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[新辅助表柔比星-环磷酰胺治疗后序贯白蛋白结合型紫杉醇治疗可手术乳腺癌患者——一项单中心Ⅱ期试验]

[Neoadjuvant Epirubicin-Cyclophosphamide Therapy followed by Nab-Paclitaxel in Patients with Operable Breast Cancer-A Single-Center Phase Ⅱ Trial].

作者信息

Ogata Ryohei, Yamamoto Yutaka, Jo Azusa, Fukuma Yuna, Mikami Tsuyoshi, Kawano Shiori, Kishino Emi, Saito Wataru, Koike Yoshikazu, Soda Mai, Nomura Tsunehisa, Tanaka Katsuhiro, Kurebayashi Junichi

机构信息

Dept. of Breast and Thyroid Surgery, Kawasaki Medical School.

出版信息

Gan To Kagaku Ryoho. 2022 Jun;49(6):677-682.


DOI:
PMID:35799395
Abstract

Clinical studies have confirmed that nab-paclitaxel(nab-PTX)therapy is effective and safe in patients with metastatic breast cancer. Neoadjuvant chemotherapy(NAC) with nab-PTX has resulted in a pathological complete response (pCR) rate of 29% in all cases and 58% in HER2-positive cases. However, these data were obtained from an overseas study, and the effectiveness and safety of NAC with nab-PTX remain unclear in Japan. Thus, the present study was conducted to investigate these aspects. In patients with T1-3, N0-2, M0 breast cancer, 4 cycles of 260 mg/m2 nab-PTX were administered every 3 weeks after 4 cycles of EC therapy(100 mg/m2 of epirubicin and 600 mg/m2 of cyclophosphamide)as NAC. In HER2- positive patients, trastuzumab was used in combination with nab-PTX. Overall, 14 patients were registered between October 2014 and October 2018. One patient who had requested for another drug after providing informed consent was excluded, and the remaining 13 patients were analyzed. The primary endpoint was pCR rate. The median age of the subjects was 57 years, and the median tumor diameter was 35 mm. There were 7 cases of Stage Ⅱ disease and 6 cases of Stage Ⅲ disease. As for tumor subtype, there were 7 cases of Luminal-type, 2 cases of Luminal- HER2-type, 4 cases of HER2-type, and no triple negative-type tumors(the cut-off values for estrogen receptor [ER] and progesterone receptor were both 1%). The objective response rate to NAC was 77%(10/13 cases), and no PD was observed. The pCR rate was 54%(7/13 cases): 2 patients had Luminal-type tumors, 1 had a Luminal-HER2-type tumor, and 4 had HER2-type tumors. Predictive factors for pCR were ER negativity and HER2 positivity. Common adverse events of chemotherapy were hair loss, pain, malaise, anemia, dysgeusia, constipation, itchiness, and numbness, but their severity was modest, and they were manageable. This study suggests the efficacy and safety of nab-PTX after EC therapy in Japanese patients with operable breast cancer.

摘要

临床研究已证实,纳米白蛋白结合型紫杉醇(nab-PTX)治疗转移性乳腺癌患者有效且安全。采用nab-PTX的新辅助化疗(NAC)在所有病例中的病理完全缓解(pCR)率为29%,在HER2阳性病例中为58%。然而,这些数据来自一项海外研究,在日本,采用nab-PTX的NAC的有效性和安全性仍不明确。因此,开展本研究以调查这些方面。在T1-3、N0-2、M0期乳腺癌患者中,作为NAC,在4周期EC治疗(表柔比星100 mg/m²和环磷酰胺600 mg/m²)后,每3周给予260 mg/m²的nab-PTX,共4周期。在HER2阳性患者中,曲妥珠单抗与nab-PTX联合使用。总体而言,2014年10月至2018年10月期间登记了14例患者。1例在签署知情同意书后要求使用其他药物的患者被排除,其余13例患者进行分析。主要终点为pCR率。受试者的中位年龄为57岁,中位肿瘤直径为35 mm。有7例Ⅱ期疾病和6例Ⅲ期疾病。至于肿瘤亚型,有7例Luminal型、2例Luminal-HER2型、4例HER2型,无三阴性肿瘤(雌激素受体[ER]和孕激素受体的临界值均为1%)。NAC的客观缓解率为77%(10/13例),未观察到疾病进展(PD)。pCR率为54%(7/13例):2例为Luminal型肿瘤,1例为Luminal-HER2型肿瘤,4例为HER2型肿瘤。pCR的预测因素为ER阴性和HER2阳性。化疗的常见不良事件为脱发、疼痛、不适、贫血、味觉障碍、便秘、瘙痒和麻木,但其严重程度较轻,且可控制。本研究提示了在日本可手术乳腺癌患者中,EC治疗后使用nab-PTX的有效性和安全性。

相似文献

[1]
[Neoadjuvant Epirubicin-Cyclophosphamide Therapy followed by Nab-Paclitaxel in Patients with Operable Breast Cancer-A Single-Center Phase Ⅱ Trial].

Gan To Kagaku Ryoho. 2022-6

[2]
Preoperative neoadjuvant chemotherapy using nanoparticle albumin-bound paclitaxel followed by epirubicin and cyclophosphamide for operable breast cancer: a multicenter phase II trial.

Breast Cancer. 2017-7

[3]
Neoadjuvant chemotherapy using nanoparticle albumin-bound paclitaxel plus trastuzumab and pertuzumab followed by epirubicin and cyclophosphamide for operable HER2-positive primary breast cancer: a multicenter phase II clinical trial (PerSeUS-BC04).

Breast Cancer. 2023-3

[4]
Neoadjuvant Chemotherapy With Nab-paclitaxel Plus Trastuzumab Followed by 5-Fluorouracil/Epirubicin/Cyclophosphamide for HER2-positive Operable Breast Cancer: A Multicenter Phase II Trial.

Anticancer Res. 2019-4

[5]
Phase II Study of Neoadjuvant Anthracycline-Based Regimens Combined With Nanoparticle Albumin-Bound Paclitaxel and Trastuzumab for Human Epidermal Growth Factor Receptor 2-Positive Operable Breast Cancer.

Clin Breast Cancer. 2015-6

[6]
[Efficacy and Safety of Nanoparticle Albumin-Bound Paclitaxel as Neoadjuvant Chemotherapy in Breast Cancer Patients].

Gan To Kagaku Ryoho. 2019-9

[7]
Feasibility Study of Nanoparticle Albumin-Bound-Paclitaxel and S-1 Followed by Epirubicin/Cyclophosphamide as Neoadjuvant Chemotherapy in Patients With Operable Breast Cancer: A Prospective Study.

Clin Breast Cancer. 2022-4

[8]
Dual HER2-blockade with pertuzumab and trastuzumab in HER2-positive early breast cancer: a subanalysis of data from the randomized phase III GeparSepto trial.

Ann Oncol. 2017-3-1

[9]
Randomized Multicenter Phase II Trial of Neoadjuvant Therapy Comparing Weekly Nab-paclitaxel Followed by FEC With Docetaxel Followed by FEC in HER2 Early-stage Breast Cancer.

Clin Breast Cancer. 2018-6-27

[10]
Neoadjuvant triweekly nanoparticle albumin-bound paclitaxel followed by epirubicin and cyclophosphamide for Stage II/III HER2-negative breast cancer: evaluation of efficacy and safety.

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