GeparSepto: Long-Term Clinical Outcomes With Neoadjuvant Nab-paclitaxel vs Solvent-Based Paclitaxel in Early Breast Cancer
As reported in the Journal of Clinical Oncology by Untch et al, long-term follow-up in the GeparSepto trial showed that patients with early breast cancer receiving neoadjuvant nab-paclitaxel vs solvent-based paclitaxel followed by epirubicin/cyclophosphamide had better invasive disease–free survival, with no difference in overall survival being observed.
The primary analysis of the study, reported in 2016 in The Lancet, showed that the nab-paclitaxel–based regimen significantly improved pathologic complete response rate. The study involved 1,206 patients randomly assigned to either the nab-paclitaxel group (n = 606) or the solvent-based paclitaxel group (n = 606). Patients with HER2-positive disease received dual antibody treatment with trastuzumab and pertuzumab concurrently with chemotherapy and continued for 1 year.
Clinical Outcomes
Median follow-up was 49.6 months. At 4 years, invasive disease-free survival was 84.0% in the nab-paclitaxel group vs 76.3% in the solvent-based paclitaxel group (hazard ratio [HR] = 0.66, P = .002). Hazard ratios were similar in favoring nab-paclitaxel among breast cancer subtypes, with the hazard ratio being significant among patients with HER2-negative/hormone receptor–positive disease (HR = 0.67, P = .030).
Of the 137 deaths reported, 63 were in the nab-paclitaxel group and 74 were in the solvent-based paclitaxel group. No significant difference was observed in 4-year overall survival (89.7% vs 87.2%, HR = 0.82; P = .260).
Resolution of Peripheral Sensory Neuropathy
The dose of nab-paclitaxel was reduced from 150 mg/m2 to 125 mg/m2 on the basis of a preplanned interim safety analysis and recommendation of the independent data monitoring committee after recruitment of 464 patients.
Overall, 29.4% of patients reported grade 2 to 4 peripheral sensory neuropathy. Long-term follow-up of treatment-related peripheral sensory neuropathy showed that the median time to resolve grade 2 to 4 to grade 1 peripheral sensory neuropathy was 12.7 weeks with nab-paclitaxel at 150 mg/m2 vs 6.4 weeks with 125 mg/m2 (P = .014), with no significant difference in median time to resolution between the 125 mg/m2 subgroup and the solvent-based paclitaxel group (7.0 weeks, P = .740).
The investigators concluded, “The significantly higher pathologic complete response rate with nab-paclitaxel translated into a significantly improved [invasive disease–free survival] in patients with early [breast cancer] as compared with [solvent-based] paclitaxel. Peripheral sensory neuropathy improved much faster under nab-paclitaxel 125 mg/m2 compared with nab-paclitaxel 150 mg/m2.”
Sibylle Loibl, MD, of the German Breast Group, c/o GBG Forschungs GmbH, Neu-Isenburg, is the corresponding author for the Journal of Clinical Oncology article.
Disclosure: The study was supported by Celgene Germany and Roche Germany. For full disclosures of the study authors, visit jco.ascopubs.org.
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