Biomedical subjects

P T Lavin

Publications and source records attributed to P T Lavin.

At least 55 records · Page 3Linked to original sources

PubMed1988

An evaluation of the effect of aspartame on weight loss.

This study explores whether the addition of aspartame-sweetened foods and beverages to a low fat, hypocaloric diet enhances compliance and resulting weight loss. Fifty-nine obese (130-225% of ideal body weight), free living men and women were randomly assigned to either a Balanced Deficit Diet (BDD) or a BDD supplemented with aspartame. Over a 12-week weight loss period, volunteers attended weekly support group meetings including behavior modification training and exercise instruction. Males achieved a clinically significant weight loss (greater than 23 lb) in both study groups, while females lost an average of 12.8 lb in the control group vs. 16.5 lb in the experimental group. In both treatment groups, sleep, general energy level, level of physical activity, and feeling of well-being showed clinically meaningful improvement. This study suggests possible advantages to supplementing a BDD with aspartame-sweetened foods as part of a multidisciplinary weight loss program. The small sample size prohibits definitive conclusions but does provide the protocol for a larger, outpatient clinical trial.

Adult↗

PubMed1987

Gallbladder adenocarcinoma: the prognostic significance of histologic grade.

Gallbladder adenocarcinoma (GBA) postresection 5-year survival rates are less than 5%, but when histologically confined to the mucosa or submucosa, survival rates of 64% (5 years) and 44% (10 years) have been reported. Whether any other histologic features of GBA have prognostic significance is unknown. This investigation was conducted to determine if GBA histologic grade correlates with survival. Thirty patients with advanced stage GBA participating in Eastern Cooperative Oncology Group (ECOG) treatment protocol EST-2273 served as the study material. Using glandular tumor grade criteria recommended by others, a panel of 7 ECOG pathologists categorized the GBA as either predominantly low or high histologic grade. Each patient's GBA histologic section measured no less than 1.0 X 1.0 cm. Predominant grade was defined as being that grade present in greater than 75% of the histologic section. Patient survival times by grade were calculated from date of initiation of chemotherapy until date of death. The 13-week low grade GBA patient survival was significantly longer than the 7-week high grade GBA patient survival (p less than 0.01). Stratification of patients by either high or low predominant histologic grade is recommended in future GBA treatment studies.

Adenocarcinoma↗

PubMed1987

CA 125 for the monitoring of ovarian carcinoma during primary therapy.

Thirty-one patients with ovarian cancer were monitored with the CA 125 antigenic determinant in the interval between cytoreductive surgery and the completion of subsequent chemotherapy. Distinct CA 125 assay trends have emerged from prospective serial monitoring. Among patients who were clinically and surgically free of disease after the completion of cytoreductive chemotherapy, the CA 125 assay always fell to levels under 35 U/mL within the first three months of cytoreductive chemotherapy, and stayed at low levels. Patients with partial cytoreduction operations had decreases in serum CA 125 levels only if there was a response to further therapy. The rate of fall of the CA 125 levels correlated with clinical outcome. All 13 patients with serum CA 125 above 35 U/mL after three months of treatment invariably had persistent tumors after subsequent chemotherapy, whereas in patients showing reduction of the CA 125 to levels below 35 U/mL, there were no surgically detectable tumors. Measurement of CA 125 during treatment might permit an early change to alternative and optimal forms of therapeutic management. The CA 125 level three months after treatment appears to be a critical predictor of response to therapy.

Antigens, Neoplasm↗

PubMed1987

Evaluating the role of therapy in histiocytosis-X. Clinical studies, staging, and scoring.

Histiocytosis-X is a difficult disease on which to perform clinical studies. It is a rare disease, with great clinical heterogeneity. The natural history is characterized by periods of spontaneous disease stabilization, remission, and exacerbation. Clinical care is given by several diverse types of physicians. Several suggestions are made for the optimal design and performance of clinical studies aimed at evaluating potentially new therapies, including the proper identification and use of controls. In addition, a staging system is described, and a comprehensive scoring system is given. This scoring system will allow accurate determination of disease activity, and permit analysis of the clinical effectiveness of any new treatment.

Drug Evaluation↗

PubMed1986

Carcinoids: the prognostic effect of primary site histologic type variations.

