2种化疗方案在人表皮生长因子受体2阳性乳腺癌患者新辅助化疗中疗效比较的回顾性研究

doi:10.3877/cma.j.issn.1674-0807.2023.02.004

目的

比较ACH-TH(脂质体多柔比星+环磷酰胺+曲妥珠单克隆抗体序贯紫杉醇+曲妥珠单克隆抗体)与TCH(多西他赛+卡铂+曲妥珠单克隆抗体)2种新辅助化疗方案在HER-2阳性乳腺癌患者中的疗效差别。

方法

回顾性收集2017年1月1日至2020年1月31日就诊于东南大学附属中大医院、南京市第一医院、江苏省中医院和江苏省肿瘤医院等4家医院的HER-2阳性并接受新辅助化疗的36例乳腺癌患者临床资料，其中ACH-TH组17例，TCH组19例，采用Fisher确切概率法比较2组患者的pCR率及不良反应发生率。

结果

ACH-TH组的pCR率高于TCH组(13/17比4/19，P＝0.002)。ACH-TH组骨髓抑制和脱发的发生率明显低于TCH组(2/17比10/19，P＝0.014；0比19/19，P<0.001)，而2组的心脏毒性、胃肠道反应、口腔黏膜反应、手足综合征等不良反应发生率比较，差异无统计学意义(P＝1.000、1.000、0.216、0.487)。

结论

ACH-TH方案是HER-2阳性乳腺癌患者新辅助化疗的优选方案。

关键词: 乳腺肿瘤, 受体，ErbB-2, 新辅助治疗, 多柔比星

Objective

To compare the efficacy of the ACH-TH regimen (liposomal-encapsulated doxorubicin+ cyclophosphamide+ trastuzumab, followed by paclitaxel+ trastuzumab) and the TCH regimen (docetaxel + carboplatin + trastuzumab) for neoadjuvant chemotherapy of HER-2 positive breast cancer.

Methods

We retrospectively collected the clinical data of 36 HER-2 positive breast cancer patients who received neoadjuvant chemotherapy in four hospitals (Zhongda Hospital of Southeast University, Nanjing First Hospital, Jiangsu Provincial Hospital of Traditional Chinese Medicine and Jiangsu Provincial Cancer Hospital) from January 1, 2017 to January 31, 2020, including 17 cases in the ACH-TH group and 19 cases in the TCH group. The pathological complete response (pCR) rate and incidence of adverse reactions between the two groups were compared using Fisher’s exact test.

Results

The pCR rate was 13/17 in the ACH-TH group, which was significantly higher than that in the TCH group (4/19) (P=0.002). The incidences of bone marrow suppression and alopecia in the ACH-TH group were significantly lower than those in the TCH group (2/17 vs 10/19, P=0.014; 0 vs 19/19, P<0.001). However, there was no significant difference in the incidence of other adverse events such as cardiotoxicity, gastrointestinal reactions, oral mucosal reactions and hand-foot syndrome between the two groups (P=1.000, 1.000, 0.216, 0.487).

Conclusion

ACH-TH regimen is the optimal regimen for neoadjuvant chemotherapy of HER-2 positive breast cancer patients.

Key words: Breast neoplasms, Receptor, ErbB-2, Neoadjuvant therapy, Doxorubicin

表1 接受2种不同新辅助化疗方案的HER-2阳性乳腺癌患者基线资料比较

组别	例数	年龄(岁)	TNM分期		腋窝淋巴结		激素受体		组织学分级
组别	例数	年龄(岁)	Ⅱ期	Ⅲ期	阴性	阳性	阴性	阳性	2级	3级
ACH-TH组	17^a	50.5±7.1	6	11	5	12	9	8	10	7
TCH组	19^a	51.7±8.7	9	10	2	17	4	15	13	6
检验值		t＝－0.394
P值		0.696	0.516^b		0.219^b		0.082^b		0.730^b

