The KEYNOTE-522 trial has been a focal point of discussion in the oncology community, with significant results presented at the recent #ESMO24 conference. This Phase III trial, presented by Prof. Peter Schmid from @QMBCI, has demonstrated impressive outcomes in the treatment of high-risk early-stage triple-negative breast cancer (TNBC).
KEYNOTE-522 Study Design
The KEYNOTE-522 trial encompassed patients with high-risk early-stage TNBC, specifically those with tumors of at least 2 cm or positive lymph nodes, suggesting the introduction of high-risk parameters. The study's structure included:
- Neoadjuvant Phase: Patients received neoadjuvant (pre-surgery) treatment with pembrolizumab (an anti-PD-1 therapy) combined with chemotherapy.
- Adjuvant Phase: Following surgery, patients continued with pembrolizumab if they had received it preoperatively, or a placebo if they had not.
Key Results: Significant Overall Survival (OS) Benefit
The findings from the trial indicated several critical improvements:
- 5-Year Overall Survival (OS): The rate was 86.6% in the pembrolizumab arm versus 81.7% in the placebo arm, with a Hazard Ratio (HR) of 0.66, denoting a 34% reduction in the risk of death.
- Event-Free Survival (EFS): The study demonstrated a 9% improvement in EFS over five years.
KEYNOTE-522 Discussion Points
The impressive results from the KEYNOTE-522 trial have sparked numerous discussions within the oncology community, with several key points highlighted:
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Biomarker Identification: Researchers are keen to identify biomarkers that can predict who will benefit from pembrolizumab. This will help avoid unnecessary treatment and associated toxicities in patients unlikely to respond (Sushil (@Sushilberiwal)
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Minimizing Toxicity: The rigorous regimen's toxicity has been a concern, so there's a concerted effort to refine treatment plans to balance efficacy and quality of life (Hope Rugo (@hoperugo), Naoto T Ueno (@teamoncology)).
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Tailoring Treatment: There's a significant interest in tailoring the treatment regimen to individual patients, potentially reducing the chemotherapy burden where feasible. This is especially relevant given the different responses observed in patients achieving complete pathologic response (pCR) versus non-pCR (Timothée Olivier, MD (@Timothee_MD)).
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Clinical Practice Integration: Researchers and oncologists are exploring how to best integrate these findings into clinical practice, with emphasis on adjusting current treatment protocols based on these results (Sara Tolaney (@stolaney1), Erika Hamilton, MD (@ErikaHamilton9)).
