Trial reportCancer imaging : the official publication of the International Cancer Imaging Society2018
Discrepancies of assessments in a RECIST 1.1 phase II clinical trial - association between adjudication rate and variability in images and tumors selection.
Trial report in Cancer imaging : the official publication of the International Cancer Imaging Society, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01500720 (Randomized Phase II Study of Cabazitaxel Versus Topotecan in Small Cell Lung Cancer Patients With Progressive Disease During or After a First Line Platinum Based Chemotherapy), which is not on this map. Cited by 30 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.
Randomized Phase II Study of Cabazitaxel Versus Topotecan in Small Cell Lung Cancer Patients With Progressive Disease During or After a First Line Platinum Based Chemotherapy
Who cites it
30 citing papers in PubMed, 1 synthesis or guideline pooled it, 38 citations in OpenAlex.
- Twenty Years On: RECIST as a Biomarker of Response in Solid Tumours an EORTC Imaging Group - ESOI Joint Paper.Frontiers in oncology · 2021Pooled it
- Interobserver Variability in CT-based Morphologic Tumor Response Assessment of Colorectal Liver Metastases.Radiology. Imaging cancer · 2022Trial
- Decentralized Clinical Trials in Oncology-A Radiological Perspective.Korean journal of radiology · 2026Article
- Setting the standard: empirical benchmarks for case-level site-central discordance in radiographic endpoints in oncology clinical trials.Contemporary clinical trials communications · 2026Article
- What are RECIST 1.1 progressions made of? Variability in double-read oncology trials.European radiology · 2026Article
- Assessing the reliability of Response Evaluation Criteria In Solid Tumors (RECIST): a systematic review of the factors contributing to inter-observer variability.Insights into imaging · 2026Article
- Review
- Advancing deep learning-based segmentation for multiple lung cancer lesions in real-world multicenter CT scans.European radiology experimental · 2025Article
- Limitations of Radiographic Response Assessments of Systemic Therapy for Advanced Hepatocellular Carcinoma.JCO precision oncology · 2025Article
- Using Dose-Escalation and -Expansion Cohort Study as Pivotal Trial for Targeted Anticancer Drug Approval.JCO precision oncology · 2025Review
- Methylation-Based ctDNA Tumor Fraction Changes Predict Long-Term Clinical Benefit From Immune Checkpoint Inhibitors in RADIOHEAD, a Real-World Pan-Cancer Study.Cancer research communications · 2025Article
- Article
- A call for objectivity: Radiologists' proposed wishlist for response evaluation in solid tumors (RECIST 1.1).Cancer imaging : the official publication of the International Cancer Imaging Society · 2024Review
- RECIST 1.1 assessments variability: a systematic pictorial review of blinded double reads.Insights into imaging · 2024Review
- Can blood-based markers predict RECIST progression in non-small cell lung cancer treated with immunotherapy?Journal of cancer research and clinical oncology · 2024Article
- Reproducing RECIST lesion selection via machine learning: Insights into intra and inter-radiologist variation.European journal of radiology open · 2024Article
- The ins and outs of errors in oncology imaging: the DAC framework for radiologists.Frontiers in oncology · 2024Review
- Deep learning models for automatic tumor segmentation and total tumor volume assessment in patients with colorectal liver metastases.European radiology experimental · 2023Article
- Discrepant Assessments of Progressive Disease in Clinical Trials between Routine Clinical Reads and Formal RECIST 1.1 Interpretations.Radiology. Imaging cancer · 2023Article
- RECIST 1.1 Target Lesion Categorical Response in Metastatic Renal Cell Carcinoma: A Comparison of Conventional versus Volumetric Assessment.Radiology. Imaging cancer · 2023Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors at 6 institutions in 5 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundIn imaging-based clinical trials, it is common practice to perform double reads for each image, discrepant interpretations can result from these two different evaluations. In this study we analyzed discrepancies that occurred between local investigators (LI) and blinded independent central review (BICR) by comparing reader-selected imaging scans and lesions. Our goal was to identify the causes of discrepant declarations of progressive disease (PD) between LI and BICR in a clinical trial.
methodsWe retrospectively analyzed imaging data from a RECIST 1.1-based, multi-sites, phase II clinical trial of 179 patients with adult small cell lung cancer, treated with Cabazitaxel compared to Topotecan. Any discrepancies in the determination of PD between LI and BICR readers were reviewed by a third-party adjudicator. For each imaging time point and reader, we recorded the selected target lesions, non-target lesions, and new lesions. Odds ratios were calculated to measure the association between discrepant declarations of PD and the differences in reviewed imaging scans (e.g. same imaging modality but with different reconstruction parameters) and selected lesions. Reasons for discrepancies were analyzed.
resultsThe average number of target lesions found by LI and BICR was respectively 2.9 and 3.4 per patient (p < 0.05), 18.4% of these target lesions were actually non-measurable. LI and BICR performed their evaluations based on different baseline imaging scans for 59% of the patients, they selected at least one different target lesion in 85% of patients. A total of 36.7% of patients required adjudication. Reasons of adjudication included differences in 1) reporting new lesions (53.7%), 2) the measured change of the tumor burden (18.5%), and 3) the progression of non-target lesions (11.2%). The rate of discrepancy was not associated with the selection of non-measurable target lesions or with the readers' assessment of different images. Paradoxically, more discrepancies occurred when LI and BICR selected exactly the same target lesions at baseline compared to when readers selected not exactly the same lesions.
conclusionsFor a large proportion of evaluations, LI and BICR did not select the same imaging scans and target lesions but with a limited impact on the rate of discrepancy. The majority of discrepancies were explained by the difference in detecting new lesions.
trial registrationARD12166 ( https://clinicaltrials.gov/ct2/show/NCT01500720 ).
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.