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既往研究表明，对于早期三阴性乳腺癌，如果术前蒽环类＋环磷酰胺→紫杉类新辅助化疗获得病理完全缓解，患者生存率显著较高。卡铂显著可提高早期三阴性乳腺癌术前蒽环类＋环磷酰胺→紫杉类新辅助化疗的病理完全缓解率，病理完全缓解患者的无事件生存和总生存显著较长。不过，蒽环类对心脏毒性较大，如果卡铂＋紫杉类不加蒽环类，与蒽环类＋环磷酰胺→紫杉类相比，效果如何？ 2021年10月7日，国际抗癌联盟《国际癌症杂志》在线发表广东省人民医院暨广东省医学科学院、汕头市中心医院、中山大学附属第一医院、郑州大学附属肿瘤医院暨河南省肿瘤医院、东莞市人民医院、包头市肿瘤医院的NeoCART研究报告，对早期三阴性乳腺癌术前卡铂＋多西他赛与表柔比星＋环磷酰胺→多西他赛的效果进行了比较。 NeoCART (NCT03154749): DCb (Docetaxel / Carboplatin) Versus EC-D (Epirubicin / Cyclophosphamide Followed by Docetaxe) as Neoadjuvant Chemotherapy for Triple-Negative Breast Cancer (Neoadjuvant Docetaxel Carboplatin Versus Epirubicin Cyclophosphamide Followed by Docetaxel in Triple-Negative, Early-Stage Breast Cancer: Study Protocol for a Multicenter, Randomized Controlled, Open-Label, Phase 2 Trial) 该多中心非盲随机对照而期临床研究于2016年9月1日至2019年12月31日从全国6家医院入组II～III期三阴性乳腺癌术前患者93例，按1∶1的比例随机分为两组进行新辅助化疗，其中47例卡铂＋多西他赛6个周期，46例表柔比星＋环磷酰胺4个周期→多西他赛4个周期，主要结局为病理完全缓解（ypT0/is ypN0）。 结果，多西他赛＋卡铂组与表柔比星＋环磷酰胺→多西他赛组相比：
亚组分析分析表明，无论年龄、肿瘤分级、肿瘤大小、淋巴结状态、临床分期如何，多西他赛＋卡铂组与表柔比星＋环磷酰胺→多西他赛组相比，病理完全缓解率都显著较高。 中位随访37个月结束时，多西他赛＋卡铂组与表柔比星＋环磷酰胺→多西他赛组相比，总生存率和无事件生存率相似。病理完全缓解患者与未病理完全缓解患者相比，总生存率和无事件生存率显著较高。 因此，该小样本随机对照二期临床研究结果表明，早期三阴性乳腺癌术前患者，卡铂＋多西他赛与标准新辅助化疗方案（表柔比星＋环磷酰胺→多西他赛）相比，病理完全缓解率显著较高，总生存率和无事件生存率相似。多西他赛＋卡铂是一种很有希望的替代方案，尤其对蒽环类有禁忌症的三阴性乳腺癌患者，故有必要进一步开展大样本随机对照三期临床研究进行验证。 相关链接 Int J Cancer. 2021 Oct 7. Online ahead of print. Neoadjuvant docetaxel plus carboplatin vs epirubicin plus cyclophosphamide followed by docetaxel in triple-negative, early-stage breast cancer (NeoCART): Results from a multicenter, randomized controlled, open-label phase II trial. Zhang L, Wu ZY, Li J, Lin Y, Liu Z, Cao Y, Zhang G, Gao HF, Yang M, Yang CQ, Zhu T, Cheng MY, Ji F, Li J, Wang K. Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, Guangzhou, China; Shantou Central Hospital, Shantou, Guangdong, China; The First Affiliated Hospital, Sun Yat-Sen University, Guangdong, P. R. China; Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou, China; Dongguan People's Hospital, Dongguan, Guangdong, China; Baotou Cancer Hospital, Baotou, Inner Mongolia, China. What's new? In triple-negative breast cancer (TNBC), neoadjuvant chemotherapy based on anthracycline and taxane can improve survival, if pathologic complete response (pCR) is achieved. The addition of carboplatin to this neoadjuvant regimen for TNBC potentially improves pCR rate. The randomized trial reported here shows that, compared to a standard taxane- and anthracycline-based regimen without carboplatin, pCR rate is significantly improved by combining docetaxel and carboplatin and leaving out anthracycline. Survival rates were similar between the different regimens. The findings suggest that docetaxel plus carboplatin is a promising alternative approach, particularly in TNBC patients who have a contraindication to treatment with an anthracycline. Previous studies have shown that the addition of carboplatin to neoadjuvant chemotherapy improved the pathologic complete response (pCR) rate in patients suffering from triple-negative breast cancer (TNBC) and patients who obtained a pCR could achieve prolonged event-free survival (EFS) and overall survival (OS). However, no studies have assessed the effects of the combination of docetaxel and carboplatin without anthracycline with taxane-based and anthracycline-based regimens. The NeoCART study was designed as a multicenter, randomized controlled, open-label, phase II trial to assess the efficacy and safety of docetaxel combined with carboplatin in untreated stage II-III TNBC. All eligible patients were randomly assigned, at a 1:1 ratio, to an experimental docetaxel plus carboplatin (DCb) for six cycles group (DCb group) or an epirubicin plus cyclophosphamide for four cycles followed by docetaxel for four cycles group (EC-D group). PCR (ypT0/is ypN0) was evaluated as the primary outcome. Between 1 September 2016 and 31 December 2019, 93 patients were randomly assigned and 88 patients were evaluated for the primary endpoint (44 patients in each group). In the primary endpoint analysis, 27 patients in the DCb group (61.4%, 95% CI 47.0-75.8) and 17 patients in the EC-D group achieved a pCR (38.6%, 95% CI 24.3-53.0; odds ratio 2.52, 95% CI 2.4-43.1; P noninferiority = .004). Noninferiority was met, and the DCb regimen was confirmed to be superior to the EC-D regimen (P = .044, superiority margin of 5%). At the end of the 37-month median follow-up period, OS and EFS rates were equivalent in both groups. KEYWORDS: Triple-negative breast cancer; carboplatin; neoadjuvant chemotherapy PMID: 34591977 DOI: 10.1002/ijc.33830
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