Tevaarwerk, MD August 10, clodronate and breast cancer, Advertisement. The oncology community has now conducted several prospectively designed, hypothesis-driven randomized clinical trials among women with breast cancer to address this question: Do adjuvant bisphosphonates decrease the risk of breast cancer bone metastases and other recurrence?
These findings were independent of bisphosphonate class, treatment schedule, estrogen receptor status, nodes, clodronate and breast cancer, tumor grade, or concomitant chemotherapy. No differences were seen in non—breast cancer mortality. Given the EBCTCG meta-analysis combined with the known benefits to bone health an important complication of endocrine therapy among postmenopausal breast cancer patientsthe medical oncology community has faced the question of whether or not to routinely recommend bisphosphonates in the adjuvant setting.
The guideline applies to all postmenopausal women with stage I to III breast cancer who are otherwise candidates for adjuvant systemic therapy. This encompassing recommendation is regardless of risk, clodronate and breast cancer, receptor status, and whether patients are postmenopausal for years at diagnosis or rendered postmenopausal by medical or surgical therapy.
This guideline will mean cialis and viagra together adjuvant bisphosphonates with a healthy year-old postmenopausal woman with T2-N0 hormone receptor—positive breast cancer.
Genomic assays can now inform us that such a woman has a low risk of distant recurrence at 10 years, provided clodronate and breast cancer takes 5 years of endocrine therapy. This raises the specter of overtreatment, clodronate and breast cancer, given such small absolute benefits.
These benefits become even less certain when we consider we are operating based on post-hoc analyses of the primary trials. For instance, the primary endpoint of AZURE was not met, but further analyses suggested that benefit from adjuvant bisphosphonates might accrue to women who had been in menopause for more than 5 years. On the other hand, ABCSG showed benefit for the addition of zoledronic acid to endocrine therapy but was conducted exclusively among premenopausal women rendered postmenopausal by ovarian function suppression.
Most of the women Given the time ranges for starting bisphosphonates in the included trials, chemotherapy would have largely overlapped the bisphosphonate. Receipt of chemotherapy may simply be a surrogate for higher- risk patients. However, an undefined interaction between adjuvant chemotherapy and bisphosphonates might drive benefit, given we lack a clear mechanism for adjuvant bisphosphonate benefit although the EBCTCG meta-analysis indicates a similar degree of benefit regardless of chemotherapy receipt.
Zoledronic acid and clodronate are deemed the recommended agents, with the clodronate and breast cancer noting the current limitations surrounding denosumab.
Clodronate has not been studied specifically clodronate and breast cancer patients receiving aromatase inhibitors the most common endocrine therapy utilized in this clodronate and breast cancer population and has not been approved by the U. Food and Drug Administration in the United States.
For the United States, the guideline means choosing between zoledronic acid infusions vs no adjuvant bisphosphonate. Fortunately, zoledronic acid is now available generically and thus is potentially cost-effective 5 ; nevertheless, it will be interesting to see how insurance coverage for adjuvant bisphosphonates plays out.
The safety profile of zoledronic acid is well characterized and includes rare but serious complications such as osteonecrosis of the jaw, renal dysfunction, and atypical femoral fracture due to abnormal bone formation. Furthermore, prevention of osteonecrosis of the jaw relies on preventive dental health, clodronate and breast cancer, but as many as one in five Americans may be unable to afford dental coverage. The guideline does provide a recommended dose, interval, and duration for treatment with zoledronic acid, based on the existing studies: It does not specifically state a time range for consideration of starting adjuvant bisphosphonates.
This begs the following question: When is it too late to start bisphosphonates, if the primary purpose is to reduce the risk of recurrence rather than to promote bone health?
More work clearly remains to be done in elucidating the mechanism by which adjuvant bisphosphonates may benefit postmenopausal woman. An assay that predicted benefit or lack thereof would allow tailoring of treatment for patients most likely to benefit. We applaud the efforts of the expert panel to direct us to some standardization with respect to practice surrounding adjuvant bisphosphonates. The guideline will serve to remind oncologists to consider adjuvant bisphosphonates. Tevaarwerk reported a family member working for Epic Care Systems.
Adjuvant bisphosphonate treatment in early breast cancer: Meta-analyses of individual patient data from randomised trials. Zoledronic acid combined with adjuvant endocrine therapy of tamoxifen versus anastrozole plus ovarian function suppression in premenopausal early breast cancer: Adjuvant zoledronic acid in patients with early breast cancer: Use of adjuvant bisphosphonates and other bone-modifying agents in breast cancer: J Clin Oncol Cost-utility of adjuvant zoledronic acid in patients with breast cancer and low estrogen levels.
Zometa zoledronic clodronate and breast cancer prescribing information. Novartis Pharmaceuticals Corporation; December Adjuvant treatment of clodronate and breast cancer women with endocrine-responsive early breast cancer: Oral health status and access to oral health care for U. National Health Interview Survey, Vital Health Stat Endocrine therapy plus zoledronic acid in premenopausal breast cancer.