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Biomedical subjects

P T Lavin

Publications and source records attributed to P T Lavin.

At least 73 records · Page 4Linked to original sources
PubMed1982

Uveal malignant melanoma associated with ocular and oculodermal melanocytosis.

Seventeen patients with ocular or oculodermal melanocytosis were identified among 1,250 Caucasian patients with uveal malignant melanoma. The uveal melanomas in these seventeen patients were similar in size, cell type, and tendency to metastasize to those occurring in reported populations without ocular or oculodermal melanocytosis. Clinical and histopathologic study of these 17 cases indicated that all of the affected eyes had episcleral and choroidal melanocytosis and that other ocular and periocular tissues (sclera, iris, conjunctiva, angle structures, and optic disc) were involved less commonly. The uveal malignant melanoma that was present in each of these cases involved the eye with melanocytosis. Furthermore, the melanoma arose from the zone of uveal melanocytosis in every eye with sectoral involvement. Statistical analysis of these data supports the contention that uveal malignant melanoma has a higher incidence in white persons with ocular or oculodermal melanocytosis than in those without these conditions.

Adult↗
PubMed1982

Comparison of cell-mediated lympholysis and mixed lymphocyte culture in the immunologic evaluation for renal transplantation.

We investigated the relationship between both pre-transplant cell-mediated lympholysis assay (CML) and mixed lymphocyte culture (MLC) and transplant outcome (graft function and survival) in 33 living, related donor renal transplants performed during the past 5 yr. Both assays were excellent predictors of transplant outcome. A positive CML assay was correlated with the occurrence of early acute rejection episodes (p less than 0.005), shortened time to graft dysfunction (serum creatinine greater than 1.5 mg/dl) (p less than 0.001), and poor long-term graft survival (p = 0.07). Similarly, a positive MLC was correlated with acute rejection episodes (p less than 0.005), graft dysfunction (p = 0.001), and poor graft survival (p less than 0.01). To determine the relative prognostic significance of the CML and MLC assays, we compared the correlation of each of them with the occurrence of acute rejection episodes. Under a logistic model of probability, the CML and MLC assays were equally predictive of an early acute rejection episode (p less than 0.01); however, the combination of CML and MLC together improved the accuracy of the prediction of an acute rejection episode by 50%. These results indicate that the CML and MLC assays are independent predictors of transplant outcome and that both tests should be an integral part of the immunologic evaluation of prospective living, related donors for renal transplantation.

Adolescent↗
PubMed1982

Phase II trial of doxorubicin therapy for advanced islet cell carcinoma.

Twenty evaluable patients with advanced islet cell carcinoma were treated with doxorubicin at a dosage of 60 mg/m2 every 3-4 weeks. Toxicity was clinically tolerable and characteristic of doxorubicin therapy. Although all patients had previously been treated with other chemotherapy regiments, four (20%) had objective therapeutic responses persisting for 2-301/2 months. Doxorubicin has definite therapeutic activity in islet cell carcinoma and is currently being evaluated in combination chemotherapy regimens.

Adenoma, Islet Cell↗
PubMed1981

Therapy of locally unresectable pancreatic carcinoma: a randomized comparison of high dose (6000 rads) radiation alone, moderate dose radiation (4000 rads + 5-fluorouracil), and high dose radiation + 5-fluorouracil: The Gastrointestinal Tumor Study Group.

One-hundred-ninety-four eligible and evaluable patients with histologically confirmed locally unresectable adenocarcinoma of the pancreas were randomly assigned to therapy with high-dose (6000 rads) radiation therapy alone, to moderate-dose (4000 rads) radiation + 5-fluorouracil (5-FU), and to high-dose radiation plus 5-FU. Median survival with radiation alone was only 51/2 months from date of diagnosis. Both 5-FU-containing treatment regimens produced a highly significant survival improvement when compared with radiation alone. Forty percent of patients treated with the combined regimens were still living at one year compared with 10% of patients treated with radiation only. Survival differences between 4000 rads plus 5-FU and 6000 rads plus 5-FU were not significant with an overall median survival of ten months. Significant prognostic variables, in addition to treatment, were pretreatment performance status and pretreatment CEA level.

