Gene/Protein Disease Symptom Drug Enzyme Compound
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Oral transmucosal fentanyl citrate (OTFC); Actiq) is a drug delivery formulation used for management of breakthrough cancer pain. Previous studies with open-label comparisons indicated OTFC was more effective than patients' usual opioid for breakthrough pain. The objective of this study was to compare OTFC and morphine sulfate immediate release (MSIR) for management of breakthrough pain in patients receiving a fixed scheduled opioid regimen. This double-blind, double-dummy, randomized, multiple crossover study was conducted at 19 US university- and community-based hospitals and clinics and comprised 134 adult ambulatory cancer patients. Patients were receiving a fixed scheduled opioid regimen equivalent to 60-1000 mg/day oral morphine or 50-300 microg/h transdermal fentanyl, were using a 'successful' MSIR dose (15-60 mg) as defined by entry criteria, and were experiencing 1-4 episodes of breakthrough pain per day. In open-label fashion, OTFC was titrated such that a single unit (200-1600 microg) provided adequate pain relief with acceptable side effects. Successfully titrated patients entered the double-blind phase of the study and received ten prenumbered sets of randomized capsules and oral transmucosal units. Five sets were the successful OTFC dose paired with placebo capsules, and five sets were placebo OTFC paired with capsules containing the successful MSIR dose. Patients took one set of study medication for each episode of target breakthrough pain. Pain intensity (PI), pain relief (PR) and global performance of medication (GP) scores were recorded. Pain intensity differences (PID) were calculated and 15-min PID was the primary efficacy variable. Adverse events were recorded. Sixty-nine percent of patients (93/134) found a successful dose of OTFC. OTFC yielded outcomes (PI, PID, and PR) at all time points that were significantly better than MSIR. GP also favored OTFC and more patients opted to continue with OTFC than MSIR following the study. Somnolence, nausea, constipation, and dizziness were the most common drug-associated side effects. In conclusion, OTFC was more effective than MSIR in treating breakthrough cancer pain.
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PMID:Breakthrough cancer pain: a randomized trial comparing oral transmucosal fentanyl citrate (OTFC) and morphine sulfate immediate release (MSIR). 1124 84

The symptoms and severity of anemia depend on various factors, including the degree of anemia, the rapidity of its onset, and the age and physiologic status of the patient. Although the human body tries to counterbalance the effects of anemia by various mechanisms, almost every organ system of the human body is eventually affected. The symptoms experienced by patients vary from cold skin, dizziness, and palpitations to pulmonary edema, heart failure, depression, and severe impairment of cognitive function. Anemia substantially impacts patients' quality of life, a fact that has been shown in several clinical trials in patients with renal disease as well as in patients suffering from various malignancies undergoing chemotherapy. These studies evaluated the administration of recombinant human erythropoietin (r-HuEPO, epoetin alfa) to anemic patients, and it was shown that raising hemoglobin levels with epoetin alfa ameliorated the symptoms of anemia and significantly improved the functional status and overall quality of life in cancer patients. Furthermore, preliminary data indicate that the correction of anemia in cancer patients may in addition improve treatment efficacy and possibly overall survival.
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PMID:Symptomatology of anemia. 1139 46

Hypercalcemia is a well-known manifestation of paraneoplastic syndromes associated with a variety of malignancies. However, colon cancer has only rarely been associated with hypercalcemia of malignancy. We present the case of a patient with recurrent adenosquamous carcinoma of the ascending colon found to have hypercalcemia. The patient is a 76-year-old white woman who initially presented with colon cancer in the cecum and underwent a right hemicolectomy. All lymph nodes and surgical margins were free of tumor. Pathological examination at that time revealed adenosquamous carcinoma of the colon. Eight months later she complained of dizziness, anorexia, and constipation and was found to have a calcium level of 13.6 mg/dL. CT scan revealed a mass measuring 10.5 to 12.7 cm in the right hepatic lobe, and a bone scan was normal. Her intact parathyroid hormone (PTH) level was 6 pg/mL (normal 12-72) and her PTH-related protein (PTHrP) level was 25.7 pmol/L (normal <1.3). She then underwent a hepatic resection. The serum PTH, calcium, and PTHrP levels normalized after resection. Hypercalcemia of malignancy in colon cancer is rare and has an association with adenosquamous histology. The hypercalcemia is attributed to PTHrP, and here we demonstrate this in the serum and tumor specimens. The effects of PTHrP are shown to be short-lived postoperatively. We find only 14 other cases in the literature of hypercalcemia related to a colonic neoplasm, and this is the only patient reported to be surviving. The diagnosis of a paraneoplastic syndrome mediated via PTHrP should be considered when hypercalcemia is encountered in the setting of metastatic colon carcinoma.
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PMID:Paraneoplastic hypercalcemia in a patient with adenosquamous cancer of the colon. 1140 9

