Evidence map›Paper›PMID 28336937›Full record

Trial reportLeukemia2017

Results of the randomized phase IIB ARCTIC trial of low-dose rituximab in previously untreated CLL.

D R Howard, T Munir, L McParland, A C Rawstron, D Milligan, A Schuh, A Hockaday, D J Allsup, S Marshall, A S Duncombe and 5 more

Open access · bronzeAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Leukemia, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers.

0numbers the graph read from it
0cells of the map it votes in
17citing papers in PubMed
2.5field-weighted citation impact, top 11% 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

17 citing papers in PubMed, 33 citations in OpenAlex.

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  16. Haematologica · 2018
    Review
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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

15 authors at 7 institutions in 1 country.

D R HowardClinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, UK.ORCID 0000-0003-3333-9783
T MunirDepartment of Haematology, St James's University Hospital, Leeds, UK.
L McParlandClinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, UK.
A C RawstronHaematological Malignancy Diagnostic Service, St James's University Hospital, Leeds, UK.ORCID 0000-0003-0798-9790
D MilliganCentre for Haematology and Stem Cell Transplantation, Heartlands Hospital, Birmingham, UK.
A SchuhDepartment of Oncology, University of Oxford and Department of Haematology, Oxford University Hospital Trust, Oxford, UK.
A HockadayClinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, UK.
D J AllsupDepartment of Haematology, Hull and East Yorkshire NHS Trust, Hull, United Kingdom and Hull York Medical School, University of Hull, Hull, UK.ORCID 0000-0001-6159-6109
S MarshallDepartment of Haematology, City Hospitals Sunderland, Sunderland, UK.
A S DuncombeDepartment of Haematology, University Hospital Southampton, Southampton, UK.
J L O'DwyerAcademic Unit of Health Economics, Leeds Institute of Health Sciences, University of Leeds, Leeds, UK.
A F SmithAcademic Unit of Health Economics, Leeds Institute of Health Sciences, University of Leeds, Leeds, UK.
R LongoAcademic Unit of Health Economics, Leeds Institute of Health Sciences, University of Leeds, Leeds, UK.
A VargheseDepartment of Haematology, St James's University Hospital, Leeds, UK.
P HillmenSection of Experimental Haematology, Leeds Institute of Cancer and Pathology (LICAP), University of Leeds, Leeds, UK.
University of Leeds · GBSt James's University Hospital · GBHeartlands Hospital · GBSunderland Royal Hospital · GBUniversity Hospital Southampton NHS Foundation Trust · GBUniversity of Hull · GBUniversity of Oxford · GB

Funding

Department of Health 07/01/38
6 · The paper itself

Abstract

ARCTIC was a multicenter, randomized-controlled, open, phase IIB non-inferiority trial in previously untreated chronic lymphocytic leukemia (CLL). Conventional frontline therapy in fit patients is fludarabine, cyclophosphamide and rituximab (FCR). The trial hypothesized that including mitoxantrone with low-dose rituximab (FCM-miniR) would be non-inferior to FCR. A total of 200 patients were recruited to assess the primary end point of complete remission (CR) rates according to IWCLL criteria. Secondary end points were progression-free survival (PFS), overall survival (OS), overall response rate, minimal residual disease (MRD) negativity, safety and cost-effectiveness. The trial closed following a pre-planned interim analysis. At final analysis, CR rates were 76 FCR vs 55% FCM-miniR (adjusted odds ratio: 0.37; 95% confidence interval: 0.19-0.73). MRD-negativity rates were 54 FCR vs 44% FCM-miniR. More participants experienced serious adverse reactions with FCM-miniR (49%) compared to FCR (41%). There are no significant differences between the treatment groups for PFS and OS. FCM-miniR is not expected to be cost-effective over a lifetime horizon. In summary, FCM-miniR is less well tolerated than FCR with an inferior response and MRD-negativity rate and increased toxicity, and will not be taken forward into a confirmatory trial. The trial demonstrated that oral FCR yields high response rates compared to historical series with intravenous chemotherapy.

Indexed as

AdultAgedAged, 80 and overAntineoplastic AgentsCosts and Cost AnalysisDose-Response Relationship, DrugFemaleHumansLeukemia, Lymphocytic, Chronic, B-CellMaleMiddle AgedRituximabSurvival AnalysisAntineoplastic AgentsRituximab

Identifiers

PMID28336937
OpenAlexW2602893476

What OpenQuestion holds

Textmetadata
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 OpenQuestion graph.