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PubMed1976

Tumorigenicity of tetramethylhydrazine hydrochloride in Swiss mice.

Tetramethylhydrazine hydrochloride (TEMH) was administered in drinking water as a 0.125% solution to randomly bred Swiss mice for life beginning at 6 weeks of age. As a result of treatment, the incidence of blood vessel tumors rose from 5 to 96% in females and from 6 to 88% in males, while that of lung tumors increased from 21 to 36% in females and from 23 to 28% in males, as compared with untreated controls. The increased incidence of blood vessel tumors, but not of lung neoplasms, was statistically significant. Histopathologically, the tumors exhibited the characteristics of angiomas and angiosarcomas of blood vessels and adenomas of the lung. The investigation proved for the first time the tumorigenicity of TEMH. The possible role of increased methyl substitution on hydrazine in tumorigenesis was also discussed, as well as hydrazine derivatives as a tumor-producing class.

Adenoma↗
PubMed2002

Generating longitudinal screening algorithms using novel biomarkers for disease.

Recent advances in molecular technology are leading to the discovery of new tumor biomarkers that may be useful for cancer screening and early diagnosis. Translating a potential screening biomarker from the laboratory to its use in patient care may require an algorithm or screening rule for its application. An algorithm that can detect the smallest deviation from a defined norm is likely to achieve the highest sensitivity, but any practical screening algorithm must do so with strict controls on test specificity to avoid false-positive results, and unnecessary patient alarm and risk. Longitudinal algorithms that make use of previous tumor marker values and trends are likely to obtain improvements over single threshold rules. Thus far, a few longitudinal screening algorithms have been proposed (e.g., using serial prostate-specific antigen values for the detection of prostate cancer and serial CA125 values for the detection of ovarian cancer), but these algorithms are not appropriate for novel tumor marker discoveries, because they rely on unverifiable assumptions that may not translate to the behavior of the new marker. The algorithm presented here is motivated by: (a) the need to develop an algorithm for early detection using novel markers; (b) the practical demands on data and specimen availability; and (c) the need to be robust enough to accommodate a wide range of tumor growth behavior. We use Parametric Empirical Bayes statistical theory to model the trajectory of markers over time in a cohort of asymptomatic healthy subjects, and use the estimated trajectory to produce person-specific thresholds that depend on the screening history of each person. The thresholds are chosen to give the person (or population) a specified false-positive rate. The resulting algorithm is simple and can be represented in a simple graph or a chart. The statistical analysis needed to generate the algorithm can be found in nearly every basic statistical package. The algorithm is highly robust and can detect a wide range of tumor behaviors. The Parametric Empirical Bayes screening algorithm should take a central role when evaluating marker discoveries for use in screening. The algorithm is particularly useful when screening with a new marker of which the behavior in the preclinical period is not well known.

Algorithms↗
PubMed1986

The perceived clinical value of NMR measurements on biopsy specimens. Part I. Interval estimates of diagnostic error rates and a note on an effect of the law of small numbers.

There are currently two conflicting views concerning the value of NMR measurements (in vivo and in vitro) of the proton T1 and T2 relaxation times in tissues, in discriminating between normal (Ca) and malignant (Ca) conditions. Damadian repeatedly asserted that a linear combination of these two measurements, the so-called malignancy index, can, "...discriminate between normal and cancer tissue on a case-by-case basis...considerably better than 90%" and thus "...the technique is now ready for use by pathologists as an adjunct to present methods of diagnosing malignancy." On the other hand, Hollis countered that, "Neither nmr nor any other method requiring surgical biopsy is likely to replace or even supplement the standard histopathological techniques." Part I of the present paper examines the relation between the first of these two views and the sample data presented in their support. Part I is a "cautionary tale" in which the procedures used by Koutcher to obtain point estimates of the misclassification rates from these data are shown to be incorrect. (These procedures are identical to those used two decades earlier by Ternberg in an advocacy of the diagnostic use of EPR measurements on biopsied tissues.) It is also shown that the interval estimates of the misclassification rates obtained from these data, which have not previously been reported, are large enough to embrace both views; these data are "user-friendly"--a characteristic of small samples. It is shown that, in accordance with the Tversky-Kahneman (1971) Law of Small Numbers, the disparity in the two views can be accounted for by, "...underestimates of the breadth of confidence intervals" (due to the small sample sizes) by each group. The appropriate statistical procedures for determining point and interval estimates of such misclassification rates are also described and illustrated with the Koutcher, data. Part II describes a Discriminant Analysis of these data. It is, of course, still possible that proton T1 and T2 measurements can be used to reliably distinguish between normal and malignant tissues since absence of evidence is not always evidence of absence for an effect.

