In an analysis of the German phase II WSG TP-II trial reported in the Journal of Clinical Oncology, Gluz et al found that neoadjuvant trastuzumab/pertuzumab with endocrine therapy (ET) or paclitaxel were both associated with high rates of 5-year overall survival in patients with hormone receptor (HR)-positive/HER2-positive breast cancer.
Study Details
In the multicenter trial, 207 patients were randomly assigned to receive ET (n = 100) or once-weekly paclitaxel (n = 107) together with 12 weeks of neoadjuvant trastuzumab/pertuzumab. In the primary analysis, the pathologic complete response rate (pCR) was higher in the paclitaxel group than the ET group (56.4% vs 23.7%). Subsequent standard chemotherapy was given to all patients without pCR and was optional among those with pCR.
Key Findings
At 5-year follow-up, overall survival rates were 100% (95% confidence interval [CI] = 100.0%–100.0%) in the ET group vs 97.9% (95% CI = 95.0%–100.0%) in the paclitaxel group.
The corresponding 5-year event-free survival–ductal carcinoma in situ rates were 92.1% (95% CI = 86.6%–97.9%) vs 94.8% (95% CI = 90.5%–99.3%). The corresponding 5-year invasive disease–free survival rates were 97.7% (95% CI = 94.5%–100.0%) vs 79.8% (95% CI = 55.6%–100.0%).
The investigators concluded: “Our results show excellent survival outcomes in patients with HR-positive/HER2-positive [early breast cancer] who received either a de-escalated chemotherapy or ET in combination with trastuzumab and pertuzumab in the neoadjuvant setting. WSG TP-II confirms the safety and efficacy of a de-escalated and well-tolerated neoadjuvant therapy approach with pCR-guided adjuvant therapy in HR-positive/HER2-positive [early breast cancer].”
Oleg Gluz, MD, of Breast Center, Evangelisches Krankenhaus Bethesda Klinik, Moenchengladbach, Germany, is the corresponding author for the Journal of Clinical Oncology article.
DISCLOSURE: The study was supported by Roche Pharma AG. For full disclosures of the study authors, visit ascopubs.org.
