Trial reportBritish journal of clinical pharmacology2026
Main factors associated with variability in the assessment of the objective response rate. A re-analysis of the PHEREXA phase 3 clinical trial.
Trial report in British journal of clinical pharmacology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01026142 (A Multicenter Randomized Phase III Study to Compare the Combination Trastuzumab and Capecitabine, With or Without Pertuzumab, in Patients With HER2-Positive Metastatic Breast Cancer That Have Progressed After One Line of Trastuzumab-Based Therapy in the Metastatic Setting), which is not on this map. Cited by 2 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.
A Multicenter Randomized Phase III Study to Compare the Combination Trastuzumab and Capecitabine, With or Without Pertuzumab, in Patients With HER2-Positive Metastatic Breast Cancer That Have Progressed After One Line of Trastuzumab-Based Therapy in the Metastatic Setting (PHEREXA)
Who cites it
2 citing papers in PubMed.
- Main factors associated with variability in the assessment of the objective response rate. A re-analysis of the PHEREXA phase 3 clinical trial.British journal of clinical pharmacology · 2026Trial
- Matching-adjusted indirect comparison of enzalutamide versus apalutamide with androgen-deprivation therapy in patients with metastatic hormone-sensitive prostate cancer.Future oncology (London, England) · 2026Article
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.
Funding
No grant is acknowledged in the PubMed record.
Abstract
aimLocal investigators (LIs) overestimate the objective response rate (ORR) in comparison to Blinded Independent Central Reviewers (BICR) in oncology. In this study, we re-analysed data obtained in the PHEREXA trial (NCT01026142) with the following aims: i) to confirm at the single-patient level the discrepancy observed by analysing aggregated data; ii) to investigate the causes underlying such discrepancy.
methodsIndividual data, available on the VIVLI platform, were analysed. For each patient, the best response was established for LIs and BICR. "Eligible" patients were those with at least one target lesion at screening. The degree of agreement was assessed through the Cohen's Kappa coefficient. Multivariate logistic regression analysis was performed to understand the reasons underlying the discrepancy.
resultsEligible subjects were 364/452 according to LIs and 371/450 per BICR. We confirmed that LIs overestimate the ORR. We found moderate agreement between the two evaluations (Cohen's κ= 0.48, p < 0.001). The probability of discrepancy increased by 20% with the increasing number of target lesions evaluated. Selection of 8-10 lesions was associated with an increased risk of discrepancy (OR, 5.27; CI 95% = 1.21-24.92; p < 0.03). The evaluation of breast, lung and lymph nodes (only) significantly increased the probability of discrepancy in comparison to the analysis of lymph nodes + organ.
conclusionThe overestimation of the tumour response by LIs increases with the number of target lesions analysed as well as with specific evaluation sites. Thus, the adoption of the two evaluations appears necessary in uncontrolled trials to provide a better estimate of tumour response.
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