5247 Elkhorn Blvd
Sacramento CA 95842
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Phase III randomized, intergroup trial assessing imatinib mesylate at two dose levels in patients with unresectable or metastatic gastrointestinal stromal tumors expressing the kit receptor tyrosine kinase: S0033. - Journal of clinical oncology : official journal of the American Society of Clinical Oncology
To assess potential differences in progression-free or overall survival when imatinib mesylate is administered to patients with incurable gastrointestinal stromal tumors (GIST) at a standard dose (400 mg daily) versus a high dose (400 mg twice daily).Patients with metastatic or surgically unresectable GIST were eligible for this phase III open-label clinical trial. At registration, patients were randomly assigned to either standard or high-dose imatinib, with close interval follow-up. If objective progression occurred by Response Evaluation Criteria in Solid Tumors, patients on the standard-dose arm could reregister to the trial and receive the high-dose imatinib regimen.Seven hundred forty-six patients with advanced GIST from 148 centers across the United States and Canada were enrolled onto this trial in 9 months. With a median follow-up of 4.5 years, median progression-free survival was 18 months for patients on the standard-dose arm, and 20 months for those receiving high-dose imatinib. Median overall survival was 55 and 51 months, respectively. There were no statistically significant differences in objective response rates, progression-free survival, or overall survival. After progression on standard-dose imatinib, 33% of patients who crossed over to the high-dose imatinib regimen achieved either an objective response or stable disease. There were more grade 3, 4, and 5 toxicities noted on the high-dose imatinib arm.This trial confirms the effectiveness of imatinib as primary systemic therapy for patients with incurable GIST but did not show any advantage to higher dose treatment. It appears reasonable to initiate therapy with 400 mg daily and to consider dose escalation on progression of disease.
Children's exposure to environmental tobacco smoke: using diverse exposure metrics to document ethnic/racial differences. - Environmental health perspectives
Four metrics were used to assess exposure to environmental tobacco smoke (ETS) for a probability sample (n = 152) of elementary school-age children in two economically disadvantaged neighborhoods: a) caregiver responses to a baseline questionnaire (BQ) about smoking status and behavior; b) 48-hr time-activity (T-A) data on location and time spent by children in the presence of tobacco smoke; c) total urinary cotinine as a marker for nicotine uptake; and d) urinary NNAL [4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol] + NNAL-Gluc [4-(methylnitrosamino)-1- (3-pyridyl)-1-(O-beta-D-glucopyranuronosyl)butane] as a marker for uptake of the tobacco-specific lung carcinogen 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanone (NNK). Consistent differences in ETS exposure by ethnicity and race were observed. Although data were insufficient to determine differences for NNAL + NNAL-Gluc, BQ responses, T-A data, and cotinine levels all indicated that average ETS exposure was highest for African-American children, moderately high for those designated "other" (white, Southeast Asian, Native American), moderately low for Hispanic children, and lowest for Somali immigrant children. For example, in February 2000, mean cotinine levels were 14.1 ng/mL for African Americans, 12.2 ng/mL for other, 4.8 ng/mL for Hispanics, and 4.4 ng/mL for Somalis. The BQ and T-A data together were reasonably good predictors of total cotinine levels (adjusted r2 = 0.69), and based on limited data, measured total cotinine values were a relatively good predictor of NNAL + NNAL-Gluc (adjusted r2 = 0.73). The results suggest that when children are exposed to ETS primarily in their homes, questionnaires and T-A logs might be effective screening tools for identifying those likely to experience higher uptake of nicotine.
A confirmatory factor analysis of the WISC-III in a clinical sample with cross-validation in the standardization sample. - Child neuropsychology : a journal on normal and abnormal development in childhood and adolescence
Maximum likelihood confirmatory factor analysis was applied to the Wechsler Intelligence Scale for Children-Third Edition (WISC-III; Wechsler, 1991) data of a mixed clinical sample of 318 children. Analyses were designed to determine which of nine hypothesized oblique factor solutions could best explain intelligence as measured by the WISC-III in the clinical sample. Competing latent variable models were identified in previous studies, and results in the clinical sample were cross-validated by testing all models in the WISC-III standardization sample (n = 2200). Findings in both the clinical and standardization samples supported a five-factor model including Verbal Comprehension, Constructional Praxis, Visual Reasoning, Freedom from Distractibility, and Processing Speed factors. The Visual Reasoning factor was defined primarily by Picture Arrangement, whereas Mazes did not appear to improve model fit. Potential opportunities and pitfalls with regard to the interpretation of the proposed Visual Reasoning factor are discussed.
