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Bevacizumab/Capecitabine Combo Shows Promise in Women With HER2-Negative Metastatic Breast Cancer

Phase III trials demonstrate improved survival

Positive results have been reported from the phase III IMELDA study, which showed that the combination of bevacizumab (Avastin, Genentech) plus capecitabine (Xeloda, Genentech) chemotherapy as maintenance treatment after initial induction treatment with bevacizumab-based therapy resulted in clinically meaningful gains in overall survival (OS) and progression-free survival (PFS) in women with human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer.

The IMELDA trial was an open-label, randomized study investigating the efficacy and safety of maintenance treatment with bevacizumab plus capecitabine chemotherapy compared with bevacizumab alone in 185 patients whose HER2-negative metastatic breast cancer had not progressed during first-line induction treatment with bevacizumab plus capecitabine chemotherapy.

The study met its primary endpoint, with nearly a threefold improvement in PFS in patients treated with bevacizumab plus capecitabine maintenance therapy compared with bevacizumab alone (median PFS after induction treatment: 11.9 months vs. 4.3 months, respectively; hazard ratio [HR] = 0.38; P P

A second phase III study (TANIA) showed that women who received bevacizumab plus standard chemotherapy as initial treatment for their HER2-negative metastatic breast cancer and then continued with bevacizumab plus chemotherapy after their disease had progressed (in the second-line setting) lived significantly longer without their disease getting worse, compared with people who received chemotherapy alone second-line.

The TANIA trial was an open-label, randomized study evaluating the efficacy and safety of bevacizumab-based therapy in the second-line setting in patients treated with bevacizumab plus chemotherapy as an initial (first-line) treatment for HER2-negative metastatic breast cancer.

The study met its primary endpoint of improving PFS, with a statistically significant 25% reduction in the risk of tumor progression in women who received bevacizumab plus chemotherapy in the second-line compared with chemotherapy alone (median PFS: 6.3 months vs. 4.2 months, respectively; HR = 0.75, P = 0.0068).

Results from both studies will be presented September 28 at the European Society of Medical Oncology (ESMO) 2014 Congress in Madrid, Spain. Both trials have also been accepted for publication in The Lancet Oncology, with an anticipated publication date of September 28, 2014.

Source: Roche; September 25, 2014.

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