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Purpose <p>We 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).</p> Methods <p>Participants 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.</p> Results <p>Among 1,174 randomized participants (pembrolizumab plus chemotherapy, <i>n</i> = 784; placebo plus chemotherapy, <i>n</i> = 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.</p> Conclusions <p>These findings show that adding neoadjuvant pembrolizumab to chemotherapy had no adverse impact on surgical outcomes (including type, timing, and safety).</p> <p><i>Trial registration</i> ClinicalTrials.gov, NCT03036488 <a href="https://www.clinicaltrials.gov/study/NCT03036488">https://www.clinicaltrials.gov/study/NCT03036488</a></p>

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Surgical Outcomes After Neoadjuvant Pembrolizumab Plus Chemotherapy for Triple-Negative Breast Cancer: Results from the Randomized, Placebo-Controlled Phase 3 KEYNOTE-522 Study

  • 期刊论文

  • 发表日期：

    2026年2月25日

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  • Sherko Kuemmel,
  • Peter A. Fasching,
  • Peter Schmid,
  • Nadia Harbeck,
  • Masato Takahashi,
  • Michael Untch,
  • Jean-Francois Boileau,
  • Javier Cortes,
  • Rebecca Dent,
  • Joyce O’Shaughnessy,
  • Lajos Pusztai,
  • Theodoros Foukakis,
  • Yeon Hee Park,
  • Rina Hui,
  • Fatima Cardoso,
  • Carsten Denkert,
  • Liyi Jia,
  • Wilbur Pan,
  • Vassiliki Karantza,
  • Heather McArthur

摘要

Purpose

We 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).

Methods

Participants 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.

Results

Among 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.

Conclusions

These 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