Ji Qiao, Ding Jingxian, Hao Meiqi, Luo Nachuan, Huang Jiabing, Zhang Wenxiong
Department of Radiation Oncology, The Third Hospital of Nanchang, Nanchang, China.
Department of Breast surgery, The Second Affiliated Hospital of Nanchang University, Nanchang, China.
Front Oncol. 2021 Dec 16;11:795650. doi: 10.3389/fonc.2021.795650. eCollection 2021.
It is still controversial whether immune checkpoint inhibitors (ICIs) can improve the curative effect when added to original standard chemotherapy treatment for triple-negative breast cancer (TNBC). We compared their antitumor efficacy and adverse effects (AEs) to make a better clinical decision.
Seven databases were searched for eligible articles. Progression-free survival (PFS), overall survival (OS), and AEs were measured as the primary outcomes.
Nine randomized controlled trials (RCTs) involving 4,501 patients were included. ICI+chemotherapy treatment achieved better PFS (hazard ratio [HR]: 0.78, [0.70-0.86], < 0.00001), OS (HR: 0.86, [0.74-0.99], = 0.04), and complete response (584/1,106 341/825, risk ratio [RR]: 1.38, [1.01-1.89], = 0.04). With the prolongation of survival, the survival advantage of ICI+chemotherapy increased compared with chemotherapy. Subgroup analysis suggested that the addition of ICIs might not have a better effect in Asian patients, patients with locally advanced disease, or patients with brain metastases. In the toxicity analysis, more Grade 3-5 AEs and serious AEs were found in the ICI+chemotherapy group. For Grade 3-5 AEs, more cases of diarrhea, severe skin reactions, pneumonitis, hepatitis, and adrenal insufficiency were related to the ICI+chemotherapy group.
ICI+chemotherapy appears to be better than chemotherapy alone for TNBC treatment, with better OS and PFS. However, its high rates of serious AEs need to be taken seriously.
PROSPERO Registration: CRD42021276394.
免疫检查点抑制剂（ICI）添加到三阴性乳腺癌（TNBC）的原标准化疗方案中是否能提高疗效仍存在争议。我们比较了它们的抗肿瘤疗效和不良反应（AE），以做出更好的临床决策。
检索七个数据库以获取符合条件的文章。将无进展生存期（PFS）、总生存期（OS）和AE作为主要结局指标进行测量。
纳入了9项涉及4501例患者的随机对照试验（RCT）。ICI联合化疗治疗取得了更好的PFS（风险比[HR]：0.78，[0.70 - 0.86]，<0.00001）、OS（HR：0.86，[0.74 - 0.99]，=0.04）和完全缓解率（584/1106对341/825，风险比[RR]：1.38，[1.01 - 1.89]，=0.04）。随着生存期的延长，与化疗相比，ICI联合化疗的生存优势增加。亚组分析表明，在亚洲患者、局部晚期疾病患者或脑转移患者中添加ICI可能没有更好的效果。在毒性分析中，ICI联合化疗组发现更多3 - 5级AE和严重AE。对于3 - 5级AE，更多的腹泻、严重皮肤反应、肺炎、肝炎和肾上腺功能不全病例与ICI联合化疗组有关。
ICI联合化疗在TNBC治疗中似乎优于单纯化疗，具有更好的OS和PFS。然而，其高严重AE发生率需要引起重视。
PROSPERO注册：CRD42021276394。
