Liposomal Doxorubicin Reduces Cardiac Risk Among Women Treated for Advanced Breast Cancer: Presented at SABCS
By Alex Morrisson
SAN ANTONIO, Tex -- December 12, 2011 -- Women with advanced breast cancer appear to reduce their risk of experiencing a major decline in cardiac function if they receive treatment with nonpegylated liposomal doxorubicin in addition to docetaxel, researchers said here at the 34th Annual San Antonio Breast Cancer Symposium (SABCS).
“We still see a decline in cardiac function, but it is less rapid and seems feasible in these patients, many of whom have been pretreated with anthracyclines or have other conditions that put them at risk for cardiac toxicity,” said Pieter Paul Schiphorst, MD, Streekziekenhuis Koningin Beatrix, Winterswijk, the Netherlands, on December 8.
Dr. Schiphorst said that the mean left ventricular ejection fraction was reduced from 63% to 59% among all 56 women in the study. Four patients met criteria for cardiotoxicity, and 3 other patients were withdrawn from the treatment before reaching those criteria. However, none of the patients exhibited signs or symptoms of heart failure. Six of the 7 patients removed from the drug had been pretreated with anthracyclines.
“We have shown in this study that we can give patients who have been pretreated with anthracyclines or may have indications against anthracyclines a treatment that includes these drugs,” said Dr. Schiphorst.
The study enrolled 25 women who had been pretreated with anthracycline therapies for breast cancer and 31 women who had not received previous anthracycline therapy. The researchers were primarily interested in cardiotoxicity during treatment and in the 6 months after therapy. Forty-nine of the women in the study were able to complete 6 cycles of therapy.
The most common toxicity was neutropenia, which occurred in 19 patients. Overall, 32 of the patients experienced 73 grade >3 toxicities in the trial.
Dr. Schiphorst noted that a partial response or better was observed in 64% of the women in the study.
“We think that liposomal doxorubicin might provide more cardiac safety than conventional anthracyclines,” Dr. Schiphorst said. “Patients pretreated with conventional anthracyclines seem to be more prone to left ventricular ejection fraction decreases.”
The ejection fraction decreased from a mean of 63.9% at baseline to a mean of 56.8% after 6 cycles of therapy among the women who had been pretreated with anthracyclines. Among those who did not received anthracyclines, the baseline ejection fraction of 63.0% declined to 60.3%.
“The combination of nonpegylated liposomal doxorubicin and docetaxel is efficacious and sufficiently well tolerated,” Dr. Schiphorst said.
Although the patients in this study appeared to avoid heart failure episodes, he said that careful monitoring of their heart function is warranted.
Funding for this study was provided by Cephalon and sanofi-aventis.
[Presentation title: Cardiac Safety of Non-Pegylated Liposomal Doxorubicin and Docetaxel as 1st Line Treatment in Metastatic HER2 Negative Breast Cancer (Myotax Study). Abstract P3-16-13]
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