Evidence map›Paper›PMID 34334330›Full record

Trial reportClinical lymphoma, myeloma & leukemia2021

A Prospective Economic Analysis of Early Outcome Data From the Alliance A041202/ CCTG CLC.2 Randomized Phase III Trial Of Bendamustine-Rituximab Compared With Ibrutinib-Based Regimens in Untreated Older Patients With Chronic Lymphocytic Leukemia.

Matthew C Cheung, Nicole Mittmann, Carolyn Owen, Nizar Abdel-Samad, Graeme A M Fraser, Selay Lam, Michael Crump, Catherine Sperlich, Richard van der Jagt, Anca Prica and 10 more

Registry-linked trialOpen access · greenAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
In one paragraph

Trial report in Clinical lymphoma, myeloma & leukemia, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02414022 (Prospective Economic Analysis), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.5field-weighted citation impact, top 33% 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.

NCT02414022 active not recruitingnot on this map

Prospective Economic Analysis: A Randomized Phase III CLL Study of Bendamustine Plus Rituximab Versus Ibrutinib + Rituximab vs Ibrutinib Alone in Untreated Older Patients (≥65 Years of Age) With Chronic Lymphocytic Leukemia (CLL)

TypeobservationalSponsorCanadian Cancer Trials GroupRan2015 to 2026Enrolled55ConditionsChronic Lymphocytic Leukemia
3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 5 citations in OpenAlex.

  1. Trial
  2. 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

20 authors at 14 institutions in 2 countries.

Matthew C CheungDivision of Hematology, Department of Medicine, Odette Cancer Centre, Sunnybrook Health Sciences Centre, University of Toronto, Toronto, Canada; Canadian Cancer Trials Group, Queens University, Kingston, Canada. Electronic address: matthew.cheung@sunnybrook.ca.
Nicole MittmannCanadian Cancer Trials Group, Queens University, Kingston, Canada; Department of Pharmacology and Toxicology and Institute for Health Policy Management and Evaluation, Sunnybrook Research Institute, Sunnybrook Health Sciences Centre, University of Toronto, Toronto, Canada.
Carolyn OwenFoothills Medical Centre and Tom Baker Cancer Centre, Calgary, Canada.
Nizar Abdel-SamadDivision of Hematology, The Moncton Hospital, Moncton, Canada.
Graeme A M FraserDepartment of Oncology, Juravinski Cancer Centre, McMaster University, Hamilton, Canada.
Selay LamVictoria Hospital, Western University, London, Canada.
Michael CrumpCanadian Cancer Trials Group, Queens University, Kingston, Canada; Division of Hematology, Department of Medicine, Princess Margaret Hospital and University of Toronto, Toronto, Canada.
Catherine SperlichCentre integre de Santé et de Services Sociaux de la Montérégie-Centre, Greenfield Park, Canada.
Richard van der JagtHematology, Ottawa Hospital, University of Ottawa, Ottawa, Canada.
Anca PricaCanadian Cancer Trials Group, Queens University, Kingston, Canada; Division of Hematology, Department of Medicine, Princess Margaret Hospital and University of Toronto, Toronto, Canada.
Stephen CoubanCanadian Cancer Trials Group, Queens University, Kingston, Canada; Queen Elizabeth II Health Sciences Centre, Dalhousie University, Halifax, Canada.
Jennifer A WoyachDivision of Hematology, The Ohio State University, Columbus, OH.
Amy S RuppertDivision of Hematology, The Ohio State University, Columbus, OH; Alliance Statistics and Data Center, Mayo Clinic, Rochester, MN.
Allison M BoothAlliance Statistics and Data Center, Mayo Clinic, Rochester, MN; Department of Quantitative Health Sciences, and Alliance Statistics and Data Center, Mayo Clinic, Rochester, MN.
Sumithra J MandrekarDepartment of Quantitative Health Sciences, and Alliance Statistics and Data Center, Mayo Clinic, Rochester, MN.
Gail McDonaldCanadian Cancer Trials Group, Queens University, Kingston, Canada.
Lois E ShepherdDepartment of Pharmacology and Toxicology and Institute for Health Policy Management and Evaluation, Sunnybrook Research Institute, Sunnybrook Health Sciences Centre, University of Toronto, Toronto, Canada.
Hope YenCanadian Cancer Trials Group, Queens University, Kingston, Canada.
Bingshu E ChenCanadian Cancer Trials Group, Queens University, Kingston, Canada.
Annette E HayCanadian Cancer Trials Group, Queens University, Kingston, Canada; Department of Medicine, Queen's University, Kingston, Ontario, Canada.
Queen's University · CAAlliance Data (United States) · USThe Ohio State University · USUniversity of Toronto · CADalhousie University · CAFoothills Medical Centre · CAHealth Sciences Centre · CAJuravinski Cancer Centre · CAMoncton Hospital · CAPrincess Margaret Cancer Centre · CASanté Montérégie · CASunnybrook Health Science Centre · CAUniversity of Ottawa · CAVictoria Hospital · CA

