Combination therapy improves overall survival in women with advanced breast cancer
September 16, 2015
Final safety analysis showed the incidence of adverse events were similar among both treatment groups with the exception of the incidence of grade 1 and 2 diarrhea, which was significantly higher in the combination group (P = 0.03). The incidence of grade 3 or higher AEs was similar among treatment groups (7%).The most common adverse events (incidence greater than or equal to 10%) were diarrhea, nausea, rash, fatigue and vomiting. Of the Grade 3/4 adverse events observed, cardiac events were reported in three patients on the combination arm and in one patient on the monotherapy arm. One patient in the combination arm experienced cardiac failure and later died due to pulmonary thromboembolism that was caused by disease progression and/or study medication.
"Very few clinical studies have shown a survival benefit in metastatic breast cancer," said Steven Stein, M.D., Vice President, Medicine Development, GSK Oncology. "It's very encouraging to see the results gained by combining these two agents."
TYKERB is currently indicated in combination with Xeloda?® (capecitabine) for the treatment of patients with advanced or metastatic breast cancer whose tumors overexpress HER2 and who have received prior therapy including an anthracycline, a taxane, and Herceptin (trastuzumab). TYKERB alone or in combination with HERCEPTIN is not approved in this setting.