ArticleClinical cancer research : an official journal of the American Association for Cancer Research2022
Replication of Overall Survival, Progression-Free Survival, and Overall Response in Chemotherapy Arms of Non-Small Cell Lung Cancer Trials Using Real-World Data.
Article in Clinical cancer research : an official journal of the American Association for Cancer Research, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers, 1 of them a synthesis that pooled it.
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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
14 citing papers in PubMed, 1 synthesis or guideline pooled it, 22 citations in OpenAlex.
- KRASFrontiers in oncology · 2026Pooled it
- Constructing an External Control Arm Using the French REALYSA Cohort to Replicate Outcomes of a Randomized Trial Arm in Advanced Hodgkin Lymphoma.Clinical pharmacology and therapeutics · 2026Article
- Sieving for gold: external comparator studies to prioritize drugs for late-stage clinical trial.Journal of comparative effectiveness research · 2026Review
- Article
- Efficacy of atezolizumab plus bevacizumab for unresectable HCC: Systematic review and meta-analysis of real-world evidence.JHEP reports : innovation in hepatology · 2025Article
- Characterization of the Population, Treatment Patterns, and Outcomes of Patients with Advanced or Metastatic Non-Small-Cell Lung Cancer (NSCLC) with Epidermal Growth Factor Receptor Mutation (EGFRm): A Retrospective Cohort Study from IPO Porto.Current oncology (Toronto, Ont.) · 2025Article
- Comparative effectiveness among BRAF plus MEK inhibitors for patients with BRAF V600-mutant melanoma.ESMO real world data and digital oncology · 2024Article
- Real-World Treatment Patterns and Clinical Outcomes Among Patients with Metastatic or Unresectable EGFR-Mutated Non-Small Cell Lung Cancer Previously Treated with Osimertinib and Platinum-Based Chemotherapy.Advances in therapy · 2024Article
- Response- and Progression-Based End Points in Trial and Observational Cohorts of Patients With NSCLC.JAMA network open · 2024Observational
- Real-World Treatment Patterns and Clinical Outcomes After Platinum-Doublet Chemotherapy and Immunotherapy in Metastatic Non-Small Cell Lung Cancer: A Multiregional Chart Review in the United States, Europe, and Japan.JCO global oncology · 2024Article
- Measurement error and bias in real-world oncology endpoints when constructing external control arms.Frontiers in drug safety and regulation · 2024Article
- Evaluation of the effectiveness of a nationwide precision medicine program for patients with advanced non-small cell lung cancer in Germany: a historical cohort analysis.The Lancet regional health. Europe · 2024Article
- Overview of approaches to estimate real-world disease progression in lung cancer.JNCI cancer spectrum · 2023Review
- Using Bayesian Evidence Synthesis Methods to Incorporate Real-World Evidence in Surrogate Endpoint Evaluation.Medical decision making : an international journal of the Society for Medical Decision Making · 2023Article
Corrections and comments
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Authors and funding
10 authors at 4 institutions in 3 countries.
Funding
Abstract
purposeThe utility of real-world data (RWD) for use as external controls in drug development is informed by studies that replicate trial control arms for different endpoints. The purpose of this study was to replicate control arms from four non-small cell lung cancer (NSCLC) randomized controlled trials (RCT) to analyze overall survival (OS), progression-free survival (PFS), and overall response rate (ORR) using RWD. PATIENTS AND
methodsThis study used RWD from a nationwide de-identified database and a clinico-genomic database to replicate OS, PFS, and ORR endpoints in the chemotherapy control arms of four first-line NSCLC RCTs evaluating atezolizumab [IMpower150-wild-type (WT), IMpower130-WT, IMpower131, and IMpower132]. Additional objectives were to develop a definition of real-world PFS (rwPFS) and to evaluate the real-world response rate (rwRR) endpoint.
resultsBaseline demographic and clinical characteristics were balanced after application of propensity score weighting methods. For rwPFS and OS, RWD external controls were generally similar to their RCT control counterparts. Across all four trials, the hazard ratio (HR) point estimates comparing trial controls with external controls were closer to 1.0 for the PFS endpoint than for the OS endpoint. An exploratory assessment of rwRR in RWD revealed a slight but nonsignificant overestimation of RCT ORR, which was unconfounded by baseline characteristics.
conclusionsRWD can be used to reasonably replicate the OS and PFS of chemotherapy control arms of first-line NSCLC RCTs. Additional studies can provide greater insight into the utility of RWD in drug development.
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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.