ReviewAnnals of oncology : official journal of the European Society for Medical Oncology2021
Immunotherapy use outside clinical trial populations: never say never?
Review in Annals of oncology : official journal of the European Society for Medical Oncology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 22 papers, 1 of them a synthesis that pooled 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.
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.
Who cites it
22 citing papers in PubMed, 1 synthesis or guideline pooled it, 38 citations in OpenAlex.
- Immune Checkpoint Inhibitors in the Treatment of Patients With Cancer and Preexisting Psoriasis: A Systematic Review and Meta-Analysis of Observational Studies.Frontiers in oncology · 2022Pooled it
- Immune-related adverse events between elderly patients with gastrointestinal and lung cancers: A real-world study.Chinese medical journal · 2026Article
- The management of rheumatic immune related adverse events.Best practice & research. Clinical rheumatology · 2026Review
- Management of Metastatic Colorectal Cancer in Pregnancy: A Systematic Review of a Multidisciplinary Challenge.Visceral medicine · 2026Review
- A Healthy Pregnancy During Treatment of Metastatic Melanoma with Immune Checkpoint Inhibitors: A Case Report.Journal of clinical medicine · 2025Article
- Article
- Autophagy inhibition improves the efficacy of anlotinib and PD-1 inhibitors in the treatment of NSCLC.Journal for immunotherapy of cancer · 2025Article
- Advances in molecular pathology and therapy of non-small cell lung cancer.Signal transduction and targeted therapy · 2025Review
- Assessment of Quality of Life and Difficulties in Recording Data from Health-Related Quality of Life Questionnaires in Patients with Cancer Undergoing Immunotherapy Treatment.Healthcare (Basel, Switzerland) · 2025Article
- Efficacy and safety of anlotinib monotherapy or combination therapy in the treatment of patients with advanced non-small cell lung cancer: a retrospective real-world study conducted in East China.BMC pulmonary medicine · 2025Article
- PD-L1: From cancer immunotherapy to therapeutic implications in multiple disorders.Molecular therapy : the journal of the American Society of Gene Therapy · 2024Review
- Article
- Article
- Article
- Outcomes of Chemoimmunotherapy Among Patients With Extensive-Stage Small Cell Lung Cancer According to Potential Clinical Trial Eligibility.JAMA network open · 2023Article
- Immune checkpoint inhibitors for patients with pre-existing autoimmune diseases.Nagoya journal of medical science · 2023Article
- Mechanism and Management of Checkpoint Inhibitor-Related Toxicities in Genitourinary Cancers.Cancers · 2022Review
- Choosing the optimal immunotherapeutic strategies for non-small cell lung cancer based on clinical factors.Frontiers in oncology · 2022Review
- Treatment of Cutaneous Squamous Cell Carcinoma with Immune Checkpoint Inhibitors in Special Populations.Dermatology practical & conceptual · 2021Review
- Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors at 3 institutions in 2 countries.
Funding
Abstract
backgroundBased on favourable outcomes in clinical trials, immune checkpoint inhibitors (ICIs), most notably programmed cell death protein 1 (PD-1) and cytotoxic T-lymphocyte antigen-4 (CTLA-4) inhibitors, are now widely used across multiple cancer types. However, due to their strict inclusion and exclusion criteria, clinical studies often do not address challenges presented by non-trial populations.
designThis review summarises available data on the efficacy and safety of ICIs in trial-ineligible patients, including those with autoimmune disease, chronic viral infections, organ transplants, organ dysfunction, poor performance status, and brain metastases, as well as the elderly, children, and those who are pregnant. In addition, we review data concerning other real-world challenges with ICIs, including timing of therapy switch, relationships to radiotherapy or surgery, re-treatment after an immune-related toxicity, vaccinations in patients on ICIs, and current experience around ICI and coronavirus disease-19. Where possible, we provide recommendations to aid the often-difficult decision-making process in those settings.
conclusionsData suggest that ICIs are often active and have an acceptable safety profile in the populations described above, with the exception of PD-1 inhibitors in solid organ transplant recipients. Decisions about whether to treat with ICIs should be personalised and require multidisciplinary input and careful counselling of patients with respect to potential risks and benefits. Clinical judgements need to be carefully weighed, considering factors such as underlying cancer type, feasibility of alternative treatment options, or activity in trial-eligible patients.
Indexed as
Identifiers
What OpenQuestion holds
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.