Efficacy and Safety of neoadjuvant stereotactic body radiotherapy plus adebrelimab and chemotherapy for triple-negative breast cancer: A pilot study

  1. Guanglei Chen
  2. Xi Gu
  3. Xu Zhang
  4. Xiaopeng Yu
  5. Yu Zhang
  6. Jinqi Xue
  7. Ailin Li
  8. Yi Zhao
  9. Guijin He
  10. Meiyue Tang
  11. Fei Xing
  12. Jianqiao Yin
  13. Xiaobo Bian
  14. Ye Han
  15. Shuo Cao
  16. Chao Liu
  17. Xiaofan Jiang
  18. Keliang Zhang
  19. Yan Xia
  20. Huajun Li
  21. Nan Niu
  22. Caigang Liu
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Abstract

Background

Emerging data have supported the immunostimulatory role of radiotherapy, which could exert a synergistic effect with immune checkpoint inhibitors (ICIs). With proven effective but suboptimal efficacy of ICI and chemotherapy in triple-negative breast cancer (TNBC), we designed a pilot study to explore the efficacy and safety of neoadjuvant stereotactic body radiotherapy (SBRT) plus adebrelimab and chemotherapy in TNBC patients.

Methods

Treatment-naïve TNBC patients received two cycles of intravenous adebrelimab (20mg/kg, every 3 weeks), and SBRT (24Gy/3f, every other day) started at the second cycle, then followed by six cycles of adebrelimab plus nab-paclitaxel (125 mg/m2on days 1 and 8) and carboplatin (area under the curve 6 mg/mL per min on day 1) every 3 weeks. The surgery was performed within 3-5 weeks after the end of neoadjuvant therapy. Primary endpoint was pathological complete response (pCR, ypT0/is ypN0). Secondary endpoints included objective response rate (ORR), residual cancer burden (RCB) 0-I and safety.

Results

13 patients were enrolled and received at least one dose of therapy. 10 (76.9%) patients completed SBRT and were included in efficacy analysis. 90% (9/10) of patients achieved pCR, both RCB 0-I and ORR reached 100% with 3 patients achieved complete remission. Adverse events (AEs) all-grade and grade 3-4 occurred in 92.3% and 53.8%, respectively. 1 (7.7%) patient had treatment-related serious AEs. No radiation-related dermatitis or death occurred.

Conclusions

Adding SBRT to adebrelimab and neoadjuvant chemotherapy led to a substantial proportion of pCR with acceptable toxicities, supporting further exploration of this combination in TNBC patients.

Funding

This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors.

Clinical trial number

NCT05132790.

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