Compared with epirubicin plus cyclophosphamide (EC) and cyclophosphamide plus methotrexate and 5-fluorouracil (CMF), treatment with nab-paclitaxel led to more treatment discontinuations and nonhematological toxicities in elderly patients with moderate or high-risk breast cancer, a new study published online ahead of print in the journal Cancer has shown.
For the phase II trial, researchers randomly assigned 391 patients at least 65 years of age with moderate or high-risk breast cancer to receive either EC/CMF or nab-paclitaxel plus capecitabine. Primary endpoints were overall frequency of adverse events and treatment discontinuations.
Results showed that 6.6% of those who received EC/CMF discontinued treatment compared with 35.8% in the nab-paclitaxel group (P<0.001). One patient in the EC/CMF group died versus five patients in the nab-paclitaxel arm.
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Researchers found that 90.9% of patients treated with EC/CMF experienced grade 3 to 5 adverse events compared with 64.8% of those treated with nab-paclitaxel (P<0.001). Hematological toxicities were more common in those treated with nab-paclitaxel while hematological toxicities were more frequent with EC/CMF (P<0.001 for both).
In regard to efficacy, there was no difference in survival between the two treatment arms after 22.8 months.
- von Minckwitz G, Conrad B, Reimer T, et al. A randomized phase 2 study comparing EC or CMF versus nab-paclitaxel plus capecitabine as adjuvant chemotherapy for nonfrail elderly patients with moderate to high-risk early breast cancer (ICE II-GBG 52). Cancer. 2015. [epub ahead of print]. doi: 10.1002/cncr.29506.