Prognosis After Pathologic Complete Response to Neoadjuvant Therapy in Early-Stage Breast Cancer: A Population-Based Study
Breast Center, Karolinska Comprehensive Cancer Center, Stockholm, Sweden
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Department of Surgery and Oncology, Capio Sankt Göran Hospital, Stockholm, Sweden
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Breast Center, Karolinska Comprehensive Cancer Center, Stockholm, Sweden
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Breast Center, Karolinska Comprehensive Cancer Center, Stockholm, Sweden
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Breast Center, Karolinska Comprehensive Cancer Center, Stockholm, Sweden
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Background: Pathologic complete response (pCR) following neoadjuvant chemotherapy (NACT) for early-stage breast cancer is prognostic, but not the sole surrogate marker for long-term outcome at a trial level, given that recurrence risk persists in patients who achieve pCR. This study aimed to investigate factors affecting the outcome of patients who achieve pCR. Methods: This population-based cohort study prospectively enrolled patients who received NACT for nonmetastatic breast cancer between 2007 and 2020 in the Stockholm-Gotland region, which comprises 25% of the entire Swedish population. The primary endpoint was distant relapse-free survival (DRFS), defined as time from surgery to distant recurrence or death from any cause. Results: Median follow-up from surgery was 5.9 years. Among 2,487 patients, 661 (26.6%) attained pCR. Several factors were independently associated with DRFS in patients with pCR, including increasing age (adjusted hazard ratio [aHR], 1.04; 95% CI, 1.01–1.06), T3/T4 stage (aHR, 2.02; 95% CI, 1.05–3.87), and HER2 positivity (aHR, 0.34; 95% CI, 0.17–0.68). Node positivity predicted distant recurrence during the first year postsurgery (aHR, 2.84; 95% CI, 1.16–6.94), whereas estrogen receptor positivity predicted distant recurrence at 5 to 10 years (aHR, 4.30; 95% CI, 1.06–17.49). The rate of central nervous system relapse as the first site of recurrence was not affected by pCR status (5.3% vs 4.1%; P=.21). Conclusions: In this population-based study, our findings suggest that patients achieving pCR after NACT are a heterogeneous group in terms of long-term prognosis. Baseline tumor characteristics should be considered when investigating post-neoadjuvant therapy approaches.
Submitted September 4, 2024; final revision received November 20, 2024; accepted for publication November 25, 2024. Published online March 12, 2025.
Author contributions: Concept & design: Boman, Matikas. Data acquisition: Boman, Tranchell, Eriksson Bergman, Toli, Matikas. Statistical analysis: Liu. Interpretation: Boman, Bergh, Foukakis, Matikas. Administrative, technical, or material support: Bergh, Foukakis, Matikas. Writing—original draft: Boman, Liu, Matikas. Writing—review & editing: All authors.
Data availability statement: The dataset supporting the findings of this study is available from the National Quality Registry for Breast Cancer (NKBC) upon request.
Disclosures: Dr. Bergh had disclosed receiving institutional grant/research support from Amgen, AstraZeneca, Bayer, Merck, Pfizer, Roche, and Sanofi; serving as a consultant for Novartis and for Stratipath AB; receiving honoraria from Roche and AstraZeneca; and being a stockholder of Stratipath AB. Dr. Foukakis has disclosed serving as a consultant for AstraZeneca, Gilead, Roche, Affibody, Pfizer, Novartis, Veracyte, and Exact Sciences; serving as a scientific advisor for Atossa Therapeutics; serving as a principal investigator for clinical trials sponsored by AstraZeneca, Daiichi Sankyo, and Novartis; receiving honoraria from UpToDate; and receiving institutional grant/research support from Pfizer, AstraZeneca, Novartis, and Veracyte. Dr. Matikas has disclosed serving as a principal investigator for clinical trials sponsored by AstraZeneca and MSD; serving as a consultant for Veracyte, Roche, Seagen; and receiving institutional grant/research support from MSD, AstraZeneca, Novartis, and Veracyte. The remaining authors have disclosed that they have not received any financial consideration from any person or organization to support the preparation, analysis, results, or discussion of this article.
Funding: This work was supported by funding from Radiumhemmets Forskningsfonder and Cancerfonden.
Supplementary material: Supplementary material associated with this article is available online at https://doi.org/10.6004/jnccn.2024.7093. The supplementary material has been supplied by the author(s) and appears in its originally submitted form. It has not been edited or vetted by JNCCN. All contents and opinions are solely those of the author. Any comments or questions related to the supplementary materials should be directed to the corresponding author.
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