编者按:随着新型ADC药物的出现,乳腺癌治疗领域也捷报频传。2022年ASCO大会上,Destiny-Breast 04研究(以下简称“DB-04研究”)结果的公布,使我们的目光聚焦于HER2低表达患者,随之而来的HER2低表达人群相关诊断及治疗问题也备受关注。由中国医学科学院肿瘤医院袁芃教授主持编纂的《中国HER2低表达乳腺癌临床诊疗共识》将于近日发布,该共识是第一个针对于HER2低表达乳腺癌患者治疗的专家共识。为此,《肿瘤瞭望》特邀采访了袁芃教授,请她就相关内容及HER2低表达患者的诊疗进行介绍。 HER2低表达下限定义仍不明确 HER2表达具有高度异质性 HER2低表达在不同病理医生间判读一致性较低 病理检测流程环节众多,影响因素错综复杂 此外,国内的ADC药物也在HER2低表达人群中进行了积极尝试。 2021年ASCO大会报道了维迪西妥单抗(RC48)针对两项Ⅰ期研究的合并分析23,旨在探究其在HER2阳性或HER2低表达亚组中的有效性和安全性。其中大约40%的患者为HER2低表达患者。在HER2低表达亚组中,ORR和mPFS分别为39.6%(95%CI:25.8%,54.7%)和5.7个月(95%CI:4.1,8.3),这也是一个很有前景的治疗药物。由徐兵河院士牵头的评价维迪西妥单抗治疗HER2低表达局部晚期或转移性乳腺癌有效性和安全性的III期临床研究(CTR20200646)也正在进行中。 MRG002是我国自主研发的抗HER2 ADC新药。今年ASCO大会上报道了其在HER2低表达人群中II期临床试验的数据24。入组患者50.0%接受过至少2线化疗,中位治疗线数为3线。截止至2021年12月31日,共有56例患者入组,49例可评价患者的ORR和DCR分别为34.7%和75.5%。MRG002同样在HER2低表达患者中显示出了治疗效果。 袁芃 教授 国家癌症中心 中国医学科学院肿瘤医院 特需医疗部副主任 主任医师,教授,博士生导师 中国抗癌协会理事 中国抗癌协会国际医疗与交流分会主任委员 中国抗癌协会乳腺癌专业委员会常委 中国临床肿瘤学会乳腺癌专家委员会常委 中国医师协会肿瘤学分会乳腺癌学组主任委员 北京癌症防治学会理事长 国家自然科学基金评审专家 参考文献:(滑动查看) [1] Shui R, Liang X, Li X, et al. Hormone Receptor and Human Epidermal Growth Factor Receptor 2 Detection in Invasive Breast Carcinoma: A Retrospective Study of 12,467 Patients From 19 Chinese Representative Clinical Centers. Clin Breast Cancer. 2020;20(1):e65-e74. [2] Xin L, Wu Q, Zhan C, et al. Multicenter study of the clinicopathological features and recurrence risk prediction model of early-stage breast cancer with low-positive human epidermal growth factor receptor 2 expression in China (Chinese Society of Breast Surgery 021). Chin Med J (Engl). 2022;135(6):697-706. Published 2022 Mar 20. [3]Zhang G, Ren C, Li C, et al. Distinct clinical and somatic mutational features of breast tumors with high-, low-, or non-expressing human epidermal growth factor receptor 2 status. BMC Med. 2022;20(1):142. Published 2022 Apr 29. [4] Fehrenbacher L, Cecchini RS, Geyer CE Jr, et al. NSABP B-47/NRG Oncology Phase III Randomized Trial Comparing Adjuvant Chemotherapy With or Without Trastuzumab in High-Risk Invasive Breast Cancer Negative for HER2 by FISH and With IHC 1+ or 2. J Clin Oncol. 2020;38(5):444-453. [5] Press MF, Finn RS, Cameron D, et al. HER-2 gene amplification, HER-2 and epidermal growth factor receptor mRNA and protein expression, and lapatinib efficacy in women with metastatic breast cancer. Clin Cancer Res. 2008;14(23):7861-7870. [6] Krop IE, LoRusso P, Miller KD, et al. A phase II study of trastuzumab emtansine in patients with human epidermal growth factor receptor 2-positive metastatic breast cancer who were previously treated with trastuzumab, lapatinib, an anthracycline, a taxane, and capecitabine. J Clin Oncol. 2012;30(26):3234-3241. [7] Burris HA 3rd, Rugo HS, Vukelja SJ, et al. Phase II study of the antibody drug conjugate trastuzumab-DM1 for the treatment of human epidermal growth factor receptor 2 (HER2)-positive breast cancer after prior HER2-directed therapy. J Clin Oncol. 2011;29(4):398-405. [8]Hein A, et al. Eur J Cancer. 2021;155:1-12 [9] Denkert C, et al. Lancet Oncol. 2021;22(8):1151-1161. [10] 2021 ESMO ABSTRACT 291P [11]. Gilcrease MZ et al.,Am J Surg Pathol. 2009 May;33(5):759-67 [12]. Francesco Schettini et al., NPJ Breast Cancer. 2021 Jan 4;7(1):1 ; [13]. Hye Sung Won et al., Breast Cancer Res. 2022 Mar 21;24(1):22. [14] Ryan Shea Ying Cong Tan et al, BMC Med. 2022 Mar 17;20(1):105. [15] Dieras V, Deluche E, Lusque A, et al: Trastuzumab deruxtecan for advanced breast cancer patients, regardless of HER2 status: A phase II study with biomarkers analysis (DAISY). 2021 San Antonio Breast Cancer Symposium. Abstract PD8-02. Presented December 9, 2021. [16] Marchiò C, Annaratone L, Marques A, Casorzo L, Berrino E, Sapino A. Evolving concepts in HER2 evaluation in breast cancer: Heterogeneity, HER2-low carcinomas and beyond. Semin Cancer Biol. 2021 Jul;72:123-135. [17] 中华乳腺病杂志(电子版). 2022;16(1):44-46. [18] Dagogo-Jack I, Shaw AT. Tumour heterogeneity and resistance to cancer therapies. Nat Rev Clin Oncol. 2018 Feb;15(2):81-94. [19] Tarantino P et al,. Eur J Cancer. 2022 Mar;163:35-43. [20] Federica Miglietta et al., NPJ Breast Cancer. 2021 Oct 12;7(1):137. [21] Fernandez AI, Liu M, Bellizzi A, et al. Examination of Low ERBB2 Protein Expression in Breast Cancer Tissue. JAMA Oncol. 2022 Feb 3:e217239. [22] Trastuzumab Deruxtecan in Previously Treated HER2-Low Advanced Breast Cancer. N Engl J Med. 2022 Jul 7;387(1):9-20. [23] Journal of Clinical Oncology 39, no. 15_suppl (May 20, 2021) 1022-1022. [24] Journal of Clinical Oncology 40, no. 16_suppl (June 01, 2022) 1102-1102. |
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