Funding

Member Site CoreU10CA180821 · NCI · BRIGHAM AND WOMEN'S HOSPITAL · PI Evanthia Galanis · 2014 to 2026
$177.3M
Statistics CoreU10CA180882 · NCI · MAYO CLINIC ROCHESTER · PI Sumithra Jay Mandrekar · 2014 to 2026
$115.0M
NCIC Clinical Trials Group - Canadian Collaborating Clinical Trials NetworkU10CA180863 · NCI · QUEEN'S UNIVERSITY AT KINGSTON · PI Janet Ellen Dancey · 2014 to 2026
$40.4M
OSU as a Network Lead Academic Participating Site for the NCI NCTNUG1CA233331 · NCI · OHIO STATE UNIVERSITY · PI John L. Hays, Dwight H. Owen · 2019 to 2026
$8.9M
NCI NIH HHS U10 CA180821NCI NIH HHS U10 CA180863NCI NIH HHS U10 CA180882NCI NIH HHS UG1 CA233331
6 · The paper itself

Abstract

introductionThe Alliance A041202/CCTG CLC.2 trial demonstrated superior progression-free survival with ibrutinib-based therapy compared to chemoimmunotherapy with bendamustine-rituximab (BR) in previously untreated older patients with chronic lymphocytic leukemia. We completed a prospective trial-based economic analysis of Canadian patients to study the direct medical costs and quality-adjusted benefit associated with these therapies.

methodsMean survival was calculated using the restricted mean survival method from randomization to the study time-horizon of 24 months. Health state utilities were collected using the EuroQOL EQ-5D instrument with Canadian tariffs applied to calculate quality-adjusted life years (QALYs). Costs were applied to resource utilization data (expressed in 2019 US dollars). We examined costs and QALYs associated ibrutinib, ibrutinib with rituximab (IR), and BR therapy.

resultsA total of 55 patients were enrolled; two patients were excluded from the analysis. On-protocol costs (associated with protocol-specified resource use) were higher for patients receiving ibrutinib (mean $189,335; P < 0.0001) and IR (mean $219,908; P < 0.0001) compared to BR (mean $51,345), driven by higher acquisition costs for ibrutinib. Total mean costs (over 2-years) were $192,615 with ibrutinib, $223,761 with IR, and $55,413 with BR (P < 0.0001 for ibrutinib vs. BR and P < 0.0001 for IR vs. BR). QALYs were similar between the three treatment arms: 1.66 (0.16) for ibrutinib alone, 1.65 (0.24) for IR, and 1.66 (0.17) for BR; therefore, a formal cost-utility analysis was not conducted.

conclusionsDirect medical costs are higher for patients receiving ibrutinib-based therapies compared to chemoimmunotherapy in frontline chronic lymphocytic leukemia, with the cost of ibrutinib representing a key driver.

Indexed as

AdenineAgedAntineoplastic Combined Chemotherapy ProtocolsBendamustine HydrochlorideFemaleHumansLeukemia, Lymphocytic, Chronic, B-CellMalePiperidinesProspective StudiesRituximabSurvival AnalysisTreatment OutcomeAdenineBendamustine HydrochlorideibrutinibPiperidinesRituximabChronic lymphocytic leukemia, Ibrutinib, Bendamustine-rituximab, Phase III trialEconomic analysis

Identifiers

PMID34334330
PMCPMC8568662
OpenAlexW3179993901

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

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.