Treatment with zoledronic acid reduced the risk of relapse in women with breast cancer.

According to the results derived from this research zoledronic acid treatment would avoid the recurrence of breast cancer and 800 women in Spain every year

In Spain it is estimated that 25% of women with breast cancer who have been operated and subjected to standard adjuvant therapies, will have a relapse

Currently the drug is only indicated for prevention of complications of bone metastases, although research points to its ability to prevent relapses in other organs also

Treatment with Zometa ®, zoledronic acid, could prevent recurrence of breast cancer to nearly 800 women in Spain, as concluded by Dr. Michael Martin, president of the Spanish Group for Breast Cancer Research, GEICAM, from data provided by a study recently published in The New England Journal of Medicine. Dr. Martin explained that the treatment was tested in premenopausal women with hormone receptor-positive, and in absolute numbers, achieved a reduction of recurrence of 5%. Dr. Martin goes one step further and suggests that if the benefit of Zometa ® should also apply to postmenopausal women with hormone receptor-negative and could reduce the relapse rate by another 5%, which would mean that, a year in Spain, near 800 women could prevent relapse with this treatment, the doctor estimated.

In Spain are diagnosed each year between 17,000 and 20,000 breast cancer cases and 7000 deaths are recorded by this disease. In this context, Dr. Martin said that despite surgery and standard adjuvant therapy such as chemotherapy, hormone therapy or trastuzumab, it is estimated that 25% of women with breast cancer have a relapse in the future.

Hence the importance of this finding. Dr. Ana Lluch, Head of Service of Hematology and Medical Oncology, Hospital Clínico de Valencia, recognizing the great contribution they can make the administration of zoledronic acid for treatment of breast cancer. The rate of death in Spain because of this tumor has been reduced through early diagnosis programs, which can detect tumors at very initial stages and therefore the possibilities for treatment and cure are much higher. New treatments, taxanes, biological therapies such as trastuzumab, treatment with aromatase inhibitors, letrozole, anastrozole, and exemestane have also helped this reduction in relapse rate, says Dr. who is optimistic about future zoledronic acid injections.
So far, Zometa ® is indicated for the prevention of bone encumbrances arising from metastasis. However, the ABCSG-12 study has shown that zoledronic acid not only prevents locoregional recurrence, but systemic recurrence, such as lung or skin, which is what causes death, says Ana Lluch.

The study involved more than 1,800 premenopausal women with breast cancer in initial stage, after being subjected to curative surgery and treatment with goserelin to achieve ovarian suppression with hormonal therapy were treated with or without Zometa ® for three years. After a follow-up period with an average duration of 48 months, results showed that the addition of Zometa ® to hormone therapy (tamoxifen or anastrozole) reduced by 36% the risk of relapse or death.

Dr. Lluch explains that premenopausal women have a higher risk of relapse than postmenopausal women, especially systemic or distant relapse, since age is a pejorative factor. Postmenopausal women constitute 60% of patients with breast cancer in Spain, compared with 40% of premenopausal and therefore welcomes the fact that also other studies being developed for the application of zoledronic acid in postmenopausal women. We are convinced that zoledronic acid will also have a double effect on these women. He had already proven effective in increasing bone density, if confirmed to be effective in preventing relapse of breast cancer, could have an important place in the treatment of postmenopausal women.

For the doctor, who has a drug without significant side effects and also may reduce distant metastases, which help prevent bone loss in patients and decrease the risk of fracture is very important and we are transmitting to patients. Women from 50 to 55 years are concerned about a quality of life that will not have problems associated with bone fracture risk and this is where we can give good news.

Study characteristics

The study ABCSG-12 cooperative group Austrian Austrian Breast & Colorectal Cancer Study Group (ABCSG) is the first large clinical study, Phase III, randomized, reflecting that Zometa ® provides significant protection against recurrence of breast cancer in phase Initial in premenopausal women.

The ABCSG-12 is an open-label, multicentre joined 1803 premenopausal women with breast cancer estrogen receptor positive stage I or II, with involvement of fewer than 10 axillary lymph nodes. The patients were incorporated into the study after being subjected to curative surgery and initiation of treatment with goserelin for ovarian suppression, being randomly assigned to one of four study groups: (1) anastrozole over zoledronic acid, (2) anastrozole separately , (3) tamoxifen plus zoledronic acid, (4) tamoxifen alone. The treatment period was three years and the average follow up period was 48 months at the current analysis.

