Lani
09-19-2007, 11:45 AM
Trastuzumab Has Low Incidence Cardiac Events in Properly Screened Patients
NEW YORK (Reuters Health) Sept 18 - There is a low incidence of cardiac adverse events associated with adjuvant trastuzumab in breast cancer patients who fulfill the Herceptin Adjuvant (HERA) trial eligibility criteria, according to findings published in the September issue of the Journal of Clinical Oncology.
"Trastuzumab benefits patients with metastatic breast cancer and improves disease-free and overall survival after adjuvant chemotherapy," Dr. Thomas M. Suter, of University Hospital Bern, Switzerland, and colleagues note. "However, trastuzumab treatment is also associated with congestive heart failure and cardiac dysfunction."
The HERA trial is a three-group, multicenter, open-label, randomized trial that compared 1 or 2 years of trastuzumab given once every 3 weeks with observation in HER-2-positive breast cancer patients. Eligibility criteria included completion of (neo)adjuvant chemotherapy with or without radiotherapy and a normal left ventricular ejection fraction (LVEF at least 55%). The team performed a repeat LVEF assessment in case of cardiac dysfunction.
Data were available for 1693 patients assigned to 1 year of trastuzumab and 1693 patients assigned to observation. A low incidence (4.3%) of trastuzumab discontinuation due to cardiac disorders was observed. Patients in the trastuzumab group had a significantly higher incidence of severe congestive heart failure (CHF) (0.60% versus 0.00%), symptomatic CHF (2.15% versus 0.12%), and confirmed significant LVEF drop (3.04% versus 0.53%) than those in the observation group.
The trastuzumab-treated patients also had a higher incidence of occurrence at any time of at least one significant LVEF drop (7.03% versus 2.05%). Recovery from cardiac dysfunction occurred in less than 6 months in most patients.
"The mean cumulative dose among patients with a cardiac end point was significantly higher for doxorubicin (287 mg/m squared versus 257 mg/m squared) and epirubicin (480 mg/m squared versus 422 mg/m squared)," Dr. Suter's team reports. "There were four patients treated with paclitaxel who developed a cardiac end point."
Patients with trastuzumab-associated cardiac dysfunction had a lower screening LVEF and a higher body mass index, according to the authors.
"Given the clear benefit in disease-free survival, the low incidence of cardiac adverse events, and the suggestion that cardiac dysfunction might be reversible, adjuvant trastuzumab should be considered for treatment of breast cancer patients who fulfill the HERA trial eligibility criteria," the authors conclude.
J Clin Oncol 25:3859-3865.
NEW YORK (Reuters Health) Sept 18 - There is a low incidence of cardiac adverse events associated with adjuvant trastuzumab in breast cancer patients who fulfill the Herceptin Adjuvant (HERA) trial eligibility criteria, according to findings published in the September issue of the Journal of Clinical Oncology.
"Trastuzumab benefits patients with metastatic breast cancer and improves disease-free and overall survival after adjuvant chemotherapy," Dr. Thomas M. Suter, of University Hospital Bern, Switzerland, and colleagues note. "However, trastuzumab treatment is also associated with congestive heart failure and cardiac dysfunction."
The HERA trial is a three-group, multicenter, open-label, randomized trial that compared 1 or 2 years of trastuzumab given once every 3 weeks with observation in HER-2-positive breast cancer patients. Eligibility criteria included completion of (neo)adjuvant chemotherapy with or without radiotherapy and a normal left ventricular ejection fraction (LVEF at least 55%). The team performed a repeat LVEF assessment in case of cardiac dysfunction.
Data were available for 1693 patients assigned to 1 year of trastuzumab and 1693 patients assigned to observation. A low incidence (4.3%) of trastuzumab discontinuation due to cardiac disorders was observed. Patients in the trastuzumab group had a significantly higher incidence of severe congestive heart failure (CHF) (0.60% versus 0.00%), symptomatic CHF (2.15% versus 0.12%), and confirmed significant LVEF drop (3.04% versus 0.53%) than those in the observation group.
The trastuzumab-treated patients also had a higher incidence of occurrence at any time of at least one significant LVEF drop (7.03% versus 2.05%). Recovery from cardiac dysfunction occurred in less than 6 months in most patients.
"The mean cumulative dose among patients with a cardiac end point was significantly higher for doxorubicin (287 mg/m squared versus 257 mg/m squared) and epirubicin (480 mg/m squared versus 422 mg/m squared)," Dr. Suter's team reports. "There were four patients treated with paclitaxel who developed a cardiac end point."
Patients with trastuzumab-associated cardiac dysfunction had a lower screening LVEF and a higher body mass index, according to the authors.
"Given the clear benefit in disease-free survival, the low incidence of cardiac adverse events, and the suggestion that cardiac dysfunction might be reversible, adjuvant trastuzumab should be considered for treatment of breast cancer patients who fulfill the HERA trial eligibility criteria," the authors conclude.
J Clin Oncol 25:3859-3865.