GeparSepto Trial: Long-Term Results With Nab-paclitaxel in Early Breast Cancer
Posted: Tuesday, December 3, 2019
In patients with early breast cancer, treatment with nab-paclitaxel significantly improved invasive disease–free survival when compared with solvent-based paclitaxel, according to the long-term results of the GeparSepto trial. Initial findings from the study had revealed a higher pathologic complete response rate in patients receiving nab-paclitaxel as well.
“The long-term results support the use of nab-paclitaxel [at] 125 mg/m2 instead of solvent-based paclitaxel in patients with early breast cancer,” stated Michael Untch, MD, PhD, of the Helios Hospital Berlin-Buch, Berlin, and colleagues. The latest findings of the prospective phase III study were published in the Journal of Clinical Oncology.
A total of 1,206 patients with histologically confirmed primary breast cancer were randomly assigned to 12 weeks of weekly nab-paclitaxel (n = 606) or solvent-based paclitaxel (n = 600), followed in both arms by epirubicin plus cyclophosphamide every 3 weeks. Following a study amendment on the results of a preplanned interim safety analysis, the dose of nab-paclitaxel was decreased to 125 mg/m2. Women with HER2-positive disease also received trastuzumab and pertuzumab for 1 year with the assigned chemotherapy.
After 4 years of follow-up, patients treated with nab-paclitaxel had significantly better invasive disease–free survival compared with those treated with solvent-based paclitaxel (84% vs. 76.3%, P = .002). Event-free survival was also significantly improved with nab-paclitaxel, but overall survival did not appear to differ between the two arms. Treatment-related peripheral sensory neuropathy improved “much faster” with nab-paclitaxel at 125 mg/m2 than with nab-paclitaxel at 150 mg/m2.
Disclosure: For full disclosures of the study authors, visit ascopubs.org.