This open-label study evaluated the long-term safety and tolerability of oral transmucosal fentanyl citrate (OTFC) in ambulatory cancer patients with breakthrough pain undergoing cancer care at 32 university- or community-based practices. Patients had participated in a previous short-term titration trial of OTFC, were experiencing at least one episode per day of breakthrough pain, and had achieved relief of their breakthrough pain with an opioid. Patients received OTFC units at a starting dosage strength determined in the short-term trial (200-1600 microg). Outcome measures included number of successfully treated breakthrough pains, global satisfaction rating (0 = poor through 4 = excellent), and side effects. In total, 41,766 units of OTFC were used to treat 38,595 episodes of breakthrough pain in 155 patients. Number of treatment days ranged from 1 to 423 (mean, 91 days). Patients averaged 2.9 breakthrough pain episodes per day. About 92% of episodes were successfully treated with OTFC and there was no trend toward decreased effectiveness over time. Most patients (61%) did not require dose escalation during treatment. Global satisfaction ratings were consistently above 3, indicating very good to excellent relief. Common adverse events associated with OTFC were somnolence (9%), constipation (8%), nausea (8%), dizziness (8%), and vomiting (5%). Six patients (4%) discontinued therapy due to an OTFC-related adverse event. There were no reports of abuse and no concerns about the safety of the drug raised by patients or families. OTFC was used safely and effectively during long-term treatment of breakthrough pain in cancer patients at home.
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PMID:Long-term safety of oral transmucosal fentanyl citrate for breakthrough cancer pain. 1151 99

Anaemia occurs in a significant number of patients with cancer, and is associated with symptoms of fatigue, dizziness, headache and decreased health-related quality of life. Clinical trials have demonstrated the ability of epoetin alfa to increase haemoglobin concentrations and reduce transfusion requirements in patients with cancer. Data from three large, open-label, community-based trials of >7000 patients, as well as a series of smaller, randomized, placebo-controlled studies, have confirmed the efficacy of treatment with epoetin alfa in patients undergoing chemotherapy. In two of the community-based studies (>2000 patients in each), patients undergoing chemotherapy received epoetin alfa, 150-300 IU/kg or 10,000-20,000 IU, three times weekly. Significant (P<0.01) increases in haemoglobin concentrations and reductions in transfusion rates were seen in both studies. Significant improvements in quality of life were also reported, as measured by the Linear Analogue Scale Assessment and the Functional Assessment of Cancer Therapy-Anaemia. Importantly, the increases in quality of life were independent of tumour response. These findings were also observed in randomized, placebo-controlled studies. The third study, in approximately 3000 patients, evaluated the efficacy of once-weekly dosing, which significantly (P<0.01) increased haemoglobin concentrations, reduced transfusion requirements and improved quality of life. Greater increases in haemoglobin concentration were associated with greater improvements in quality-of-life scores. The safety and efficacy profile of the once-weekly regimen was comparable with that of the three times weekly regimen. Maintaining optimal quality of life, while achieving tumour stabilization or regression, is essential to the successful management of patients with cancer. Epoetin alfa has been shown to increase haemoglobin concentration, decrease transfusion requirements and increase quality of life. Given the frequency of adverse sequelae associated with anaemia, its aggressive management should become an integral and routine part of cancer treatment.
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PMID:Managing cancer-related anaemia with epoetin alfa. 1181 17

Anemia is a common complication in patients with hematologic malignancies, and is caused by a variety of mechanisms, including neoplastic cell infiltration into the bone marrow, hemolysis, nutritional deficiencies, and defects in erythropoiesis as a result of the disease itself or cytotoxic therapy. The anemia associated with multiple myeloma is caused by inadequate erythropoietin levels consequent to renal impairment and the effect of inflammatory cytokines. The degree of anemia can have prognostic importance, as is the case with multiple myeloma, or be a significant indicator of disease stage, as noted with chronic lymphocytic leukemia. Anemia results in fatigue, exhaustion, dizziness, headache, dyspnea, and decreased motivation, seriously affecting a patient's quality of life. Since anemia is so prevalent in hematologic malignancy patients, its treatment must be an integral part of disease management, to improve quality of life and to possibly increase potential survival. Clinical studies have shown that effectively treating anemia and increasing hemoglobin levels using recombinant human erythropoietin (rHuEPO, epoetin alfa) has a significant effect on transfusion requirements and quality of life.
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PMID:The effects of anemia in hematologic malignancies: more than a symptom. 1208 53

Primary choriocarcinoma of the stomach is an extremely rare and highly malignant tumor. A 68-year-old Japanese man was admitted to our department with symptoms of epigastric pain, abdominal fullness, and dizziness. Primary gastric choriocarcinoma with regional lymph node metastases was diagnosed preoperatively by the detection of elevated serum levels of a tumor marker, radiography, and immunohistochemical staining of biopsy specimens. The patient underwent total gastrectomy and jejunal reconstruction (Roux-en-Y method), followed by chemotherapy. Histological examination of the resected stomach revealed typical choriocarcinoma accompanied by common adenocarcinomatous elements. After postoperative chemotherapy the patient survived for 4 years and 6 months, and died with no evidence of recurrence of carcinoma. This is the first known patient with primary gastric choriocarcinoma to have survived for such a long period without recurrent elevation of the serum level of human chorionic gonadotropin (HCG), which was a useful marker when reevaluating the patient.
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PMID:A patient with primary gastric choriocarcinoma who received a correct preoperative diagnosis and achieved prolonged survival. 1211 88

