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Biomedical subjects

J Simeone

Publications and source records attributed to J Simeone.

14 recordsLinked to original sources
PubMed2000

Pamidronate prevents skeletal complications and is effective palliative treatment in women with breast carcinoma and osteolytic bone metastases: long term follow-up of two randomized, placebo-controlled trials.

BACKGROUND: Pamidronate therapy previously has been shown to reduce skeletal complications effectively for up to 12 months in breast carcinoma patients with bone metastases. The current study data provide further follow-up results regarding the effects of long term (up to 24 months) pamidronate treatment in women with breast carcinoma and osteolytic metastases. METHODS: Follow-up results from two prospective, multicenter, randomized, double-blind, placebo-controlled intervention trials conducted at academic and community oncology centers were combined to provide a large data set with which to evaluate the long term efficacy and safety of pamidronate therapy. Seven hundred fifty-four women with Stage IV breast carcinoma and osteolytic metastases were randomized to the 2 treatment arms of the trial. Three patients were excluded from the intent-to-treat population for the analysis. A total of 751 evaluable patients were randomized to receive either a 90-mg intravenous pamidronate infusion (367 patients) or a placebo infusion (384 patients) every 3-4 weeks. The primary outcome measures were skeletal morbidity rate (events/year), proportion of patients developing a skeletal complication, and time to first skeletal complication. RESULTS: Of the 367 women receiving pamidronate, 115 (31.3%) completed the trial and 81 (22.1%) discontinued the study due to adverse events. Of the 384 women who received placebo, 100 (26.0%) completed the study and 76 (19.8%) discontinued the study due to adverse events. The skeletal morbidity rate was 2.4 in the pamidronate group and 3.7 in the placebo group (P < 0.001). In the pamidronate group, 186 of the 367 patients (51%) had skeletal complications compared with 246 of the 384 patients in the placebo group (64%) (P < 0.001). The median time to first skeletal complication was 12.7 months in the pamidronate group and 7 months in the placebo group (P < 0.001). Six patients treated with pamidronate discontinued treatment due to drug-related adverse events. Pain and analgesic scores were significantly worse in the placebo group compared with those patients in the pamidronate group. CONCLUSIONS: In the current study, monthly infusions of 90 mg of pamidronate as a supplement to antineoplastic therapy were found to be well tolerated and superior to antineoplastic therapy alone in preventing skeletal complications and palliating symptoms for at least 24 months in breast carcinoma patients with osteolytic bone metastases.

Aged↗
PubMed1999

Pamidronate reduces skeletal morbidity in women with advanced breast cancer and lytic bone lesions: a randomized, placebo-controlled trial. Protocol 18 Aredia Breast Cancer Study Group.

PURPOSE: To assess whether pamidronate can reduce the frequency of skeletal morbidity in women with lytic bone metastases from breast cancer treated with hormone therapy. PATIENTS AND METHODS: Three hundred seventy-two women with breast cancer who had at least one lytic bone lesion and who were receiving hormonal therapy were randomized to receive 90 mg of pamidronate or placebo as a 2-hour intravenous infusion given in double-blind fashion every 4 weeks for 24 cycles. Patients were evaluated for skeletal complications: pathologic fractures, spinal cord compression, irradiation of or surgery on bone, or hypercalcemia. The skeletal morbidity rate (the ratio of the number of skeletal complications to the time on trial) was the primary efficacy variable. Bone pain, use of analgesics, quality of life, performance status, bone tumor response, and biochemical parameters were also evaluated. RESULTS: One hundred eighty-two patients who received pamidronate and 189 who received placebo were assessable. The skeletal morbidity rate was significantly reduced at 12, 18, and 24 cycles in patients treated with 90 mg of pamidronate (P = .028, .023, and .008, respectively). At 24 cycles, the proportion of patients having had any skeletal complication was 56% in the pamidronate group and 67% in the placebo group (P = .027). The time to the first skeletal complication was longer for patients receiving pamidronate than for those given placebo (P = .049). There was no statistical difference in survival or in objective bone response rate. Pamidronate was well tolerated. CONCLUSION: Treatment with 90 mg of pamidronate as a 2-hour intravenous infusion every 4 weeks in addition to hormonal therapy significantly reduces skeletal morbidity from osteolytic metastases.

Adolescent↗
PubMed1996

Efficacy of pamidronate in reducing skeletal events in patients with advanced multiple myeloma. Myeloma Aredia Study Group.

