Behandelpatronen en veiligheid van adjuvante therapie na chemo-immunotherapie bij vroegstadium TNBC

PURPOSE: For early-stage triple-negative breast cancer (TNBC), the KEYNOTE-522 trial established neoadjuvant pembrolizumab plus chemotherapy (CT), followed by adjuvant pembrolizumab, as the standard of care. Nevertheless, uncertainties remain on how to integrate this regimen with other adjuvant therapies such as capecitabine or olaparib. This study evaluated real-world treatment patterns and safety of adjuvant therapies following neoadjuvant chemoimmunotherapy. METHODS: The Neo-Real study includes patients with TNBC treated with neoadjuvant pembrolizumab plus CT in Brazil and Argentina. This study describes real-world adjuvant treatment patterns and safety; survival outcomes are not reported in this analysis. RESULTS: Among 726 patients included, 692 underwent surgery, and 62.9% achieved pathologic complete response (pCR). Of those with pCR, 84.8% received adjuvant pembrolizumab alone, while 14.3% received no adjuvant therapy. Among patients with residual disease and no germline BRCA1/2 mutations (n = 207), 57.5% received pembrolizumab plus capecitabine, 26.1% pembrolizumab alone, and 12.6% capecitabine alone. In BRCA1/2-mutated patients (n = 26), 57.7% received pembrolizumab plus olaparib, 19.2% pembrolizumab alone, and 11.5% olaparib alone. Safety data were available for 359 patients. Adjuvant pembrolizumab alone caused a lower incidence of grade ≥ 3 AEs (6.7%) compared with combination regimens (P = 0.002). Drug discontinuation due to toxicity occurred in 5.7%, 11.2%, and 7.7% of patients receiving pembrolizumab, pembrolizumab + capecitabine, and pembrolizumab + olaparib, respectively (P = 0.126). CONCLUSION: Most patients with pCR continued adjuvant pembrolizumab, while combination strategies predominated among those with residual disease and were associated with higher rates of grade ≥ 3 AEs. The efficacy of these combined regimens remains to be determined.