Eli Lilly and Company's (LLY) Gemzar (gemcitabine, HCl) in combination with Taxotere (docetaxel) demonstrated similar efficacy, but with an improved safety profile, when compared to a regimen of Xeloda (capecitabine) and docetaxel in the treatment of metastatic breast cancer, according to a new data from a Phase III clinical trial.
The study, presented at the 41st annual meeting of the American Society of Clinical Oncology (ASCO), compared the two combinations as first- or second-line treatment in patients with metastatic breast cancer. The study further demonstrates Gemzar's ability to be combined with other agents in providing patients with the benefit of survival, while maintaining a manageable level of side effects. Gemzar in combination with Taxol (paclitaxel) is approved for use in the US, Europe and more than 60 countries for the treatment of metastatic breast cancer, a company release stated.
According to the study report, patients receiving the Gemzar-based combination had the same progression- free survival time (the length of time during and after treatment that the cancer does not grow) and tumour response rate (tumour shrinkage) as patients receiving the capecitabine-based combination. Patients administered the Gemzar combination also experienced significantly fewer toxic side effects, such as mucositis (an inflammation of the gastrointestinal lining resulting in painful sores in the mouth and throat), diarrhoea and hand-foot syndrome (a drug-related skin condition that results in redness, tenderness, peeling and numbness of the palms and soles).
"Treatment-related side effects can be severely debilitating for women with metastatic breast cancer and have a tremendous impact on their quality of life," Stephen Chan, primary investigator of the study says adding, "The combination of efficacy and improved tolerability seen in this study with Gemzar/docetaxel suggests that we've taken an important step forward where we can treat the cancer while helping women live their everyday lives more comfortably and with less risk of side effects."
This 16-month study evaluated 302 patients with pre-treated metastatic breast cancer who were randomized and treated with either Gemzar/docetaxel (n=152) or capecitabine/docetaxel (n=150) combination therapy. The primary endpoint of this study was progression-free survival. Secondary endpoints were overall response rate, time to treatment failure, overall survival, toxicity and quality of life.