Adenocarcinoma↗
PubMed1981

A statistical evaluation of baseline and follow-up carcinoembryonic antigen in patients with resectable colorectal carcinoma.

A long-term CEA follow-up was evaluated statistically for a series of 74 patients with primary colorectal carcinoma who underwent resections for cure. Thirty-three recurrences and 29 deaths were reported among this population after a median follow-up interval of 55 months. Preoperative CEA levels correlated with the Dukes' classification. However, the preoperative level adds significant information to Dukes' classification in the prediction of recurrence. Postoperative CEA assays taken later in the clinical evaluation process carry the most prognostic information for subsequent recurrence. Using matched-pairs techniques, the authors noted that CEA often rose in anticipation of recurrence, sometimes as early as one year before recurrence. The following four follow-up CEA events were evaluated: 1) three consecutive rising CEA's 2) CEA rises 5.0 ng/ml; 3) CEA exceeds 5.0 ng/ml; 4) CEA exceeds 5.0 ng/ml two consecutive times. The follow-up CEA events examined were characterized by false positive rates ranging from 17% to 66% and true positive rates ranging from 43% to 56% in the prediction of recurrence. From follow-up CEA evaluations, further clinical investigation appeared most warranted when CEA exceeds 5.0 ng/ml at two consecutive follow-up evaluations, but the chances of finding any subsequent recurrent disease was near 50%. Among patients experiencing recurrences, although forewarned by CEA elevations, there was no subsequent time when patients were most likely to have recurrence of disease.

Carcinoembryonic Antigen↗
PubMed1981

An alternative model for the evaluation of antitumor activity.

To date, in cancer clinical trials, treatment programs have been evaluated using objective tumor response as the primary means to demonstrate antitumor activity. This measure, which is based upon a dichotomous outcome whether or not a 50% decrease in tumor area has occurred, is complemented by the alternative measure of the distribution of the ratio of the tumor area taken at a fixed time point compared to the tumor area at the start of protocol treatment. It is inferred that the distribution of the tumor area ratio obeys a log-normal distribution for advanced gastric cancer and that this result may hold for many advanced measurable cancer studies. The identification of this distribution allows for the evaluation of treatment programs using parametric tests. In situations where log-normality does not apply, a Normal Scores test is recommended. This concept may be applied to completed studies to gain additional perspective regarding antitumor activity. A marked reduction in sample size requirements can be achieved when the tumor area ratio is used as a study design criteria. This approach is especially recommended in the phase II setting.

Antineoplastic Agents↗
PubMed1980

Studies in variation associated with the measurement of solid tumors.

The existing system for solid tumor evaluation is criticized and revised criteria are proposed. The foundation for this analysis is a tumor stimulation experiment to determine the distribution associated with measurement of solid tumors. This tumor simulation experiment was conducted among 26 oncologists in order to assess the errors associated with the measurement of solid tumors by means of palpation. Tumor size, shape, and texture were included as study factors. Tumor texture did not appear to affect measurement outcome. Overall, the statistical law governing tumor area measurement is best described as a log-normal distribution. Under this assumption, the sufficient statistic for the evaluation of tumor response or progression is simply the ratio of the tumor areas at each evaluation. The data generalize to permit the construction of statistical power curves for the probability of declaring response or progression, based upon the theoretic tumor/area ratios. Response and progression criteria are related in logarithmic proportion, i.e., a 50% decrease for response corresponds to a 100% increase for progression. The use of more sensitive progression criteria (a 25% increase in solid tumor area), in light of the nature of tumor measurement error, can lead to premature rejection of any therapy that stabilizes or reduces disease. Furthermore, the use of specified cutoffs for progression and response introduce a significant error into clinical evaluations of solid tumors.