Carcinoids are histologically classified as insular (A), trabecular (B) glandular (C), undifferentiated (D) or mixed. These have prognostic significance, i.e. Group 1 (most favorable, A + C); 2 (favorable, A, B, A + B); 3 (relatively unfavorable, all non A + C or A + B mixed types); and 4 (unfavorable, C, D). Midgut primaries have a better prognosis than either foregut or hindgut/cloacal primaries. Carcinoids from 114 Eastern Cooperative Oncology Group patients were studied to determine if primary site prognostic differences result from histologic prognostic group occurrence rate differences across primary sites. By primary site the following rates were observed: Foregut: 1 (0%), 2 (79.2%), 3 (12.5%), 4 (8.3%); midgut: 1 (26.7%), 2 (58.7%), 3 (6.6%), 4 (8.0%); hindgut/cloaca: 1 (0%), 2 (42.9%), 3 (42.9%), 4 (14.2%); nongut: 1 (0%), 2 (75.0%), 3 (12.5%), 4 (12.5%), p less than 0.01. The results demonstrate that primary site prognostic differences are highly dependent upon histologic prognostic group occurrence rate variations across primary sites. In addition multivariate analysis of survivorship by both histologic type (p less than 0.05) and primary site (p less than 0.05) demonstrated that each variable has independent prognostic significance.

Aged↗

PubMed1986

Gallbladder adenocarcinoma: prognostic significance of tumor acid mucopolysaccharide content.

The gall bladder mucosa is composed of neutral mucopolysaccharide and protein radical containing secretory cells, protein radical containing migratory cells, and neutral and acid mucopolysaccharides plus sialic acid containing goblet cells. The prognostic significance of histologic or histochemical parameters in gall bladder adenocarcinoma (GBA) are unknown. To determine if histochemical acid mucopolysaccharide content in GBA has prognostic value, GBA histologic sections from 26 advanced stage disease patients participating in Eastern Cooperative Oncology Group (ECOG) treatment study EST-2273 were stained with alcian blue at pH. 1.0, assessed by a pathology panel for either high (greater than 50%) or low (less than 50%) acid mucopolysaccharide content, and correlated with patient survival. Initial panel unanimous concurrence rate on acid mucopolysaccharide content was 88.9%. Median survival times from the start of chemotherapy to date of death for high acid mucopolysaccharide content GBA was 14 weeks versus five weeks for the low content GBA (P less than 0.0001). The results indicate that high acid mucopolysaccharide content in GBA significantly improves prognosis. ECOG recommends stratification by acid mucopolysaccharide content in future GBA treatment investigations.

Adenocarcinoma↗

PubMed1986

The CA 125 assay as a predictor of clinical recurrence in epithelial ovarian cancer.

Serum CA 125 levels were obtained from 55 women with epithelial ovarian cancer before a second-look surgical procedure and serially thereafter. All patients were clinically and radiographically free of tumor at the time of the second-look operation and were followed to clinical recurrence. Median follow-up was 12 months. CA 125 levels obtained at the second-look operation had a sensitivity and specificity for predicting clinical recurrence of 94% and 88%, respectively. Patients with an elevated CA 125 level (greater than or equal to 35 U/ml) had a 60% chance of clinical recurrence within 4 months, while patients with levels less than 35 U/ml had a 5% chance of clinical recurrence over the same time period. Serial CA 125 levels obtained after second-look operations were strong predictors of clinical outcome, and distinctly different monitoring profiles were observed among those patients remaining clinically free of tumor and those suffering clinical recurrence. The CA 125 assay became elevated (greater than or equal to 35 U/ml) before clinical recurrence in 94% of 35 cases with a median lead time of 3 months. The CA 125 assay identifies patients destined to suffer a clinical recurrence and provides a warning measurable in months. This may have important implications for therapy.

Adult↗

PubMed1986

CA 125 serum levels correlated with second-look operations among ovarian cancer patients.

