The frequency of administration of zolendronic acid can be safely reduced by 67% in patients suffering from breast cancer with bone metastases. Clinical studies have shown that reducing dosages leads to a reduction in serious side effects of the drug, such as osteonecrosis of the mandible and renal toxicity.
The frequency of administration of zolendronic acid can be safely reduced by 67% in patients suffering from breast cancer with bone metastases. The data from the Phase III clinical trial presented at the 2014 ASCO Annual Symposium convincingly showed that reducing dosages leads to a reduction in serious side effects of zolendronic acid, such as osteonecrosis of the mandible and renal toxicity.
Zolendronic acid, being a nitrogen-containing bisphosphonate of the 3rd generation, reduces the severity of clinical manifestations of bone metastases. The standard mode of administration of the drug is 4 mg intravenously every 3-4 weeks for the 1st year. The optimal duration of the treatment regimen has not yet been presented. However, long-term monthly use of zolendronic acid (more than 3 years) It can lead to serious complications such as osteonecrosis of the jaw and chronic renal failure.
The double-blind multicenter phase III OPTIMIZE-2 study included 403 breast cancer patients (mean age 59 years) with bone metastases who were treated with intravenous bisphosphonates for 10 to 15 months. The patients continued treatment with zolendronic acid monthly (200 patients) or every 3 months (203 patients) for 1 year. Neither the researcher nor the patient could know what specific treatment they were receiving: the women in the control group were given a placebo. The characteristics of the patients were identical in both groups.
The result was the ratio of skeleton-related events (CVD), defined as the ratio of patients with ≥1 CVD (i.e., pathological fracture, spinal cord compression, with the need for radiation therapy or orthopedic intervention). The term "noninferiority" was specifically introduced, i.e. "no deterioration" when prescribing zolendronic acid with an extended interval compared to standard treatment. At the same time, the time before the onset of CVD, the dynamics of bone markers were studied, pain was assessed on a pain scale and the safety of the prescribed treatment.
The results were presented at a median follow-up of 11.9 months. At the same time, the primary point of the study was achieved: the results of prescribing zolendronic acid once every 12 weeks were no worse than the monthly regimen. The differences were 1.2% in CCC ratio (95% CI, 7.5%-9.8%; P = .724), at 22% (n = 44) and 23.2% (n = 47) in the first and second observation groups, respectively.
Secondary goals were also comparable between the two groups. The time to the onset of the first CVD (HR = 1.06; 95% CI, 0.70-1.60; P = .792) and the deviations in bone remodeling markers were also identical.
The toxicity profiles were also comparable between the two groups, with side effects occurring equally frequently.Grade 3-4 toxicity was described in 47.5% (n = 94) and 42.6% (n = 86) of the follow-up groups, respectively. The severity of pain and the need for painkillers did not vary in the groups.
A less intensive bisphosphonate regimen minimized the incidence of serious side effects, such as osteonecrosis of the mandible, to 0. Renal toxicity was also lower in this mode, 7.9% (n = 16) versus 9.6% (n = 19)
A less intensive bisphosphonate regimen minimized the incidence of serious side effects, such as osteonecrosis of the mandible, to 0. Renal toxicity was also lower in this mode, 7.9% (n = 16) versus 9.6% (n = 19)
Thus, after 9-12 months of monthly administration of intravenous nitrogen-containing bisphosphonates, it is advisable to continue their administration once every 12 weeks. This does not lead to a decrease in the effectiveness of treatment of metastatic bone disease in breast cancer in women, while increasing the psychological comfort of patients and, importantly, reducing the cost of drug treatment for this complex category of patients
The OPTIMIZE-2 study was sponsored by Novartis, the manufacturer of zolendronic acid.
Hortobagyi GN, et al. ASCO 2014. Abstract LBA9500
BP, bisphosphonate; IV, intravenous; q4w, every 4 weeks; q12w, every 12 weeks; SRE, skeletal-related events. AE, adverse event; ONJ, osteonecrosis of the jaw; q4w, every 4 weeks; q12w, every 12 weeks; SD, standard deviation.
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