表1 接受2种不同新辅助化疗方案的HER-2阳性乳腺癌患者基线资料比较

组别	例数	年龄(岁)	TNM分期		腋窝淋巴结		激素受体		组织学分级
组别	例数	年龄(岁)	Ⅱ期	Ⅲ期	阴性	阳性	阴性	阳性	2级	3级
ACH-TH组	17^a	50.5±7.1	6	11	5	12	9	8	10	7
TCH组	19^a	51.7±8.7	9	10	2	17	4	15	13	6
检验值		t＝－0.394
P值		0.696	0.516^b		0.219^b		0.082^b		0.730^b

表2 2种不同新辅助化疗方案的不良反应比较

组别	例数	骨髓抑制	心脏毒性	脱发	口腔黏膜炎	手足综合征	胃肠道反应
ACH-TH组	17^a	2	0	0	2	0	0
TCH组	19^a	10	1	19	0	2	1
P值		0.014^b	1.000^b	<0.001^b	0.216^b	0.487^b	1.000^b

表2 2种不同新辅助化疗方案的不良反应比较

组别	例数	骨髓抑制	心脏毒性	脱发	口腔黏膜炎	手足综合征	胃肠道反应
ACH-TH组	17^a	2	0	0	2	0	0
TCH组	19^a	10	1	19	0	2	1
P值		0.014^b	1.000^b	<0.001^b	0.216^b	0.487^b	1.000^b