CA 125, which is an antigenic determinant expressed by many epithelial ovarian cancers, is measured in serum using a solid phase immunoradiometric assay. Sera from 55 patients who were in clinical remission and underwent a second-look operation to assess disease status after chemotherapy were studied prospectively. All patients had the CA 125 assay performed within one week before their second-look operation. Twenty-four patients (44%) had no histologic or cytologic evidence of disease, seven patients (13%) had microscopic disease, 13 patients (24%) had disease measuring 1 mm to 1.5 cm, and ten patients (18%) had disease greater than or equal to 1.5 cm in maximum tumor dimension. None of the 24 patients with a negative second-look operation had a positive CA 125 antigen level (greater than or equal to 35 U/mL), compared with six of 20 patients (30%) with less than 1.5 cm disease, and six of ten (60%) with greater than or equal to 1.5 cm disease (P less than .0001). All 12 patients with an elevated CA 125 antigen level (greater than or equal to 35 U/mL) had disease discovered at their second-look operation. Thus, in this setting the predictive value of a positive CA 125 titer (greater than or equal to 35 U/mL) was 100%. The predictive value of a negative CA 125 antigen level (less than 35 U/mL) was 56%, ie, the test did not exclude the presence of disease in 44% of patients with a positive second look. The maximum tumor size associated with at least one prior negative antigen level was 1.9 cm.(ABSTRACT TRUNCATED AT 250 WORDS)

Antigens, Neoplasm↗

PubMed1986

Serial levels of CA 19-9 and CEA in colonic cancer.

The use of serial carbohydrate antigen (CA) 19-9 assays was assessed by comparison with serial carcino-embryonic antigen (CEA) levels on the plasmas of 53 patients with colorectal carcinoma. The patients had all undergone resection for their primary tumors and in six instances subsequent resections for hepatic metastases. Initial CA 19-9 levels were greater than or equal to 37 U/mL in 22 of the 53 patients (41%) and in 68% of the patients with metastatic disease. Similar trends of serial CA 19-9 and CEA levels were found in 79% of the 53 patients. One patient with initially normal CEA levels had elevated CA 19-9 levels from the start. In ten of the 53 patients (19%), serial CA 19-9 levels remained low despite tumor recurrence or progression, and despite increasing CEA levels above 5 ng/mL. The increasing serial CEA trends predicted recurrence in 88% and increasing CA 19-9 trends in 50% of cases, which was increased to 70% by including trends of CA 19-9 levels below 37 U/mL. Following hepatic lobectomy, both serial CEA and CA 19-9 levels decreased rapidly. Used alone, serial CA 19-9 levels did not appear to be as sensitive as standard CEA in this retrospective study of selected patients.

Adult↗

PubMed1985

Postoperative adjuvant 5-fluorouracil plus methyl-CCNU therapy for gastric cancer patients. Eastern Cooperative Oncology Group study (EST 3275).

After en bloc resection of gastric adenocarcinoma, 180 patients were randomized to 2 years of 5-fluorouracil (5-FU) + semustine (MeCCNU) chemotherapy or to observation only. After a median follow-up time of 64 months, 48 of 89 control patients and 51/91 treated patients recurred (P less than 0.71). The sites of recurrent cancer were similar for both groups: liver, 32%; local esophagus or stomach, 51%; abdominal nodes and peritoneum, 38%; and extra-abdominal nodes, 14%. The survival curves overlap; 51/89 controls and 57/91 treated patients died with a median survival of 32.7 and 36.6 months, respectively (P less than 0.73). Treated patients experienced clinically important hematologic toxicity and two treated patients died of marrow failure with leukemia. Because of the toxicity and the lack of effectiveness, adjuvant 5-FU + MeCCNU is not recommended for patients with resectable gastric cancer.

Adenocarcinoma↗

PubMed1985

Hematologic toxicity of cisplatin and mitomycin in combination for squamous cell carcinoma of esophagus.

Seventy-six patients with squamous cell carcinoma of the esophagus (SCE) were treated with either cisplatin and mitomycin in combination or as single agents on ECOG protocol 2278. Sixty-six patients were evaluated for toxicity. Of 13 evaluable mitomycin and cisplatin treated patients, six (46%) experienced ECOG grade 4 thrombocytopenia and/or leukopenia. Of 28 evaluable patients treated with mitomycin alone, two (7%) experienced such toxicity; and of 25 evaluable patients treated with cisplatin alone, none experienced this toxicity. The average total dose prior to toxicity for those receiving mitomycin and cisplatin in combination was 51 mg and 131 mg, respectively, with average time to toxicity 3.6 weeks. For those two patients who received mitomycin alone, the average total dose was 68 mg and average time to toxicity 6.5 weeks. For those patients receiving cisplatin alone, the average total dose was 220 mg. The reasons for the enhanced hematologic toxicity of the agents together are not apparent, but it would be prudent to caution investigators using these agents in combination with potentially myelosuppressive drugs.