Algorithms↗
PubMed2000

Immunohistochemical detection of p53 tumor-suppressor protein is a poor indicator of prognosis for canine cutaneous mast cell tumors.

Eighty-three canine cutaneous mast cell tumors were graded histologically and evaluated immunohistochemically for p53 tumor-suppressor protein expression. An avidin-biotin immunohistochemical protocol incorporated a rabbit polyclonal antibody (CM-1) directed against normal and mutant p53 protein. Positive staining was observed in 44.6% (37/83) of tumors and included 50% (12/24) of grade I (well differentiated) tumors, 46.9% (23/49) of grade II (intermediate differentiation) tumors, and 20% (2/10) of grade III (poorly differentiated) tumors. A statistically significantly higher proportion (P < 0.019) of tumors from the head and neck (83.3%, 10/12), stained positive for p53 than tumors from the thorax, back, abdomen, and axilla (39.4%, 13/33), legs (35.7%, 10/28), or prepuce, scrotal, or inguinal areas (44.4%, 4/9). No statistically significant difference between p53 labeling and histologic grade, breed, or tumor size was present. Survival data were available for 53/83 (63.9%) of dogs. Positive reactivity for p53 was observed in 47% (25/53) of tumors within this group, with 57.9% (11/19) of grade I, 43.3% (13/30) of grade II, and 25% (1/4) of grade III tumors labeled. Mean survival time for the 53 dogs was 12.1 months. The median survival time for dogs with grade III tumors or tumors >5 cm was statistically significantly shorter (P < 0.0001) than for dogs with grades I and II or smaller tumors. Although p53 protein abnormalities may play a role in tumor development or behavior in some canine cutaneous mast cell tumors, immunoreactivity was not associated with lack of tumor differentiation, tumor locations previously shown to demonstrate aggressive biological behavior, breed predisposition, or survival times.

Adenocarcinoma↗
PubMed2004

Karyometry detects subvisual differences in chromatin organization state between cribriform and flat high-grade prostatic intraepithelial neoplasia.

This digital texture analysis-based study evaluates the chromatin organization state in flat and cribriform high-grade prostatic intraepithelial neoplasia (PIN), in the adjacent normal looking secretory epithelium and in the co-occurring adenocarcinoma. Digital texture analysis (karyometry) was carried out on hematoxylin and eosin-stained sections from 24 radical prostatectomy specimens with high-grade PIN (12 with flat and 12 with cribriform architectural pattern, respectively) and cancer. Quantification was also conducted on the normal looking secretory epithelium. Discriminant analysis and the nonsupervised learning algorithm P-index were used to identify suitable subsets of features useful for the discrimination and classification of pathological groups and to explore multivariate data structure in the pathological subgroups. The average nuclear abnormality increases monotonically from the histologically normal appearing secretory epithelium to high-grade PIN and to adenocarcinoma. The nuclei from the so-called perimeter compartment of the flat high-grade PIN lesions show a higher nuclear abnormality compared to the nuclei of the cribriform high-grade PINs. Discriminant analysis shows that flat and cribriform high-grade PINs fall into two populations. Processing by the nonsupervised learning algorithm P-index revealed the existence of three well-defined, distinct subpopulations of nuclei of different chromatin phenotype. In the flat high-grade PIN lesions the proportions of nuclei in the three subpopulations are 16.5% (low abnormality), 25.0% (mid abnormality) and 58.5% (high abnormality), respectively. In the cribriform high-grade PIN lesions, 100% of the nuclei are in the mid-abnormality subpopulation. These differences are also discernible in the co-occurring adenocarcinoma and the histologically normal appearing secretory epithelium. To conclude, karyometry and statistical analysis detect the existence of distinct cell subpopulations of different chromatin packaging and phenotype, with the nuclei from the flat high-grade PIN lesions, adjacent normal looking epithelium and co-occurring adenocarcinoma expressing a greater nuclear abnormality than in the specimens with cribriform high-grade PIN.

