ArticleJAMA oncology2021
Uptake and Survival Outcomes Following Immune Checkpoint Inhibitor Therapy Among Trial-Ineligible Patients With Advanced Solid Cancers.
Article in JAMA oncology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 36 papers, 1 of them a synthesis that pooled it.
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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
36 citing papers in PubMed, 1 synthesis or guideline pooled it, 61 citations in OpenAlex.
- Changes to Primary End Points in Randomized Clinical Trials on Immune Checkpoint Inhibitors in Urothelial, Renal Cell, and Lung Cancers: A Systematic Review.JAMA oncology · 2023Pooled it
- Fcγ Receptor Polymorphism in Patients with Relapsed/Refractory High-Risk Neuroblastoma Correlates with Outcomes in the SIOPEN Dinutuximab Beta Long-Term Infusion Trial.Clinical cancer research : an official journal of the American Association for Cancer Research · 2025Trial
- COVID-19 vaccination around immune checkpoint inhibitor start and survival in a nationwide cohort of patients with cancer.Nature medicine · 2026Article
- Racial disparities and utilization trends of first-line targeted therapies for metastatic breast cancer.JNCI cancer spectrum · 2026Article
- High-Grade Immune-Related Adverse Events Resulting from Immune Checkpoint Inhibitor Treatment: Evaluation of Diagnostics and Outcomes in Admitted Patients.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2026Article
- The impact of concomitant medications on treatment outcomes in patients with cancer receiving immune checkpoint inhibitors.Nature reviews. Cancer · 2026Review
- Trends in real-world outcomes of patients with metastatic renal cell cancer in the recent treatment era: a single-institution analysis.International journal of clinical oncology · 2025Article
- Reproducible single-cell annotation of programs underlying T cell subsets, activation states and functions.Nature methods · 2025Article
- Changes in prescribing patterns and access to immune checkpoint inhibitors in german lung cancer patients - a claims data analysis.BMC public health · 2025Article
- Association Between Area-Level Socioeconomic Disadvantage and Immunotherapy in Patients With Non-Small Cell Lung Cancer.Cancer medicine · 2025Article
- Off-Label Use of First-Line Immunotherapy for Metastatic Renal Cell Carcinoma.Clinical genitourinary cancer · 2025Article
- Higher incidence of dermatological immune-related adverse events in cancer patients treated with immune checkpoint inhibitors vs. other treatments: a TriNetX research network study.Archives of dermatological research · 2025Article
- Associations between immune checkpoint inhibitor response, immune-related adverse events, and steroid use in RADIOHEAD: a prospective pan-tumor cohort study.Journal for immunotherapy of cancer · 2025Article
- Review
- Evaluating generalizability of oncology trial results to real-world patients using machine learning-based trial emulations.Nature medicine · 2025Article
- Temporal Effect on PD-L1 Detection and Novel Insights Into Its Clinical Implications in Non-Small Cell Lung Cancer.Cancer medicine · 2024Article
- Efficacy of first-line immune checkpoint inhibitors in pulmonary sarcomatoid carcinoma.Translational lung cancer research · 2024Article
- The performance status gap in immunotherapy for frail patients with advanced non-small cell lung cancer.Cancer immunology, immunotherapy : CII · 2024Article
- Targeting of focal adhesion kinase enhances the immunogenic cell death of PEGylated liposome doxorubicin to optimize therapeutic responses of immune checkpoint blockade.Journal of experimental & clinical cancer research : CR · 2024Article
- Chemoimmunotherapy vs. Immunotherapy for First Line Treatment of Advanced Non-small Cell Lung Cancer With a PD-L1 Expression ≥50% or ≥90.Clinical lung cancer · 2023Article
Corrections and comments
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Authors and funding
9 authors at 3 institutions in 2 countries.
Funding
Abstract
importanceImmune checkpoint inhibitors (ICIs) are part of standard of care for patients with many advanced solid tumors. Patients with poor performance status or organ dysfunction are traditionally ineligible to partake in pivotal randomized clinical trials of ICIs.
objectiveTo assess ICI use and survival outcomes among patients with advanced cancers who are traditionally trial ineligible based on poor performance status or organ dysfunction. DESIGN, SETTING, AND
participantsThis retrospective cohort study was conducted in 280 predominantly community oncology practices in the US and included 34 131 patients (9318 [27.3%] trial ineligible) who initiated first-line systemic therapy from January 2014 through December 2019 for newly diagnosed metastatic or recurrent nontargetable non-small cell lung, urothelial cell, renal cell, or hepatocellular carcinoma. Data analysis was performed from December 1, 2019, to June 1, 2021. EXPOSURES: Trial ineligibility (Eastern Cooperative Oncology Group performance status ≥2 or the presence of kidney or liver dysfunction); first-line systemic therapy. MAIN OUTCOMES AND MEASURES: The association between trial ineligibility and ICI monotherapy uptake was assessed using inverse probability-weighted (IPW) logistic regressions. The comparative survival outcomes following ICI and non-ICI therapy among trial-ineligible patients were assessed using treatment IPW survival analyses. Because we observed nonproportional hazards, we reported 12-month and 36-month restricted mean survival times (RMSTs) and time-varying hazard ratios (HRs) of less than 6 months and 6 months or greater.
resultsAmong the overall cohort (n = 34 131), the median (IQR) age was 70 (62-77) years; 23 586 (69%) were White individuals, and 14 478 (42%) were women. Over the study period, the proportion of patients receiving ICI monotherapy increased from 0% to 30.2% among trial-ineligible patients and 0.1% to 19.4% among trial-eligible patients. Trial ineligibility was associated with increased ICI monotherapy use (IPW-adjusted odds ratio compared with non-ICI therapy, 1.8; 95% CI, 1.7-1.9). Among trial-ineligible patients, there were no overall survival differences between ICI monotherapy, ICI combination therapy, and non-ICI therapy at 12 months (RMST, 7.8 vs 7.7 vs 8.1 months) or 36 months (RMST, 15.0 vs 13.9 vs 14.4 months). Compared with non-ICI therapy, ICI monotherapy showed evidence of early harm (IPW-adjusted HR within 6 months, 1.2; 95% CI, 1.1-1.2) but late benefit (adjusted HR among patients who survived 6 months, 0.8; 95% CI, 0.7-0.8). CONCLUSIONS AND RELEVANCE: In this cohort study, compared with trial-eligible patients, trial-ineligible patients with advanced cancers preferentially received first-line ICI therapy. A survival difference was not detected between ICI and non-ICI therapies among trial-ineligible patients. Positive results for ICI in phase 3 trials may not translate to this vulnerable population.
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