Biometry↗
PubMed1980

Prognostic effect of weight loss prior to chemotherapy in cancer patients. Eastern Cooperative Oncology Group.

The prognostic effect of weight loss prior to chemotherapy was analyzed using data from 3,047 patients enrolled in 12 chemotherapy protocols of the Eastern Cooperative Oncology Group. The frequency of weight loss ranged from 31 percent for favorable non-Hodgkin's lymphoma to 87 percent in gastric cancer. Median survival was significantly shorter in nine protocols for the patients with weight loss compared to the patients with no weight loss. Chemotherapy response rates were lower in the patients with weight loss, but only in patients with breast cancer was this difference significant. Decreasing weight was correlated with decreasing performance status except for patients with pancreatic and gastric cancer. Within performance status categories, weight loss was associated with decreased median survival. The frequency of weight loss increased with increasing number of anatomic sites involved with metastases, but within categories of anatomic involvement, weight loss was associated with decreased median survival. These observations emphasize the prognostic effect of weight loss, especially in patients with a favorable performance status or a limited anatomic involvement with tumor.

Activities of Daily Living↗
PubMed1979

Chemotherapy of gastric and pancreatic carcinoma: a controlled evaluation of combinations of 5-fluorouracil with nitrosoureas and "lactones".

By random assignment a total of 176 eligible patients with advanced nonmeasurable pancreatic carcinoma were treated with 5-fluorouracil (5-FU) either alone or in combination with a nitrosourea (streptozotocin), in combination with a "lactone" (spironolactone), or in combination with both. By random assignment a total of 179 patients with advanced nonmeasurable gastric carcinoma were treated with 5-FU either alone or in combination with a nitrosourea (methyl CCNU), in combination with a lactone (testolactone), or in combination with both. The median survival period for all pancreatic carcinoma patients was 17 weeks, and for all gastric carcinoma patients 30 weeks. The addition of the nitrosoureas or the lactones or a combination of both produced no improvement in length of patient survival for either primary carcinoma when compared to treatment with 5-FU alone.

Adenocarcinoma↗
PubMed1979

Phase II evaluation of diglycoaldehyde, VP-16-213, and the combination of methyl-CCNU and beta-2'-deoxythioguanosine in previously treated patients with colorectal cancer: an Eastern Cooperative Oncology Group study (EST-1275).

The Eastern Cooperative Oncology Group assessed the activity of diglycoaldehyde (DGA), VP-16-213, and the combination of methyl-CCNU and beta-2'-deoxythioguanosine in previously treated patients with advanced colorectal cancer. Objective responses were seen in two of 40 evaluable patients receiving methyl-CCNU and beta-2'-deoxythioguanosine and in one of 35 patients receiving DGA. None of 33 patients responded to VP-16-213, but one death related to sepsis and bone marrow failure occurred. Survival of patients whose previous chemotherapy included a nitrosourea was markedly shortened compared to those who had not been exposed to nitrosoureas. With the possible exception of DGA, further treatment of patients with colorectal cancer with these therapies is not warranted.

Aldehydes↗
PubMed1978

Randomized phase II clinical trial of adriamycin, methotrexate, and actinomycin-D in advanced measurable pancreatic carcinoma: a Gastrointestinal Tumor Study Group Report.

Sixty-six patients with advanced pancreatic carcinoma were randomized to receive single agent chemotherapy with either adriamycin, methotrexate, or actinomycin-D using conventional dose, route and schedule of administration. All patients had measurable lesions which were used to objective assessment of response. For adriamycin, 2 of 25 patients (8%) evidenced a partial response (2 of 15 (13%) previously untreated patients). One of 25 patients treated with methotrexate and one of 28 received actinomycin-D responded. The duration of responses ranged from 43-64 days for those patients with no chemotherapy prior to study entry. The median survival of patients who received adriamycin as initial treatment was 12 weeks compared to 8 weeks for methotrexate and 6 weeks for actinomycin-D therapy.

