Background: Triple-negative breast cancer (TNBC) is associated with poor prognosis and a high risk of early relapse. The incorporation of platinum-based agents into neoadjuvant chemotherapy (NACT) regimens has been linked to improved pathological complete response (pCR) rates. However, the clinical benefit of carboplatin (CBDCA) remains debated due to variable long-term survival outcomes and concerns over cumulative toxicity. This meta-analysis evaluates the efficacy of adding CBDCA to NACT in early-stage TNBC (eTNBC). Methods: A systematic review and meta-analysis were conducted by searching MEDLINE, PubMed, and major oncology conference proceedings (2014–2024), with no language restrictions. Randomized phase II–III trials assessing the addition of CBDCA to standard NACT in eTNBC and reporting pCR and survival outcomes were included. The systematic review followed the recommendations of the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA). The protocol has not been registered. The primary endpoint was pCR; the secondary endpoint was disease-free survival (DFS). For pCR, a random-effects model was used, and odds ratios (OR) were log-transformed. For DFS, a mixed-effects model was applied, extracting hazard ratios (HR) and converting them into logHR values. Heterogeneity was assessed using I2statistics, and publication bias was evaluated through the Fail-Safe N method and Egger’s regression test. Statistical analyses were performed using Jamovi v2.4.11. Results: Of 30 studies identified, 9 randomized clinical trials were eligible; 6 (BrighTNess, GeparSixto, GS5-01, BR-15-1 PEARLY, NACATRINE, CALGB 40603) met all inclusion criteria, totaling 3402 patients. The addition of CBDCA to NACT significantly improved pCR (OR 1.63; 95% CI: 1.38–1.92;p< 0.001), with low heterogeneity (I2= 0.81%) and no publication bias. DFS was also significantly improved (SHR 0.81; 95% CI: 0.63–0.91;p= 0.003), with moderate heterogeneity (I2= 27.95%) and no bias detected. Conclusions: Adding carboplatin to NACT significantly improves pCR and DFS in patients with early-stage TNBC.
背景：三阴性乳腺癌（TNBC）预后较差，早期复发风险高。在新辅助化疗（NACT）方案中加入铂类药物与病理完全缓解（pCR）率的提高相关。然而，由于长期生存结果存在差异以及对累积毒性的担忧，卡铂（CBDCA）的临床获益仍存争议。本荟萃分析评估了在早期TNBC（eTNBC）的NACT中添加CBDCA的疗效。 方法：通过检索MEDLINE、PubMed及主要肿瘤学会议记录（2014–2024年），无语言限制，进行系统综述和荟萃分析。纳入评估在eTNBC标准NACT中添加CBDCA并报告pCR和生存结果的随机II–III期试验。系统综述遵循《系统综述和荟萃分析优先报告条目》（PRISMA）建议。研究方案未注册。主要终点为pCR；次要终点为无病生存期（DFS）。对于pCR，采用随机效应模型，并对比值比（OR）进行对数转换。对于DFS，应用混合效应模型，提取风险比（HR）并将其转换为logHR值。使用I²统计量评估异质性，并通过失效安全数法和Egger回归检验评估发表偏倚。统计分析使用Jamovi v2.4.11软件进行。 结果：在确定的30项研究中，9项随机临床试验符合条件；其中6项（BrighTNess、GeparSixto、GS5-01、BR-15-1 PEARLY、NACATRINE、CALGB 40603）满足所有纳入标准，共计3402例患者。在NACT中添加CBDCA显著提高了pCR（OR 1.63；95% CI：1.38–1.92；p < 0.001），异质性低（I² = 0.81%），且无发表偏倚。DFS也显著改善（SHR 0.81；95% CI：0.63–0.91；p = 0.003），存在中度异质性（I² = 27.95%），未检测到偏倚。 结论：在NACT中添加卡铂可显著改善早期TNBC患者的pCR和DFS。
肿瘤(癌症)患者之家