Two Phase III Studies Evaluating Bevacizumab in Metastatic Breast Cancer Presented At ESMO

Two Phase III Studies Evaluating Bevacizumab in Metastatic Breast Cancer Presented At ESMO

shutterstock_92514937The results of two randomised phase III clinical trials in HER2-negative metastatic breast cancer were presented at the European Society for Medical Oncology (ESMO) 2014 meeting, Madrid, Spain.

Dr. Joseph Gligorov of the Medical Oncology Department, Tenon University Hospital, Paris, France, presented results on the randomized Phase III IMELDA study, which evaluated the efficacy and safety of maintenance bevacizumab, a monoclonal antibody that inhibits angiogenesis, with or without capecitabine after initial first-line bevacizumab plus docetaxel.

The results demonstrated that combining bevacizumab with first-line chemotherapy significantly improved progression free survival in HER2-negative breast cancer patients with locally recurrent and/or metastatic breast cancer.

The researchers wanted to determine if switching to a more tolerable chemotherapy with a different mechanism of action while continuing VEGF inhibition could be more effective. As such, after 3‒6 cycles of bevacizumab/docetaxel, patients who did not suffer from disease progression were treated with bevacizumab alone or with bevacizumab/capecitabine until disease progression.

The results demonstrated that in groups of patients who benefit from first-line bevacizumab therapy, the continuous administration of bevacizuamb with capecitabine significantly improves efficacy.

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Dr. Gunther von Minckwitz, Managing Director of the German Breast Group and University Women’s Hospital, Neu-Isenburg, Germany, presented the results from the randomized Phase III TANIA trial, which evaluated the efficacy and safety of continued or reintroduced bevacizumab after first-line bevacizumab for HER2-negative locally recurrent and/or metastatic breast cancer.

For a period of two years, 494 patients were enrolled: 247 in the chemotherapy arm and 247 in the chemotherapy plus bevacizumab arm.

Patients in both groups had similar ages and were diagnosed with triple negative breast cancer.

The results demonstrated that the best objective response rate was similar in both arms, however, 33.5% of patients in the chemotherapy arm reached stable disease vs 48.9% in the bevacizumab/chemotherapy arm.

Overall, the researchers concluded that the primary objective of the study was met, since progression free survival was significantly improved with bevacizumab after disease progression on first-line bevacizumab-containing therapy. Furthermore, safety results were also as expected from previous studies.

However, Dr. Hope Rugo who also discussed the results of this study, stated that bevacizumab alone should not be used as maintenance therapy, since at present, its precise role in breast cancer is still unclear.