Background: This study aimed to determine if the neoadjuvant (NAT) KEYNOTE-522 regimen was associated with higher rates of pathologic complete response (pCR), corresponding to higher rates of breast conservation therapy (BCT) in early-stage triple-negative breast cancer (TNBC) patients.
Patients And Methods: Stage II-III TNBC patients diagnosed between 2019 and 2022 who underwent NAT were analyzed retrospectively. NAT with KEYNOTE-522 versus control NAT were compared for rates of BCT, axillary node dissection (ALND), pCR, and survival outcomes. The prevalence of immune-related adverse events (irAE) from chemoimmunotherapy was recorded.
Results: Of 240 patients identified: 86 received KEYNOTE-522 and 154 received control. The frequency of pCR was significantly higher in KEYNOTE versus the control cohort, 59.3% and 33.1%, respectively (p = 0.001). There was no significant difference in the rate of BCT between the control (33.1%) and the KEYNOTE-522 (32.1%) groups (p = 0.47). Rates of ALND were significantly lower with KEYNOTE-522 (25.6%) as compared with control (39.6%); p = 0.03. The rate of development of grade 2 or higher irAEs was 34.9%. At a median follow-up of 2.4 years, there was no difference in survival outcomes. BRCA1 patients had high rates of pCR regardless of treatment group, KEYNOTE-522: 80.0% (4/5) and control: 75% (9/12), (p = 1).
Conclusion: This real-world evidence supports the use of the KEYNOTE-522 regimen in patients with early-stage TNBC given the higher pCR rate and corresponding decrease in the rate of ALND. The majority of patients in both NAT cohorts became BCT eligible, but the rate of BCT did not differ between the two groups.
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View Article and Find Full Text PDFReal-World Outcomes with the KEYNOTE-522 Regimen in Early-Stage Triple-Negative Breast Cancer.
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From the Centre for Experimental Cancer Medicine, Barts Cancer Institute, Queen Mary University of London, London (P.S.); International Breast Cancer Center, Pangaea Oncology, Quirónsalud Group, and Medical Scientia Innovation Research, Barcelona, and IOB Madrid, Institute of Oncology, Hospital Beata María Ana, and the Faculty of Biomedical and Health Sciences, Department of Medicine, Universidad Europea de Madrid, Madrid - all in Spain (J.C.); National Cancer Center Singapore, Duke-National University of Singapore Medical School, Singapore (R.D.); University of Texas Southwestern Medical Center (H.M.) and Baylor University Medical Center, Texas Oncology, Sarah Cannon Research Institute (J.O.) - both in Dallas; Yale School of Medicine, Yale Cancer Center, New Haven, CT (L.P.); the Breast Unit, Department of Gynecology with Breast Center, Kliniken Essen-Mitte, Essen (S.K.), Charité-Universitätsmedizin Berlin (S.K.) and the Breast Cancer Center, Helios Klinikum Berlin-Buch (M.U.), Berlin, the Institute of Pathology, Philipps University of Marburg and University Hospital Marburg, Marburg (C.D.), the Breast Center, Department of Obstetrics and Gynecology and Comprehensive Cancer Center Munich, LMU University Hospital, Munich (N.H.), and University Hospital Erlangen, Comprehensive Cancer Center Erlangen-European Metropolitan Region of Nuremberg, Erlangen (P.A.F.) - all in Germany; Samsung Medical Center, Sungkyunkwan University School of Medicine (Y.H.P.), and Seoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine, Seoul National University (S.-A.I.) - both in Seoul, South Korea; Westmead Breast Cancer Institute, Westmead Hospital and the University of Sydney, Sydney (R.H.); the Center of Cancer Medicine, School of Clinical Medicine, University of Hong Kong, Hong Kong (R.H.); Hokkaido University Hospital, Sapporo, Japan (M.T.); Centre Jean-Perrin, Clermont-Ferrand, France (M.-A.M.-R.); the Department of Oncology-Pathology, Karolinska Institutet, and Breast Center, Theme Cancer, Karolinska University Hospital, Stockholm (T.F.); Instituto Português de Oncologia do Porto Francisco Gentil, Porto (M.F.), and the Breast Unit, Champalimaud Clinical Center-Champalimaud Foundation, Lisbon (F.C.) - both in Portugal; and the Department of Oncology, Merck, Rahway, NJ (X.Z., V.K., K.T., G.A.).
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Article Synopsis
- - The KEYNOTE-522 trial demonstrated that adding pembrolizumab to standard chemotherapy improves outcomes in patients with early triple negative breast cancer (TNBC), prompting a study to evaluate similar outcomes without this drug in a high-quality care setting.
- - A retrospective analysis of 168 untreated stage II or III TNBC patients receiving chemotherapy from 2012 to 2022 found a 52.7% rate of pathological complete response (pCR) and event-free survival (EFS) of 83.3% at 36 months.
- - Results suggest that specialized care in a certified Breast Unit can achieve outcomes comparable to those seen with the addition of pembrolizumab, indicating the importance of quality care in cancer treatment.
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