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Neoadjuvant chemotherapy plus sintilimab improved response rates versus chemotherapy alone in 61 patients with triple-negative breast cancerCombination therapy improved response rates in a small study of triple-negative breast cancer patients

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Key Takeaway
Consider that neoadjuvant chemotherapy plus sintilimab is associated with higher response rates in TNBC, but verify in prospective trials.

This retrospective cohort study assessed the efficacy and safety of adding sintilimab to neoadjuvant chemotherapy (NAC) in patients with triple-negative breast cancer (TNBC). The analysis included 61 patients treated at The First Hospital of Lanzhou University, comparing the combination regimen against NAC alone. The primary outcome was pathological complete response (pCR), with secondary outcomes including objective response rate (ORR), safety, and tumor marker changes.

Results indicated that the combination group achieved a significantly higher ORR of 85.2% compared to 58.8% in the NAC alone group (P<0.05). The pCR rate was also significantly higher in the combination group at 59.3% versus 32.4% (P<0.05). Additionally, post-treatment Ki-67 levels were significantly lower in the combination group (P<0.05), though specific absolute numbers were not reported.

Regarding safety, the overall incidence of adverse events was comparable between groups (P>0.05). However, leukopenia occurred more frequently in the combination group (P<0.05). No serious adverse events or discontinuations were reported, suggesting a manageable safety profile for the combination regimen. The study did not report specific follow-up durations.

Key limitations include the retrospective design and single-center nature of the data, which restrict generalizability. As an observational study, the results demonstrate association rather than causation. While the practice relevance highlights positive clinical value, clinicians should interpret these findings with caution pending validation in prospective trials.

This study looked at how well adding the immunotherapy drug sintilimab to standard neoadjuvant chemotherapy worked for patients with triple-negative breast cancer. The team analyzed data from 61 patients treated at The First Hospital of Lanzhou University. They compared those who received chemotherapy plus sintilimab against those who received chemotherapy by itself.

The results showed that the combination group had a significantly higher objective response rate of 85.2% compared to 58.8% for chemotherapy alone. Additionally, the rate of pathological complete response was 59.3% in the combination group versus 32.4% in the chemotherapy-only group. The combination group also had lower Ki-67 levels after treatment, which often indicates slower tumor growth.

Regarding safety, the overall incidence of adverse events was comparable between the two groups. However, leukopenia, or low white blood cell counts, was more frequent in the group receiving sintilimab. Despite this, the researchers noted that the combination regimen showed a manageable safety profile with no reported serious adverse events or discontinuations. Readers should understand that because this was a retrospective study, it shows an association rather than proving causation. These findings come from a single center and may not apply to all patients or settings.

What this means for you:
A small retrospective study suggests combination therapy improves response rates in triple-negative breast cancer, but results need confirmation.

Study Details

Study typeCohort
Sample sizen = 27
EvidenceLevel 3
PublishedApr 2026
View Original Abstract ↓
Purpose This study aimed to evaluate the efficacy and safety of neoadjuvant chemotherapy (NAC) combined with the programmed death protein 1 (PD-1) inhibitor sintilimab versus NAC alone in patients with triple-negative breast cancer (TNBC). Materials and Methods In this retrospective cohort study, we collected clinical data from 61 patients with triple-negative breast cancer (TNBC) who received neoadjuvant therapy at The First Hospital of Lanzhou University between July 2024 and July 2025. These patients were divided into two groups: the neoadjuvant chemotherapy (NAC) plus sintilimab group (n=27) and the NAC-alone group (n=34). The primary endpoint was the pathological complete response (pCR) rate. Secondary endpoints included objective response rate (ORR), safety, and changes in tumor markers. Results The combination therapy group showed significantly higher ORR (85.2% vs. 58.8%) and pCR rates (59.3% vs. 32.4%) compared to the NAC alone group (both P<0.05). Post-treatment Ki-67 levels were also significantly lower in the combination group (P<0.05). The overall incidence of adverse events was comparable between groups (P>0.05), although leukopenia was more frequent with sintilimab (P<0.05). Conclusion In the neoadjuvant setting for TNBC, the addition of sintilimab to NAC significantly improves ORR and pCR rates, effectively reduces the tumor proliferation index Ki-67, and does not significantly increase the overall burden of adverse events. The combination regimen shows a manageable safety profile and demonstrates positive clinical value. Keywords Triple Negative Breast Cancer, Immunotherapy, Sintilimab, Combination neoadjuvant chemotherapy, Efficacy, Real-World data.
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