BACKGROUND: Skeletal complications are a major clinical manifestation of multiple myeloma. These complications are caused by soluble factors that stimulate osteoclasts to resorb bone. Bisphosphonates such as pamidronate inhibit osteoclastic activity and reduce bone resorption. METHODS: Patients with stage III multiple myeloma and at least one lytic lesion received either placebo or pamidronate (90 mg) as a four-hour intravenous infusion given every four weeks for nine cycles in addition to antimyeloma therapy. The patients were stratified according to whether they were receiving first-line (stratum 1) or second-line (stratum 2) antimyeloma chemotherapy at entry into the study. Skeletal events (pathologic fracture, irradiation of or surgery on bone, and spinal cord compression), hypercalcemia (symptoms or a serum calcium concentration > or = 12 mg per deciliter [3.0 mmol per liter]), bone pain, analgesic-drug use, performance status, and quality of life were assessed monthly. RESULTS: Among 392 treated patients, the efficacy of treatment could be evaluated in 196 who received pamidronate and 181 who received placebo. The proportion of patients who had any skeletal events was significantly lower in the pamidronate group (24 percent) than in the placebo group (41 percent, P < 0.001), and the reduction was evident in both stratum 1 (P = 0.04) and stratum 2 (P = 0.004). The patients who received pamidronate had significant decreases in bone pain and no deterioration in performance status and quality of life. Pamidronate was tolerated well. CONCLUSIONS: Monthly infusions of pamidronate provide significant protection against skeletal complications and improve the quality of life of patients with stage III multiple myeloma.

Aged↗
PubMed1990

Detection of hepatic metastases: comparison of contrast-enhanced CT, unenhanced MR imaging, and iron oxide-enhanced MR imaging.

Diagnostic accuracy of contrast-enhanced CT, unenhanced MR imaging, and MR images enhanced with superparamagnetic iron oxide was evaluated in 10 patients with histologically proved hepatic metastases. First, diagnostic performance of the imaging technique with respect to the ability of radiologists to recognize the presence or absence of a metastasis was measured by using receiver-operating-characteristic (ROC) analysis of single images. Second, the total number of lesions (N = 108) detected by "complete" CT and MR examinations was counted. Finally, lesion-liver contrast-to-noise ratios (CNR) were measured in all MR sequences. The area under the ROC curve was .67 +/- .03 for contrast-enhanced CT, .81 +/- .07 for the unenhanced SE 260/14 sequence, and .92 +/- .01 for the iron oxide-enhanced SE 1500/40 sequence. The enhanced SE 1500/40 sequence yielded significantly (p less than .005) greater accuracy than did contrast-enhanced CT. The same sequence detected significantly (p less than .05) more lesions than all other imaging techniques (19% more than the best unenhanced MR sequence and 36% more than contrast-enhanced CT). The enhanced SE 1500/40 sequence also yielded the highest CNR value (19.5 +/- 10.2) of all MR sequences. These results indicate that iron oxide-enhanced MR imaging is a superior imaging technique for the detection of hepatic lesions.

Adult↗
PubMed1987

Sigmoid diverticular abscesses: percutaneous drainage as an adjunct to surgical resection in 24 cases.

Twenty-four patients with acute sigmoid diverticulitis and associated pelvic fluid collections seen on computed tomographic scans underwent percutaneous catheter drainage as an adjunct to surgical therapy. Fourteen of the 24 underwent a single-stage surgical procedure within 10 days of drainage. Five patients required two-stage surgical procedures because localized inflammatory changes precluded a primary resection despite the absence of a residual abscess at surgery. Two of the three remaining patients initially had no surgery, but they had recrudescences of their symptoms that required surgical drainage within 8 months. One patient in whom surgical resection was deferred remained asymptomatic 10 months after percutaneous drainage. A retrospective review of 87 patients undergoing surgery for diverticulitis suggested that the percentage of two-stage surgical procedures has decreased in the last 5-10 years, but there remains a substantial number of patients who might benefit from percutaneous catheter drainage of diverticular abscess of the sigmoid colon.

Abscess↗
PubMed1985

Objective evaluation of ampullary stenosis with ultrasonography and pancreatic stimulation.

Ultrasonography can detect changes in pancreatic and bile duct sizes after pancreatic stimulation by secretin or morphine and prostigmine. The effects of the two pharmacologic regimens on pancreatic duct dilatation were comparable and correlated with papillary stenosis determined at surgery, but the morphine and prostigmine combination produced more false-positive responses than did secretin. After administration of intravenous secretin (1 unit/kg), the pancreatic duct dilated in 83 percent of 12 symptomatic patients found at surgery to have a stenotic sphincter of Oddi and in 72 percent of 17 symptomatic patients found to have a stenotic accessory papilla associated with the pancreas divisum anomaly. Comparable dilatation occurred in 14 percent of 14 control subjects without suspected ampullary disease and in none of 10 patients with surgically disproved stenosis (p less than 0.001). The morphine and prostigmine combination produced more false-positive results in both the pancreatic duct and bile duct. Concomitant elevation of the serum amylase level and reproduction of pain were found to be of no discriminatory value. In patients whose pancreatic duct dilated preoperatively during secretin stimulation, dilatation did not occur after surgical sphincteroplasty. A positive test result was associated with a 90 percent success rate in preventing recurrent pancreatitis and ameliorating pain. A negative test result was associated with a 29 percent success rate. Ultrasonography of the pancreatic duct with secretin stimulation may provide objective criteria to supplement clinical judgment in selecting patients for sphincteroplasty to treat stenosis of either the sphincter of Oddi or the accessory papilla in pancreas divisum.

