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Capecitabine Does Not Improve Survival in Elderly Patients With Early-Stage Breast Cancer
In elderly breast cancer patients with moderate- to high-risk early-stage disease for whom standard chemotherapy is too toxic, the chemotherapy capecitabine, which causes fewer adverse effects than standard chemotherapy agents, did not improve outcomes when tested as monotherapy, according to data from the phase III ICE trial, presented at the 2014 San Antonio Breast Cancer Symposium, held December 9–13.
“We tested capecitabine as single-agent chemotherapy in elderly women with early-stage breast cancer, who also took the bisphosphonate ibandronate. After 61 months of follow-up, we found no difference in disease-free survival and overall survival between those who took capecitabine plus ibandronate and those who took ibandronate alone,” said lead investigator Gunter von Minckwitz, MD, chairman of the German Breast Group.
“We used ibandronate because many patients at this age have osteopenia/osteoporosis, especially after chemotherapy. Bisphosphonates are also potentially preventive for breast cancer metastasis,” von Minckwitz added.
Although approximately 50% of newly diagnosed breast cancers occur in women older than 65 years of age, these subjects are under-represented in clinical trials, and frail elderly patients cannot be treated with conventional chemotherapy, such as anthracyclines and/or taxanes, von Minckwitz explained. A subgroup analysis of an earlier trial involving patients with metastatic breast cancer showed that capecitabine was well tolerated in elderly patients, and this finding served as a rationale for the ICE study.
In the ICE trial, 677 older women (aged 64 to 88 years) with breast cancer were randomly assigned to six cycles of capecitabine plus ibandronate, and 681 were randomly assigned to ibandronate only (control group). Approximately 80% of the patients in both groups had hormone receptor-positive disease and received standard-of-care endocrine therapy.
The study’s primary endpoint was disease-free survival (DFS), and secondary endpoints included overall survival (OS), compliance, and safety.
The investigators found no difference in DFS at the end of 3 years (85% of the capecitabine group versus 84% of the control group) and at the end of 5 years (79% of the capecitabine group versus 75% of the control group). Moreover, there was no difference in OS at the end of 3 years (95% percent of the capecitabine group versus 94% of the control group) and at the end of 5 years (90% of the capecitabine group versus 88% of the control group).
Approximately 8% of patients discontinued capecitabine treatment because of adverse events, and another 8% discontinued for other reasons.
Thirty-one percent of patients in the capecitabine-plus-ibandronate group experienced grade 3 or grade 4 adverse events compared with 8.7% of the ibandronate group.
The study was funded by Roche and AstraZeneca.
Source: American Association for Cancer Research; December 11, 2014.