Background: Neoadjuvant pembrolizumab (pembro) plus chemotherapy was approved in July 2021 for high-risk, early-stage triple-negative breast cancer (TNBC) based on improved event-free survival in the KEYNOTE-522 trial.Real-world evidence describing clinical outcomes following pembro use in patients with TNBC in routine practice remains limited. Methods:This retrospective real-world study used electronic medical records accessed via the N-power Medicine platform to evaluate adults with Stage II-III TNBC who initiated neoadjuvant pembro plus chemotherapy between August 2021 and July 2022.Patient characteristics and clinical outcomes, including pathologic complete response (pCR) and 3-year event-free survival endpoints, were summarized descriptively. Results: In total, 88 patients with Stage II (54.5%) or Stage III (45.5%)TNBC received neoadjuvant pembro plus chemotherapy.At diagnosis, 39.8% were aged 50 years, 34.1% were 51-64 years, and 26.1% were 65 years.AH1 AV2 Most patients were White (61.4%), and nearly all received carboplatin as part of neoadjuvant therapy (97. 7%).MM3 AH4 AV5In total, 40.9% had node-positive disease (N1-N2).Following neoadjuvant pembro plus chemotherapy, 44 (50.0%) of the included patients received adjuvant pembro monotherapy.pCR, defined as no residual invasive cancer in the breast or axillary lymph nodes (ypT0/Tis ypN0), was achieved by 61.4% of patients.Real-world event-free survival (rwEFS) was assessed, with 13 events observed among the included patients.When stratified by pathologic response, the estimated 3-year median rwEFS probability was 89.8% (95% confidence interval CI: 81.7-98.8%)among patients achieving pCR, versus 71.2% (95% CI: 55.9-90.7%)among those not achieving pCR.Conclusions: Neoadjuvant pembro plus chemotherapy was associated with high rates of pCR and favorable survival after three years.Patients achieving pCR showed improved event-free survival, highlighting the clinical relevance of pCR as a prognostic marker in managing patients with high-risk early-stage TNBC.These findings support the effectiveness of pembrolizumab-containing neoadjuvant therapy outside of clinical trial settings.
Srigadha et al. (Fri,) studied this question.
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