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GeparSepto: Long-Term Clinical Outcomes With Neoadjuvant Nab-paclitaxel vs Solvent-Based Paclitaxel in Early Breast Cancer

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Key Points

  • Four-year invasive disease–free survival was improved in the nab-paclitaxel vs solvent-based paclitaxel group.
  • Resolution of grade 2 to 4 peripheral sensory neuropathy was longer with the higher vs reduced nab-paclitaxel dose. 

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.

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.


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