Evidence map›Paper›PMID 34234443›Full record

ArticleTherapeutics and clinical risk management2021

Adverse Events Induced by PD-1/PD-L1 Inhibitors: A Real-World Single-Centre Experience with a Management-Based Approach.

Fabien Grimaud, Guillaume Penaranda, Chloé Stavris, Frédérique Retornaz, Véronique Brunel, Sylvie Cailleres, Hervé Pegliasco, Jacques Le Treut, Vincent Grisoni, Emilie Coquet and 2 more

Open access · goldAbstract read
In one paragraph

Article in Therapeutics and clinical risk management, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
1.1field-weighted citation impact, top 20% 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

5 citing papers in PubMed, 13 citations in OpenAlex.

  1. Article
  2. Article
  3. Review
  4. Review
  5. Review
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

12 authors at 1 institution in 1 country.

Fabien GrimaudDepartment of Pharmacy, Hôpital Européen, Marseille, France.
Guillaume PenarandaDepartment of Biostatistics, Hôpital Européen, Marseille, France.ORCID 0000-0002-7461-4254
Chloé StavrisDepartment of Internal Medicine, Hôpital Européen, Marseille, France.
Frédérique RetornazDepartment of Internal Medicine, Hôpital Européen, Marseille, France.
Véronique BrunelDepartment of Haemato-Oncology, Hôpital Européen, Marseille, France.
Sylvie CailleresDepartment of Haemato-Oncology, Hôpital Européen, Marseille, France.
Hervé PegliascoDepartment of Pulmonology, Hôpital Européen, Marseille, France.
Jacques Le TreutDepartment of Pulmonology, Hôpital Européen, Marseille, France.
Vincent GrisoniDepartment of Urology, Hôpital Européen, Marseille, France.
Emilie CoquetDepartment of Pharmacy, Hôpital Européen, Marseille, France.ORCID 0000-0003-4344-0658
Laurent ChicheDepartment of Internal Medicine, Hôpital Européen, Marseille, France.ORCID 0000-0002-0582-694X
Amélie RognonDepartment of Pharmacy, Hôpital Européen, Marseille, France.
Hôpital Européen · FR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimTo assess the efficacy and tolerance of programmed death-1 (PD-1) and PD-ligand 1 (PD-L1) inhibitors and the impact of a standardised management-based protocol in a real-world setting. PATIENTS AND

methodsData from patients who had received anti-PD-(L)1 were collected from our pharmacy database. Clinical response and toxicity were assessed using RECIST criteria and CTCAE version 5.0, respectively. Overall survival (OS) and progression-free survival (PFS) were estimated with the Kaplan-Meier method. Potential prognostic factors were identified using Cox's model.

resultsA total of 196 patients and 201 lines of treatment were included (median age: 66 (range: 38-89) years). Types of cancer included non-small cell lung cancer (73%), transitional cell carcinoma (10%), renal cell carcinoma (6%), small cell lung cancer (5%), head and neck squamous cell carcinoma (4%) and classical Hodgkin's lymphoma (1%). Twenty-five (12%) patients had pre-existing autoimmune conditions. Our standardised management-based protocol included 129 (64%) patients. Objective response rate was 29%, median OS was 10 months (IQR: 7-15) and median PFS was 5 months (IQR: 1-22). Patients with an abnormal baseline complete blood count had a worse OS (HR=2.48 [95% CI: 1.24-4.96]; p=0.0103). Thirty-three (16%) patients experienced severe (grade 3 or 4) immune-related adverse event (irAE). There were three (1%) irAE-related deaths. AEs resolved faster when patients were assessed by an internist before anti-PD-(L)1 initiation (p=0.0205).

conclusionPD-1 and PD-L1 inhibitors are effective and safe in a real-world setting. Implementation of a standardised management-based protocol with internal medicine specialists is an effective way to optimise irAE management.

Indexed as

elderlyimmune-related adverse eventsimmunotherapyPD-1 inhibitorPD-L1 inhibitorPDL-1 inhibitorprognostic biomarkerssafetysolid tumours

Identifiers

PMID34234443
PMCPMC8256379
OpenAlexW3176672913

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.