[1]	Ferlay J, Colombet M, Soerjomataram I, et al. Cancer statistics for the year 2020: an overview[J]. Int J Cancer, 2021，149：778-789.
[2]	中国临床肿瘤学会指南工作委员会．中国临床肿瘤学会(CSCO)乳腺癌诊疗指南(2017.V1)[M]. 北京：人民卫生出版社，2017.
[3]	Cortazar P, Zhang L, Untch M, et al. Pathological complete response and long-term clinical benefit in breast cancer: the CTNeoBC pooled analysis[J]. Lancet, 2014, 384(9938)：164-172.
[4]	U．S. Department of Health and Human Services. Common terminology criteria for adverse events (CTCAE) version 5.0[EB/OL]. [2021-10-17]. URL
[5]	Lambertini M, Pond NF, Solinas C, et al. Adjuvant trastuzumab: a 10-year overview of its benefit[J]. Expert Rev Anticancer Ther, 2017，17(1)：61-74.
[6]	Pomponio MK, Burkbauer L, Goldbach M, et al. Refining the indications for neoadjuvant chemotherapy for patients with HER-2+ breast cancer: A single institution experience[J]. J Surg Oncol, 2020，121(3)：447-455.
[7]	Wolff AC, Hammond ME, Hicks DG, et al. Recommendations for human epidermal growth factor receptor 2 testing in breast cancer: American Society of Clinical Oncology/College of American Pathologists clinical practice guideline update[J]．J Clin Oncol, 2013, 31(31)：3997-4013.
[8]	Demichele A, Yee D, Paoloni M, et al. Neoadjuvant as future for drug development in breast cancer: response[J]. Clin Cancer Res, 2016，22(1)：269-269.
[9]	中国抗癌协会乳腺癌专业委员会．中国抗癌协会乳腺癌诊治指南与规范(2017年版)[J]．中国癌症杂志，2017，27(9)：695-759.
[10]	Houssami N, Macaskill P, Minckwitz GV, et al. Meta-analysis of the association of breast cancer subtype and pathologic complete response to neoadjuvant chemotherapy[J]. Eur J Cancer, 2012，48(18)：3342-3354.
[11]	Mauri D, Pavlidis N, Ioannidis JPA. Neoadjuvant versus adjuvant systemic treatment in breast cancer: a meta-analysis[J]. J Natl Cancer Inst, 2005，97(3): 188-194.
[12]	Gianni L, Pienkowski T, Im YH, et al. 5-year analysis of neoadjuvant pertuzumab and trastuzumab in patients with locally advanced, inflammatory, or early-stage HER-2-positive breast cancer (NeoSphere): a multicentre, open-label, phase 2 randomised trial[J]. Lancet Oncol, 2016, 17(6): 791-800.
[13]	Simon PS. Neoadjuvant therapy of early stage human epidermal growth factor receptor 2 positive breast cancer: latest evidence and clinical implications[J]. Ther Adv Med Oncol, 2014，6(5)：210-221.
[14]	廖宁，张国淳，李学瑞，等．联合曲妥珠单克隆抗体的新辅助化疗方案用于HER-2阳性乳腺癌的Meta分析[J]．南方医科大学学报，2009，29(5)：943-945.
[15]	Gradishar WJ, Anderson BO, Balassanian R, et al. Breast cancer, version 4. 2017, NCCN clinical practice guidelines in oncology[J]. J Natl Compr Canc Netw, 2018，15(3)：310-320.
[16]	中国抗癌协会乳腺癌专业委员会．中国抗癌协会乳腺癌诊治指南与规范(2019年版)[J]. 中国癌症杂志，2019，29(8)：609-680.
[17]	Lazaridis G, Pentheroudakis G, Pavlidis N. Integrating trastuzumab in the neoadjuvant treatment of primary breast cancer: accumulating evidence of efficacy, synergy and safety[J]. Crit Rev Oncol Hematol, 2008，66(1)：31-41.
[18]	Untch M, Eidtmann H, Bois A, et al. Cardiac safety of trastuzumab in combination with epirubicin and cyclophosphamide in women with metastatic breast cancer: results of a phase I trial[J]. Eur J Cancer, 2004, 40(7)：988-997.
[19]	Hyams D, Leichman G, Klein P, et al. Phase II trial of neoadjuvant pegylated liposomal doxorubicin with paclitaxel and trastuzumab in patients with operable HER-2-positive breast cancer[J]. Cancer Res, 2010，69(24 Suppl)：1098-1098.
[20]	Gavila J, Guerrero A, Climent MA, et al. Efficacy and safety of neoadjuvant chemotherapy with concurrent liposomal-encapsulated doxorubicin, paclitaxel and trastuzumab for human epidermal growth factor receptor 2-positive breast cancer in clinical practice[J]. Int J Clin Oncol, 2015，20(3)：480-489.
[21]	Uriarte-Pinto M, Escolano-Pueyo A, Gimeno-Ballester V, et al. Trastuzumab, non-pegylated liposomal-encapsulated doxorubicin and paclitaxel in the neoadjuvant setting of HER-2 positive breast cancer[J]. Int J Clin Pharm, 2016, 38(2)：446-453.
[22]	马腾，史亚飞，马天怡，等. AC-TH与TCH方案对HER-2过表达乳癌新辅助化疗效果比较[J]. 青岛大学学报：医学版，2021, 57(3)：365-368.
[23]	徐玲，叶京明，朱赛楠，等．HER-2阳性早期乳腺癌TCH方案新辅助治疗疗效分析[J]．中华医学杂志，2018，98(12)：907-911.
[24]	Echavarria I, Granja M, Bueno C, et al. Multicenter analysis of neoadjuvant docetaxel, carboplatin, and trastuzumab in HER2-positive breast cancer[J]. Breast Cancer Res Treat, 2017，162(1)：181-189.
[25]	Baselga1 J, Manikhas A, Cortés J, et al. Phase III trial of nonpegylated liposomal doxorubicin in combination with trastuzumab and paclitaxel in HER-2-positive metastatic breast cancer[J]. Ann Oncol, 2014，25(3)：592-598.
[26]	Harris L, Batist G, Belt R, et al. Liposome-encapsulated doxorubicin compared with conventional doxorubicin in a randomized multicenter trial as first-line therapy of metastatic breast carcinoma[J]. Cancer, 2002，94(1)：25-36.
[27]	Rivankar S. An overview of doxorubicin formulations in cancer therapy[J]. J Cancer Res Ther, 2014，10(4)：853-858.