Cell Nucleus↗
PubMed1981

Comparison of thrombelastography with common coagulation tests.

Thrombelastography, although proven as a useful research tool has not been evaluated for its clinical utility against common coagulation laboratory tests. In this study we compare the thrombelastographic measurements with six common tests (the hematocrit, platelet count, fibrinogen, prothrombin time, activated thromboplastin time and fibrin split products). For such comparisons, two samples of subjects were selected, 141 normal volunteers and 121 patients with cancer. The data was subjected to various statistical techniques such as correlation, ANOVA, canonical and discriminant analysis to measure the extent of the correlations between the two sets of variables and their relative strength to detect blood clotting abnormalities. The results indicate that, although there is a strong relationship between the thrombelastographic variables and these common laboratory tests, the thrombelastographic variables contain additional information on the hemostatic process.

Blood Coagulation Disorders↗
PubMed2004

Both pretreatment prostate-specific antigen level and posttreatment biochemical failure are independent predictors of overall survival after radiotherapy for prostate cancer.

PURPOSE: To assess the impact of pretreatment prognostic factors plus subsequent biochemical failure on overall survival after radiotherapy for prostate cancer. METHODS AND MATERIALS: We analyzed the prostate-specific antigen (PSA) and survival records of 1571 men with clinically localized prostate cancer treated with external beam radiotherapy monotherapy at the former Queensland Radium Institute between 1990 and 1997. The pretreatment PSA level, biopsy Gleason score, clinical stage, patient age, and the development of biochemical failure were assessed in relationship to overall survival and cause-specific survival, using fixed, as well as time-dependent, statistics. RESULTS: The median follow-up was 88.1 months (95 months for those still alive). The actuarial overall survival, cause-specific survival, and biochemical failure-free survival rate at 10 years was 61.1%, 80.9%, and 25.9% respectively. Cause-specific survival was independently influenced by the pretreatment PSA level, Gleason score, clinical stage, and the development of biochemical failure (relative risk, 19.1). Using the overall survival endpoint, multivariate analysis showed age, pretreatment PSA level, Gleason score, and biochemical failure (relative risk 1.27) to be statistically significant variables. CONCLUSION: In addition to previously identified factors, the pretreatment PSA level and occurrence of biochemical failure after radiotherapy for prostate cancer are associated with an increased overall mortality risk. Both pretreatment PSA level and posttreatment biochemical failure are independent predictors of overall survival after radiotherapy for prostate cancer.

Adult↗
PubMed1981

[Prognostic histopathological features of cutaneous malignant melanomas. New statistical approach (author's transl)].

The records of 203 Cutaneous Malignant Melanomas treated at the Centre René Huguenin in Saint-Cloud from october, 1959 to december, 1978 were reviewed. The histologic data were reexamined and 155 cases were retained. Previously classified according to the histologic type and the invasion level of Clark, they were evaluated according to the thickness of the tumor by the ocular micrometer in 100 ths of a millimeter, as was done by Breslow. Other histologic data were collected for each case. Clinical and therapeutic informations and carcinologic events were gathered together. From this research, 155 cases were proved significant in accordance with Multifactorial Statistic Analysis. This study pointed out significant facts: 1) The thickness of the tumor is the utmost important factor, i.e. correlative with survival rate, recurrence and metastasis. 2) Starting with a short number of histologic and clinical variables it seems possible to draw a profile of a patient with cutaneous malignant melanoma and to obtain a precise prognosis and so prepare complementary treatment.

Humans↗
PubMed1995

The effects of calcium antagonists on anthrone skin tumor promotion and promoter-related effects in SENCAR mice.

