SynthesisThe Lancet. Oncology2019
Disease-free survival as a surrogate for overall survival in patients with HER2-positive, early breast cancer in trials of adjuvant trastuzumab for up to 1 year: a systematic review and meta-analysis.
Synthesis in The Lancet. Oncology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 44 papers, 8 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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
44 citing papers in PubMed, 8 syntheses or guidelines pooled it.
- Thermal ablation for early-stage breast cancer: cryoablation, microwave ablation, radiofrequency ablation, high-intensity focused ultrasound ablation, and laser ablation - a systematic review.Breast (Edinburgh, Scotland) · 2026Pooled it
- Efficacy and safety of antibody-drug conjugate based therapy in locally advanced or metastatic urothelial carcinoma: a systematic review and network meta-analysis of emerging clinical evidence.Frontiers in immunology · 2026Pooled it
- Evaluating surrogates for overall survival in the adjuvant treatment of bladder cancer with chemotherapy.Urologic oncology · 2025Pooled it
- Correlation between pathologic complete response, event-free survival/disease-free survival and overall survival in neoadjuvant and/or adjuvant HR+/HER2-breast cancer.Frontiers in oncology · 2023Pooled it
- Surrogacy analysis of intermediate end-points for overall survival in randomized controlled trials of rhabdomyosarcoma.Scientific reports · 2022Pooled it
- Evaluation of pathological complete response as surrogate endpoint in neoadjuvant randomised clinical trials of early stage breast cancer: systematic review and meta-analysis.BMJ (Clinical research ed.) · 2021Pooled it
- Surrogate endpoint evaluation using data from one large global randomized controlled trial.BMC medical informatics and decision making · 2021Pooled it
- Do all patients with HER2 positive breast cancer require one year of adjuvant trastuzumab? A systematic review and meta-analysis.Breast (Edinburgh, Scotland) · 2020Pooled it
- (Neo)adjuvant approvals for solid tumors by the US Food and Drug Administration 2010-2023.Journal of the National Cancer Institute · 2026Article
- Evaluating the potential of candidate surrogate endpoints for overall survival in treatment-naive metastatic melanoma treated with anti-PD-1-based regimens with or without anti-CTLA-4 therapy.Journal for immunotherapy of cancer · 2026Article
- Harnessing health economic evaluation for policy and practice.Communications medicine · 2026Review
- Intermediate endpoints as surrogates for long-term outcomes in breast cancer adjuvant chemotherapy trials.The oncologist · 2025Article
- Balancing evidence and individualization in adjuvant CDK4/6 therapy.Translational cancer research · 2025Article
- Article
- Frequently asked questions on surrogate endpoints in oncology-opportunities, pitfalls, and the way forward.EClinicalMedicine · 2024Review
- Intermediate clinical endpoints in early-stage breast cancer: an analysis of individual patient data from the Gruppo Italiano Mammella and Mammella Intergruppo trials.EClinicalMedicine · 2024Article
- Article
- Comprehensive analysis of ACKR family members in breast cancer using prognostic values.Oncology letters · 2023Article
- Cardiotoxicity from neoadjuvant targeted treatment for breast cancer prior to surgery.Frontiers in cardiovascular medicine · 2023Review
- Changing the role of pCR in breast cancer treatment - an unjustifiable interpretation of a good prognostic factor as a "factor for a good prognosis".Frontiers in oncology · 2023Article
Corrections and comments
- Commented on by
- Erratum issued
Authors and funding
12 authors.
Funding
Abstract
backgroundAlthough frequently used as a primary endpoint, disease-free survival has not been validated as a surrogate for overall survival in early breast cancer. We investigated this surrogacy in the adjuvant setting of treatment with anti-HER2 antibodies.
methodsIn a systematic review and meta-analysis, we identified published and non-published randomised controlled trials with completed accrual and available disease-free survival and overall survival results for the intention-to-treat population as of September 2016. Bibliographic databases (MEDLINE, Embase, and Cochrane Central Register of Controlled Trials), clinical trial registries (Clinicaltrials.gov, EU Clinical Trials Register, WHO International Clinical Trials Registry Platform, and PharmNet.Bund), and trial registries from relevant pharmaceutical companies were searched. Eligibility for treatment of HER2-positive early breast cancer required at least one group to have an anti-HER antibody treatment (ie, trastuzumab, pertuzumab, or trastuzumab emtansine) planned for 12 months, and at least one control arm with chemotherapy without the antibody, a lower total dose or duration of the antibody, or observation alone. Units of analysis were contrasts: two-group trials gave rise to one contrast, whereas trials with more than two groups gave rise to more than one contrast. We excluded trials enrolling patients with recurrent, metastatic, or non-invasive disease, and those testing neoadjuvant therapy exclusively. Our primary objective was to estimate patient-level and trial-level correlations between disease-free survival and overall survival. We measured the association between disease-free survival and overall survival using Spearman's correlation coefficient (r
findingsEight trials (n=21 480 patients) gave rise to a full set (12 contrasts). Patient-level associations between disease-free and overall survival were strong (r
interpretationThese findings suggest that it is appropriate to continue to use disease-free survival as a surrogate for overall survival in trials in HER-2-positive, early breast cancer. The key limitation of this study is the dependence of its results on the trials included and on the existence of an outlying trial.
fundingRoche Pharma AG.
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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.