The use of depo-medroxyprogesterone acetate (DMPA), or Depo Provera, has been debated for the 20 years since it became available in 1967. The US Food and Drug Administration (FDA) refused to approve Depo Provera on the basis that it caused breast tumors in a controlled study of Beagle dogs and Rhesus monkeys conducted by Upjohn, the manufacturer. Depo Provera has been approved in over 60 other countries and is in use in 30 or 40 others with an estimated total of almost 5 million users. A natural hormone, progesterone, DMPA is injected intramuscularly and absorbed slowly. Common dosage is 150 mg every 3 months and usually is administered during the 1st week of the menstrual cycle. The pregnancy rate with Depo Provera is .44 pregnancies/100 women years for women receiving 100 mg every 3 months. No pregnancies were recorded in recent studies for women receiving 150 mg. Possible side effects include amenorrhea, weight gain, dizziness and headaches. The median time for contraception after the presumed duration of one's last injection is 5-1/2 months. Some countries only permit women who already have 1 child to use Depo Provera. The FDA in the US approves the use of Depo Provera for treatment of endometrial and renal cancer but accuses it of causing cancer in Beagles and Rhesus monkeys. The studies were conducted over 7 and 10-year periods, respectively, with extremely negative results including the death of 3 dogs due to "drug-induced diabetes," atrophication of adrenal glands, and malignant tumors. There were similar results for the monkey study. In the UK, the Committee for Safety in Medicine supports Upjohn's view that Beagles are unsuitable for comparison testing because "all dogs are acutely sensitive to progesterone." Groups such as the National Women's Health Network, the institute for Food and Development Policy, and "Mother Jones" have used the media to generate opposition to Depo Provera, citing a double standard for rich and poor women, developed and less developed countries. The proponents of Depo Provera criticize health activists for imposing their own standards on women in developing countries. Regarding concerns about greater risk of Acquired Immune Deficiency Syndrome (AIDS), Depo Provera can be injected with disposable needles. In response to the controversy, Upjohn withdrew its application to the FDA in September 1986 but intends to resubmit with new information from a World Health Organization report, which showed no evidence of an increased risk of cancers of the endometrium, liver, or breast.
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PMID:Depo Provera: still controversial. 1217 73

(1) Some cancer patients suffer occasional breakthrough pain despite well-conducted opiate treatment, warranting the use of immediate-release oral morphine. (2) A fentanyl preparation for oral transmucosal administration has just been granted this indication in France. (3) The evaluation file mainly contains results from a randomised double-blind cross-over trial comparing transmucosal fentanyl with oral morphine tablets in cancer patients. It showed a small gain in terms of rapidity and efficacy of pain relief with fentanyl relative to morphine, but this was of dubious clinical relevance. (4) The adverse effects of oral transmucosal fentanyl are those of all opiates, such as drowsiness, dizziness, nausea, vomiting and confusion. (5) The oral transmucosal fentanyl preparation has the taste and appearance of a lollipop, and may therefore be attractive to children. The packaging seems to take this risk into account, but precautions must be taken to keep this treatment away from children, especially after opening. (6) Immediate-release oral morphine remains the standard treatment for breakthrough pain in patients receiving opiate therapy. If it is inadequate, oral transmucosal fentanyl may sometimes be slightly better.
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PMID:Oral transmucosal fentanyl: new preparation. For breakthrough cancer pain when morphine fails. 1219 62

Highly effective medicinal herbs are being used successfully in China to treat malaria, for example, using Ching Hao Su, an extract from wormwood. There are 5000 varieties of medicinal herbs cataloged, some more effective than western drugs. China's barefoot doctors investigate diseases and collect effective drugs, one of which is Muching which has been highly effective in treating chronic bronchitis. Salvia miltiorrhiza, used in ancient times to activate blood circulation, is used to treat coronary artery diseases and has proved effective in 87% of angina pectoris cases. Medicinal herbs are used to treat burns, hypertension, and cancer and, although the herbs are readily available and inexpensive, they work slowly. Using medicinal herbs, a Shansi Medical College affiliated hospital successfully treated over 800 cases of extra-uterine pregnancy and, in 90% of the cases, no surgery was performed. Treatment showed medicinal herbs checked bleeding, improved circulation, and eradicated blood clots. Research is being conducted with herbal prescriptions to find safer, more effective and convenient contraceptives for men and women. A breakthrough for the Institute of Medicine of the Chinese Academy of Medicine Sciences was seen in the successful cultivation of gastrodia elata which has been used for 2000 years to treat dizziness, headaches, and infantile coma.
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PMID:China: a new medicine born of tradition. 1230 32


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