Evidence map›Paper›PMID 34606378›Full record

Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2022

Ibrutinib Plus Rituximab Versus Placebo Plus Rituximab for Waldenström's Macroglobulinemia: Final Analysis From the Randomized Phase III iNNOVATE Study.

Christian Buske, Alessandra Tedeschi, Judith Trotman, Ramón García-Sanz, David MacDonald, Veronique Leblond, Beatrice Mahe, Charles Herbaux, Jeffrey V Matous, Constantine S Tam and 10 more

Open access · hybridAbstract readClinical Trial, Phase IIIComparative StudyMulticenter Study
In one paragraph

Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 64 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
64citing papers in PubMed, 1 pooled it
10.8field-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

64 citing papers in PubMed, 1 synthesis or guideline pooled it, 107 citations in OpenAlex.

  1. Pooled it
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  7. Zanubrutinib Versus Ibrutinib in Symptomatic Waldenström Macroglobulinemia: Final Analysis From the Randomized Phase III ASPEN Study.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2023
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  8. Single-Agent Ibrutinib for Rituximab-Refractory Waldenström Macroglobulinemia: Final Analysis of the Substudy of the Phase III InnovateClinical cancer research : an official journal of the American Association for Cancer Research · 2021
    Trial
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4 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

20 authors at 17 institutions in 8 countries.

Christian BuskeInstitute of Experimental Cancer Research, Comprehensive Cancer Center Ulm, University Hospital of Ulm, Ulm, Germany.ORCID 0000-0002-9782-9012
Alessandra TedeschiASST Grande Ospedale Metropolitano Niguarda, Milano, Italy.
Judith TrotmanConcord Hospital, University of Sydney, Sydney, Australia.ORCID 0000-0001-8009-4593
Ramón García-SanzDepartment of Hematology, University Hospital of Salamanca (HUS/IBSAL), CIBERONC and Cancer Research Institute of Salamanca-IBMCC (USAL-CSIC), Salamanca, Spain.ORCID 0000-0003-4120-2787
David MacDonaldThe Ottawa Hospital, University of Ottawa, Ottawa, Canada.ORCID 0000-0002-7750-2733
Veronique LeblondDépartement d'Hématologie Hôpital Pitié-Salpêtrière AP-HP, Sorbonne Université, Paris, France.
Beatrice MaheCentre Hospitalier Universitaire de Nantes, Nantes, France.
Charles HerbauxCentre Hospitalier Régional Universitaire de Lille, Institute of Hematology-Transfusion, Lille, France.
Jeffrey V MatousColorado Blood Cancer Institute, Denver, CO.
Constantine S TamPeter MacCallum Cancer Centre & St Vincent's Hospital and the University of Melbourne, Melbourne, Australia.ORCID 0000-0002-9759-5017
Leonard T HeffnerWinship Cancer Institute of Emory University, Atlanta, GA.
Marzia VarettoniFondazione IRCCS Policlinico San Matteo, Pavia, Italy.
M Lia PalombaMemorial Sloan Kettering Cancer Center, New York, NY.ORCID 0000-0001-5099-9156
Chaim ShustikRoyal Victoria Hospital at McGill University Health Centre, Montreal, Canada.
Efstathios KastritisNational and Kapodistrian University of Athens School of Medicine, Athens, Greece.ORCID 0000-0001-8191-5832
Steven P TreonDana-Farber Cancer Institute, Boston, MA.ORCID 0000-0001-6393-6154
Jerry PingPharmacyclics LLC, an AbbVie Company, Sunnyvale, CA.
Bernhard HaunsPharmacyclics LLC, an AbbVie Company, Sunnyvale, CA.
Israel Arango-HisijaraPharmacyclics LLC, an AbbVie Company, Sunnyvale, CA.
Meletios A DimopoulosNational and Kapodistrian University of Athens School of Medicine, Athens, Greece.ORCID 0000-0001-8990-3254
AbbVie (United States) · USNational and Kapodistrian University of Athens · GRAzienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda · ITCentre Hospitalier Universitaire de Lille · FRCentre Hospitalier Universitaire de Nantes · FRColorado Blood Cancer Institute · USDana-Farber Cancer Institute · USEmory University · USInstituto de Investigación Biomédica de Salamanca · ESMemorial Sloan Kettering Cancer Center · USPoliclinico San Matteo Fondazione · ITRoyal Victoria Regional Health Centre · CASorbonne Université · FRThe University of Melbourne · AUThe University of Sydney · AUUniversity Hospital Ulm · DEUniversity of Ottawa · CA

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI SELWYN M VICKERS · 1985 to 2026
$347.4M
NCI NIH HHS P30 CA008748
6 · The paper itself

Abstract

purposeThe double-blind, randomized, placebo-controlled phase III iNNOVATE study showed sustained efficacy of ibrutinib-rituximab in Waldenström's macroglobulinemia (WM). Here, we present the final analysis from iNNOVATE.

methodsPatients had confirmed symptomatic WM, either previously untreated or previously treated; patients with prior rituximab had at least a minor response to their last rituximab-based regimen. Patients were randomly assigned to once-daily ibrutinib 420 mg plus rituximab or placebo plus rituximab (n = 75 per arm). The primary end point was progression-free survival (PFS). Secondary end points included response rate, time to next treatment, hemoglobin improvement, overall survival, and safety.

resultsWith a median follow-up of 50 (range, 0.5-63) months, median (95% CI) PFS was not reached (57.7 months to not evaluable) with ibrutinib-rituximab versus 20.3 months (13.0 to 27.6) with placebo-rituximab (hazard ratio, 0.250;

conclusionIn the final analysis of iNNOVATE with a median follow-up of 50 months, ibrutinib-rituximab showed ongoing superiority across clinical outcomes in patients with WM regardless of

Indexed as

AdenineAdultAgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsBiomarkers, TumorDouble-Blind MethodFemaleHumansMaleMiddle AgedMutationMyeloid Differentiation Factor 88PiperidinesProgression-Free SurvivalReceptors, CXCR4AdenineBiomarkers, TumorCXCR4 protein, humanibrutinibMYD88 protein, humanMyeloid Differentiation Factor 88PiperidinesReceptors, CXCR4Rituximab

Identifiers

PMID34606378
PMCPMC8683240
OpenAlexW3203864709

What Socratic holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

None linked

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 Socratic graph.