Neoadjuvant Taxane Plus Trastuzumab and Pertuzumab With or Without Carboplatin in Human Epidermal Growth Factor Receptor 2-Positive Breast Cancer: The Randomized Noninferiority Phase III neoCARHP Trial.

Methods

The neoCARHP was a multicenter, randomized, phase III, noninferiority study.

neoCARHP是一项多中心、随机、III期、非劣效性研究。

Eligible patients were women age 18 years or older with previously untreated, stage II and III, HER2-positive invasive breast cancer.

符合条件的患者为年龄18岁或以上的女性，患有之前未经治疗的、II期和III期、HER2阳性的浸润性乳腺癌。

Patients were randomly assigned (1:1) to receive six 3-week cycles of TCbHP or THP.

患者被随机分配（1:1）接受六个3周周期的TCbHP或THP治疗。

The primary end point was pathologic complete response (pCR) rate in the breast and axilla (ypT0/is ypN0) in the modified intention-to-treat(mITT) population (all randomly assigned patients receiving at least one dose of study treatment).

主要终点是改良意向治疗(mITT)人群(所有随机分配的患者至少接受一次研究治疗)中乳腺和腋窝的病理完全缓解(pCR)率(ypT0/is ypN0)。

Safety was evaluated in all patients who received any study treatment.

所有接受任何研究治疗的患者均进行了安全性评估。

Results

Between April 30, 2021, and August 27, 2024, 774 patients were randomly assigned and 766 were included in the mITT population (382 in THP and 384 in TCbHP). pCR was achieved in 245 (64.1% [95% CI, 59.1 to 69.0]) patients in the THP group and 253 (65.9% [60.9-70.6]) in the TCbHP group (absolute difference, -1.8% [95% CI, -8.5 to 5.0]; odds ratio, 0.93 [95% CI, 0.69 to 1.25]; Pnoninferiority = .0089).

在2021年4月30日至2024年8月27日期间，774名患者被随机分配，766名患者被纳入mITT人群（THP组382人，TCbHP组384人）。THP组有245名（64.1% [95% 置信区间，59.1至69.0]）患者达到pCR，而TCbHP组有253名（65.9% [95% 置信区间，60.9-70.6]）（绝对差异，-1.8% [95% 置信区间，-8.5至5.0]；优势比，0.93 [95% 置信区间，0.69至1.25]；P非劣效性 = .0089）。

The THP group had fewer grade 3 and 4 adverse events (20.7% v 34.6%) and serious adverse events (1.3% v 4.7%) than the TCbHP group.

THP组的3级和4级不良事件（20.7%对比34.6%）以及严重不良事件（1.3%对比4.7%）均少于TCbHP组。

The most common grade 3 and 4 adverse events with THP were neutropenia (6.8% v 16.4% with TCbHP), leukopenia (5.5% v 14.8%), and diarrhea (2.6% v 4.2%).

THP治疗中最常见的3级和4级不良事件是中性粒细胞减少症（6.8%对比TCbHP的16.4%）、白细胞减少症（5.5%对比14.8%）和腹泻（2.6%对比4.2%）。

No treatment-associated deaths occurred.

未发生与治疗相关的死亡事件。

Conclusions

THP provided noninferior pCR rates and improved tolerability compared with TCbHP.

THP 提供了与 TCbHP 相比非劣的病理完全缓解（pCR）率，并改善了耐受性。

Omitting carboplatin may be applicable in HER2-positive breast cancer.

在 HER2 阳性乳腺癌中，省略卡铂可能是适用的。