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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Dermoid cyst and pregnancy
An ultrasound revealed a mass in my left ovary during the first pregnancy. I was told that it is a dermoid cyst. Five years have passed since then. I gave birth to a second child. An ultrasound was performed annually. There were differences in size, but not significant. Since I’m going to have the 3rd child, another
ultrasound was done today. The doctor said that the cyst had increased. I am concerned about it. Don't know where to start. What tests are needed? Thank you.
...more Surgical treatment is strictly indicated in your case given the long history of the mass in the ovary and its rapid growth in recent times. In our clinic, we perform such an intervention laparoscopically through 3 small punctures. Patients go home next morning after the surgery and may return to work after 3 days.
This surgery must be as delicate to preserve healthy ovarian tissue (considering your reproductive plans) as radical at the same time to remove the mass together with the capsule. At the preoperative stage an expert level ultrasound with Doppler is required, as well as blood tests for Ca-125 and НЕ-4 tumor markers. The decision concerning the necessity of FEGDS and colonoscopy is taken based on the results of these tests.
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Total knee replacement
My mom suffers from gonarthrosis for the past three years. Despite treatment by injections the pain is still present. MRI revealed a meniscal tear in the posterior horn, the presence of small bony osteophytes on the patella, a small amount of fluid in the joint cavity (signs of exudative synovitis were detected)
joint space is asymmetrically narrowed in the medial segment. The pain is ongoing but the knee remains flexible. Tell me, please, whether the surgery is contraindicated for meniscal tear in case of arthrosis? Is it possible to do an arthroscopic surgery on the meniscus in our case or it should be «major» surgery? And what would you advice concerning knee replacement for the patient in the age of 57? What is the life time of the artificial joint?
...more It is necessary to make an X-ray of the knee in direct projection in standing position. If it turns out that there is no medial cartilage in the medial area, then the knee replacement is the only solution. The age of 57 is normal for the prosthetics. Modern artificial knee joint (when properly placed of course) will
serve for a lifetime. You can make an appointment via phone +7 (495) 933-66-44.
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Kardanov Andrey
07 September 2016
Pain
I am 19 years old, professionally engaged in weightlifting. I did an arthroscopy of both knee joint a year ago, now feel pain in them and it prevents me from training at full capacity. I visited a traumatologist, and «osteoarthritis of 1 degree» was diagnosed. Could you advise me some medicines or anything else to
relief the pain? Thank you very much for the answer!
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First of all you should undergo an MRI and find out what was done at arthroscopy; if it’s really an arthrosis of 1 degree, hyaluronic acid injections are possible and physiotherapy is not required. Anyway, you are always welcome to consultation for thorough examination.
Question to Dr. Yakobashvili
Tell me, please, at which age child's hearing should be checked-up if we were informed at the hospital before discharge that one ear does not hear. At the moment the child’s age is 1.5 months. Thank you.
These tests done in the hospital are often false negative. Hearing can be tested now, it is necessary to make an appointment to the audiologist.
Cought
A child of 11 years old, suffers from cough for more than six months. The cough is dry, sometimes attack-like, mainly begins during the day, and often occurs before sleep. There is no cough at night. CBC is normal, glucose is 4.16, total IgE 111.80, Toxocara, Ascaride are negative, Cytomegalovirus, Mycoplasma are
negative, PPD test is negative as well. A chest x-ray is normal. We have already consulted with a therapist, otolaryngologist, pulmonologist, neurologist, gastroenterologist... the cough is still present. What should we do?
...more First of all, there are no results of whooping cough testing among the results provided above. The disease cannot be ruled out, even if your child was vaccinated. The blood test for antibodies against the whooping cough germ is required (blood test for class M and G antibodies against Bordetella pertussis). Second,
even a slight increase in class E antibodies is a reason to visit an allergist and to perform an evaluation of respiratory function with bronchodilator. This method will detect a latent bronchial spasm in your child. Even if the results of the test will be normal, allergologist mast rule out the allergic nature of the cough even if it's not obstructive syndrome. Third, this cough can be due to gastroesophageal reflux. It is difficult to draw any conclusions having no data of gastroenterologist’s consultation. 24-hour acidity monitoring of the stomach and esophagus is carried out to confirm or exclude the presence of reflux. Fourth, you didn’t mention whether x-ray of nasopharynx and paranasal sinuses was done. Perhaps, after all, the pathology is associated with ENT organs.
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