Non-Opioid Pain Relief from Bone Mestatses for Breast and Prostate Cancer Patients
What are bone metastases?
Bone metastases, or metastatic bone disease, is a class of cancer metastases that results from primary tumor invasion to bone. Bone-originating primary tumors such as osteosarcoma, chondrosarcoma, and Ewing’s sarcoma are rare.
What causes bone metastases?
About three out of four cases of bone metastasis result from tumors in the breast, prostate, lung, or kidney. Almost 70% of people with advanced breast or prostate cancer have bone metastasis; bone is commonly the first area of metastasis for these cancers.
Who is most likely to get bone metastases?
Q. Bones, lungs, and the liver are the most common places for cancer cells to spread, or “metastasize.” Once in the bone, these cancer cells can form new metastatic tumors.
Do you then have bone cancer?
A. No, you have the cancer which you were diagnosed except now it is metastatic. For example, breast cancer that spreads is known as “metastatic breast cancer.” Metastatic cancers in the bone are also called bone metastases, or bone “mets.”
What are the symptoms of bone metastases?
Bone Pain Broken Bones Urinary Incontinence Bowel Incontinence
Weakness in the legs or arms High levels of calcium in the blood
Current Standard of care
Pain is the most common sign of bone cancer, and may become more noticeable as a tumor grows. Bone pain can cause a dull or deep ache in a bone or bone region (e.g. back, pelvis, legs, ribs, arms). Treatment options include: opiods, orthodpedic procedures, radiation therapy and radiopharmaceuticals.
FDA-Approved Non-Opiod Pain Medication for Painful Metastases
About Strontium Chloride Sr89 Injection, USP
Following intravenous injection, soluble strontium compounds behave like their calcium analogs, clearing rapidly from the blood and selectively localizing in bone mineral. Uptake of strontium by bone occurs preferentially in sites of active osteogenesis, thus primary bone tumors and areas of metastatic involvement (blastic lesions) can accumulate significantly greater concentrations of strontium than surrounding normal bone. Strontium-89 Chloride is retained in metastatic bone lesions much longer than in normal bone, where turnover is about 14 days. In patients with extensive skeletal metastases, well over half of the injected dose is retained in the bones. Excretion pathways are two-thirds urinary and one-third fecal in patients with bone metastases. Urinary excretion is higher in people without bone lesions. Urinary excretion is greatest in the first two days following injection. Strontium-89 is a pure beta emitter and Strontium-89 Chloride selectively irradiates sites of primary and metastatic bone involvement with minimal irradiation of soft tissues distant from the bone lesions. (The maximum range in tissue is 8 mm; maximum energy is 1.463 MeV.) Clinical trials have examined relief of pain in cancer patients who have received therapy for bone metastases (external radiation to indexed sites) but in whom persistent pain recurred.
INDICATIONS AND USAGE: Strontium-89 Chloride Injection is indicated for the relief of bone pain in patients with painful skeletal metastases. The presence of bone metastases should be confirmed prior to therapy.
CONTRAINDICATIONS: None known.
WARNINGS: Use of Strontium-89 Chloride (Sr89) in patients with evidence of seriously compromised bone marrow from previous therapy or disease infiltration is not recommended unless the potential benefit of the treatment outweighs its risks. Bone marrow toxicity is to be expected following the administration of Strontium-89 Chloride, particularly white blood cells and platelets. The extent of toxicity is variable. It is recommended that the patient’s peripheral blood cell counts be monitored at least once every other week. Typically, platelets will be depressed by about 30% compared to preadministration levels. The nadir of platelet depression in most patients is found between 12 and 16 weeks following administration of Sr89. White blood cells are usually depressed to a varying extent compared to pre-administration levels. Thereafter, recovery occurs slowly, typically reaching pre-administration levels six months after treatment unless the patient’s disease or additional therapy intervenes. In considering repeat administration of Sr89, the patient’s hematologic response to the initial dose, current platelet level and other evidence of marrow depletion should be carefully evaluated. Verification of dose and patient identification is necessary prior to administration because Strontium-89 Chloride delivers a relatively high dose of radioactivity. Strontium-89 Chloride may cause fetal harm when administered to a pregnant woman. There are no adequate and well-controlled studies in pregnant women. If this drug is used during pregnancy, or if the patient becomes pregnant while receiving this drug, the patient should be apprised of the potential hazard to the fetus. Women of childbearing potential should be advised to avoid becoming pregnant.
Market Potential for Bone Cancer Pain Palliation is estimated at $60-$80 million
HOW IT WORKS
Generic Strontium Chloride Sr89 Injection USP (Strontium89) is a radioactive pharmaceutical injection to relieve bone pain in patients with painful skeletal metastases. In the body, Strontium acts similar to calcium and is preferentially taken up in osteoblastic tissue while the unabsorbed isotope is excreted in the urine the first 2 to 3 days following injection, clearing rapidly from the blood and selectively localizing in bone mineral. Uptake of strontium by bone occurs preferentially in sites of active osteogenesis, thus primary bone tumors and areas of metastatic involvement (blastic lesions) can accumulate significantly greater concentrations of strontium than surrounding normal bone.
Generic Strontium Chloride Sr89 Injection USP can be used in combination with opiate based drugs like Oxycotin®, Morphine, Percocet® as well as cancer therapeutic drugs. Clinical studies have demonstrated that the combination of alternating weekly chemohormonal therapies with Sr89 demonstrated a prolonged progression-free and overall survival with acceptable toxicity.
Generic Strontium89 injection is a pure beta emitter, and selectively irradiates sites of primary and metastatic bone involvement with minimal irradiation of soft tissues distant from bone lesions. The presence of bone metastases should be confirmed prior to therapy.
When blastic osseous metastases are present, significantly enhanced localization of the radiopharmaceutical will occur with corresponding higher doses to the metastases compared with normal bones and other organs. Although responses can vary, pain relief typically begins 7 to 20 days after injection and lasts for months.
Uptake of strontium by bone occurs preferentially in sites of active osteogenesis, thus primary bone tumors and areas of metastatic involvement (blastic lesions) can accumulate significantly greater concentrations of strontium than surrounding normal bone.
Treatment Comparative Analysis
Pain Relief Studies
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