomelService Cancérologie Biologique CHU Poitiers, Poitiers, France.ORCID http://orcid.org/0000-0001-9227-1104
Marc MullerLaboratoire de Génétique, CHRU Nancy, Nancy, France.
Ludovic LhermitteLaboratory of Onco-Hematology, Assistance Publique-Hôpitaux de Paris, Hôpital Necker Enfants-Malades, Paris, France.ORCID http://orcid.org/0000-0003-2498-0376
Marc DelordClinical Research Department, Hôpital André Mignot, Versailles, France.ORCID http://orcid.org/0000-0002-0455-6749
Claude PreudhommeHematology Laboratory, Center for Biologic Pathology, Lille, France.
Gabriel EtienneClinical Hematology Department, Institut Bergonié, Bordeaux, France.
François-Xavier MahonClinical Hematology Department, Institut Bergonié, Bordeaux, France.
Franck-Emmanuel NicoliniHematology Department, INSERM U1052, CRCL, Centre Leon Berard, Lyon, France.
France Intergroupe des Leucémies Myéloïdes Chroniques, Fi-LMC
Inserm · FRAssistance Publique – Hôpitaux de Paris · FRInstitut Bergonié · FRCentre hospitalier Bretagne Atlantique · FRHôpital Pontchaillou · FRSorbonne Université · FRUniversité Paris-Est Créteil · FRCentre Hospitalier Universitaire d'Angers · FRCentre Hospitalier Universitaire de Caen Normandie · FRCentre Hospitalier Universitaire de Poitiers · FRHôpital André Mignot · FRHôtel-Dieu de Paris · FRCentre Hospitalier Annecy Genevois · FRCentre Hospitalier de Beauvais · FRCentre Hospitalier de Roubaix · FRCentre Hospitalier de Troyes · FRCentre Hospitalier de Valenciennes · FRCentre Hospitalier Régional de Metz-Thionville · FRCentre Hospitalier Régional et Universitaire de Nancy · FRCentre Hospitalier Régional Universitaire de Brest · FR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The STI571 prospective randomised trial (SPIRIT) French trial is a four-arm study comparing imatinib (IM) 400 mg versus IM 600 mg, IM 400 mg + cytarabine (AraC), and IM 400 mg + pegylated interferon alpha2a (PegIFN-α2a) for the front-line treatment of chronic-phase chronic myeloid leukaemia (CML). Long-term analyses included overall and progression-free survival, molecular responses to treatment, and severe adverse events. Starting in 2003, the trial included 787 evaluable patients. The median overall follow-up of the patients was 13.5 years (range 3 months to 16.7 years). Based on intention-to-treat analyses, at 15 years, overall and progression-free survival were similar across arms: 85%, 83%, 80%, and 82% and 84%, 87%, 79%, and 79% for the IM 400 mg (N = 223), IM 600 mg (N = 171), IM 400 mg + AraC (N = 172), and IM 400 mg + PegIFN-α2a (N = 221) arms, respectively. The rate of major molecular response at 12 months and deep molecular response (MR4) over time were significantly higher with the combination IM 400 mg + PegIFN-α2a than with IM 400 mg: p = 0.0001 and p = 0.0035, respectively. Progression to advanced phases and secondary malignancies were the most frequent causes of death. Toxicity was the main reason for stopping AraC or PegIFN-α2a treatment.

Indexed as

AdultAgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsCytarabineDose-Response Relationship, DrugFemaleFollow-Up StudiesHumansImatinib MesylateInterferon-alphaLeukemia, Myelogenous, Chronic, BCR-ABL PositiveMaleMiddle AgedPolyethylene GlycolsPrognosisCytarabineImatinib MesylateInterferon-alphapeginterferon alfa-2aPolyethylene GlycolsRecombinant Proteins

Identifiers

PMID33483613
OpenAlexW3121163735

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.