Pegylated Liposomal Doxorubicin Prolongs Time to Progression in Metastatic Breast Cancer: Presented at ESMO

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Title: Pegylated Liposomal Doxorubicin Prolongs Time to Progression in Metastatic Breast Cancer: Presented at ESMO
URL: http://www.pslgroup.com/dg/22C696.htm
Doctor's Guide
September 16, 2008

By Janet Fricker

STOCKHOLM, Sweden -- September 15, 2008 -- Use of pegylated liposomal doxorubicin (PLD) as maintenance therapy after-first line chemotherapy significantly prolongs time to progression with no late cardiotoxicity in patients with metastatic breast cancer, according to results of a study presented here at the 33rd European Society for Medical Oncology Congress (ESMO).

Traditionally, patients with metastatic breast cancer would be left without treatment until progression of disease, explained principal investigator Emilio Alba, MD, University of Malaga, Malaga, Spain, who presented the study on behalf of the Grupo Español de Investigación en Cáncer de Mama (GEICAM) investigators.

"Our trial confirms that PLD maintenance therapy with its proven efficacy and significantly improved safety profile can be a highly effective treatment strategy for patients with metastatic breast cancer by delaying disease progression," Dr. Alba said.

PLD is a long circulating pegylated liposomal formulation of doxorubicin. It is currently approved in the European Union as monotherapy for treatment of metastatic breast cancer for patients who are at increased cardiac risk, and is also licensed for use in metastatic ovarian cancer.

In their phase 3 study, Dr. Alba and colleagues enrolled 155 patients with metastatic breast cancer from 7 different centres in Spain. Patients received induction chemotherapy with 3 cycles of anthracycline therapy followed by 3 cycles of taxane therapy. They were then randomised to PLD 40 mg/m² every 4 weeks for 6 cycles of therapy or to observation.

Results showed that patients in the PLD arm had a time to progression of 13.18 months compared with 10.06 months for patients in the observation arm (P = .0005)

Although the study did not reveal a statistically significant difference in overall survival, a nonplanned analysis performed at 12 months showed that 81% of patients receiving PLD were still alive compared with 66% of patients in the observation arm (P = .04).

Toxicity was shown to be infrequent and manageable (eg, nausea, vomiting, and diarrhoea), with no cardiotoxicity and 4 cases of hand-foot syndrome in the active group.

"Based on these results, adding PLD to patients responding to first-line therapy will be the standard arm for future GEICAM studies," said Dr. Alba.

[Presentation title: Multicentre Phase III Trial to Evaluate Pegylated Liposomal Doxorubicin as Maintenance Chemotherapy (CT) Versus Observation, After First-Line CT With Sequential Doxorubicin and Docetaxel in Metastatic Breast Cancer. Abstract 145P]

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