Aged↗

PubMed1984

A deficit survival analysis to assess the natural history of uveal melanoma.

A deficit survival analysis was conducted using a retrospective series of 230 patients with uveal melanoma. All underwent enucleation as primary treatment for their disease. Considering the three leading prognostic factors (epithelioid cells per high power field, tumor size, and tumor location), median age was plotted against median survival to determine pathways of disease spread, local and metastatic disease phases, consequences of delayed diagnosis, and the timing of enucleation. The subgroup with all three factors favorable could be subdivided into younger and older subsets on the basis of a bimodal age distribution. Only the older subset could be identified as a local disease state where survival following enucleation corresponded to normal population survival. All remaining subgroups were metastatic because of survival deficits compared to the normal population. Disease tended to progress according to three well defined pathways with 6-8 years required to progress from one subgroup to the next along these paths. These pathways were characterized by constant deficit survivals, suggesting that delays in diagnosis did not translate into loss in survival. Moreover, the value of enucleation as primary therapy can be questioned in the context that it does not appear to alter the natural history of the disease, except for tumors greater than 10 mm in largest dimension which are located anterior to the equator with fewer than 2 epithelioid cells per high power field. Findings suggest that uveal melanoma can be treated by means other than enucleation to allow a chance for prolonged survival with vision preservation.

Adult↗

PubMed1984

Streptozocin plus fluorouracil versus doxorubicin therapy for metastatic carcinoid tumor.

EST 5275 is a phase II and III study of fluorouracil plus streptozocin (5-FU plus STZ) or doxorubicin in patients with measurable progressive carcinoid tumor. Among one hundred seventy-two cases with no prior chemotherapy and no heart disease, the response rate was 22% for 5-FU plus STZ and 21% for doxorubicin, while the median response duration and median survival were 31 weeks and 64 weeks for the combination and 26 weeks and 48 weeks for doxorubicin. Thirty-three patients who failed 5-FU plus STZ crossed over to doxorubicin and achieved an 18% response. Of the thirty-five patients who failed on doxorubicin, 29% responded to 5-FU plus STZ. Hematologic toxicity was similar for both treatments; however, the 5-FU plus STZ patients experienced more vomiting but acceptable renal toxicity. Both chemotherapy regimens have antitumor activity in carcinoid tumors.

Adult↗

PubMed1984

An Eastern Cooperative Oncology Group evaluation of combinations of methyl-CCNU, mitomycin C, Adriamycin, and 5-fluorouracil in advanced measurable gastric cancer (EST 2277).

In a prospectively randomized trial, patients with advanced locally recurrent or metastatic gastric adenocarcinoma were randomized to receive 5-fluorouracil (5-FU) and methyl-CCNU; 5-FU, Adriamycin (Adria Laboratories, Columbus, Ohio), and methyl-CCNU; 5-FU, Adriamycin, and mitomycin C; or Adriamycin and mitomycin C alone. One hundred eighty-three previously untreated evaluable patients were randomized among the four arms. An additional 39 patients previously treated with 5-FU, were assigned to treatment directly to Adriamycin and mitomycin C. Response rates were 14%, 29%, 39%, and 29%, respectively, among previously untreated patients and 21% for Adriamycin and mitomycin C among previously treated patients. 5-Fluorouracil, Adriamycin, and mitomycin C, the arm containing the largest number of responders (18), was the combination associated with the longest median survival. A larger proportion of patients in this arm survived one year or more. In addition, the 5-FU, Adriamycin, and mitomycin C program had the lowest rate of severe or worse toxicity of any of the treatments and was effective in patients who were less than fully ambulatory and in those who had lost weight. 5-Fluorouracil, Adriamycin, and mitomycin C appear to be a likely combination to be considered in a surgical adjuvant program.

Adenocarcinoma↗

PubMed1983

A prognostic factor study of disease-free interval and survival following enucleation for uveal melanoma.

Prognostic indicators of uveal melanoma disease-free interval and survival following enucleation were evaluated for 267 patients. The median follow-up time was 17 years. Analysis involved Kaplan-Meier survival curves based on time to tumor-related deaths and multivariate proportional hazards analysis, which provides an estimate of the "force of mortality." Prognostic indicators considered included demographic, clinical, and histopathological factors. Cell type was classified according to the number of epithelioid cells present per high-power field (HPF) on light microscopy. Various classifications of size of the tumor were compared for prognostic value. The five leading predictors of survival in order of importance were as follows: (1) number of epithelioid cells per HPF, (2) largest dimension of the tumor, (3) location of the anterior margin of the tumor, (4) invasion to the line of transection, and (5) degree of pigmentation. Risk categories for survival were constructed based on the three leading prognostic factors.

