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SAN ANTONIO – The combination of capecitabine plus the bisphosphonate ibandronate didn’t improve disease-free survival in elderly women with moderate- or high-risk breast cancers.
After 5 years, there was an absolute – but nonsignificant – difference of 3.8% in favor of the combination treatment, Dr. Gunter von Minckwitz said at the San Antonio Breast Cancer Symposium. “But thereafter, the survival curves crossed and there was no statistically significant difference between the groups.”
But the results of the 5-year Ibandronate with or without Capecitabine for Elderly Patients with Early Breast Cancer (ICE) trial do suggest that women older than 65 years can tolerate a complete chemotherapy regimen quite well, and shouldn’t be denied the chance to receive such treatment, Dr. von Minckwitz, chair of the German Breast Group , said during his presentation.
“We still see a large fraction of elderly patients who are not getting appropriate treatment. These women were about 71 years old at the beginning of this study, and after 5 years, 90% are still surviving. This shows us that the life expectancy of these patients is long. This is important information when treatment decisions are being made in these patients, who have perhaps not been considered fit enough to receive adjuvant chemotherapy, including endocrine treatment,” he said.
Investigators randomized 1,358 women aged 65 years or older to either ibandronate alone or ibandronate plus capecitabine. In each arm, patients and their physicians could decide on the ibandronate delivery mode – either 50 mg daily or 6 mg intravenously, delivered every 4 weeks. Capecitabine was delivered in six cycles of 2,000 mg/m2 daily on days 1 and 4, followed by thrice weekly for six cycles in conjunction with the preferred ibandronate schedule. Both treatments continued for 2 years.
The patients were a mean of 71 years, with 25% being at least 75 years. About 10% had a Charlson comorbidity score of at least 2. About 20% of the tumors were HER2-positive, and 15%, triple negative. Most (80%) were hormone-receptor positive. About 3/4 of the cohort had only been treated with an aromatase inhibitor.
At 3 years, there was no difference in disease-free survival, with an 85% rate in the combination group and 84% in the ibandronate-only group. At 5 years, disease-free survival was 79% and 75%, respectively. Nor was there any difference in overall survival at 3 years; in fact, survival was quite good, Dr. von Minckwitz said, with 95% still alive in the combination group and 94% in the ibandronate-only group. At 5 years, patients continued to do very well, with an overall survival of 90% in the combination group and 88% in the ibandronate-only group.
There were no significant between-group differences in any subgroup analyzed, including separation by age; pN status; hormone-receptor status; hemoglobin, albumin, and creatinine clearance; comorbidity status; or body mass index.
Adverse events of grades 3 or 4 were significantly more common in the combination group (31% vs. 9%). Two individual events drove that finding – gastrointestinal problems (6.7% vs. 1%), and skin disorders, especially hand-foot syndrome (14.6% vs. 0.6%).
Other adverse events more common in the combination group included blood and lymphatic disorders (1.2% vs 0.7%); neuropathy and dizziness (2.5% vs. 0.7%) arrhythmias and cardiac ischemia (1.8% vs. 0.4%); and thromboembolic events (2.8% vs.1.3%).
Ibandronate completion was virtually identical – about 76% in each group. Most patients in the combination group (83%) also completed the treatment.
A quarter of patients in each group experienced a bone-related adverse event, excluding metastasis. These included fractures, surgery, and new osteoporosis. Because these were so frequent, Dr. von Minckwitz suggested that bisphosphonates should be part of any treatment regimen for this population.
The ICE survival curves are so good, Dr. Minckwitz said, that they raise a bit of a question, which only time can answer. “Due to the excellent survival data, we need longer follow-up to observe any potential late effect of capecitabine.”
He had no relevant financial disclosures. The German Breast Group has no financial ties with any pharmaceutical company.
On Twitter @alz_gal
SAN ANTONIO – The combination of capecitabine plus the bisphosphonate ibandronate didn’t improve disease-free survival in elderly women with moderate- or high-risk breast cancers.
