新辅助帕妥珠单抗治疗非转移性HER2阳性乳腺肿瘤:秘鲁多中心研究(NeoHer)

Neoadjuvant pertuzumab in non-metastatic HER2-positive breast tumors: Multicentric study in Peru (NeoHer).

作者信息

Falcon Silvia, Riva Luis, Flores Christina, Vera Delphis, Pinto Joseph A, Gomez Henry L

机构信息

Department of Medical Oncology, Aliada, Lima 15036, Peru.

Department of Medical Oncology, Clínica Internacional, Lima 15036, Peru.

出版信息

Mol Clin Oncol. 2022 Mar;16(3):70. doi: 10.3892/mco.2022.2503. Epub 2022 Jan 25.

Abstract

Several clinical trials have demonstrated the benefit of adding pertuzumab to trastuzumab plus neoadjuvant chemotherapy in the treatment of human epidermal growth factor receptor 2 (HER2)-positive breast cancer. The comparison of outcomes between nonrandomized groups of patients who received similar treatments in routine practice remains difficult. The present study aimed to evaluate the pathological complete response (pCR) rates achieved with pertuzumab among patients in routine clinical care in Peru using real-world data. The definition of pCR used was the absence of residual invasive cancer from the complete resected breast specimen and all sampled regional lymph nodes following completion of neoadjuvant systemic therapy. A total of 44 patients with non-metastatic HER2-positive breast cancer (stages II and III) treated with pertuzumab in the neoadjuvant setting and who underwent surgery at three private clinics in Lima (Peru) were retrospectively evaluated. The pCR was the efficacy endpoint and it was determined and compared with the results from other clinical trials. Furthermore, safety data were described. The median age was 44 years (interquartile range, 39.5-50.5 years) and 65.9% of patients were premenopausal. Regarding the clinical stage, 56.8% were IIA/IIB and 36.4% were IIIA/IIIB/IIIC. All treatment schemes included concurrent trastuzumab. The patients' treatment comprised neoadjuvant therapy of docetaxel/trastuzumab/pertuzumab (THP) with a median of 4 cycles in 30 patients (68.2%) or docetaxel/trastuzumab/pertuzumab/carboplatin (THPCarb) with a median of 6 cycles in 14 patients (31.8%). In total, 70.5% of patients experienced pCR; among hormone receptor-negative cases, 75.0% achieved pCR and in tumors expressing hormone receptors, the rate of pCR was 66.7%. Of those patients subjected to neoadjuvant treatment with THP, 66.7% (20/30) achieved pCR, whereas 78.6% (11/14) of patients who received THPCarb had a pCR. The incidence of drug-related adverse events was 59.1% and in none of the patients, administration was discontinued due to toxicity. The present results of Peruvian patients with HER2 breast cancer treated according to clinical routine demonstrated that dual blockade of HER2 with trastuzumab and pertuzumab in the neoadjuvant setting achieved high rates of pCR even in hormone receptor-positive patients. These results are consistent with those of randomized controlled trials, with a good safety profile.

摘要

多项临床试验已证明,在曲妥珠单抗加新辅助化疗的基础上添加帕妥珠单抗治疗人表皮生长因子受体2(HER2)阳性乳腺癌具有益处。在常规实践中,对接受类似治疗的非随机分组患者的治疗结果进行比较仍然很困难。本研究旨在利用真实世界数据评估秘鲁常规临床护理中接受帕妥珠单抗治疗的患者的病理完全缓解(pCR)率。所采用的pCR定义为新辅助全身治疗完成后,完整切除的乳腺标本及所有取样区域淋巴结中无残留浸润性癌。对在秘鲁利马的三家私立诊所接受新辅助治疗且使用帕妥珠单抗治疗的44例非转移性HER2阳性乳腺癌(II期和III期)患者进行了回顾性评估。pCR为疗效终点,并与其他临床试验结果进行了比较。此外,还描述了安全性数据。患者的中位年龄为44岁(四分位间距,39.5 - 50.5岁),65.9%的患者为绝经前患者。在临床分期方面,56.8%为IIA/IIB期,36.4%为IIIA/IIIB/IIIC期。所有治疗方案均包括同时使用曲妥珠单抗。患者的治疗方案包括多西他赛/曲妥珠单抗/帕妥珠单抗(THP)新辅助治疗,30例患者(68.2%)的中位疗程为4个周期,或多西他赛/曲妥珠单抗/帕妥珠单抗/卡铂(THPCarb)新辅助治疗,14例患者(31.8%)的中位疗程为6个周期。总体而言,70.5%的患者实现了pCR;在激素受体阴性病例中,75.0%实现了pCR,在表达激素受体的肿瘤中,pCR率为66.7%。在接受THP新辅助治疗的患者中,66.7%(20/30)实现了pCR,而接受THPCarb治疗的患者中,78.6%(11/14)实现了pCR。药物相关不良事件的发生率为59.1%,且没有患者因毒性而停药。秘鲁HER2乳腺癌患者按照临床常规治疗的当前结果表明,在新辅助治疗中使用曲妥珠单抗和帕妥珠单抗双重阻断HER2,即使在激素受体阳性患者中也能实现较高的pCR率。这些结果与随机对照试验的结果一致,且安全性良好。

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