Denosumab superior to zoledronic acid for breast cancer patients with bone metastases

August 14, 2012

Treatment with denosumab resulted in a greater reduction in skeletal-related events in patients with breast cancer that spread to the bones compared with zoledronic acid, while also maintaining health-related quality of life, according to the results of a phase III study published in Clinical Cancer Research.

"Our data indicate that denosumab should be the treatment of choice for the of skeletal-related events and hypercalcemia in patients with that has metastasized to the ," said Miguel Martin, M.D., Ph.D., professor of medicine and head of the Medical Service at Hospital General Universitario Gregorio Marañón in Madrid, Spain.

Bone metastases can have devastating consequences for breast cancer patients including hypercalcemia, bone fractures, spinal cord compression and more, according to Martin. The introduction of bisphosphonates, such as , into the clinic has delayed the onset of these skeletal-related events. However, the use of these drugs is associated with acute reactions and kidney toxicity. Denosumab has a mechanism of action that is more specific than zoledronic acid, and it does not cause these adverse events.

Martin and colleagues have previously reported the study results indicating that denosumab is superior to zoledronic acid in preventing skeletal-related events in women with breast cancer and bone metastases. In the study, they randomly assigned 2,046 patients with breast cancer to receive subcutaneous denosumab and intravenous placebo, or intravenous zoledronic acid and subcutaneous placebo. In their current analysis, the researchers further analyzed the data from that study to get more information about bone-related complications and .

The data indicated that only 31 percent of patients on denosumab experienced a skeletal-related event compared with 36 percent assigned to zoledronic acid. Among those who experienced a skeletal-related event, few patients assigned denosumab experienced a second event while enrolled in the study.

Treatment with denosumab reduced the need for radiation therapy to the bone by 26 percent, and those patients also had an 18 percent lower risk for developing a skeletal-related event or hypercalcemia of malignancy. Quality of life also improved. In addition, patients assigned to denosumab had fewer acute phase reactions associated with a flu-like syndrome and fewer adverse events related to kidney dysfunction compared with those assigned to zoledronic acid.

"This analysis provides additional evidence of the superiority of denosumab over zoledronic acid," Martin said. "The clinical implication of this analysis is clear: Denosumab offers an improved therapeutic index with respect to the prior standard."

Martin and colleagues plan to continue to evaluate the use of denosumab to prevent bone-related issues in cancer patients. Due to the drug's ability control the bone microenvironment and to curb the growth of breast cancer cells, they are also testing denosumab as a preventive adjuvant therapy for early breast cancer patients.

Explore further: Drug prevents bone loss side effects of breast cancer medication

Related Stories

Drug prevents bone loss side effects of breast cancer medication

October 10, 2011
A new study has found that an osteoporosis drug protects against the bone damaging side effects of certain breast cancer medications. Published early online in Cancer, a peer-reviewed journal of the American Cancer Society, ...

Denosumab delays development of prostate cancer bone metastasis

November 16, 2011
An international clinical trial has found that treatment with a drug that suppresses the normal breakdown of bone can delay the development of bone metastases in men with prostate cancer. The study, receiving Online First ...

Immediate bisphosphonate use with endocrine therapy increased survival in postmenopausal early breast cancer

December 7, 2011
The addition of zoledronic acid to adjuvant endocrine therapy increased bone mineral density and reduced the risk for disease recurrence among postmenopausal women with early hormone receptor-positive breast cancer, according ...

Recommended for you

No dye: Cancer patients' gray hair darkened on immune drugs

July 21, 2017
Cancer patients' gray hair unexpectedly turned youthfully dark while taking novel drugs, and it has doctors scratching their heads.

Shooting the achilles heel of nervous system cancers

July 20, 2017
Virtually all cancer treatments used today also damage normal cells, causing the toxic side effects associated with cancer treatment. A cooperative research team led by researchers at Dartmouth's Norris Cotton Cancer Center ...

Molecular changes with age in normal breast tissue are linked to cancer-related changes

July 20, 2017
Several known factors are associated with a higher risk of breast cancer including increasing age, being overweight after menopause, alcohol intake, and family history. However, the underlying biologic mechanisms through ...

Immune-cell numbers predict response to combination immunotherapy in melanoma

July 20, 2017
Whether a melanoma patient will better respond to a single immunotherapy drug or two in combination depends on the abundance of certain white blood cells within their tumors, according to a new study conducted by UC San Francisco ...

Discovery could lead to better results for patients undergoing radiation

July 19, 2017
More than half of cancer patients undergo radiotherapy, in which high doses of radiation are aimed at diseased tissue to kill cancer cells. But due to a phenomenon known as radiation-induced bystander effect (RIBE), in which ...

Definitive genomic study reveals alterations driving most medulloblastoma brain tumors

July 19, 2017
The most comprehensive analysis yet of medulloblastoma has identified genomic changes responsible for more than 75 percent of the brain tumors, including two new suspected cancer genes that were found exclusively in the least ...

0 comments

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.