ASCO 2019: Final Results of KRISTINE Trial of Neoadjuvant Regimens in HER2-Positive Breast Cancer
Posted: Thursday, June 20, 2019
According to the final outcome results from the phase III KRISTINE trial, presented at the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting (Abstract 500), the neoadjuvant regimen of trastuzumab, pertuzumab, docetaxel, and carboplatin (TCHP) yielded a higher pathologic complete response than ado-trastuzumab emtansine (also known as T-DM1) and pertuzumab. However, T-DM1 plus pertuzumab was linked to fewer grade 3 and higher adverse events yet more treatment discontinuations.
“[Event-free survival] numerically favors TCHP due to locoregional progression events with T-DM1 plus pertuzumab prior to surgery,” concluded Sara A. Hurvitz, MD, of the University of California Los Angeles, and colleagues.
The KRISTINE study included patients with HER2-positive stages II to III breast cancer. Participants underwent 6 cycles of either T-DM1 plus pertuzumab or TCHP every 3 weeks, after which those receiving T-DM1 plus pertuzumab continued to receive adjuvant treatments and those receiving TCHP continued to receive adjuvant trastuzumab and pertuzumab, each for 12 cycles. In addition, patients treated with T-DM1 plus pertuzumab who did not achieve a pathologic complete response were advised to undergo adjuvant chemotherapy prior to receiving adjuvant T-DM1 plus pertuzumab.
At a median follow-up of 37 months, patients in the TCHP arm had a superior event-free survival response (hazard ratio = 2.61), primarily due to more locoregional progression events occurring in those treated with T-DM1 plus pertuzumab (6.7% vs. 0%). The number of deaths occurring during treatment was similar with TCHP (5; 2.3%) and T-DM1 plus pertuzumab (6; 2.7%). Adverse events of at least grade 3 were more common among the TCHP group; however, adverse events that led to treatment discontinuation were more common for those receiving T-DM1 plus pertuzumab.
Disclosure: The study authors’ disclosure information may be found at coi.asco.org.