Panel Backs Bone Drugs for Postmenopausal Breast Cancer


“Appropriately selected postmenopausal women with breast cancer warrant consideration for adjuvant bisphosphonate therapy, according to an updated clinical guideline.

“Either zoledronic acid (Zometa) or clodronate may be considered for adjuvant therapy, as data supporting use of other bisphosphonates remain limited. The RANK ligand-targeted monoclonal antibody denosumab (Xgeva) did not make the cut as recommended therapy because of a lack of long-term survival data to support its use.

” ‘Data for adjuvant denosumab look promising but are currently insufficient to make any recommendation,’ concluded a panel of experts representing the American Society of Clinical Oncology (ASCO) and Cancer Care Ontario.”

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Osteoporosis Drug Shows Promise for Breast Cancer Prevention in BRCA1 Carriers


“TNFSF11, also known as RANKL, shows potential as a genetic pathway in the prevention of breast cancer for women carrying BRCA1 mutations. Early study findings, published in Nature Medicine, show that a drug currently used in the treatment of osteoporosis, denosumab (Xgeva)—an inhibitor of RANKL—could also be used for the prevention and delay of tumor growth for BRCA1-mutation carriers.

“ ‘These findings imply an integral role for the RANK pathway in tumor initiation in BRCA1-mutation carriers and lend support to clinical studies for the “repurposing” of denosumab as a novel preventative therapy strategy in these and possibly other “high-risk” women,’ wrote study authors.”

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De-escalation of Bone-Targeting Agents Appears Safe in Bone Metastases

“A new meta-analysis suggests that de-escalation of bone-targeted agents such as bisphosphonates and denosumab is a safe strategy in patients with bone metastases from breast cancer. There is a growing body of evidence suggesting such de-escalation will soon be considered standard of care.

“Bone-targeted agents are generally given every 3 to 4 weeks beginning at the time of diagnosis of bone metastases, until death. ‘If de-escalation of treatment is as efficacious as 3–4 weekly dosing, it could reduce clinic visits, drug side effects for patients, in addition to reducing costs to both the patient and the health care system,’ wrote study authors led by Mark Clemons, MD, of the Ottawa Hospital Cancer Centre in Canada.

“Clemons and colleagues conducted a systematic review and meta-analysis of published research on de-escalation of bone-targeted agents; six studies reported data for at least one ‘outcome of interest’ involving pamidronate, zoledronate, and denosumab. Results of the analysis were published online ahead of print in Annals of Oncology.

Denosumab Reduces Clinical Fracture Risk in Postmenopausal Women Receiving Aromatase Inhibitors

“In a phase III trial (ABCSG-18) reported in The Lancet, Gnant et al found that adjuvant denosumab (Xgeva) reduced the risk of clinical fracture in women with breast cancer receiving aromatase inhibitor therapy.

“In the double-blind study, 3,420 women from Austria and Sweden with early hormone receptor–positive breast cancer receiving aromatase inhibitors were randomized between December 2006 and July 2013 to receive subcutaneous denosumab 60 mg (n = 1,711) or placebo (n = 1,709) every 6 months.

“The primary endpoint was time to first clinical fracture on intention-to-treat analysis. Patients were treated until the prespecified number of 247 first clinical fractures was reached.

“Patients had a median age of 64 years. At baseline, 55% had normal total lumbar spine bone mineral density (T score ≥ –1.0), and the remainder had T scores lower than –1.0. Overall, 16% of patients started aromatase inhibitor therapy at the time of randomization, with the remainder having been on treatment for a median of 1 month prior to randomization. In total, 25% of patients had also received (neo)adjuvant chemotherapy.”

Amgen Says FDA Approves Xgeva as a Treatment for Rare Bone-Destroying Cancer Complication

The gist: The drug denosumab (Xgeva) has been approved by the U.S. Food and Drug Administration (FDA) for treating a bone condition called hypercalcemia of malignancy. Doctors in the U.S. can now prescribe Xgeva to patients whose hypercalcemia of malignancy does not get better after treatment with drugs called bisphosphonates. Hypercalcemia of malignancy is a rare but potentially fatal complication in people with advanced cancer.

“Amgen’s Xgeva, which is used to treat bone disorders related to cancer, received an additional U.S. marketing approval.

“The Food and Drug Administration approved Xgeva as a treatment for hypercalcemia of malignancy, a condition in which a patient’s bones break down at an accelerated rate, the company said. It is related to advanced cancer and increases the risk of fractures. It can also lead to kidney failure, mental impairment, coma and death. Amgen said hypercalcemia of malignancy is considered an orphan disease, meaning there are fewer than 200,000 patients in the U.S.

“The biotech giant also sells Xgeva for the prevention of skeletal damage from solid tumors, and for inoperable cases of a rare condition called giant cell tumor of bone. The tumors destroy bones, which can cause painful fractures, joint problems, deformity and amputation. The drug is also marketed under the name Prolia as a treatment for osteoporosis.”

Researchers Review New Treatments for Advanced Prostate Cancer and Their Cost Implications

Advanced prostate cancer patients used to be treated with palliative chemotherapy that did not improve survival. But in the past decade, researchers have introduced several new therapies for castration-resistant prostate cancer (CRPC) and related complications. These drugs include cabazitaxel (Jevtana), abiraterone acetate (Zytiga), enzalutamide (Xtandi), sipuleucel-T (Provenge), radium-223, and denosumab (Xgeva or Prolia). Two researchers recently performed a cost-benefit analysis on these new therapies. They say that costs will come down as treatment strategies—including precisely timed combinations of drugs—are refined to minimize progression and side effects.