ArticleJournal of clinical oncology : official journal of the American Society of Clinical Oncology2014
Impact of informative censoring on the Kaplan-Meier estimate of progression-free survival in phase II clinical trials.
Article in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 26 papers.
What it found
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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
26 citing papers in PubMed.
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- Trastuzumab and bevacizumab combined with docetaxel, oxaliplatin and capecitabine as first-line treatment of advanced HER2-positive gastric cancer: a multicenter phase II study.Investigational new drugs · 2016Trial
- Evaluating Post-Progression Survival in the Context of Progression-Free Survival Benefits: A Revisit of the CodeBreaK200 Design.Therapeutic innovation & regulatory science · 2026Article
- Selection Biases in Perinatal Research: A Comparison of Inverse Probability Weighting, Instrumental Variable and Sibling-Comparison Design.Paediatric and perinatal epidemiology · 2026Article
- Informative censoring in externally controlled clinical trials: a potential source of bias.ESMO open · 2025Article
- Estimand Framework and Statistical Considerations for Integrated Analysis of Clinical Trial Safety Data.Therapeutic innovation & regulatory science · 2024Article
- Twelve ESMO Congress 2022 breakthroughs: practicing oncologists' perceptions and potential application on presented data.ESMO open · 2023Article
- Informative Censoring-A Cause of Bias in Estimating COVID-19 Mortality Using Hospital Data.Life (Basel, Switzerland) · 2023Article
- A novel dynamic Bayesian network approach for data mining and survival data analysis.BMC medical informatics and decision making · 2022Article
- An updated estimate of posttransplant survival after implementation of the new donor heart allocation policy.American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons · 2022Article
- Non-steroidal anti-inflammatory drug-associated acute kidney injury: does short-term NSAID use pose a risk in hospitalized patients?European journal of clinical pharmacology · 2021Article
- Hospitalization for acute coronary syndrome increases the long-term risk of pneumonia: a population-based cohort study.Scientific reports · 2021Article
- Stromal microenvironment promoted infiltration in esophageal adenocarcinoma and squamous cell carcinoma: a multi-cohort gene-based analysis.Scientific reports · 2020Article
- BrandJournal of the Royal Statistical Society. Series A, (Statistics in Society) · 2020Article
- Is it too early to investigate survival outcomes of the new US heart allocation system?The Journal of heart and lung transplantation : the official publication of the International Society for Heart Transplantation · 2020Article
- An evaluation of the impact of missing deaths on overall survival analyses of advanced non-small cell lung cancer patients conducted in an electronic health records database.Pharmacoepidemiology and drug safety · 2019Observational
- Treatment of Neuroblastoma with a Novel Delayed Intensification Chemotherapy.Indian journal of pediatrics · 2019Article
- Tumor Size and Overall Survival in Patients With Platinum-Resistant Ovarian Cancer Treated With Chemotherapy and Bevacizumab.Clinical Medicine Insights. Oncology · 2019Article
- Review
- Interpretation of Results from Under-accruing Studies.The oncologist · 2018Article
Corrections and comments
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Authors and funding
2 authors.
Funding
Abstract
Informative censoring in a progression-free survival (PFS) analysis arises when patients are censored for initiation of an effective anticancer treatment before the protocol-defined progression, and these patients are at a different risk for treatment failure than those who continue on therapy. This may cause bias in the estimated PFS when using the Kaplan-Meier method for analysis. Although there are several articles that discuss this issue from a theoretical perspective or in randomized phase III studies, there are little data to demonstrate the magnitude of the bias on the estimated quantities from a phase II trial. This article describes the issues by using two oncology phase II trials as examples, evaluates the impact of the bias using simulations, and provides recommendations. The two trials were selected because they demonstrate two different reasons for censoring. Simulations show that the magnitude of the bias depends primarily on the proportion of patients who are informatively censored and secondarily on the hazard ratio between the group of patients who remain on study and the group of patients who are informatively censored. Recommendations include using an alternative end point, which includes inadequate response and initial signs of clinical progression as treatment failure, and a competing risk analysis for studies in which competing events preclude or modify the probability of observing the primary event of interest. If informative censoring cannot be avoided, then all patients should be observed until progression, and sensitivity analyses should be used as appropriate.
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