Metabolites of a tobacco-specific lung carcinogen in the urine of elementary school-aged children. - Cancer epidemiology, biomarkers & prevention : a publication of the American Association for Cancer Research, cosponsored by the American Society of Preventive Oncology
Limited data are available in the literature on carcinogen uptake by children exposed to environmental tobacco smoke (ETS). In this study, we quantified metabolites of the tobacco-specific lung carcinogen 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanone (NNK) in the urine of elementary school-aged children participating in the School Health Initiative: Environment, Learning, Disease study, a school-based investigation of the environmental health of children. The metabolites of NNK are 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (NNAL) and its glucuronide (NNAL-Gluc). We also measured cotinine and its glucuronide (total cotinine). Urine samples were collected from 204 children. Seventy (34.3%) of these had total cotinine > or =5 ng/ml. NNAL or NNAL-Gluc was detected in 52 of 54 samples with total cotinine > or =5 ng/ml and in 10 of 20 samples with total cotinine < 5 ng/ml. Levels of NNAL plus NNAL-Gluc and total cotinine were significantly higher when exposure to ETS was reported than when no exposure was reported. However, even when no exposure to ETS was reported, levels of NNAL, NNAL-Gluc, and NNAL plus NNAL-Gluc were higher than in children with documented low exposure to ETS, as determined by cotinine levels < 5 ng/ml. Levels of NNAL, NNAL-Gluc, and cotinine were not significantly different in samples collected twice from the same children at 3-month intervals. Levels of NNAL plus NNAL-Gluc in this study were comparable with those observed in our previous field studies of adults exposed to ETS. There was a 93-fold range of NNAL plus NNAL-Gluc values in the exposed children. The results of this study demonstrate widespread and considerable uptake of the tobacco-specific lung carcinogen NNK in this group of elementary school-aged children, raising important questions about potential health risks. Our data indicate that objective biomarkers of carcinogen uptake are important in studies of childhood exposure to ETS and cancer later in life.
Truly silent ischemia and the relationship of chest pain and ST segment changes to the amount of ischemic myocardium: evaluation by supine bicycle stress echocardiography. - Journal of the American College of Cardiology
The objectives of this study were 1) to determine the relationship between the amount of exercise-induced ischemic myocardium and the presence or absence of chest pain and ST segment depression, and 2) to define the incidence and characteristics of "truly silent ischemia," that is, ischemia that is not manifested by symptoms or electrocardiographic (ECG) findings.There are no prior data relating ischemia to chest pain and ST depression. Thallium-201 imaging studies have evaluated perfusion but not ischemia. In contrast, supine bicycle stress echocardiography demonstrates exercise-induced ischemic dysfunction.Supine bicycle stress echocardiography and arteriography were performed in 130 patients and the severity and geographic extent of ischemic myocardium were compared in three groups. On exercise, Group I patients had both chest pain and ST segment depression (symptomatic ischemia), Group II patients ST depression without chest pain (asymptomatic ischemia) and Group III patients had neither chest pain nor ST depression (truly silent ischemia).There were no differences among groups in arteriographic characteristics. The incidence of "truly silent ischemia" was 43%. The number of abnormally contracting ischemic segments, average score per segment and sum of scores were virtually identical in Groups I and II and significantly greater than in Group III for the patients (p < 0.01 to < 0.0001), for the vessels as a group (p < 0.01 to < 0.0001) and for the left anterior descending (p < 0.01 to < 0.0001) and right (p < 0.05) coronary arteries. By multivariate analysis, positive findings on the stress ECG was the single most significant variable in relation to the amount of ischemia (p < 0.001); exercise chest pain had no significant relationship.Exercise-induced ST segment depression is the single most significant variable in relation to the amount of ischemic myocardium; exercise-induced chest pain is not related to the amount of ischemia. Patients with "truly silent ischemia" constitute almost 50% of patients with coronary artery disease and have less ischemia than do patients with ECG indications of ischemia, with or without chest pain.
