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2023年乳腺癌临床研究进展年终盘点OA北大核心CSTPCD

Year-end review of clinical research progress in breast cancer in 2023

中文摘要英文摘要

乳腺癌作为全球发病例数第一的恶性肿瘤,多年来一直是研究的热点.2023年,乳腺癌临床研究在局部治疗和系统治疗方面取得显著进展.在局部治疗方面,如何评估腋窝肿瘤负荷及选择合适的治疗手段是研究焦点.SOUND研究发现前哨淋巴结活检(SLNB)与无腋窝手术对于术前腋窝超声淋巴结阴性早期乳腺癌患者的5年无远处转移生存率相似,在术前超声对腋窝淋巴结筛查结果明确的情况下可避免SLNB.SENOMAC研究提供证据支持低负荷前哨淋巴结患者不进行腋窝淋巴结清扫(ALND)的可能性.OPBC05研究指出新辅助治疗后残留孤立肿瘤细胞(ITCs)的患者中ALND不改善长期生存,暗示豁免ALND的可行性.NSABP B-51研究显示,新辅助化疗(NAC)后腋窝淋巴结阴性(ypN0)患者的局部淋巴结放疗(RNI)并未显著改善主要研究终点.这些研究强调了个体化治疗方案的重要性,为乳腺癌的外科治疗和后续治疗提供重要指导.在系统治疗方面,早期激素受体阳性[HR(+)]乳腺癌治疗主要依赖手术、放疗及术后辅助内分泌治疗,但约30%的中高危患者仍面临复发和转移风险.MoHER2narchE 和 NATALEE 研究证实了CDK4/6 抑制剂(CDK4/6i)在早期HR(+)/人表皮生长因子受体2阴性[HER-2(-)]乳腺癌患者中的效果.此外,有关免疫治疗的研究,如KEYNOTE-756和CheckMate 7FL试验,探讨了PD-1单抗联合NAC在提高病理完全缓解(pCR)率和降低高危患者复发风险中的潜力.晚期HR(+)乳腺癌的标准治疗已从单一内分泌治疗发展为CDK4/6i联合内分泌治疗,但仍存在耐药问题,新型药物如ADC药物、PI3K/Akt/mTOR抑制剂正在被探索以提供更多治疗选项.TROPiCS-02和TROPION-Breast01研究验证了TROP2靶向ADC药物在治疗耐药HR(+)/HER-2(-)晚期乳腺癌患者中的有效性.同时,INAVO 120和Capitello-291研究突显了PI3K/Akt/mTOR信号通路抑制剂在提高治疗效果方面的潜力,尤其是对PIK3CA突变患者.在早期HER-2(+)乳腺癌治疗方面,PHERGain研究表明,基于18F-FDG PET/CT和根据pCR调整的降阶梯化疗在早期HER-2(+)乳腺癌新辅助治疗中有效.APTneo研究发现阿替利珠单抗联合化疗对新辅助治疗的pCR率提升有限,需进一步研究以优化疗效和安全性.在晚期HER-2(+)乳腺癌方面,PHILA和HER2CLIMB-02研究展示了TKI药物在一线和二线治疗中的有效性.DESTINY-Breast系列研究证明了德曲妥珠单抗(T-DXd)对HER-2(+)转移性乳腺癌各年龄段患者都有效且展现出良好的安全性.同时其对经治/稳定和未经治/活动性脑转移患者均有显著的疗效.早期三阴性乳腺癌(TNBC)的研究重点在于免疫治疗与化疗的联合应用,KEYNOTE-522研究显示化疗联合帕博利珠单抗的新辅助治疗及其作为后续辅助治疗显著提高了pCR率和无事件生存率,美国食品药品管理局和欧洲药物管理局已批准其用于高危早期TNBC的治疗.然而,IMpassion030研究表明,术后辅助免疫治疗可能并非所有早期TNBC患者的有效选项.对于晚期TNBC,KEYLYNK-009研究结果显示帕博利珠单抗联合PARP抑制剂奥拉帕利与帕博利珠单抗加化疗相比,并未显著改善预后,但在具有tBRCA突变的患者群体中,该联合疗法显著提高了中位无进展生存期(PFS),表明其可作为这一患者群体的晚期一线维持治疗.BEGONIA研究的结果表明,Dato-DXd和度伐利尤单抗联合治疗显示出高反应率和较长的PFS,可能为晚期TNBC患者提供新的治疗选择.综上,2023年乳腺癌治疗领域的研究不仅在治疗方法上取得了突破,也在治疗理念上进行了革新,为乳腺癌患者带来了新的希望.

