In a Chinese phase III trial (neoCARHP) reported in the Journal of Clinical Oncology, Gao et al found that neoadjuvant therapy with a taxane plus trastuzumab and pertuzumab (THP) was noninferior in pathologic complete response (pCR) compared with THP plus carboplatin (TCbHP) in patients with stage II or III HER2-positive breast cancer.
Study Details
In the multicenter open-label trial, 766 eligible patients (modified intention-to-treat [mITT] population) were randomly assigned between April 2021 and August 2024 to receive six 3-week cycles of THP (n = 382) or TCbHP (n = 384). The THP group received an investigator-selected taxane (docetaxel at 100 mg/m2, paclitaxel at 175 mg/m2 , or nab-paclitaxel at 260 mg/m2) with concurrent trastuzumab (8 mg/kg loading dose followed by 6 mg/kg every 3 weeks) and pertuzumab (840 mg loading dose followed by 420 mg every 3 weeks). The TCbHP group received an investigator-selected taxane (docetaxel at 75 mg/m2, paclitaxel at 175 mg/m2, or nab-paclitaxel at 260 mg/m2) plus carboplatin (AUC = 6) with concurrent trastuzumab and pertuzumab. The primary endpoint was pCR rate in the breast and axilla (ypT0/is ypN0) in the mITT population.
Key Findings
pCR was achieved in 245 patients (64.1%, 95% confidence interval [CI] = 59.1%–69.0%) in the THP group vs 253 patients (65.9%, 95% CI = 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 = 0.69–1.25; P for noninferiority = .0089).
Grade 3 or 4 treatment-related adverse events occurred in 20.7% of the THP group vs 34.6% of the TCbHP group; the most common in the THP group were neutropenia (6.9% vs 16.4% in the TCbHP group), leukopenia (5.5% vs 14.8%), and diarrhea (2.6% vs 4.2%). Treatment-related serious adverse events occurred in 1.3% vs 4.7% of patients. No treatment-related deaths were reported.
The investigators concluded: “THP provided noninferior pCR rates and improved tolerability compared with TCbHP. Omitting carboplatin may be applicable in HER2-positive breast cancer.”
Kun Wang, MD, PhD, of Cancer Center, Guangdong Provincial People’s Hospital, Guangdong Academy of Medical Sciences, Southern Medical University, Guangzhou, China, is the corresponding author for the Journal of Clinical Oncology article.
DISCLOSURE: The study was supported by the National Science and Technology Major Project and National Natural Science Foundation of China. For full disclosures of the study authors, visit ascopubs.org.