Ampulla of Vater↗
PubMed1981

The apical cap.

Apical caps, either unilateral or bilateral, are a common feature of advancing age and are usually the result of subpleural scarring unassociated with other diseases. Pancoast (superior sulcus) tumors are a well recognized cause of unilateral asymmetric apical density. Other lesions arising in the lung, pleura, or extrapleural space may produce unilateral or bilateral apical caps. These include: (1) inflammatory: tuberculosis and extrapleural abscesses extending from the neck; (2) post radiation fibrosis after mantle therapy for Hodgkin disease or supraclavicular radiation in the treatment of breast carcinoma; (3) neoplasm: lymphoma extending from the neck or mediastinum, superior sulcus bronchogenic carcinoma, and metastases; (4) traumatic: extrapleural dissection of blood from a ruptured aorta, fractures of the ribs or spine, or hemorrhage due to subclavian line placement; (5) vascular: coarctation of the aorta with dilated collaterals over the apex, fistula between the subclavian artery and vein; and (6) miscellaneous: mediastinal lipomatosis with subcostal fat extending over the apices.

Adult↗
PubMed1980

Liquefactive necrosis of the pancreas: the pancreatic sac.

The authors describe an unusual form of pancreatic necrosis in which the excavated necrotic core is surrounded by a shell of tissue and forms a sac which generally conforms to the axis and contour of the pancreas. This debris-containing sac could be misinterpreted on ultrasound and CT and is best defined by direct injection into the pancreatic duct.

Adult↗
PubMed1979

A new computed tomographic sign of pancreatitis.

Computed body tomography has become useful in the diagnosis of pancreatic disease. Pancreatitis frequently results in lateral and posterior extension of inflammatory tissue into the pararenal fat planes, which can be visualized by CT. In our series it was associated with clinically diagnosed pancreatitis. Of 100 cases studied for abdominal pathology where pancreatic visualization was optimum, 10 had enlargement of the pancreas with destruction of soft tissue planes extending into the left pararenal space and clinical findings of pancreatitis. Carcinoma of the pancreas was identified in 12; no abnormality was identified in 49; the remaining cases were mixed intraabdominal and retroperitoneal pathology. The value of this sign lies in separating inflammatory processes from neoplastic disease; the sign was not found in normals.

Acute Disease↗
PubMed1978

Prospective comparison of ultrasound and computed tomography in the evaluation of gynecologic pelvic masses.

A prospective evaluation of computed tomography and ultrasound was performed on 24 consecutive patients with suspected pelvic masses. Of the 24 patients, 22 had subsequent surgical identification of abnormalities; two were considered normal on clinical follow-up. Ultrasound provided important clinical information in 17 of 24 patients; CT in 15 of 24 patients. There were three false negative examinations with each method and no false positives. Differentiation between benign and malignant disease could not be made in four of 24 patients by ultrasound and five of 24 patients by CT. Because both imaging techniques depict similar pathology and use similar diagnostic criteria, the two methods tend not to be complementary.

Diagnostic Errors↗
PubMed1976

Esophageal aperistalsis secondary to metastatic invasion of the myenteric plexus.

A case of aperistalsis of the esophagus secondary to isolated invasion of the myenteric plexus of Auerbach by metastatic carcinoma is presented. The unique pattern of tumor involvement and the resultant aperistalsis supports the contention that involvement of the neurons in the deep myenteric plexus, either by inflammation or tumor, may be the key factor in producing aperistalsis. No similar cases were found in the literature.

Aged↗
PubMedDate not supplied

Scintigraphy, ultrasound and CT scanning of the liver.

Isotope examination of the liver depends on the functional activity of the liver phagocytes, while ultrasound and CT scanning display the anatomical structure. Cold areas on an isotope scan may be due to impaired function or space-occupying lesions. The method is nonspecific and does not differentiate between cysts, abscesses and metastases. Both ultrasound and CT scanning can differentiate space-occupying lesions with a high degree of accuracy so that both techniques can be used to improve the accuracy and specificity of the radioisotope examination. CT scanning of the liver is limited by relatively slow data acquisition and the small differences in X-ray absorption within soft tissues unless contrast agents are used. In comparison, ultrasonic data are rapidly collected and displayed and liver consistency is imaged without contrast media or ionizing radiation. Diffuse abnormalities of the liver, such as cirrhosis, cannot be detected by CT scanning but are apparent on ultrasound examination. In addition, equipment purchase and maintenance costs for ultrasound are a fraction of those for CT scanning. Experience to date at Yale indicates that ultrasound and CT scanning are complementary and supplementary to isotope examination of the liver but that ultrasound in most patients produces better resolution and enhanced tissue differentiation at considerably less cost.

Ascites↗