(ChemotherapyAdvisor) – No association has been found between taxane-induced neuropathy and clinical outcomes in patients who received adjuvant taxane-containing therapy for operable breast cancer, an Eastern Cooperative Oncology Group (ECOG) study concluded in the Journal of Clinical Oncology online July 30, 2012.
“Recent studies have identified candidate single nucleotide polymorphisms associated with taxane-induced neuropathy,” noted Bryan P. Schneider, MD, of ECOG on behalf of the trial investigators. “Therefore, we sought to determine whether neuropathy was associated with breast cancer recurrence in a clinical trial population who received adjuvant taxane therapy.”
The E1199 trial analyzed 4,554 women who had received up to 4 cycles of doxorubicin and cyclophosphamide every 3 weeks followed by paclitaxel 175mg/m2 every 3 weeks for 4 cycles, paclitaxel 80mg/m2 weekly for 12 cycles, docetaxel 100mg/m2 every 3 weeks for 4 cycles (D3), or docetaxel 35mg/m2 weekly for 12 cycles.
Of those who had received at least one dose of a taxane, grade 2–4 neuropathy developed in 18% enrolled in the every 3 weeks paclitaxel arm, 22% in the weekly paclitaxel arm, 15% in the every 3 weeks docetaxel arm, and 13% in the docetaxel weekly arm.
“In a model that included age, race, obesity, menopausal status, tumor size, nodal status, treatment arm, neuropathy, and hyperglycemia, no significant relationship was found between neuropathy and disease-free survival, overall survival, and recurrence-free survival,” they reported.
They concluded that the analysis “demonstrated that taxane-induced peripheral neuropathy does not correlate with improved outcomes in patients with operable breast cancer treated with adjuvant taxane therapy. This finding provides reassurance that biomarkers predictive for neuropathy will likely not enrich for patients who are more likely to benefit from taxane therapy and may also be useful for the identification of patients who are most likely to benefit from adjunctive therapies to mitigate neuropathy.”