The primary endpoint of the four groups of study was disease-free survival or systemic recurrence. The locoregional recurrence-free survival, overall survival and bone mineral density were secondary endpoints.

With a mean follow up of 48 months, developments in disease-free survival or systemic recurrence was reduced by 36% (P = 0.01) and the risk of local recurrence-free events dropped by 35% (P = 0.02) Zometa ® added to hormone therapy compared with hormonal therapy alone. There were 16 deaths among patients who received Zometa ® with hormonal therapy, compared with 26 patients receiving hormonal sóloterapia, which entailed a nonsignificant reduction in risk of death in patients receiving Zometa ® compared with those received hormonal therapy alone (P = 0.11). A similar trend was observed in the reduction of bone metastases among patients receiving Zometa ® compared with those who received hormone therapy alone (P = 0.22). You will need longer follow-up and a larger number of events to determine if there are significant differences between groups in overall survival and survival free of bone metastasis. In general, treatment was well tolerated and side effects were consistent with the known safety profile of medicamento1.

About Zometa ®
Zometa ®, zoledronic acid, is indicated for the prevention of skeletal related events (pathological fractures, spinal cord compression, radiation or surgery to bone) in patients with advanced malignancies involving bone, and for the treatment of hypercalcemia induced by tumor. Zometa ® is approved and indicated for the treatment of patients with advanced tumors involving bone. Zometa ® is approved and indicated for the treatment of patients with multiple myeloma and patients with documented bone metastases in solid tumors, along with the usual antineoplastic therapy. Zometa ®, an intravenous bisphosphonate, is the only treatment able to show efficacy in reducing or delaying bone complications in various types of tumors such as breast, prostate, lung and renal cell cancer, administering monthly in patients with metastatic disease. Zometa ® provides patients, health professionals and medical practice 15 minutes infusion.

Zometa ® is the leading treatment worldwide for the prevention or delay of skeletal related events (SREs) in patients with advanced tumors with bone involvement in a wide variety of tumors. The laboratory research has suggested that zoledronic acid could also help to protect patients in the spread of cancer to other parts of the body (distant metastases areas) and help keep patients recurrence-free, although not approved indication for Zometa ®.

Zometa ® slows the bone-destroying effect that occurs with bone metastases, combating abnormal activation of osteoclasts, cells that normally deteriorate old bone, and osteoblasts, cells that normally participate in the development of new bone. Growth factors produced by cancer cells on osteoclasts and stimulate osteoblasts, causing excessive erosion of bone and / or the accumulation of new bone, but unstable.

Important Safety Information
In clinical studies, the safety profile with Zometa ® was similar to that of pamidronate. Zometa ® has been associated with reports of kidney failure. Patients should be monitored serum creatinine level before receiving each dose of Zometa. Caution is advised when Zometa ® use in patients sensitive to aspirin or with aminoglycosides, loop diuretics, and other potentially nephrotoxic drugs. Due to the risk of clinically significant deterioration in renal function, single doses of Zometa ® should not exceed 4 mg. and duration of infusion should not be less than 15 minutes in 100ml. diluent.

In clinical studies in patients with bone metastases and hypercalcemia of malignancy, Zometa ® had a safety profile similar to other oral bisphosphonates. The most frequently reported adverse events were flu-like syndrome (fever, arthralgias, myalgias, skeletal pain), fatigue, gastrointestinal reactions, anemia, weakness, cough, dyspnea and edema. Zometa ® should not be used during pregnancy. Zometa ® is contraindicated in patients with clinically significant hypersensitivity to zoledronic acid or other bisphosphonates, or any of the excipients in the formulation of Zometa ®.

Osteonecrosis of the jaw (ONJ): ONJ has been reported of patients with cancer receiving treatment including bisphosphonates, chemotherapy and / or corticosteroids. Most reported cases have been associated with dental procedures like dental extractions. It should consider a dental examination with appropriate preventive dental care before treatment with bisphosphonates in patients with concomitant risk factors. During treatment, these patients should avoid invasive dental procedures whenever possible. We have no data to suggest whether the cessation of bisphosphonate therapy reduces the risk of ONJ in patients requiring dental procedures.