Trial reportBreast cancer research : BCR2012
Prognostic and predictive value of TP53 mutations in node-positive breast cancer patients treated with anthracycline- or anthracycline/taxane-based adjuvant therapy: results from the BIG 02-98 phase III trial.
Trial report in Breast cancer research : BCR, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00174655 (An Intergroup Phase III Trial to Evaluate the Activity of Docetaxel, Given Either Sequentially or in Combination With Doxorubicin, Followed by CMF, in Comparison to Doxorubicin Alone or in Combination With Cyclophosphamide, Followed by CMF, in the Adjuvant Treatment of Node-positive Breast Cancer Patients.), which is not on this map. Cited by 32 papers, 2 of them syntheses that pooled it.
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.
An Intergroup Phase III Trial to Evaluate the Activity of Docetaxel, Given Either Sequentially or in Combination With Doxorubicin, Followed by CMF, in Comparison to Doxorubicin Alone or in Combination With Cyclophosphamide, Followed by CMF, in the Adjuvant Treatment of Node-positive Breast Cancer Patients.
Who cites it
32 citing papers in PubMed, 2 syntheses or guidelines pooled it, 57 citations in OpenAlex.
- Impact of TP53 somatic mutations on prognosis in endometrial cancer: a systematic review and meta-analysis.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2026Pooled it
- Clinicopathologic characteristics of brain tumors are associated with the presence and patterns of TP53 mutations: evidence from the IARC TP53 Database.Neuromolecular medicine · 2014Pooled it
- p53 immunohistochemistry in endometrial cancer: clinical and molecular correlates in the PORTEC-3 trial.Modern pathology : an official journal of the United States and Canadian Academy of Pathology, Inc · 2022Trial
- Prognostic interaction between expression of p53 and estrogen receptor in patients with node-negative breast cancer: results from IBCSG Trials VIII and IX.Breast cancer research : BCR · 2012Trial
- Baseline gene expression and dynamic endocrine therapy use in ER+ breast cancer: associations with recurrence in a real-world cohort.Research square · 2026Article
- A retrospective analysis of taxane-based chemotherapy in small bowel adenocarcinoma.The oncologist · 2026Article
- Clinical Relevance ofCancers · 2024Article
- Prognostic Role of p53 Immunohistochemical Status in Invasive Breast Cancer. A Retrospective Review of 1387 Cases With Luminal-Like/Her2 Negative Breast Tumors.The oncologist · 2024Article
- The Mutational Spectrum of Pre- and Post-Neoadjuvant Chemotherapy Triple-Negative Breast Cancers.Genes · 2023Article
- Article
- Prognostic Value of theCancer management and research · 2021Article
- Triple-Negative Breast Cancer: Assessing the Role of Immunohistochemical Biomarkers on Neoadjuvant Treatment.Breast cancer (Dove Medical Press) · 2021Article
- Adjuvant regional nodal irradiation did not improve outcomes in T1-2N1 breast cancer after breast-conserving surgery: A propensity score matching analysis of BIG02/98 and BCIRG005 trials.Breast (Edinburgh, Scotland) · 2020Article
- TP53 Mutations and Outcomes in Breast Cancer: Reading beyond the Headlines.Trends in cancer · 2020Review
- Pathogenic mutations and overall survival in 3,084 patients with cancer: the Hellenic Cooperative Oncology Group Precision Medicine Initiative.Oncotarget · 2020Article
- Comment to Impact of postmastectomy radiotherapy on the outcomes of breast cancer patients with T1-2 N1 disease; an individual patient data analysis of three clinical trials.Strahlentherapie und Onkologie : Organ der Deutschen Rontgengesellschaft ... [et al] · 2019Article
- Impact of postmastectomy radiotherapy on the outcomes of breast cancer patients with T1-2 N1 disease : An individual patient data analysis of three clinical trials.Strahlentherapie und Onkologie : Organ der Deutschen Rontgengesellschaft ... [et al] · 2019Article
- Prognostic significance of CD117 expression andOncology letters · 2018Article
- Article
- Exome Sequencing Identifies Potentially Druggable Mutations in Nasopharyngeal Carcinoma.Scientific reports · 2017Article
Corrections and comments
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Authors and funding
17 authors at 8 institutions in 6 countries.
Funding
Abstract
introductionPre-clinical data suggest p53-dependent anthracycline-induced apoptosis and p53-independent taxane activity. However, dedicated clinical research has not defined a predictive role for TP53 gene mutations. The aim of the current study was to retrospectively explore the prognosis and predictive values of TP53 somatic mutations in the BIG 02-98 randomized phase III trial in which women with node-positive breast cancer were treated with adjuvant doxorubicin-based chemotherapy with or without docetaxel.
methodsThe prognostic and predictive values of TP53 were analyzed in tumor samples by gene sequencing within exons 5 to 8. Patients were classified according to p53 protein status predicted from TP53 gene sequence, as wild-type (no TP53 variation or TP53 variations which are predicted not to modify p53 protein sequence) or mutant (p53 nonsynonymous mutations). Mutations were subcategorized according to missense or truncating mutations. Survival analyses were performed using the Kaplan-Meier method and log-rank test. Cox-regression analysis was used to identify independent predictors of outcome.
resultsTP53 gene status was determined for 18% (520 of 2887) of the women enrolled in BIG 02-98. TP53 gene variations were found in 17% (90 of 520). Nonsynonymous p53 mutations, found in 16.3% (85 of 520), were associated with older age, ductal morphology, higher grade and hormone-receptor negativity. Of the nonsynonymous mutations, 12.3% (64 of 520) were missense and 3.6% were truncating (19 of 520). Only truncating mutations showed significant independent prognostic value, with an increased recurrence risk compared to patients with non-modified p53 protein (hazard ratio = 3.21, 95% confidence interval = 1.740 to 5.935, P = 0.0002). p53 status had no significant predictive value for response to docetaxel.
conclusionsp53 truncating mutations were uncommon but associated with poor prognosis. No significant predictive role for p53 status was detected.
trial registrationClinicalTrials.gov NCT00174655.
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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.