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Post-neoadjuvant strategies in breast cancer: From risk assessment to treatment escalation
Giacomo Pelizzari1, Lorenzo Gerratana1, Debora Basile1
1Dipartimento di Oncologia Clinica, Centro di Riferimento Oncologico di Aviano (CRO), IRCCS, 33081 Aviano, Italy; Department of Medicine (DAME), University of Udine, 33100 Udine, Italy.
Abstract:
The post-neoadjuvant setting in early breast cancer represents an attractive scenario for adjuvant clinical trials, offering the opportunity to test new drugs or combinations in high-risk patients who did not achieve pathologic complete response after primary treatment. No standard therapies are routinely proposed to patients with residual disease after neoadjuvant chemotherapy and few trials have explored this setting. To date, only one randomized phase III study showed the benefit of additional capecitabine after neoadjuvant chemotherapy, and international guidelines recommend at least to consider its use, particularly for triple negative breast cancer. Therefore, the management of these patients is still a clinical challenge, with limited data supporting the use of an additional adjuvant non-cross-resistant chemotherapy. Escalation strategies are currently under evaluation, with new agents proposed as supplementary post-neoadjuvant treatment (e.g. platinum salts, capecitabine, poly ADP-ribose polymerase inhibitors, immune checkpoint inhibitors, cyclin-dependent kinase 4/6 inhibitors). Based on these premises, selection criteria are critical to identify patients who may benefit from post-neoadjuvant therapies, through the validation of prognostic and predictive biomarkers for a reliable risk assessment and estimation of benefit. The present review summarizes the efforts in introducing new therapeutic options for patients with breast cancer and residual disease after neoadjuvant treatment, with a particular focus on the ongoing clinical trials and useful biomarkers for risk stratification.
Insights
For early breast cancer patients with residual disease post-neoadjuvant treatment, new therapies are being explored. Biomarkers are crucial for identifying high-risk individuals who may benefit from these post-neoadjuvant strategies.
Area of Science:
- Oncology
- Clinical Trials
- Breast Cancer Research
Background:
- The post-neoadjuvant setting for early breast cancer (BC) patients with residual disease (RD) after primary treatment is a critical unmet need.
- Limited standard therapies exist for managing high-risk BC patients who do not achieve pathologic complete response (pCR).
- Current guidelines suggest considering capecitabine for specific subtypes, highlighting the need for further research.
Purpose of the Study:
- To review emerging therapeutic options and ongoing clinical trials for early BC patients with RD post-neoadjuvant therapy.
- To emphasize the importance of prognostic and predictive biomarkers for risk stratification and treatment selection.
- To discuss the challenges and future directions in managing this patient population.
Main Methods:
- Literature review of clinical trials and studies in the post-neoadjuvant setting for early breast cancer.
- Analysis of current treatment strategies and emerging therapeutic agents.
- Focus on biomarker research for patient selection and risk assessment.
Main Results:
- Several novel agents, including platinum salts, PARP inhibitors, and immune checkpoint inhibitors, are under investigation.
- Capecitabine has shown benefit in a phase III trial and is recommended for consideration, especially in triple-negative BC.
- Biomarker validation is essential for identifying patients likely to benefit from post-neoadjuvant interventions.
Conclusions:
- The post-neoadjuvant setting presents a vital opportunity for clinical trials in high-risk early breast cancer.
- Effective risk stratification using biomarkers is paramount for optimizing treatment selection.
- Continued research into novel therapies and biomarkers is necessary to improve outcomes for patients with residual disease.
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