Evidence map›Paper›PMID 34121184›Full record

Observational studyBritish journal of haematology2021

A retrospective observational study to evaluate the clinical outcomes and routine management of patients with chronic lymphocytic leukaemia treated with idelalisib and rituximab in the UK and Ireland (RETRO-idel).

Toby A Eyre, Gavin Preston, Huseini Kagdi, Amin Islam, Toby Nicholson, Harry W Smith, Adam P Cursley, Heribert Ramroth, Guan Xing, Lin Gu and 2 more

Open access · greenAbstract readMulticenter StudyObservational Study
In one paragraph

Observational study in British journal of haematology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed, 1 pooled it
2.0field-weighted citation impact, top 13% 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

12 citing papers in PubMed, 1 synthesis or guideline pooled it, 19 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Article
  4. PI3K Inhibitors in Hematology: When One Door Closes….Clinical cancer research : an official journal of the American Association for Cancer Research · 2024
    Review
  5. Review
  6. Article
  7. Review
  8. Review
  9. Review
  10. Review
  11. Review
  12. PI3K Inhibitors in Cancer: Clinical Implications and Adverse Effects.International journal of molecular sciences · 2021
    Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

12 authors at 8 institutions in 3 countries.

Toby A EyreHaematology, Oxford University NHS Trust, Oxford, UK.ORCID 0000-0002-6631-9749
Gavin PrestonHaematology, Aberdeen Royal Infirmary, Aberdeen, UK.
Huseini KagdiDepartment of Haematology, London North West Healthcare NHS Trust, Harrow, UK.
Amin IslamHaematology, Southend University Hospital NHS Foundation Trust, Westcliff-on-Sea, UK.
Toby NicholsonDepartment of Haematology, St Helens and Knowsley Teaching Hospitals NHS Trust, Prescot, UK.
Harry W SmithMedical Affairs, Gilead Sciences Europe Ltd, London, UK.ORCID 0000-0002-0575-8844
Adam P CursleyClinical Operations, Gilead Sciences Europe Ltd, Uxbridge, UK.
Heribert RamrothEpidemiology, Gilead Sciences Europe Ltd, Uxbridge, UK.
Guan XingGilead Sciences Inc, Foster City, USA.
Lin GuBiostatistics, Gilead Sciences Inc, Foster City, USA.
Nishanthan RajakumaraswamyOncology/Hematology, Gilead Sciences Inc, Foster City, USA.
Christopher FeganDepartment of Haematology, University Hospital of Wales, Cardiff, UK.ORCID 0000-0001-9685-0621
Gilead Sciences (United Kingdom) · GBGilead Sciences (United States) · USAberdeen Royal Infirmary · GBLondon North West Healthcare NHS Trust · GBOxford University Hospitals NHS Trust · GBSouthend University Hospital NHS Foundation Trust · GBSt Helens and Knowsley Teaching Hospitals NHS Trust · GBUniversity Hospital of Wales · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Idelalisib (IDL) is an oral first-in-class phosphatidylinositol 3-kinase delta (PI3Kδ) inhibitor approved for chronic lymphocytic leukaemia (CLL) alongside rituximab (R) since 2014. However, little data exist on routine practice. The RETRO-idel was a protocol-led, retrospective study of 110 patients [n = 27 front-line (1L)] who received IDL-R. The primary end-point was clinical overall response rate (ORR). The median (range) follow-up of the whole cohort was 30·2 (0·1-51·9) months. The median (range) age was 72 (48-89) years. Tumour protein p53-disruption was common [100% 1L, 32·5% relapsed/refractory (R/R)]. The best ORR (intention-to-treat) was 88·2% (1L 96·3%, R/R 85·5%). Overall, the median event-free survival (mEFS) was 20·3 months and time-to-next treatment was 29·2 months. The mEFS for 1L patients was 18·7 months and R/R patients was 21·7 months. The 3-year overall survival was 56·1% (95% confidence interval 45·7-65·3). IDL was discontinued in 87·3% (n = 96). More patients discontinued due to adverse events in the front-line setting (1L 63·0% vs. R/R 44·6%) and due to progressive disease in R/R patients (20·5% vs. 3·7% in 1L). Lower respiratory tract infection/pneumonia were reported in 34·5% (Grade ≥3, 19·1%), diarrhoea in 30·9% (Grade ≥3, 6·4%), and colitis in 9·1% (Grade ≥3, 5·5%). Overall, these data describe clear efficacy for IDL-R in routine practice. No new safety signals were identified, although careful management of known toxicities is required.

Indexed as

AgedAntineoplastic Combined Chemotherapy ProtocolsFemaleGastrointestinal DiseasesHematologic DiseasesHumansIrelandKaplan-Meier EstimateLeukemia, Lymphocytic, Chronic, B-CellMaleMiddle AgedPhosphoinositide-3 Kinase InhibitorsProgression-Free SurvivalPurinesQuinazolinonesRespiratory Tract DiseasesidelalisibPhosphoinositide-3 Kinase InhibitorsPurinesQuinazolinonesRituximabB-cell receptor inhibitorchronic lymphocytic leukaemiaidelalisibPI3Kretrospective

Identifiers

PMID34121184
PMCPMC8361941
OpenAlexW3171998694

What OpenQuestion 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 OpenQuestion graph.