Interim Safety Data Compared in Ixabepilone TITAN Trial

Researchers are continuing to explore whether ixabepilone (Ixempra) is a better choice as adjuvant chemotherapy for patients with early-stage, triple-negative breast cancer than the standard paclitaxel (Taxol).

In one facet of that research, the toxicity profile of ixabepilone is proving to be similar to weekly paclitaxel, making it a feasible option, researchers said in presenting preliminary safety monitoring data for the phase III TITAN trial.

The trial includes an estimated 1800 women initially treated with doxorubicin/ cyclophosphamide and then randomized to receive either ixabepilone at 40 mg/m2 every 3 weeks for 12 weeks or paclitaxel at 80 mg/m2 every week for 12 weeks.

The Sarah Cannon Research Institute in Nashville, Tennessee, launched the 5-year study in 2008 at 71 sites in the United States and Puerto Rico.

The safety data involve the first 441 patients who completed the treatment regimen, according to a poster presented at ASCO by lead investigator Denise Aysel Yardley, MD, an oncologist at Sarah Cannon.

Overall, “the incidence and spectrum of toxicity” were similar in the 2 treatment arms, investigators reported. The most frequently reported hematologic toxicity in both arms was grade 3/4 neutropenia, with incidents totaling 26 in the ixabepilone arm versus 12 in the paclitaxel group.

There was 1 treatment-related death in the ixabepilone arm from neutropenia/ sepsis, versus 0 deaths in the paclitaxel group.

The number of patients discontinuing treatment prematurely was higher in the paclitaxel arm at 15%, versus 8% in the ixabepilone arm, with neuropathy accounting for most of the difference (8% vs 3%). Abstract 1103