Adult↗
PubMed1978

Chemotherapy of advanced measurable colon and rectal carcinoma with oral 5-fluorouracil, alone or in combination with cyclophosphamide or 6-thioguanine, with intravenous 5-fluorouracil or beta-2'-deoxythioguanosine or with oral 3(4-methyl-cyclohexyl)-1(2-chlorethyl)-1-nitrosourea: a Phase II-III study of the Eastern Cooperative Oncology Group (EST 4273).

In a randomized multi-institutional trial of the Eastern Cooperative Oncology Group, 316 patients with advanced measurable colorectal adenocarcinoma were treated with a weekly schedule of 5-fluorouracil given orally and intravenously with oral-5-fluorouracil in combination with cyclophosphamide or 6-thioguanine, or with oral Methyl CCNU administered once every eight weeks. On failure or progression, 133 protocol patients crossed-over to a secondary therapy, while 116 other patients previously treated with 5-fluorouracil off protocol were randomized to treatment with Methyl CCNU or B-2'-deoxythioguanosine. Response rates among patients who had received no prior chemotherapy were 18% to oral 5-FU, 15% to intravenous 5-FU and to MeCCNU, 12% to 5-FU and 6-thioguanine and 5% to cyclophosphamide and 5-FU, with little activity (3% response rate) in crossover or previously treated patients. Treatment with 5-FU, particularly oral 5-FU was associated with the least drug-related toxicity. Hematologic toxicity was greatest with Methyl CCNU, but was no more frequent in previously treated than in untreated patients. A tendency toward cumulative bone marrow depression was noted. 5-FU was effective only in ambulatory patients, whereas responses among non-ambulatory patients were seen only in the group treated with Methyl-CCNU.

Adenocarcinoma↗
PubMed1976

Nitrosoureas: useful agents for the treatment of advanced gastrointestinal cancer.

Patients with a wide range of gastrointestinal cancers have been treated with nitrosoureas by the Eastern Cooperative Oncology Group. Methyl-CCNU, CCNU, and streptozotocin have been evaluated as single agents in the treatment of colorectal carcinoma. Methyl-CCNU has had an extensive trial in gastric carcinoma as a single agent and in combination with 5-fluorouracil (5-FU). It has also been used to treat pancreatic carcinoma and, in a few patients, carcinoma of the biliary tract. In gastric cancer it would appear that a synergistic effect on response rates has resulted from the combination of methyl-CCNU and 5-FU. The addition of cyclophosphamide to this combination as an induction agent detracted significantly.

Clinical Trials as Topic↗
PubMedDate not supplied

Comparison of the efficacy and tolerability of Prinivil and Procardia XL in black and white hypertensive patients.

The efficacy and tolerability of Prinivil and Procardia XL were compared in 135 (67 black, 68 white) patients with mild to moderate uncomplicated essential hypertension. The goal of therapy was to achieve and maintain a supine diastolic blood pressure (SDBP) of > 90 mmHg or a decrease in SDBP > or = 10 mmHg. Patients received Prinivil 10 to 40 mg once daily or Procardia XL 30 to 120 mg once daily during a titration period of 2 to 8 weeks to achieve the goal blood pressure before a 4-week maintenance period. The mean baseline supine systolic/diastolic blood pressures were 151/97 mmHg in patients receiving Prinivil and 153/99 mmHg in patients receiving Procardia XL. Ninety-one percent of patients receiving Prinivil and 95% of those receiving Procardia XL achieved SDBP control at the end of titration therapy. At the end of the maintenance treatment period, 79% of patients receiving Prinivil and 80% of those receiving Procardia XL had SDBP control. Mean decreases in SDBP from baseline were comparable for both treatment groups. At the end of the titration period, mean decreases were 9.6 mmHg in patients receiving Prinivil and 11.3 mmHg in patients receiving Procardia XL; at the end of the maintenance period, mean decreases were 10.8 mmHg and 12.1 mmHg, respectively. There were no differences in treatment responses in either the black or white hypertensive subgroups. Thus both drugs were equally effective in black and white patients with mild to moderate essential hypertension. Both drugs were generally well tolerated, but the number of adverse experiences requiring discontinuation of therapy was significantly higher (P = 0.03) in patients receiving Procardia XL.

