The use of adjuvant capecitabine in elderly patients with moderate- to high-risk early breast cancer resulted in no improvement in disease-free survival.
The use of adjuvant capecitabine in elderly patients with moderate- to high-risk early breast cancer resulted in no improvement in disease-free survival, according to a study presented at the 2014 San Antonio Breast Cancer Symposium.
The phase III ICE study tested ibandronate, a bisphosphonate, with or without capecitabine in women aged 65 years or older.
“At 3 years there was no difference in invasive disease-free survival between the treatment arms,” said study presenter, Gunter von Minckwitz, MD, chairman of the German Breast Group and a professor of gynecology at University of Frankfurt, Germany. “After 5 years, the curves seem to slightly separate, but after the curves cross, showing no statistically significant difference.”
According to von Minckwitz, capecitabine was chosen because it is associated with fewer side effects than conventional chemotherapy using anthracyclines or taxanes. In addition, in 2004, when the trial was started, there was evidence that the use of bisphosphonates in the elderly might prevent breast cancer relapse.
The study included 1,358 patients who were randomly assigned to ibandronate with or without capecitabine. Patients with high rates of comorbidities were excluded from the trial.
“We allowed two modes of application of ibandronate, either orally or intravenous application,” von Minckwitz explained. “The method was chosen according to the preferred method of the patient to find out the most appropriate method to give.”
The median age of patients was 71 years with about 25% of patients on each arm aged 75 years or older. About two-thirds of patients chose an oral application of ibandronate.
Although there was no significant difference between the two treatment arms for disease-free survival, von Minckwitz said that the outcome of those patients receiving ibandronate alone was favorable with a disease-free survival of 77% and an overall survival of 88% at 5 years.
Bone-related events were still frequent despite preventive use of bisphosphonates, occurring in about 25% of patients in each arm during a median observation period of 2 years.
“These patients have to be followed out further because, as we know from other capecitabine studies, long-term follow-up of adjuvant treatment is necessary to see differences,” von Minckwitz said.
“Combination chemotherapy should be tried with optimal supportive care even in elderly patients,” he said.
1. von Minckwitz G, Reimer T, Potenberg J, et al. The phase III ICE study: Adjuvant ibandronate with or without capecitabine in elderly patients with moderate or high risk early breast cancer. Presented at 2014 San Antonio Breast Cancer Symposium; December 9-13, 2014; San Antonio, Texas. Abstract S3-04.