After 5 years, there was an absolute – but nonsignificant – difference of 3.8% in favor of the combination treatment, Dr. Gunter von Minckwitz said at the San Antonio Breast Cancer Symposium. “But thereafter, the survival curves crossed and there was no statistically significant difference between the groups.”
But the results of the 5-year Ibandronate with or without Capecitabine for Elderly Patients with Early Breast Cancer (ICE) trial do suggest that women older than 65 years can tolerate a complete chemotherapy regimen quite well, and shouldn’t be denied the chance to receive such treatment, Dr. von Minckwitz, chair of the German Breast Group , said during his presentation.
“We still see a large fraction of elderly patients who are not getting appropriate treatment. These women were about 71 years old at the beginning of this study, and after 5 years, 90% are still surviving. This shows us that the life expectancy of these patients is long. This is important information when treatment decisions are being made in these patients, who have perhaps not been considered fit enough to receive adjuvant chemotherapy, including endocrine treatment,” he said.
Investigators randomized 1,358 women aged 65 years or older to either ibandronate alone or ibandronate plus capecitabine. In each arm, patients and their physicians could decide on the ibandronate delivery mode – either 50 mg daily or 6 mg intravenously, delivered every 4 weeks. Capecitabine was delivered in six cycles of 2,000 mg/m2 daily on days 1 and 4, followed by thrice weekly for six cycles in conjunction with the preferred ibandronate schedule. Both treatments continued for 2 years.
The patients were a mean of 71 years, with 25% being at least 75 years. About 10% had a Charlson comorbidity score of at least 2. About 20% of the tumors were HER2-positive, and 15%, triple negative. Most (80%) were hormone-receptor positive. About 3/4 of the cohort had only been treated with an aromatase inhibitor.
At 3 years, there was no difference in disease-free survival, with an 85% rate in the combination group and 84% in the ibandronate-only group. At 5 years, disease-free survival was 79% and 75%, respectively. Nor was there any difference in overall survival at 3 years; in fact, survival was quite good, Dr. von Minckwitz said, with 95% still alive in the combination group and 94% in the ibandronate-only group. At 5 years, patients continued to do very well, with an overall survival of 90% in the combination group and 88% in the ibandronate-only group.
There were no significant between-group differences in any subgroup analyzed, including separation by age; pN status; hormone-receptor status; hemoglobin, albumin, and creatinine clearance; comorbidity status; or body mass index.
Adverse events of grades 3 or 4 were significantly more common in the combination group (31% vs. 9%). Two individual events drove that finding – gastrointestinal problems (6.7% vs. 1%), and skin disorders, especially hand-foot syndrome (14.6% vs. 0.6%).
Other adverse events more common in the combination group included blood and lymphatic disorders (1.2% vs 0.7%); neuropathy and dizziness (2.5% vs. 0.7%) arrhythmias and cardiac ischemia (1.8% vs. 0.4%); and thromboembolic events (2.8% vs.1.3%).
Ibandronate completion was virtually identical – about 76% in each group. Most patients in the combination group (83%) also completed the treatment.
A quarter of patients in each group experienced a bone-related adverse event, excluding metastasis. These included fractures, surgery, and new osteoporosis. Because these were so frequent, Dr. von Minckwitz suggested that bisphosphonates should be part of any treatment regimen for this population.
The ICE survival curves are so good, Dr. Minckwitz said, that they raise a bit of a question, which only time can answer. “Due to the excellent survival data, we need longer follow-up to observe any potential late effect of capecitabine.”
He had no relevant financial disclosures. The German Breast Group has no financial ties with any pharmaceutical company.
On Twitter @alz_gal
SAN ANTONIO – The combination of capecitabine plus the bisphosphonate ibandronate didn’t improve disease-free survival in elderly women with moderate- or high-risk breast cancers.
After 5 years, there was an absolute – but nonsignificant – difference of 3.8% in favor of the combination treatment, Dr. Gunter von Minckwitz said at the San Antonio Breast Cancer Symposium. “But thereafter, the survival curves crossed and there was no statistically significant difference between the groups.”
