S-P's Caelyx increases TTP in breast cancer

US drugmaker Schering Plough says that its anticancer drug Caelyx (pegylated liposomal doxorubicin HCl) significantly increases time-to-progression in patients with metastatic breast cancer. The announcement was made at the annual American Society of Clinical Oncology conference.

The findings are based on data from a Phase III trial of the drug in 288 patients, 155 of whom had responded to initial therapy or had stable-disease. Those randomized to receive treatment, 40mg/m2 of the drug once every four weeks for six cycles, experienced an average improvement in time to progression of three months (13.2 months versus 10.2 months). The firm added that the incidence of clinical toxicity associated with treatment was low and manageable, with 21% of subjects experiencing nausea and vomiting, while 29% suffered alopecia.

S-P also said that, importantly, neither clinically relevant left ventricular ejection fraction (a decrease in cardiac function), or clinical congestive heart failure had been observed. The firm added that further evaluation would be required to establish that the drug was safe and effective for metastatic breast cancer patients who are at increased cardiac risk.