Investigating the Efficacy and Safety of a Dose-Dense Paclitaxel, Cyclophosphamide With Trastuzumab in Stage I-II Human Epidermal Growth Factor Receptor 2 (HER2) Positive Breast Cancer

IF 2.9 3区医学 Q2 ONCOLOGY

Clinical breast cancer Pub Date : 2024-07-17 DOI:10.1016/j.clbc.2024.07.002

Lina Elsayed , Elizabeth Reed , Shivani Modi , Pavan K. Tandra , Mehmet S. Copur , Kaeli Samson , Jairam Krishnamurthy

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引用次数: 0

Abstract

Background

The evolution of systemic therapies has improved outcomes for patients with human epidermal growth factor receptor 2 positive (HER2+) breast cancer. Nonetheless, the tolerability and safety profile of systemic therapies represent an area for further improvement. Here we report the results of a phase 2 trial evaluating a nonanthracycline, nonplatinum adjuvant treatment regimen for patients following initial surgical resection.

Methods

We enrolled patients with stage I or II HER2+ breast cancer who underwent upfront surgery to receive adjuvant treatment with 6 cycles of dose-dense Paclitaxel, cyclophosphamide and Trastuzumab (PC-H) every 2 weeks, followed by 13 cycles of maintenance trastuzumab every 3 weeks to complete 52 weeks of treatment (compromising 19 cycles). The primary objective was to determine the safety and feasibility of adjuvant PC-H, measured by the completion rate frequency and the grade of adverse events, using National Cancer Institute Common Terminology Criteria. The secondary objective was to estimate relapse-free survival and overall survival.

Results

Between 2010 and 2019, a total of 39 patients were enrolled. Of those, 34 patients (87.18%) completed the planned treatment. Severe adverse events of grade 3 or 4 occurred in 27 patients (69.23%), including 3 patients (7.69%) with grade 3-4 decrease in ejection fraction. At median follow up of 5.6 years, all 39 patients were alive. The 5-year relapse-free survival was 94.30% (95% CI: 75.3-100).

Conclusions

PC-H demonstrated overall safety and efficacy, yielding high rates of relapse-free survival among patients with early stage (HER2+) breast cancer.

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研究剂量密集型紫杉醇、环磷酰胺和曲妥珠单抗治疗 I-II 期人表皮生长因子受体 2 (HER2) 阳性乳腺癌的疗效和安全性

背景系统疗法的发展改善了人表皮生长因子受体 2 阳性（HER2+）乳腺癌患者的治疗效果。然而，全身疗法的耐受性和安全性仍有待进一步改善。方法我们招募了接受前期手术的I期或II期HER2+乳腺癌患者，让他们接受每2周6个周期的剂量密集型紫杉醇、环磷酰胺和曲妥珠单抗（PC-H）辅助治疗，然后每3周13个周期的曲妥珠单抗维持治疗，完成52周的治疗（折合19个周期）。首要目标是确定PC-H辅助治疗的安全性和可行性，根据美国国家癌症研究所通用术语标准，以完成率频率和不良事件等级来衡量。次要目标是估算无复发生存率和总生存率。结果2010年至2019年期间，共有39名患者入组。其中，34 名患者（87.18%）完成了计划治疗。27名患者（69.23%）发生了3级或4级严重不良事件，包括3名患者（7.69%）射血分数下降3-4级。中位随访时间为 5.6 年，39 名患者全部存活。5年无复发生存率为94.30% (95% CI: 75.3-100)。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Clinical breast cancer 医学-肿瘤学

CiteScore

5.40

自引率

3.20%

发文量

174

审稿时长

48 days

期刊介绍： Clinical Breast Cancer is a peer-reviewed bimonthly journal that publishes original articles describing various aspects of clinical and translational research of breast cancer. Clinical Breast Cancer is devoted to articles on detection, diagnosis, prevention, and treatment of breast cancer. The main emphasis is on recent scientific developments in all areas related to breast cancer. Specific areas of interest include clinical research reports from various therapeutic modalities, cancer genetics, drug sensitivity and resistance, novel imaging, tumor genomics, biomarkers, and chemoprevention strategies.