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FDA has approved medroxyprogesterone acetate as Depo Provera Contraceptive Injection, effective for 3 months in preventing pregnancy in women. In clinical studies, the drug's failure rate was less than 1%. However, physicians must ensure that patients receive injections on schedule to prevent pregnancy. The recommended dose is 150 mg administered every 3 months by deep, intramuscular injection in the gluteal or deltoid muscle. Most women in clinical studies of Depo Provera experienced menstrual irregularities. As use continued, amenorrhea became common, reported by 57% of the women by the end of a year of treatment. Other side effects included weight gain, headache, nervousness, abdominal pain or discomfort, dizziness, and asthenia. Physicians should administer the drug only to women found not to be pregnant, because fetal exposure may lead to low birth weight and other problems. Recent data have demonstrated that longterm use may contribute to osteoporosis, and the drug's manufacturer, the Upjohn Company of Kalamazoo, Michigan, will conduct additional research to study this possible side effect. Contraindications are similar to those for other contraceptives and include undiagnosed vaginal bleeding, known or suspected malignancy of breast, thromboembolic disorders, cerebral vascular disease, and liver dysfunction. Depo Provera was developed in the 1960s and has been approved for contraception in many other countries. When FDA first reviewed data on the drug in the 1970s, animal studies raised questions about its potential to cause breast cancer. Since then, longterm controlled clinical studies in other countries have shown a risk of breast cancer comparable to oral contraceptives, and no increased risk for ovarian, liver, or cervical cancer. The studies also showed that the contraceptive injection reduced the risk of endometrial cancer. FDA approved the drug October 29, 1992.
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PMID:3-month contraceptive injection approved. 1231 15

The Norplant System of levonorgestrel implants and the Depo Provera contraceptive Injection of sterile medroxy progesterone acetate suspension (DMPA) are longterm, progestagen-based contraceptive delivery systems designed to overcome noncompliance which are under review for use in Canada. 150 mg of DMPA, a pregnane compound derived from progesterone, is injected every 3 months. Peak plasma concentrations are reached in 24 hours and plateau for 3-4 months before gradually declining. After termination, ovulation returns on average in 4.5 months, and conception occurs at a median time of 10 months. 90% conceive by 24 months. In the Norplant system, a steady daily supply of 50-80 mcg of levonorgestrel, a gonane progestin derived from the testosterone nucleus which has both progestogenic and androgenic receptor affinity, diffuses from 5 Silastic implants, which must be replaced every 5 years. Ovulation and fertility return rapidly after rod removal. The actual and lowest expected failure rates are equal for both systems. The failure rate for DMPA is .3 pregnancies per 100 women years, while that for levonorgestrel is .4% in 1 year. Although neither method affects blood pressure, DMPA appears to affect carbohydrate metabolism by impairing glucose tolerance and increasing insulin production. Lipid metabolism is also affected. 5% of those who use levonorgestrel discontinue it because of side effects, including headache, mastodynia, and acne; 19.1% of DMPA users did so, especially for weight gain and menstrual cycle abnormalities. Both methods have a higher frequency of menstrual abnormalities than normal. 27.7% of levonorgestrel users experienced prolonged bleeding, while 17% experienced spotting during the first 6 months. However, normal menses usually returned within a year, and only 7.9% discontinued use because of cycle abnormalities. In 1 study, less than 10% of DMPA users experienced normal cycles, and in another study 35% experienced amenorrhea (500/700 discontinued use). Amenorrhea replaced irregular bleeding with continued use, occurring in 68% of users by 2 years. There is also some concern about DMPA and breast cancer and bone loss. Based on 1 case-control study of 110 women with breast cancer who had taken DMPA, the relative risk is highest for those between ages 25 and 34 who use DMPA longer than 6 years. A WHO study concluded that the relative risk of developing breast cancer, because of DMPA, is inversely related to duration of use. A Phase IV study on DMPA and bone mineral density has been undertaken.
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PMID:A comparison of levonorgestrel implants with depo-medroxyprogesterone acetate injections for contraception. 1231 30