Breast cancer,as the most common malignant tumor globally,has been a hotspot of research for many years.In 2023,significant progress was made in clinical research on breast cancer in both local and systemic treatments.In terms of local treatment,evaluating axillary tumor burden and selecting appropriate treatment methods have been the focus of research.The SOUND study found that sentinel lymph node biopsy(SLNB)and axillary surgery had similar 5-year distant metastasis-free survival rates for patients with early-stage breast cancer who were negative for axillary lymph nodes on preoperative axillary ultrasound,avoiding SLNB when preoperative ultrasound screening results for axillary lymph nodes were clear.The SENOMAC study provided evidence supporting the possibility of not performing axillary lymph node dissection(ALND)for patients with low-burden sentinel lymph nodes.The OPBC05 study indicated that ALND did not improve long-term survival in patients with residual isolated tumor cells(ITCs)after neoadjuvant therapy,suggesting the feasibility of exemption from ALND.The NSABP B-51 study showed that regional lymph node irradiation(RNI)for axillary lymph node-negative patients after neoadjuvant chemotherapy(NAC)did not significantly improve the primary study endpoint.These studies emphasized the importance of personalized treatment regimens,providing important guidance for the surgical and subsequent treatment of breast cancer.In terms of systemic treatment,early-stage hormone receptor-positive[HR(+)]breast cancer treatment mainly relies on surgery,radiotherapy,and postoperative adjuvant endocrine therapy.However,approximately 30%of intermediate-to high-risk patients still face the risk of recurrence and metastasis.The MonarchE and NATALEE studies confirmed the effectiveness of CDK4/6 inhibitors in early-stage HR(+)/human epidermal growth factor receptor 2-negtive[HER-2(-)]breast cancer patients.In addition,studies on immunotherapy,such as the KEYNOTE-756 and CheckMate 7FL trials,explored the potential of PD-1 monoclonal antibodies combined with NAC in increasing the rate of pathological complete response(pCR)and reducing the risk of recurrence in high-risk patients.Standard treatment for advanced HR(+)breast cancer has evolved from single-agent endocrine therapy to combined therapy with CDK4/6 inhibitors,but resistance remains an issue.New drugs such as ADC drugs and PI3K/Akt/mTOR inhibitors are being explored to provide more treatment options.The TROPiCS-02 and TROPION-Breast0l studies validated the efficacy of TROP2-targeted ADC drugs in treating resistant HR(+)/HER-2(-)advanced breast cancer patients.Meanwhile,the INAVO 120 and Capitello-291 studies highlighted the potential of PI3K/Akt/mTOR signaling pathway inhibitors in improving treatment outcomes,especially for patients with PIK3CA mutations.In the treatment of early HER-2(+)breast cancer,the PHERGain study demonstrated the effectiveness of 18F-FDG PET/CT-based de-escalated chemotherapy adjusted according to pCR in neoadjuvant therapy for early HER-2(+)breast cancer.The APTneo study found that the addition of atezolizumab to chemotherapy had limited impact on increasing the pCR rate in neoadjuvant therapy,requiring further research to optimize efficacy and safety.Regarding advanced HER-2(+)breast cancer,the PHILA and HER2CLIMB-02 studies demonstrated the effectiveness of TKI drugs in first-line and second-line treatment.The DESTINY-Breast series of studies proved the efficacy and good safety profile of trastuzumab deruxtecan(T-DXd)in patients with HER-2(+)metastatic breast cancer across all age groups,with significant efficacy in patients with treated/stable and untreated/active brain metastases.Research on early triple-negative breast cancer(TNBC)focuses on the combination of immunotherapy and chemotherapy.The KEYNOTE-522 study showed that neoadjuvant therapy with chemotherapy plus pembrolizumab significantly increased pCR rates and event-free survival rates,and FDA and EMA have approved its use in the treatment of high-risk early-stage TNBC.However,the IMpassion030 study suggested that postoperative adjuvant immunotherapy may not be an effective option for all early-stage TNBC patients.For advanced TNBC,the KEYLYNK-009 study results showed that the combination of pembrolizumab and PARP inhibitors with chemotherapy did not significantly improve prognosis compared to pembrolizumab plus chemotherapy,but in patients with tBRCA mutations,this combination therapy significantly improved median progression-free survival(PFS),indicating its potential as first-line maintenance therapy for this patient population.The results of the BEGONIA study indicated that the combination therapy of Dato-DXd and durvalumab showed high response rates and longer PFS,potentially providing new treatment options for patients with advanced TNBC.In summary,research in the field of breast cancer treatment in 2023 has not only made breakthroughs in treatment methods but also innovated treatment concepts,bringing new hope to breast cancer patients.

郑薇;刘强

中山大学孙逸仙纪念医院乳腺肿瘤中心,广东广州 510120

临床医学

乳腺肿瘤临床研究肿瘤负荷ErbB受体抗肿瘤联合化疗方案

Breast NeoplasmsClinical StudyTumor BurdenErbB ReceptorsAntineoplastic Combined Chemotherapy Protocols

《中国普通外科杂志》 2024 (005)

669-682 / 14

10.7659/j.issn.1005-6947.2024.05.001

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