| Objective:Immunotherapy in breast cancer has received increasing attention with the good efficacy of atezolizumab in the treatment of metastatic triple-negative breast cancer,and several clinical trials involving immunotherapy in combination with neoadjuvant chemotherapy for early triple-negative breast cancer have been published.Therefore,we conducted this meta-analysis to evaluate the efficacy and safety of immunotherapy combined with neoadjuvant chemotherapy in patients with early triple-negative breast cancer.Methods: We searched the eligible studies of Pub Med,Embase and Cochrane Library up to September 24,2020 systematic to identify randomized controlled trials(RCTs)investigating immunotherapy combined with neoadjuvant chemotherapy versus neoadjuvant chemotherapy in TNBC patients.End Note was uesd for literature management and studies were appraised using the Cochrane risk of bias table.After data extraction,Review Manager Version 5.3(Cochrane Collaboration,Oxford,UK)software was used for relevant statistical analysis.Results:Four studies and 1795 patients were yielded in this meta-analysis.The plus of immunotherapy significantly increased pCR rate from 61.3% to 42.4%(RR1.42,95%CI1.14-1.76,p=0.001,I2=63%).And the pCR rate rose up when the Immunotherapy was added to neoadjuvant chemotherapy in both PD-L1 positive and negative subgroups(PD-L1 positive subgroup: 67.3%vs 52.6%,RR1.26,95%CI1.11-1.43,p=0.0002,I2=0%;PD-L1 negative subgroup: 46.6% vs32.1%,RR 1.46,95% CI 1.08-1.97,p=0.01,I2=0%).In addition,the plus of immunotherapy improve the pCR rate in lymph node positive and ECOG 0 score subgroups(lymph node positive subgroup: 63.2% vs 38.5%,RR1.56,95%CI1.27-1.93,p<0.0001,I2= 0%;ECOG 0 score subgroup: 63% vs 46.3%,RR1.34,95%CI1.17-1.52,p<0.0001,I2=0%),while there was no statistically significant difference in pCR rate between the lymph node negative and ECOG 1 score subgroups(p>0.05).There was no significant difference in the incidence of grade 3-4 adverse events between two groups.However,statistical differences were observed between two groups in the rate of adverse events such as rash(22.9% vs 19.3%,RR1.25,95%CI1.02-1.53,p=0.03,I2=42%);hypothyroidism(12.1% vs 2.7%,RR4.14,95%CI2.52-6.82,p<0.00001,I2=0%);hyperthyroidism(4.8% vs 0.78%,RR5.51%,95%CI2.33-13.06,p=0.0001,I2=0%);Aspartate aminotransferase increased(30.6% vs 21.7%,RR1.37,95%CI1.02-1.83,p=0.03,I2=0%);Infusion-related reactions(14.7% vs 8.6%,RR1.55,95%CI1.16-2.08,p=0.003,I2=0%),while such diference was not found in nausea,vomiting,diarrhea,constipation,alopecia,anemia,neutropenia,leucopenia,fatigue,peripheral neuropathy,elevated alanine aminotransferase,adrenal insufficiency,myalgia and stomatitis(p>0.05).Conclusion: Our meta-analysis demonstrated that neoadjuvant chemotherapy plus immunotherapy improve the Pathological Complete Response Rates in patients with triplenegative breast cancer,with increased pCR rate regardless of whether PD-L1 receptor was positive.But the plus of immunotherapy also increased the rate of relevant adverse events. |
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