Abstract P3-06-06: Real-world analysis of adverse events of patients with triple negative breast cancer receiving therapy per KEYNOTE-522

Abstract Background: KEYNOTE-522 was a randomized, double-blind, placebo-controlled phase 3 trial which resulted in the FDA approval of pembrolizumab with neoadjuvant chemotherapy for patients (pts) with newly diagnosed, high-risk, early-stage triple negative breast cancer (TNBC). Given the improvement in pathological complete response (pCR) and event-free survival rates, this regimen has emerged as standard-of-care (SOC) therapy. Adverse events in pts on this treatment regimen in clinical practice is unknown and understanding the real-world toxicity of this regimen is critical. Methods: In this IRB approved retrospective, single-center study we examined pts with early-stage TNBC who received planned treatment per KEYNOTE-522 per SOC from 2021-present. This regimen includes a year of pembrolizumab combined with 4 cycles of neoadjuvant carboplatin/paclitaxel followed by 4 cycles of doxorubicin/cyclophosphamide. Number and length of treatment delays, treatment related toxicities of all grades, and pCR rate were collected from the electronic medical record. Results: Of the 87 identified pts, 2 were excluded due to locally recurrent or metastatic disease and 6 did not receive immunotherapy due to concerns for toxicity or patient preference. Of the 79 pts who initiated treatment with chemotherapy and immunotherapy, median age of the cohort was 52 (27-77). 9 pts had a BRCA1 mutation and 1 pt had a BRCA2 mutation. 41 (51.9%) had T1-2 disease and 38 (48.1%) had T3-4 disease. 37 (46.8%) pts had N0 disease and 42 (53.2%) had N1-3 disease. 15 pts had baseline comorbidities, including heart disease, kidney disease, type II DM, and/or peripheral neuropathy. 68 pts (86.1%) had baseline ECOG 0, 9 (11.4%) had ECOG 1, and 2 (2.5%) had ECOG 2. At the time of analysis, 70 pts (88.6%) were receiving active treatment, of which 47 (67.1%) had completed ≥50% of the planned neoadjuvant therapy. Of pts completing ≥50% of planned neoadjuvant therapy and pts off therapy (N=56), 31 (55.4%) had 1 or more hospitalizations and 23 (41.1%) had 1 or more emergency room visits. 30 pts had treatment delays (53.6%) and 21 pts (37.5%) had dose reductions. Rates of adverse events are presented in Table 1. Of the 79 analyzed pts, 35 have undergone surgery. pCR rate was 45.7% (N=16). 8 (22.9%) pts had RCB-I, 4 (11.4%) pts had RCB-II, 3 (8.6%) pts had RCB-III, and 4 (11.4%) pts had residual disease without RCB calculation. Updated analysis will be included at time of presentation. Conclusions: In this single-center retrospective study of pts receiving chemoimmunotherapy for TNBC, we found higher rates of grade 3 toxicity, including nausea, fatigue, neutropenia, diarrhea, peripheral neuropathy, and hypothyroidism, and lower pCR rate than was reported in the KEYNOTE-522 trial. This may reflect a more heterogeneous population of pts treated in routine clinical practice who are typically less fit than pts on clinical trials. Additionally, pts in this study had higher T stages (48.1% with T3-4 disease vs 26.0% in trial) and node positive disease (53.7% with N1-3 disease vs 48.8% in trial). Limitations include immaturity of data and small sample size; however, these data warrant validation through longer-term follow-up and multicenter validation. Adverse Events in pts receiving Keynote-522 regimen as SOC and on clinical trial Citation Format: Mara Hofherr, Jennifer Hedgecorth, Foluso O. Ademuyiwa, Lindsay L. Peterson, Nusayba A. Bagegni, Rama Suresh, Ashley Frith, Ron Bose, Katherine Weilbaecher, Cynthia Ma, Andrew A. Davis, Katherine K. Clifton. Real-world analysis of adverse events of patients with triple negative breast cancer receiving therapy per KEYNOTE-522 [abstract]. In: Proceedings of the 2022 San Antonio Breast Cancer Symposium; 2022 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2023;83(5 Suppl):Abstract nr P3-06-06.