In a Chinese phase III trial (HELEN-006) reported in The Lancet Oncology, Chen et al found that the de-escalated neoadjuvant treatment with the addition of nab-paclitaxel to trastuzumab/pertuzumab produced a higher pathologic complete response rate (pCR) vs docetaxel/carboplatin plus trastuzumab/pertuzumab in patients with HER2-positive early breast cancer.
Study Details
In the multicenter open-label trial, 669 eligible women (median age = 50 years) were randomly assigned between September 2020 and March 2023 to receive weekly nab-paclitaxel at 125 mg/m² on days 1, 8, and 15 for six 3-week cycles (n = 332) or docetaxel at 75 mg/m² on day 1 plus carboplatin AUC = 6 on day 1 for six 3-week cycles. Both groups received concurrent trastuzumab at an initial loading dose of 8 mg/kg and a maintenance dose of 6 mg/kg on day 1 of each cycle and pertuzumab with a loading dose of 840 mg and a maintenance dose of 420 mg on day 1 of each cycle. The primary outcome measure was pCR.
Key Findings
Median follow-up was 26 months. pCR was observed in 66.3% (95% confidence interval [CI] = 61.2%–71.4%) of patients in the nab-paclitaxel group vs 57.6% (95% CI = 52.3%–62.9%) of patients in the docetaxel/carboplatin group (odds ratio = 1.54, 95% CI = 1.10–2.14, stratified P = .011).
Grade 3 to 4 adverse events were reported in 30% of the nab-paclitaxel group vs 38% of the docetaxel/carboplatin group; the most common such events were neuropathy (13%), diarrhea (8%), and nausea (7%) in the nab-paclitaxel group and nausea (23%), diarrhea (16%), and vomiting (8%) in the docetaxel/carboplatin group. Serious drug-related adverse events were reported in three patients (1%) vs five patients (2%). No treatment-related deaths were observed.
The investigators concluded: “These findings might suggest a potential advantage of nab-paclitaxel combined with trastuzumab and pertuzumab compared with the standard regimen in neoadjuvant therapy for patients with HER2-positive early breast cancer, suggesting that this new combination might establish a new standard for neoadjuvant treatment in this patient population.”
Zhen-Zhen Liu, MD, of Henan Breast Cancer Centre, Zhengzhou, China, is the corresponding author of The Lancet Oncology article.
Disclosure: The study was funded by the National Natural Science Foundation of China as well as Science and Technology Research Projects of Henan Province. For full disclosures of the study authors, visit www.thelancet.com.
