Abstract
BackgroundImmune checkpoint inhibitors (ICIs) have shown promising anti-tumor activity in multiple malignances including breast cancer. However, the responses can vary. This meta-analysis was conducted to evaluate the efficacy and safety profile of adding ICIs to neoadjuvant chemotherapy against triple-negative breast cancer (TNBC) and assess correlation of PD-L1 tumor status with responses.MethodsEligible studies were retrieved from the PubMed, Embase, and Web of Science databases. Randomized controlled trials (RCTs) that investigated ICI-containing versus ICI-free neoadjuvant therapy were included in this study. Meta-analyses were performed using Review Manager Version 5.2 software.ResultsThis study included four RCTs containing 1795 patients with early TNBC. Compared with ICI-free neoadjuvant therapy, ICI-containing neoadjuvant therapy significantly increased the pathological complete response (pCR) rates in TNBC (odds ratio [OR] = 2.14, 95% confidence interval [CI]: 1.37–3.35, P < 0.001). In subgroup analysis, the addition of ICI to neoadjuvant chemotherapy was significantly associated with increased pCR rate in both PD-L1-positive TNBC (OR = 1.79, 95% CI: 1.33–2.41, P < 0.001) and PD-L1-negative TNBC (OR = 1.84, 95% CI: 1.14–2.99, P = 0.01). Patients with TNBC receiving ICI-containing neoadjuvant therapy had a better event-free survival (hazard ratio = 0.66, 95% CI: 0.48–0.89, P = 0.007) than those who receiving ICI-free neoadjuvant therapy. A significantly higher risk of adverse events including adrenal insufficiency, increased aspartate aminotransferase, dry skin, hepatitis, hyperthyroidism, hypothyroidism, infusion related reaction, pyrexia, and stomatitis was associated with ICI-containing neoadjuvant therapy.ConclusionICI-containing neoadjuvant therapy significantly increased the pCR rate in TNBC patients, independently of PD-L1 status. The addition of ICI to neoadjuvant chemotherapy may be considered an option for TNBC patients.
Highlights
Neoadjuvant treatment is widely used to reduce the size and extent of tumors in high risk early breast cancer (BC)
Literatures published before October 01, 2020 were retrieved from the PubMed, Embase, and Web of Science databases with the use of the following keywords: immune checkpoint inhibitors, nivolumab, pembrolizumab, ipilimumab, avelumab, tremelimumab, atezolizumab, durvalumab, and triple-negative BC (TNBC) without further restrictions
The primary objective of this study was to compare the efficacy of Immune checkpoint inhibitors (ICIs)-containing neoadjuvant therapy versus ICI-free neoadjuvant therapy in TNBC patients, in terms of pathological complete response (pCR), which was defined as the absence of invasive tumors in the breast and regional nodes at the time of surgery
Summary
Neoadjuvant treatment is widely used to reduce the size and extent of tumors in high risk early breast cancer (BC). Patients who achieve a pathological complete response (pCR) after neoadjuvant therapy have better survival outcomes than those with residual invasive disease [1]. Current neoadjuvant treatment strategies include chemotherapy, anti-human epidermal growth receptor 2 (HER2) therapy, endocrine therapy, and co-administration for different BC subtypes. Due to the lack of anti-HER2 therapy and potential antagonism between endocrine therapy and chemotherapeutic agents, anthracycline plus cyclophosphamide- and taxane-based neoadjuvant chemotherapy remains the major choice for patients with triple-negative BC (TNBC) [2, 3]. This meta-analysis was conducted to evaluate the efficacy and safety profile of adding ICIs to neoadjuvant chemotherapy against triple-negative breast cancer (TNBC) and assess correlation of PD-L1 tumor status with responses
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