Epithelium↗

PubMed1983

Uveal findings in patients with cutaneous melanoma.

A study Of the uveas of white patients with known cutaneous melanoma and white control subjects showed that patients with cutaneous melanoma had a significantly higher frequency of iris nevi (101 of 197 patients, 51%) than control subjects (58 of 147 subjects, 39%). The frequency of choroidal nevi was also higher in the group with cutaneous melanoma but the number (eight of 197 patients compared with two of 147 control subjects) involved was too small for statistical significance to be assessed. Patients with cutaneous melanoma, particularly women, had more skin nevi than did control subjects.

Choroid Neoplasms↗

PubMed1982

Studies in prognostic factors relating to chemotherapy for advanced gastric cancer.

The prognostic value of pretreatment information relating to prior treatment, demography, physical status, symptoms, disease involvement, pathologic, immunologic, and clinical chemistries were analyzed for a series of 322 patients with advanced gastric cancer. All patients received chemotherapy upon entry into Gastrointestinal Tumor Study Group protocols which were active between 1975 and 1978. Multivariate models were used to study relationships between prognostic factors and survival for all patients and objective tumor resonse for a subset of 137 patients with measurable disease. The initial performance status was a leading determinant of survival (P less than 0.0001). In addition, new summary measures relating to blood chemistries (P less than 0.01) and differential counts (P less than 0.001) were shown to influence patient survival. Blood chemistry parameters included SGOT, total serum protein, and total direct bilirubin while differential counts included absolute granulocytes, lymphocytes, and monocytes. Thus, the initial performance status, measurable disease status, blood chemistries, and differential counts are recommended as stratification factors in the design and analysis of trials involving patients with advanced gastric cancer. The initial performance status was examined in relation to other pretreatment data. The performance status at study entry correlated independently with the degree of weight loss (P less than 0.001), blood chemistries (P less than 0.01), differential counts (P less than 0.05), and peritoneal metastases (P less than 0.05). The measurable and nonmeasurable subgroups were compared with respect to baseline characteristics. Patients with measurable disease had more liver metastases (56 versus 35%) and less peritoneal metastases (76 versus 49%) than patients with nonmeasurable disease. Controlling for the imbalance in liver and peritoneal metastases, the presence of measurable disease was less favorable than nonmeasurable disease with respect to survival. Regarding the pathways of disease spread, there was a strong correlation (P less than 0.001) between primary tumor site within the stomach and location of metastases. Diffuse lesions were associated with the lowest frequency (25%) of liver metastases. Diffuse lesions (58%) and tumors of the pyloris (54%) were associated with the highest percentage of peritoneal metastases. Tumors of the cardia or fundus were more likely to metastasize to the liver while diffuse tumors were more likely to spread to the peritoneum. Pretreatment factors under study did not appear to be the dominant factors responsible for prolongation of survival in patients with an objective tumor response. Pretreatment factors predicted a three week advantage; however, a 22 week advantage was observed for responders over nonresponders.

Adenocarcinoma↗

PubMed1982

Absolute granulocyte, lymphocyte, and moncyte counts. Useful determinants of prognosis for patients with metastatic cancer of the stomach.

Pretreatment absolute granulocyte (less than 6,000/cu mm), lymphocyte (greater than 1,500/cu mm), and monocyte (300 to 900/cu mm) counts are three independent indicators of good prognosis for patients with metastatic gastric cancer. There tests improve the prediction of survival significantly compared with estimates based on ambulatory status alone. If the patient is completely ambulatory, median survival (MS) is 27.6 weeks, and it improves further to 37.6 weeks if results of two hematology tests indicate a good prognosis. If the patient is partially ambulatory, MS is 16.2 weeks; however, if results of two blood tests indicate a good prognosis, MS is 25.7 weeks, and if two tests indicate a poor prognosis, MS is only 11.1 weeks. The model corrected a false assessment of a poor prognosis for 56% of all patients.

Clinical Trials as Topic↗