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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Adding Bone Drugs to Radium-223 May Enhance Benefit in mCRPC


“Men with bone-metastatic castration-resistant prostate cancer (mCRPC) appeared to derive additional benefits from treatment with radium-223 with concomitant bone-targeted therapies, according to data from an extended-access program.

“After a median follow-up of 7.5 months from initial injection of radium-223, patients on concomitant denosumab had yet to reach a median overall survival (OS), whereas patients treated with radium-223 alone had a median survival of 13.4 months.”

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Two Generic Drugs Shown to Reduce Breast Cancer Deaths

“There’s new evidence that two inexpensive generic drugs can improve survival rates for women who develop breast cancer after menopause.

“In two large studies published Friday in The Lancet, a class of hormone-therapy drugs called aromatase inhibitors and bone-preserving drugs called bisphosphonates improved survival and recurrence rates in postmenopausal women with early breast cancer.

” ‘It may be that this is a first step in helping us figure out which patients are more likely benefit and which patients are not,’ Dr. Dawn L. Hershman, associate professor of medicine and director of the breast cancer program at the Herbert Irving Comprehensive Cancer Center at Columbia University, told CBS News. ‘We can strategize to give the medications that are going to give the most benefit and avoid the toxicity and the cost for patients with minimal benefits.’ “

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.

Top Takeaways from ASCO: Breast Cancer

“Physicians managing patients with various breast cancer diagnoses left ASCO 2015 with new data to consider when making decisions every day – some practice-changing, others potentially so.

“Key opinion leaders offer their views on positive results from trials investigating an adjunct endocrine therapy, an aromatase inhibitor as an option to tamoxifen, a novel chemotherapy and bisphosphonates.

“Nicholas C. Turner, MD, PhD, a consultant medical oncologist at the Royal Marsden and a team leader at the Institute of Cancer Research in London, and colleagues assessed the safety and efficacy of combining palbociclib (Ibrance, Pfizer), an oral agent that blocks cyclin dependent kinases 4 and 6, with fulvestrant (Faslodex, AstraZeneca) in women with hormone receptor-positive, HER-2–negative advanced breast cancer who had progressed on prior endocrine therapy.

“ ‘The palbociclib data with fulvestrant builds on this whole concept of partnering endocrine therapy with another agent,’ William J. Gradishar, MD, FACP, professor of medicine in the division of hematology and medical oncology, Northwestern University Feinberg School of Medicine, and breast cancer section editor for HemOnc Today, told”

Bone Drugs Equal as Breast Cancer Therapies

“One bone-preserving drug is as good as another in early stage breast cancer, a researcher said here.

“In a large randomized trial, there were few differences in anti-cancer efficacy among three different members of the bisphosphonate class, according to Julie Gralow, MD, of the University of Washington in Seattle.

“And the overall safety of the drugs was also similar, Gralow reported at the annual meeting of the American Society of Clinical Oncology.

“But the study might not help settle a continuing controversy in oncology over the use of the drugs, which normally are prescribed to slow bone embrittlement by inhibiting the action of osteoclasts.”

Osteoporosis Drugs Might Help Prevent, Treat Cancers with HER Gene Abnormalities

The gist: New research shows that drugs used to treat osteoporosis might help prevent or treat certain types of lung, breast, and colorectal cancer. These drugs, called bisphosophonates, might work against tumors that have abnormalities in the HER gene.

“Researchers have discovered that bisphosphonates inactivate human epidermal growth factor (EGF) receptors to exert antitumor effects, and they say the widely prescribed osteoporosis drugs may prove to be a cheap and useful adjuvant to current therapies for HER-driven cancers.

“Bisphosphonates directly bind to and inhibit HER kinases, including commonly mutated forms that drive non-small-cell lung cancer and other cancer growth and resistance to tyrosine kinase inhibitors, according to two studies published online this week in the journal PNAS Early Edition, by researcher Mone Zaidi, MD, of Mount Sinai School of Medicine, in New York City, and colleagues.

“If the findings are confirmed, bisphosphonates could potentially be repurposed for the prevention and adjuvant treatment of breast, lung, and colorectal cancers that are driven by HER (human EGF receptor), the researchers wrote.

” ‘There is quite a lot of anecdotal literature as well as a few clinical epidemiologic studies suggesting that women who take bisphosphonates (for osteoporosis) have a lower risk for breast and colorectal cancer,’ Zaidi told MedPage Today.

“He added that several studies of cancer patients treated with intravenous bisphosphonates for bone metastasis suggest the drugs have positive effects on tumor cell burden.”

Capecitabine Ineffective in Elderly Early Breast Cancer Patients

The gist: A recent study found that elderly patients with early-stage, moderate- to high-risk breast cancer don’t benefit from the addition of the drug capecitabine to their post-surgery treatment with the drug ibandronate.

“The use of adjuvant capecitabine in elderly patients with moderate- to high-risk early breast cancer resulted in no improvement in disease-free survival, according to a study presented at the 2014 San Antonio Breast Cancer Symposium.

“The phase III ICE study tested ibandronate, a bisphosphonate, with or without capecitabine in women aged 65 years or older.

“ ‘At 3 years there was no difference in invasive disease-free survival between the treatment arms,’ said study presenter, Gunter von Minckwitz, MD, chairman of the German Breast Group and a professor of gynecology at University of Frankfurt, Germany. ‘After 5 years, the curves seem to slightly separate, but after the curves cross, showing no statistically significant difference.’ ”

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.”