Purpose <p>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.</p> Methods <p>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.</p> Results <p>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 <i>BRCA1/2</i> mutations (n = 207), 57.5% received pembrolizumab plus capecitabine, 26.1% pembrolizumab alone, and 12.6% capecitabine alone. In <i>BRCA1/2</i>-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).</p> Conclusion <p>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.</p>

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Treatment patterns and safety of adjuvant therapy after chemoimmunotherapy for early-stage triple-negative breast cancer: real-world data from the Neo-Real/GBECAM 0123 study

  • Matheus de Oliveira Andrade,
  • Renata Colombo Bonadio,
  • Agustina Ipiña,
  • Laura Testa,
  • Monique Celeste Tavares,
  • Flávia Cavalcanti Balint,
  • Carlos Henrique dos Anjos,
  • Débora de Melo Gagliato,
  • Mayana Lopes de Brito,
  • Melina Winocur,
  • Daniele Assad-Suzuki,
  • Daniela Dornelles Rosa,
  • Noele de Jesus Barros Gomes,
  • Natalia Cristina Cardoso Nunes,
  • Isadora Martins de Sousa,
  • Mariana Carvalho Gouveia,
  • Fernanda Madasi,
  • Jose Bines,
  • Carlos Gallina,
  • Rafael Dal Ponte Ferreira,
  • Candice Lima Santos,
  • Maira Tavares,
  • Mariana Ribeiro Monteiro,
  • Zenaide Silva de Souza,
  • Ana Maria Ulbricht Gomes,
  • Bruna M. Zucchetti,
  • Anezka Ferrari,
  • Maria Marcela Fernandes Monteiro,
  • Poliana Albuquerque Signorini,
  • Solange Sanches,
  • Paulo M. Hoff,
  • Gimena Ferreira,
  • Maria del Pilar Estevez-Diz,
  • Romualdo Barroso-Sousa

摘要

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.