Adult↗
PubMedDate not supplied

Comparison of the efficacy and tolerability of lisinopril and sustained-release verapamil in older patients with hypertension.

The efficacy and tolerability of lisinopril and sustained release (SR) verapamil hydrochloride were compared in 68 patients (mean age, 60 years) with mild to moderate uncomplicated essential hypertension. The goal of therapy was to achieve and maintain a supine diastolic blood pressure (SDBP) of less than 90 mmHg or a fall in SDBP greater than or equal to 10 mmHg. Patients received lisinopril (10 to 40 mg QD) or verapamil SR (120 to 480 mg QD) during a variable titration period (two to eight weeks) to achieve goal blood pressure prior to a four-week maintenance treatment period. Among the 62 patients who completed the titration period, the mean baseline supine systolic/diastolic blood pressures were 155/97 mmHg for the lisinopril group and 150/95 mmHg for the verapamil SR group. Ninety-seven percent of patients in the lisinopril group and 100% of patients in the verapamil SR group achieved SDBP control at the end of titration therapy. At the end of the maintenance treatment period, 82% of the lisinopril-treated patients and 81% of the verapamil SR-treated patients had SDBP control. Mean decreases in SDBP from baseline were comparable for both treatment groups. At the end of titration, mean decreases were 11.3 mmHg for the lisinopril group and 10.7 mmHg for the verapamil SR group; at the end of maintenance treatment, mean decreases were 10.5 mmHg and 8.5 mmHg. Thus both drugs were equally effective in older patients with mild to moderate essential hypertension. Both drugs were generally well tolerated. One patient in the lisinopril group and four patients in the verapamil SR group experienced adverse effects that required withdrawal from the study.

Aged↗
PubMedDate not supplied

Comparison of the efficacy and tolerability of lisinopril and sustained-release verapamil in black patients with hypertension.

In this clinical study the efficacy and tolerability of lisinopril and sustained-release (SR) verapamil hydrochloride were compared in black patients with mild-to-moderate uncomplicated essential hypertension. The goal of therapy was to achieve a supine diastolic blood pressure (SDBP) of less than 90 mmHg or a greater than or equal to 10-mmHg fall in SDBP. Forty-three patients completed the titration phase, 23 in the lisinopril group and 20 in the verapamil SR group. The mean baseline supine systolic/diastolic blood pressures were 147/98 mmHg for the lisinopril group and 155/100 mmHg for the verapamil SR group. At the end of a two- to eight-week titration period, 87% of the lisinopril-treated patients and 90% of the verapamil SR-treated patients had achieved SDBP control. Six patients were excluded from maintenance therapy: four in the lisinopril group (one because of urticaria and three because of failure to reach goal blood pressure) and two in the verapamil SR group (because of failure to reach goal blood pressure). After eight weeks of maintenance therapy, 68% of the lisinopril-treated patients and 72% of the verapamil SR-treated patients had achieved SDBP control. The mean decreases in SDBP were comparable for both treatment groups. At the end of titration, the mean decreases from baseline were 10.5 mmHg for the lisinopril group and 12.6 mmHg for the verapamil SR group. At the end of maintenance, the mean decreases from baseline were 7.8 mmHg for the lisinopril group and 9.2 mmHg for the verapamil SR group. Adverse experiences were few.(ABSTRACT TRUNCATED AT 250 WORDS)

Adult↗