3-Year TRAIN-2 Update on Neoadjuvant Therapy for HER2-Positive Breast Cancer
Posted: Wednesday, July 15, 2020
A 3-year follow-up of the multicenter phase III TRAIN-2 trial reported no superior clinical benefit for patients with stage II or III HER2-positive breast cancer given a neoadjuvant anthracycline-containing regimen. In fact, the inclusion of anthracyclines was found to increase the risk of adverse effects. Anna van der Voort, MD, of the Netherlands Cancer Institute, Amsterdam, presented her team’s work during the ASCO20 Virtual Scientific Program (Abstract 501).
“The 3-year follow-up of the TRAIN-2 study shows no event-free and overall survival benefit for the use of anthracyclines in patients with stage II/III HER2-positive breast cancer who received dual HER2 blockade,” said Dr. van der Voort in an ASCO press release. “A neoadjuvant anthracycline-free regimen with dual HER2 blockade should be considered in all stage II/III HER2-positive breast cancer.”
A total of 438 patients with HER2-positive breast cancer and a left-ventricular ejection fraction of 50% or greater were enrolled in the study. Patients were randomly assigned to receive fluorouracil, epirubicin, and cyclophosphamide followed by paclitaxel and carboplatin. Both regimens included trastuzumab and pertuzumab.
After 3 years, no significant difference in event-free survival was observed. The anthracycline arm had a 92.7% event-free survival rate (95% confidence interval [CI] = 89.3%–96.2%) compared with 93.6% in the anthracycline-free arm (95% CI = 90.4%–96.9%). There also appeared to be no difference in overall survival (97.7% vs. 98.2%; respectively). A decline in left-ventricular ejection fraction from baseline of between 10% and 50% was more common in patients treated with anthracyclines than in those who were not (8.6% vs. 3.2%, P = .021).
Both groups reported grade 3 or higher adverse events, including neutropenia, anemia, and thrombocytopenia. The anthracycline arm had significantly more cases of febrile neutropenia than the anthracycline-free arm (1%; P < .05).
Disclosures: For full disclosures of the study authors, visit coi.asco.org.