Supine bicycle stress echocardiography: peak exercise imaging is superior to postexercise imaging. - Journal of the American Society of Echocardiography : official publication of the American Society of Echocardiography
The abilities of peak exercise (PEAK) stress echocardiography versus postexercise (POST) stress echocardiography to detect coronary artery disease were evaluated in 136 consecutive patients undergoing supine bicycle stress echocardiography and coronary arteriography: 42 (31%) had normal coronary vessels, 38 (28%) had single-vessel disease, 34 (25%) had double-vessel disease, and 22 (16%) had triple-vessel disease. The results were as follows: (1) For detection of disease in the group of patients, sensitivity of PEAK versus POST was 94% versus 83% (p < 0.01) and specificity was 88% versus 90%. (2) For detection of disease in specific vessels, sensitivity of PEAK versus POST was 90% versus 72% (p < 0.0001) and specificity was 89% versus 92%. (3) For evaluation of the three major coronary arteries, sensitivity of PEAK versus POST was 96% versus 85% (p < 0.05) for the left anterior descending artery, 90% versus 65% (p < 0.01) for the right coronary artery, and 79% versus 60% (p < 0.05) for the left circumflex coronary artery. There were no differences in specificity. (4) The percent diameter stenosis of vessels normalizing from PEAK to POST versus vessels abnormal at PEAK and POST was 80.6% +/- 16% versus 85.9% +/- 14%, p = 0.07. There were no differences in exercise parameters between patients with and without resolution from PEAK to POST. (5) PEAK versus POST accuracy for identification of patients with multivessel disease was 93% versus 68% (p < 0.001). We conclude that stress echocardiography performed during peak exercise is superior to postexercise stress echocardiography.
Digital supine bicycle stress echocardiography: a new technique for evaluating coronary artery disease. - Journal of the American College of Cardiology
The objective of this study was to determine the accuracy of digital supine bicycle stress echocardiography, a new technique for evaluating coronary artery disease during peak exercise.Prior stress echocardiographic techniques have not utilized peak exercise imaging to determine the extent and location of coronary artery disease.Two-hundred twenty-two patients were studied: 180 underwent both supine bicycle stress echocardiography and coronary arteriography; 42 had a < 5% likelihood of disease. Forty-three patients had normal coronary arteries, 55 had single-vessel, 42 had double-vessel and 40 had triple-vessel coronary artery disease.Supine bicycle stress echocardiography was 93% sensitive, 86% specific and 92% accurate for identifying patients with coronary artery disease irrespective of prior myocardial infarction or achievement of > or = 85% maximal predicted heart rate. The "normalcy" rate in the low probability group was 100%. Supine bicycle stress echocardiography was 87% sensitive, 89% specific and 88% accurate for specific vessel identification. The sensitivity was greatest for the left anterior descending compared with the right coronary artery and the left circumflex coronary artery (95% vs. 81% vs. 78%, p < 0.01) and for vessels in patients with double- and triple-vessel compared with single-vessel disease (90% vs. 89% vs. 78%, p < 0.05). The procedure was significantly more sensitive for detection of vessels with 90% to 100% compared with 50% to 70% diameter stenosis (91% vs. 81%, p < 0.05) and was 88% correct in the prediction of multivessel disease.Supine bicycle stress echocardiography is a highly accurate tool for evaluating coronary artery disease, identifying both the patient with coronary artery disease and the location and extent of disease.
Supine bicycle stress echocardiography versus tomographic thallium-201 exercise imaging for the detection of coronary artery disease. - Journal of the American Society of Echocardiography : official publication of the American Society of Echocardiography
To compare the accuracy of supine bicycle stress echocardiography (SBSE), a new technique for evaluating coronary disease during peak exercise, with tomographic thallium-201 exercise imaging (SPECT), 71 patients were evaluated by SBSE, SPECT, and coronary arteriography. Twenty patients had normal coronary vessels; 22 had single-vessel, 14 had double-vessel, and 15 had triple-vessel disease. There were no differences in sensitivity (90% vs 92%), specificity (80% vs 65%), and accuracy (87% vs 85%) between SBSE and SPECT for the group of 71 patients. The results were similar in patients with and without prior myocardial infarction and with single-, double-, or triple-vessel disease. There were no differences between SBSE and SPECT for disease detection for the group of 213 individual vessels in sensitivity (88% vs 80%), specificity (87% vs 84%), and accuracy (88% vs 82%), but SBSE was more sensitive for the left anterior descending artery (97% vs 82%, p < 0.005) and for arteries involved in triple-vessel disease (93% vs 69%, p < 0.01) and more specific for the right coronary artery (88% vs 66%, p < 0.01). Supine bicycle exercise was associated with significantly lower maximal heart rates than treadmill exercise but with significantly higher systolic and diastolic blood pressures. There were no differences in heart rate x systolic blood pressure. We conclude that SBSE and SPECT are equally reliable for coronary disease detection in patients and for evaluation of disease in specific arteries with the exception of SBSE's higher sensitivity for the left anterior descending artery and arteries involved in triple-vessel disease and higher specificity for the right coronary artery.