But the results of the 5-year Ibandronate with or without Capecitabine for Elderly Patients with Early Breast Cancer (ICE) trial do suggest that women older than 65 years can tolerate a complete chemotherapy regimen quite well, and shouldn’t be denied the chance to receive such treatment, Dr. von Minckwitz, chair of the German Breast Group , said during his presentation.
“We still see a large fraction of elderly patients who are not getting appropriate treatment. These women were about 71 years old at the beginning of this study, and after 5 years, 90% are still surviving. This shows us that the life expectancy of these patients is long. This is important information when treatment decisions are being made in these patients, who have perhaps not been considered fit enough to receive adjuvant chemotherapy, including endocrine treatment,” he said.
Investigators randomized 1,358 women aged 65 years or older to either ibandronate alone or ibandronate plus capecitabine. In each arm, patients and their physicians could decide on the ibandronate delivery mode – either 50 mg daily or 6 mg intravenously, delivered every 4 weeks. Capecitabine was delivered in six cycles of 2,000 mg/m2 daily on days 1 and 4, followed by thrice weekly for six cycles in conjunction with the preferred ibandronate schedule. Both treatments continued for 2 years.
The patients were a mean of 71 years, with 25% being at least 75 years. About 10% had a Charlson comorbidity score of at least 2. About 20% of the tumors were HER2-positive, and 15%, triple negative. Most (80%) were hormone-receptor positive. About 3/4 of the cohort had only been treated with an aromatase inhibitor.
At 3 years, there was no difference in disease-free survival, with an 85% rate in the combination group and 84% in the ibandronate-only group. At 5 years, disease-free survival was 79% and 75%, respectively. Nor was there any difference in overall survival at 3 years; in fact, survival was quite good, Dr. von Minckwitz said, with 95% still alive in the combination group and 94% in the ibandronate-only group. At 5 years, patients continued to do very well, with an overall survival of 90% in the combination group and 88% in the ibandronate-only group.
There were no significant between-group differences in any subgroup analyzed, including separation by age; pN status; hormone-receptor status; hemoglobin, albumin, and creatinine clearance; comorbidity status; or body mass index.
Adverse events of grades 3 or 4 were significantly more common in the combination group (31% vs. 9%). Two individual events drove that finding – gastrointestinal problems (6.7% vs. 1%), and skin disorders, especially hand-foot syndrome (14.6% vs. 0.6%).
Other adverse events more common in the combination group included blood and lymphatic disorders (1.2% vs 0.7%); neuropathy and dizziness (2.5% vs. 0.7%) arrhythmias and cardiac ischemia (1.8% vs. 0.4%); and thromboembolic events (2.8% vs.1.3%).
Ibandronate completion was virtually identical – about 76% in each group. Most patients in the combination group (83%) also completed the treatment.
A quarter of patients in each group experienced a bone-related adverse event, excluding metastasis. These included fractures, surgery, and new osteoporosis. Because these were so frequent, Dr. von Minckwitz suggested that bisphosphonates should be part of any treatment regimen for this population.
The ICE survival curves are so good, Dr. Minckwitz said, that they raise a bit of a question, which only time can answer. “Due to the excellent survival data, we need longer follow-up to observe any potential late effect of capecitabine.”
He had no relevant financial disclosures. The German Breast Group has no financial ties with any pharmaceutical company.
On Twitter @alz_gal
AT SABCS 2014
Key clinical point: For elderly breast cancer patients, the combination of ibandronate and adjuvant capecitabine confers no additional progression- free or overall survival advantage over ibandronate alone.
Major finding: At 5 years, progression-free survival was 79% in the combination group and 75% in the ibandronate group, but was not statistically significant. Overall survival as 90% and 88%, respctively, also not statistically significant.
Data source: The phase III ICE study, which randomized 1,358 women 65 or older to either iabndronate alone or ibadronate pluc capecitabine.
Disclosures: Dr. von Minckwitz had no relevant financial disclosures. The German Breast Group has no financial ties with any pharmaceutical company.