Depot medroxyprogesterone acetate (DMPA, Depo-Provera) is used for contraception by 8-9 million women in more than 90 countries, including the US, as of January 1993. Pharmacologically active levels of DMPA persist for 3-4 months following injection. A 150 mg dose is used most often for high contraceptive efficacy every 3 months. Norethindrone enanthate (NET-EN, Noristerat) is somewhat less widely used and is not marketed in the US. Injectables act primarily by inhibiting ovulation, lowering the levels of follicle-stimulating hormone and luteinizing hormone. Approximately 50% of women using DMPA for 1 year report amenorrhea whose occurrence is less frequent with NET-EN. Menstrual changes are the most frequent causes of discontinuation of injectables. In cases of heavy bleeding it is appropriate to undergo gynecological examination to rule out unrelated conditions, such as vaginitis, cervicitis, or cervical lesions. The use of conjugated estrogen (12.5-2.5 mg daily) for 10-21 days will minimize bleeding. Some women using injectables experience headache, dizziness, bloating of the abdomen or breast, and mood changes. Long-term use of DMPA or NET-EN can often result in 1-3 kg weight gain. The WHO Collaborative Study of Neoplasia and Steroid Contraceptives was launched in 1979 to examine cancer risks with the use of DMPA in Thailand, Mexico, and Kenya. The relative risk of breast cancer was 1.21, which was statistically not significant. In women diagnosed with breast cancer under age 35, short-term exposure to DMPA was associated with a slightly increased breast cancer risk, which, however, was not associated with duration of use. DMPA dramatically lowers the risk of endometrial cancer for at least eight years following discontinuation of its use. DMPA did not alter the risk of cervical cancer. Fertility returns in 70% of former users within 12 months; it is suitable for postpartum and lactating women, and provides other noncontraceptive benefits.
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PMID:Injectable contraception: the USA perspective. 1234 20

Patients with hormone-sensitive breast cancer who have responded to tamoxifen may receive additional benefit from a second endocrine agent following progression or relapse after tamoxifen therapy. Fulvestrant (Faslodex((R)), ICI 182780, AstraZeneca Pharmaceuticals; Wilmington, Delaware) is a selective antagonist of estrogen designed to have no estrogenic effects. Lack of aqueous solubility led to the development of a parenteral formulation for monthly intramuscular administration. Fulvestrant has been shown to inhibit the proliferative effects of estrogen on sensitive tissues in vitro and in vivo, and is without apparent measurable estrogenic activity. The data upon which marketing approval for fulvestrant was based are summarized below. Eight hundred fifty-one postmenopausal women with advanced breast cancer were enrolled in two phase III studies, 400 in a North American double-blind study and 451 in a European open-label study, comparing the efficacy and safety of fulvestrant with anastrozole. Four hundred twenty-eight patients were randomized to receive fulvestrant 250 mg monthly by intramuscular injection and 423 patients were to receive anastrozole 1 mg daily. Patients were considered hormone sensitive either by receptor status or previous response to endocrine therapy. Over 96% of patients had previously received tamoxifen, either in the adjuvant setting or as treatment for metastatic disease. The primary study end points were response rate and time to progression. Response rates for patients treated with fulvestrant were 17% and 20% in the North American and European trials, respectively, compared with 17% and 15% in the anastrozole treatment arms. There were no statistically significant differences in response rates, time to progression, or survival between treatment arms in either study. The most common adverse events attributed to the treatment (>10%) were injection-site reactions and hot flashes. Common events (1%-10%) included asthenia, headache, and gastrointestinal disturbances (nausea, vomiting, and diarrhea), as well as rash and urinary tract infections. A small increase in joint disorders was reported in the anastrozole-treated patients. On April 25, 2002, fulvestrant 250 mg by monthly intramuscular injection was approved by the U.S. Food and Drug Administration for the treatment of hormone receptor-positive metastatic breast cancer in postmenopausal women with disease progression following antiestrogen therapy. Approval was based on similarity of response rates and time to progression between fulvestrant and anastrozole.
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PMID:FDA drug approval summaries: fulvestrant. 1249 Jul 35

