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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Questions and answers
How to lose weight correctly
I am 53 years old, my weigh is 116 kg. In 1988, my metabolism was probably, disturbed following the first childbirth. I gained weight, and since then I have been trying to fight with it periodically. I eat a lot of sweets however glucose is now normal and it always was. With age, my legs and back started to hurt me,
it is hard to “move” myself. I have undergone an examination in the district hospital, but nothing special was found. What tests and examinations I should bring to the doctor to get a diagnosis and treatment? Thank you!
...more Unfortunately, doctors not always can find the cause of excess weight. But this does not mean that there are ways to deal with it. Of course, it is not easy, but you definitely should try! At the first consultation it is desirable to have blood tests results, obtained no more than 6 months ago, total cholesterol,
glucose, glycated hemoglobin. Notes in the diary of blood pressure for 1-2 weeks are also important. Most likely, the doctor will arrange some additional examinations at visit, but everything is very individual and it's better to discuss all details with the doctor personally. You surely have to bring the results of previous all examinations with you.
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Novikova Polina
08 September 2016
Question about ultrasound
I am 36 years old. Thyroid gland ultrasound: topography: position is regular, the right lobe is enlarged W-24 mm, t-22 mm, l- 51 mm, the volume is 12.90 cm3, left lobe enlarged, W -23 mm, t-23 mm, l-56 mm, volume is 14,90 cm3, isthmus thickness is 5 mm, the total volume is 27.09 cm3, alignments are even,
echostructure is inhomogenous, echogenicity is normal, focal masses are not seen, lymph nodes are not seen, conclusion; ultrasound signs of diffuse changes in the enlarged thyroid gland. TSH 2.10 mcIU/ml (normal range 0.30-4.00). The doctor prescribed Iodocomb 50/150 for 3 months. I have been taking the medicine for 2.5 months, but TG does not seem to diminish in size and I feel discomfort (it’s like a need to stretch my neck). Whether the treatment prescribed is correct? Are any additional tests needed? Should I have my thyroid gland diminished for those 2.5 months or it is too early to talk about it? Thank you!
...more It's hard to advice any treatment by correspondence. The cause of the thyroid gland enlargement is still unclear based on the results provided. The most common cause is iodine deficiency and Iodocomb treatment is appropriate in this case. Another cause is a chronic autoimmune thyroiditis which requires different
treatment. Endocrinologists at EMC will advise you and decide on the types of treatment and necessary doses.
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Russ Irina
08 September 2016
Arthrosis
My left jaw started to hurt me after giving birth. The pain was accompanied by a crunch, clicks, discomfort when chewing. Arthrosis was diagnosed at local institution. What should I do?
The symptoms of pain and the crunch may occur following precipitating factors. It can be a trauma of the maxillofacial area, ENT-organs infections, sitting with mouth open for a long time when visiting the dentist, hypothermia, overload. Perhaps, pregnancy and childbirth were such a factor in your case. The treatment
goal in arthrosis is to reduce the load in temporomandibular joint. Treatment depends on the cause or the complex of causes that triggered the arthrosis. This may be due to the anatomical mismatch between the articular head size and the glenoid fossa. This also can be due to the long-term overload resulted from irregular bite and muscle imbalance. If increased tone of the masticatory muscles has led to increased abrasion of teeth, method of treatment with the restoration of the chewing surfaces and cutting edges of all teeth is optimal. But before that, splint therapy (mouth guards) is mandatory, which ensures the optimal position of the articular heads in articular fossae. Treatment is designed depending on the cause of changes in the joint. If the irregular bite is present pre-treatment by the orthodontist may be worthwhile.
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Problems with teeth
I have a huge problem with my teeth - all the teeth were treated, metalless ceramics were fixed in some places, a few teeth need to be removed. The treatment was carried out abroad, but the caries problem was beyond control, despite regular professional hygiene and specially selected tools. What range of dental
examinations, in addition to specialist’s consultation, I can count on in EMC Moscow?
...more Various dental diagnostic methods are available in our Dentistry Department: computed tomography of all teeth of both jaws, which gives a three-dimensional image and allows the doctor to more accurately diagnose; orthopantomography gives a flat image of all the teeth; the targeted x-ray tooth image. Tooth extraction
is performed surgically, mostly under local anesthesia. Diagnostic and treatment methods are determined individually by the attending doctor on consultation. Thank you for your message!
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How soon I may drive after LASIC?
When can I ride a car after LASIK?
Eyesight recovery is quite fast. Visual acuity is almost completely restored next morning, and most people can drive a car and get to work.
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Elias Raid
08 September 2016
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