Effects of neoadjuvant stereotactic body radiotherapy plus adebrelimab and chemotherapy for triple-negative breast cancer: A pilot study
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eLife assessment
This study presents a valuable finding of a novel combinatory regimen which integrate immunotherapy, radiotherapy and chemotherapy in the current refractory triple negative breast cancer. The evidence supporting the claims of the authors is solid, although inclusion of a larger number of patient samples would have strengthened the study. The work will be of interest to Clinicians working on breast cancer.
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Abstract
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 effect 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 (20 mg/kg, every 3 weeks), and SBRT (24 Gy/3 f, every other day) started at the second cycle, then followed by six cycles of adebrelimab plus nab-paclitaxel (125 mg/m² on 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 three patients achieved complete remission. Adverse events (AEs) of all-grade and grade 3–4 occurred in 92.3% and 53.8%, respectively. One (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:
None.
Clinical trial number:
NCT05132790 .
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eLife assessment
This study presents a valuable finding of a novel combinatory regimen which integrate immunotherapy, radiotherapy and chemotherapy in the current refractory triple negative breast cancer. The evidence supporting the claims of the authors is solid, although inclusion of a larger number of patient samples would have strengthened the study. The work will be of interest to Clinicians working on breast cancer.
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Reviewer #1 (Public Review):
This relatively small-scale cohort trial has demonstrated ideal efficacy and safety of combinatory immunotherapy, radiotherapy and chemotherapy. The study design is straightforward and the major findings are held back by solid clinical data. However, the correlation between the primary endpoint selection and long term benefit is lacking, and the current adverse events are not yet comprehensively exhibited.
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Reviewer #2 (Public Review):
The preliminary cohort study has provided the efficacy and safety profile of immunotherapy combined with SBRT and cytotoxic chemotherapy, and the data are solid to support the findings, which could serve as evidence for future basic research and larger scale randomized control trials. While the major innovation of this study concentrates on immunotherapy, the description of specific issues regarding immunotherapy should be strengthened and more detailed.
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Reviewer #3 (Public Review):
The exploratory cohort study examined the efficacy and safety of immunotherapy in combination with SBRT and cytotoxic chemotherapy. The results are well supported by the data, which may be used as justification for further fundamental investigation and larger-scale randomized control trials. Although immunotherapy is the focus of this study's main innovation, a stronger and more thorough discussion of specific immunotherapy-related difficulties is necessary.
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