Due to the long-term health risks now associated with hormone replacement therapy, many menopausal women are actively seeking alternative treatments. One such alternative is black cohosh (Actaea racemosa, syn. Cimicifuga racemosa), which has been used in the United States for the treatment of gynecologic complaints for more than 100 years. Review of the published clinical data suggests that black cohosh may be useful for the treatment of menopausal symptoms, such as hot flashes, profuse sweating, insomnia, and anxiety. Results from the most recently published trial, however, indicate that black cohosh is not effective for the treatment of menopausal symptoms in breast cancer survivors being treated with tamoxifen. Because the overall quality of the published clinical trials is low, two new randomized, double-blind, placebo-controlled clinical trials are currently underway in the United States. To date, only one standardized black cohosh extract has been tested clinically; the current recommended dose is 40-80 mg per day. At least 4-12 weeks of treatment may be required before any therapeutic benefits may be apparent. Adverse reactions such as nausea, vomiting, headaches, dizziness, mastalgia, and weight gain have been observed in clinical trials. No drug interactions are reported in the medical literature. The estrogenic effects of black cohosh are controversial, and the more recent data indicate that black cohosh extracts may have an anti-estrogenic activity. Owing to potential effects on sex hormones, however, black cohosh should not be administered to children or during pregnancy and lactation.
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PMID:Black cohosh: an alternative therapy for menopause? 1255 11

Coagulation disorders are common in cancer patients. In patients with solid tumors, a low-grade activated coagulation can result in systemic and cerebral arterial or venous thrombosis. Cancer treatments may also contribute to this coagulopathy, which usually, but not exclusively, occurs in the setting of advanced malignant disease. There may be TIAs or cerebral infarctions. Because of the widespread distribution of cerebral thromboses, there may be a superimposed encephalopathy; sometimes this is the only sign. Concurrent systemic thrombosis is present in many patients and is a useful clue to the diagnosis. In cerebral venous occlusion, the initial symptom is usually a headache. Except for cerebral intravascular coagulation that is unassociated with NBTE, neuriomaging studies usually demonstrate one or more parenchymal infarctions. MRI or MRV may demonstrate venous thrombosis. The laboratory evidence of coagulopathy is difficult to distinguish from the asymptomatic coagulopathy that often accompanies advanced cancer, and the test results must be interpreted cautiously. NBTE can be diagnosed by transesophageal echocardiography. There is no established treatment for the thrombotic coagulopathy associated with cancer, but anticoagulation should be considered. In leukemia and lymphoma, the coagulopathy is typically acute DIC that can lead to systemic and brain hemorrhages. It is especially common in acute myelogenous leukemias. The clinical signs of cerebral hemorrhage are fulminant and may be fatal. The bleeding usually occurs in the brain or subdural compartment, and rarely in the subarachnoid space. The diagnosis can be suspected by the clinical setting and by systemic thrombosis or hemorrhage. It can be established by examination of the peripheral smear, the platelet count, and tests of coagulation function. Therapy of acute DIC is controversial and should be individualized for the clinical setting. Cerebrovascular disorders can complicate metastatic or primary tumor in the brain, skull, dura, or leptomeninges. The clinical signs of infarction are indistinguishable from other causes of stroke, except that tumor-related venous occlusion will usually first produce signs of increased intracranial pressure. The diagnosis of tumor-related infarction can usually be established by neuroimaging studies that show infarction and may show extracerebral sites of tumor. CSF examination is useful in diagnosing leptomeningeal metastasis. A search for lung or cardiac tumor should be performed when embolic tumor infarction is suspected. Primary or metastatic tumors in the brain or dura may hemorrhage, producing the initial clinical signs of the brain tumor or a change in chronic signs induced by the tumor. There are helpful clues to a neoplastic hemorrhage on brain CT or MRI scans. The brain hemorrhage may require evacuation and the underlying tumor will usually require additional antineoplastic treatment. Hyperleukocytosis (extreme elevation of the cell count) in acute myelogenous leukemia is a less common cause of brain hemorrhage in recent years because of improved methods to lower the cell count. Cerebral arterial or venous thrombosis is sometimes the result of cancer therapy. The attribution of thrombosis to chemotherapy in many published cases is only speculative, because carefully conducted prospective studies that include investigation for other thrombotic causes are not available. The best-known associations with thrombosis are L-asparaginase, which is typically used in the induction therapy of acute lymphocytic leukemia, and combination hormonal therapy and chemotherapy for breast cancer. Radiation to the head and neck, typically administered for head and neck epithelial cancers or lymphoma, may result in delayed carotid atherosclerosis. The distribution of stenosis or occlusion is within the radiation portal and is typically more extensive than is atherosclerosis that develops in the absence of radiation. Small clinical series suggest that surgical treatment is equally effective as in nonirradiated carotid atherosclerosis. In children, the cerebral vessels can be affected by brain radiation resulting in stenosis or occlusion. Brain hemorrhages can result from chemotherapy effects on the hemostatic system or a microangiopathic anemia. Hemorrhages from radiation-induced vascular abnormalities are rare. Opportunistic infections, especially fungal infections, can complicate cancer or its treatment. Septic cerebral emboli may result in focal cerebral signs, seizures, or encephalopathy. Sometimes there is an associated hemorrhagic vasculitis or cerebritis. Rarely, mycotic aneurysms may bleed. A high index of suspicion is needed to diagnose fungal infection because of the difficulty in culturing the organism from the blood or CSF. A clinician can usually establish the cause of stroke in the cancer patient by performing a careful review of the clinical setting--including the type and extent of cancer and the type of antineoplastic therapy--in which the stroke occurred. Systemic thrombosis, embolism, or hemorrhage can be a clue to the cause, and appropriate neuroimaging and coagulation studies to aid in the diagnosis are available. Therapy may ameliorate symptoms or prevent further episodes. The identification of one of these unusual stroke syndromes that leads to the diagnosis of an occult and treatable cancer can be particularly rewarding.
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PMID:Cerebrovascular complications in cancer patients. 1269 Jun 49