[1]	周荷妹, 金杰, 叶建东, 夏之一, 王进进, 丁宁. 罕见成人肋骨郎格汉斯细胞组织细胞增生症被误诊为乳腺癌术后骨转移一例[J/OL]. 中华乳腺病杂志(电子版), 2024, 18(06): 380-383.
[2]	河北省抗癌协会乳腺癌专业委员会护理协作组. 乳腺癌中心静脉通路护理管理专家共识[J/OL]. 中华乳腺病杂志(电子版), 2024, 18(06): 321-329.
[3]	刘晨鹭, 刘洁, 张帆, 严彩英, 陈倩, 陈双庆. 增强MRI 影像组学特征生境分析在预测乳腺癌HER-2 表达状态中的应用[J/OL]. 中华乳腺病杂志(电子版), 2024, 18(06): 339-345.
[4]	张晓宇, 殷雨来, 张银旭. 阿帕替尼联合新辅助化疗对三阴性乳腺癌的疗效及预后分析[J/OL]. 中华乳腺病杂志(电子版), 2024, 18(06): 346-352.
[5]	邱琳, 刘锦辉, 组木热提·吐尔洪, 马悦心, 冷晓玲. 超声影像组学对致密型乳腺背景中非肿块型乳腺癌的诊断价值[J/OL]. 中华乳腺病杂志(电子版), 2024, 18(06): 353-360.
[6]	程燕妮, 樊菁, 肖瑶, 舒瑞, 明昊, 党晓智, 宋宏萍. 乳腺组织定位标记夹的应用与进展[J/OL]. 中华乳腺病杂志(电子版), 2024, 18(06): 361-365.
[7]	涂盛楠, 胡芬, 张娟, 蔡海峰, 杨俊泉. 天然植物提取物在乳腺癌治疗中的应用[J/OL]. 中华乳腺病杂志(电子版), 2024, 18(06): 366-370.
[8]	高俊颖, 张海洲, 区泓乐, 孙强. FOLFOX-HAIC 为基础的肝细胞癌辅助转化治疗的应用进展[J/OL]. 中华普通外科学文献(电子版), 2024, 18(06): 457-463.
[9]	高杰红, 黎平平, 齐婧, 代引海. ETFA和CD34在乳腺癌中的表达及与临床病理参数和预后的关系研究[J/OL]. 中华普外科手术学杂志(电子版), 2025, 19(01): 64-67.
[10]	韩萌萌, 冯雪园, 马宁. 乳腺癌改良根治术后桡神经损伤1例[J/OL]. 中华普外科手术学杂志(电子版), 2025, 19(01): 117-118.
[11]	张志兆, 王睿, 郜苹苹, 王成方, 王成, 齐晓伟. DNMT3B与乳腺癌预后的关系及其生物学机制[J/OL]. 中华普外科手术学杂志(电子版), 2024, 18(06): 624-629.
[12]	王玲艳, 高春晖, 冯雪园, 崔鑫淼, 刘欢, 赵文明, 张金库. 循环肿瘤细胞在乳腺癌新辅助及术后辅助治疗中的应用[J/OL]. 中华普外科手术学杂志(电子版), 2024, 18(06): 630-633.
[13]	赵林娟, 吕婕, 王文胜, 马德茂, 侯涛. 超声引导下染色剂标记切缘的梭柱型和圆柱型保乳区段切除术的效果研究[J/OL]. 中华普外科手术学杂志(电子版), 2024, 18(06): 634-637.
[14]	崔军威, 蔡华丽, 胡艺冰, 胡慧. 亚甲蓝联合金属定位夹及定位钩针标记在乳腺癌辅助化疗后评估腋窝转移淋巴结的临床应用价值探究[J/OL]. 中华临床医师杂志(电子版), 2024, 18(07): 625-632.
[15]	王誉英, 刘世伟, 王睿, 曾娅玲, 涂禧慧, 张蒲蓉. 老年乳腺癌新辅助治疗病理完全缓解的预测因素分析[J/OL]. 中华临床医师杂志(电子版), 2024, 18(07): 641-646.

阅读次数

全文

摘要

选择文件类型/文献管理软件名称

选择包含的内容

Efficacy comparison of two neoadjuvant chemotherapy regimens in human epidermal growth factor receptor 2 positive breast cancer: a retrospective study

模态框（Modal）标题

选择文件类型/文献管理软件名称

选择包含的内容

Efficacy comparison of two neoadjuvant chemotherapy regimens in human epidermal growth factor receptor 2 positive breast cancer: a retrospective study