An analysis of 4,554 patients who received adjuvant weekly paclitaxel and other taxane-based regimens in the E1199 trial “demonstrated that taxane-induced peripheral neuropathy does not correlate with improved outcomes in patients with operable breast cancer,” investigators reported in the Journal of Clinical Oncology. A control arm from a previous study, the N9831 trial, had shown a link between paclitaxel-related neuropathy and improved 3-year disease-free survival. The objective of the recently reported analysis was to “determine whether there was a relationship between taxane-induced neuropathy and outcomes in patients treated in the E1199 trial.”
The women in that study had axillary node-positive or high-risk node-negative breast cancer. They received up to four cycles of doxorubicin and cyclophosphamide every 3 weeks and then were randomly assigned to receive one of four further treatments: paclitaxel at 175 mg/m2 every 3 weeks for 4 cycles (P3); paclitaxel at 80 mg/m2 weekly for 12 cycles (P1); docetaxel at 100 mg/m2 every 3 weeks for 4 cycles (D3); or docetaxel at 35 mg/m2 weekly for 12 cycles (D1).
A total of 770 patients (16.9%) experienced grade 2 to 4 neuropathy after the initiation of adjuvant taxane therapy. Grade 2 neuropathy was the most common, at 71.8%, followed by grade 3 at 27.5%, and grade 4 at 0.7%. The highest percentage of grade 2 to 4 neuropathy, 22%, occurred in the P1 arm, followed by 17.5% in the P3 arm, 14.7% in the D3 arm, and 13.4% in the D1 arm.
“There was a decreased risk of neuropathy in premenopausal compared with postmenopausal patients,” the researchers reported, and a trend for a higher risk of neuropathy in blacks compared with other races and obese vs nonobese patients. “There was a significant association between hyperglycemia and neuropathy,” the authors added, “that remained significant after adjustment for age, race, obesity, and menopausal status.” There was, however, no association between neuropathy and clinical outcomes, including overall, disease-free, and relapse-free survival. ■
Schneider BP, et al: J Clin Oncol July 30, 2012 (early release online).