A Real-World Efficacy and Safety of KEYNOTE-522 Regimen in Patients With Early Triple-Negative Breast Cancer
- Author:
Shinyoung LEE
1
;
Hyehyun JEONG
;
Yeokyeong SHIN
;
Jae Ho JEONG
;
Kyung Hae JUNG
;
Sung-Bae KIM
;
Byung-Kwan JEONG
;
Hee Jin LEE
;
Gyungyub GONG
;
Hee Jung SHIN
;
Hye Joung EOM
;
Young-Jin LEE
;
Tae-Kyung YOO
;
Sae Byul LEE
;
Jisun KIM
;
Il-Yong CHUNG
;
Beom-Seok KO
;
Hee Jeong KIM
;
Jong Won LEE
;
Byung Ho SON
;
Jin-Hee AHN
Author Information
- Publication Type:Original Article
- From:Journal of Breast Cancer 2026;29(2):141-153
- CountryRepublic of Korea
- Language:English
-
Abstract:
Purpose:Based on the KEYNOTE-522 study, neoadjuvant pembrolizumab plus chemotherapy has become the standard treatment for early-stage triple-negative breast cancer (TNBC).This study evaluated the real-world efficacy, safety, and predictors of pathologic complete response (pCR) in Korean patients.
Methods:We conducted a retrospective cohort study of 174 patients with early-stage TNBC who received the KEYNOTE-522 regimen (neoadjuvant pembrolizumab plus paclitaxel and carboplatin, followed by doxorubicin and cyclophosphamide) at a tertiary cancer center between August 2022 and July 2024. We assessed the primary endpoints, including pCR rate and event-free survival (EFS). We performed univariable and multivariable logistic regression analyses to identify independent predictors of pCR.
Results:The median patient age was 50 years (range, 24–74 years). The clinical stages were II and III in 79.3% and 20.1% of patients, respectively, and 10.9% had clinical N3 disease. The overall pCR rate was 62.1%, and the N3 subgroup had a pCR rate of 47.4%. On multivariable analysis, high baseline Ki-67 expression (≥ median, 75%) was significantly associated with pCR (odds ratio, 2.84; 95% confidence interval, 1.45 to 5.66; p = 0.002). At a median followup of 18.4 months, the 12-month EFS rate was 97.4%, with significantly superior outcomes observed in patients who achieved pCR compared with those who did not achieve pCR (100% vs. 93.1%, p = 0.007). The treatment completion rate was 92.0%, and immune-related adverse events occurred in 13.8% of patients.
Conclusion:In this real-world analysis of one of the largest Asian cohorts of patients with earlystage TNBC treated with neoadjuvant pembrolizumab, the KEYNOTE-522 regimen demonstrated substantial efficacy and manageable toxicity, consistent with the original trial findings.