We report a case of a severe infusion reaction caused by trastuzumab. A 59-year-old woman with metastatic breast cancer was treated with trastuzumab. During the first infusion, initial symptoms such as severe headache and general fatigue developed. Blood pressure fell 90 minutes after these initial symptoms. A collapsed lung was demonstrated by chest X-ray and computed tomography. Steroid therapy was successfully used for these reactions. Careful monitoring of vital signs, examination of the respiratory system, and the use of steroids are recommended for severe infusion reaction.
Breast Cancer 2003
PMID:Severe infusion reaction induced by trastuzumab: a case report. 1273 72

We report a case of a 44-year-old woman with metastatic brain tumors who suffered peri-tumoral hemorrhage soon after stereotactic radiosurgery (SRS). She had been suffering from breast cancer with multiple systemic metastasis. She started to have headache, nausea, dizziness and speech disturbance 1 month before admission. There was no bleeding tendency in the hematological examination and the patient was normotensive. Neurological examination disclosed headache and slightly aphasia. Magnetic resonance imaging showed a large round mass lesion in the left temporal lobe. It was a well-demarcated, highly enhanced mass, 45 mm in diameter. SRS was performed on four lesions in a single session (Main mass: maximum dose was 30 Gy in the center and 20 Gy in the margin of the tumor. Others: maximum 25 Gy margin 20 Gy). After radiosurgery, she had severe headache, nausea and vomiting and showed progression of aphasia. CT scan revealed a peritumoral hemorrhage. Conservative therapy was undertaken and the patient's symptoms improved. After 7 days, she was discharged, able to walk. The patient died of extensive distant metastasis 5 months after SRS. Acute transient swelling following conventional radiotherapy is a well-documented phenomenon. However, the present case indicates that such an occurrence is also possible in SRS. We have hypothesized that acute reactions such as brain swelling occur due to breakdown of the fragile vessels of the tumor or surrounding tissue.
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PMID:[Peritumoral hemorrhage immediately after radiosurgery for metastatic brain tumor]. 1296 95

A 42-year-old woman with locally advanced breast cancer developed headache just after completing adjuvant chemotherapy. Magnetic resonance imaging revealed a mass located in the left subthalamic nucleus (STN) and involving the posterior part of the thalamus and the hypothalamus. The patient refused a radiologically guided biopsy and gamma knife treatment was not financially possible. Palliative whole brain radiotherapy with hormonal therapy was administered. The patient gained 19 kg body weight during 4 months follow up because of hyperphagia. This solitary tumor, either a breast cancer metastasis or a primary tumor, involving the STN is extremely unusual.
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PMID:Subthalamic nucleus tumor causing hyperphagia--case report. 1456 Aug 52

A case of a 66-year-old woman with anterior-3(rd) falx metastasis from mammary carcinoma is reported. Radiological and therapeutic aspects are reported. The clinical presentation was headache and confusion together with gait disturbance. MRI showed a frontobasal mass with dural attachment suggestive of meningioma. Surgical resection was decided. Histology confirmed the diagnosis of breast cancer dural metastasis. Dural metastases are not frequent. Two radiological aspects are described: subdural hemorrhage and dural mass. No definitive theory exists about etiopathogenesis. As radiological findings are not specific, we emphasize the importance of suspecting dural metastasis in patients with tumor mass involving dura mater.
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PMID:Dural metastasis mimicking falx meningioma. Case report. 1461 30


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