NEW YORK (Reuters Health) – Denosumab may have a stronger effect than zoledronic acid in delaying the development of severe pain in women with advanced breast cancer, according to a secondary analysis of a randomized, double-blind study.
As reported in 2010 in the Journal of Clinical Oncology, the 2,046-patient study found that denosumab significantly delayed the time to first skeletal-related event. In a new study online September 5 in Cancer, Dr. Charles S. Cleeland of the University of Texas M.D. Anderson Cancer Center in Houston and colleagues looked at several pain-related outcomes.
For example, progression to moderate to severe pain among patients on denosumab who had no or mild pain at baseline was 9.7 months, compared to 5.8 months for patients on zoledronic acid (p=0.002).
There also was a trend toward a longer time to increased pain interference with daily life activities with denosumab (16.0 months vs. 14.9 months for patients on zoledronic acid, p=0.09). And in patients on denosumab, the median time to a two-point or greater increase in pain severity score was 8.5 months, compared to 7.4 months for patients on zoledronic acid (p=0.08).
There was no significant difference between the two groups in time to pain improvement or decreased pain interference in daily life activities.
“These patient outcomes may be of particular relevance to patients with breast cancer who are newly diagnosed with bone metastases, as patients were enrolled in this study a median of two months after their diagnosis of bone metastases,” Dr. Cleeland and his colleagues write.
“These findings also illustrate the natural progression of pain in patients with metastatic breast cancer, which interferes with their ability to function and requires careful medical management,” they added.
Amgen Inc., the maker of denosumab (Xgeva), funded the study. Several of the study’s authors report receiving honoraria from Amgen, consulting for the company, or being Amgen employees.
Dr. Cleeland had not responded to a request for comment on the findings by press time.