Usefulness of supine bicycle stress echocardiography for detection of restenosis after percutaneous transluminal coronary angioplasty. - The American journal of cardiology
The role of supine bicycle stress echocardiography (SBSE) for detecting restenosis after percutaneous transluminal coronary angioplasty (PTCA) was evaluated in 80 patients: 41 (51%) with single and 39 (49%) with multivessel PTCA (total 129 dilated vessels). Total revascularization was performed in 54 (68%) and partial revascularization in 26 (32%) patients. Restenosis was angiographically demonstrated in 60 patients (75%) and in 72 vessels (56%) 6.1 +/- 2.9 months after PTCA. The results for detecting restenosis were: (1) SBSE versus exercise electrocardiographic sensitivity, 87 versus 55% (p < 0.001); (2) specificity, 95 versus 79%; and (3) accuracy, 89 versus 61% (p < 0.001). SBSE was 83% sensitive, 95% specific and 88% accurate for restenosis detection in specific vessels with comparable results for single versus multivessel PTCA and total versus partial revascularization. Sensitivity, specificity and accuracy were: 91, 93 and 91% for the left anterior descending coronary artery; 77, 94 and 85% for the right coronary artery; and 76, 96 and 88% for the left circumflex coronary artery. Ninety-four percent of the nondilated diseased vessels were correctly identified. It is concluded that SBSE is an excellent tool for identifying restenosis after PTCA.
Lesion morphology and coronary angioplasty: current experience and analysis. - Journal of the American College of Cardiology
From July 1, 1990 to February 28, 1991, 533 consecutive patients with 764 target vessels and 1,000 lesions underwent coronary angioplasty. Procedural success was achieved in 92.3%, untoward (major cardiac) events occurred in 3% (0.8% myocardial infarction, 1.3% emergency coronary bypass grafting and 0.9% both; there were no deaths). An unsuccessful uncomplicated outcome occurred in 4.7%. Lesion analysis using a modified American College of Cardiology/American Heart Association classification system showed that 8% were type A, 47.5% were type B and 44.5% were type C (36% of type B and 11% of type C were occlusions). Angioplasty success was achieved in 99% of type A, 92% of type B and 90% of type C lesions (A vs. B, p less than 0.05; B vs. C, p = NS; A vs. C, p less than 0.01). Untoward events occurred in 1.2% of type A, 1.9% of type B and 2% of type C lesions (p = NS). An unsuccessful uncomplicated outcome occurred in 0% of type A, 6% of type B and 7% of type C lesions (A vs. B, p less than 0.05; B vs. C, p = NS; A vs. C, p less than 0.05). Among the unsuccessful uncomplicated outcome group, occlusion occurred in 49%: 38% of type B and 59% of type C lesions. With B1 and B2 subtypes, success was obtained in 95% and 89.5% and untoward events occurred in 1.5% and 2.3% and an unsuccessful uncomplicated outcome in 3.7% and 8%, respectively. C1 and C2 subtyping showed success in 91% and 86%, untoward events in 1.3% and 6% and an unsuccessful uncomplicated outcome in 7.5% and 8.5%, respectively. Among the 764 vessels, success was obtained in 89.5% and untoward events occurred in 2.5% and an unsuccessful uncomplicated outcome in 8%. Assessment of lesion-vessel combinations showed a less favorable outcome with type C lesions and combinations of A-B, B-C and multiple (more than three lesions) type B and C vessels. Statistical analysis of morphologic factors associated with angioplasty success included absence of (old) occlusion (p less than 0.0001) and unprotected bifurcation lesion (p less than 0.001), decreasing lesion length (p less than 0.003) and no thrombus (p less than 0.03). The only significant factor associated with untoward events was the presence of thrombus (p less than 0.003). Predictors of an unsuccessful uncomplicated outcome included old occlusion (p less than 0.0001) and increasing lesion length (greater than 20 mm) (p less than 0.001), unprotected bifurcation lesion (p less than 0.05) and thrombus (p less than 0.03).
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5247 Elkhorn Blvd Sacramento, CA 95842