ScholarWorks@성균관대학교

초록

PurposeWe prospectively evaluated surgical outcomes following neoadjuvant pembrolizumab or placebo added to neoadjuvant chemotherapy among participants with early-stage triple-negative breast cancer (TNBC) in the phase 3 KEYNOTE-522 study (NCT03036488).MethodsParticipants with previously untreated, early-stage TNBC (AJCC stage T1c N1-2 or T2-4 N0-2) were randomized 2:1 to neoadjuvant pembrolizumab/placebo plus paclitaxel-carboplatin for 4 cycles, followed by pembrolizumab/placebo plus doxorubicin/epirubicin and cyclophosphamide for 4 cycles. After definitive surgery, participants received adjuvant pembrolizumab/placebo Q3W for 9 cycles. Surgery type and timing, nodal status postsurgery, and adverse events within 30 days following surgery were recorded.ResultsAmong 1,174 randomized participants (pembrolizumab plus chemotherapy, n = 784; placebo plus chemotherapy, n = 390), similar proportions underwent breast-conserving surgery (45.2% vs. 45.6%) and mastectomy (44.0% vs. 42.6%). Median (10th-90th percentile) time from end of on-study neoadjuvant treatment to surgery was 1.2 (0.9-1.9) months in the pembrolizumab plus chemotherapy group and 1.2 (0.9-1.7) months in the placebo plus chemotherapy group. Median (10th-90th percentile) time from surgery to adjuvant pembrolizumab/placebo was 2.6 (1.0-3.9) months in the pembrolizumab plus chemotherapy group and 2.7 (1.1-4.0) months in the placebo plus chemotherapy group. The only AE occurring in >= 5% of participants between 0 and 30 days postsurgery was procedural pain (7.0% vs. 5.8%). The rate of pathological complete nodal response at surgery was 76.7% in the pembrolizumab plus chemotherapy group versus 69.9% in the placebo plus chemotherapy group.ConclusionsThese findings show that adding neoadjuvant pembrolizumab to chemotherapy had no adverse impact on surgical outcomes (including type, timing, and safety).Trial registration ClinicalTrials.gov, NCT03036488 https://www.clinicaltrials.gov/study/NCT03036488ConclusionsThese findings show that adding neoadjuvant pembrolizumab to chemotherapy had no adverse impact on surgical outcomes (including type, timing, and safety).Trial registration ClinicalTrials.gov, NCT03036488 https://www.clinicaltrials.gov/study/NCT03036488

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