The present study investigated a possible role for Ca2+ in skin tumor promotion by anthrones. This was accomplished by testing the effects of two Ca2+ antagonists, verapamil and 3,4,5-trimethoxybenzoic acid 8-(diethylamino) octyl ester (TMB-8), on tumor promotion and promoter-related effects induced by the anthrone chrysarobin in SENCAR mice. Verapamil and TMB-8 both effectively inhibited epidermal ornithine decarboxylase (ODC) induction by a single application of chrysarobin. Both Ca2+ antagonists inhibited anthrone-induced skin edema and epidermal hyperplasia. Additionally, both verapamil and TMB-8 slightly inhibited (20-21% at the highest doses) tumor promotion with chrysarobin. Although the inhibition by both Ca2+ antagonists was not statistically significant (P > 0.05) in either case, the fact that both compounds produced a similar inhibition suggests that this effect may be biologically relevant. Collectively, the data suggest a possible role for Ca2+ in the process of skin tumor promotion by anthrones.

9,10-Dimethyl-1,2-benzanthracene↗
PubMed1987

Combination chemotherapy using adriamycin, DTIC, cyclophosphamide, and actinomycin D for advanced soft tissue sarcomas: a randomized comparative trial. A phase III, Southwest Oncology Group Study (7613).

The term soft tissue sarcoma refers to a large variety of malignant tumors arising in extraskeletal connective tissues that connect, support, and surround discrete anatomic structures. All visceral organs also contain a connective stroma that can undergo malignant transformation. Because of the histological similarities of this group of tumors and their relative rarity, treatment prescriptions for patients that have disseminated disease are most often uniform. In this study, we asked the question whether adding a third drug (cyclophosphamide or actinomycin D) to Adriamycin (Adr [Adria Laboratories, Columbus, OH])-(3,3-dimethyl-1-triazeno)- imidazole-4-carboxamide (DTIC) would improve the response rate and/or survival. A unique feature of this cooperative group clinical trial was the mandatory pathology review of the histological material. All patients of the Southwest Oncology Group between June 1, 1976, and November 17, 1979, who had a biopsy-confirmed diagnosis of a soft tissue sarcoma with convincing clinical or biopsy-documented evidence of metastatic disease were eligible for the study. Patients were randomized to receive (1) Adr, 60 mg/m2 intravenously, day 1, and DTIC, 250 mg/m2 every 3 weeks (104 patients); (2) Adr and DTIC as in (1) and cyclophosphamide, 500 mg/m2, day 1 (112 patients); or (3) Adr and DTIC as in (1) and actinomycin D, 1.2 mg/m2, day 1, (119 patients). There was no statistically significant difference in response rates (33%, 34%, and 24%) (P = .25). Median durations of response were 31 weeks in the Adr-DTIC arm, 26 weeks in the cyclophosphamide-DTIC-Adr arm, and 23 weeks in the Adr-DTIC-Actinomycin D arm (P = .78). Median durations of survival were 37, 42, and 50 weeks, respectively. Again, no statistically significant differences were observed (P = .59). Toxicities from each of these treatment arms were formidable and were equivalent. Prognostic factor analysis showed a prognosis based on bone marrow reserve, sex, and pathology subtype favorable to patients.

Adolescent↗
PubMed1984

[Nonsense--and sense?--in cause-of-death statistics. A validation study to test cancer mortality figures].

Death certificates for all clinics of the University of Heidelberg are centrally filled in at the University Pathology Institute. The certificate which accompanies the body gives the information for the official death certificate. There were 6263 autopsies between 1974 and 1978. The entry in the death certificate was compared with the complete morbid-anatomical diagnosis. Sensitivity and positive correctness showed many errors, the proportion of false-negative diagnoses being nearly three times higher than false-positive ones.

Autopsy↗
PubMed1994

Statistical analysis of data from the Third International IALSC Workshop on Lung Tumor and Differentiation Antigens.

The main aim of the statistical analysis of data collected in the Third International IALSC Workshop on Lung Tumor and Differentiation Antigens, was to identify groups of monoclonal antibodies (MAbs) having similar profiles of reactivity against a variety of cell types in flow cytometry, histology, immunofluorescence and immunocytochemistry experiments. This was achieved through cluster analysis. We describe the methods used in the cluster analysis, and in the data processing leading to it.

Antibodies, Monoclonal↗
PubMed1979

Discriminant analysis on cells from developing squamous cancer of the respiratory tract.

Cytologic preparations made from the tracheobronchial tree taken by the Schreiber catheter have been scanned by three color microphotometry. The digitized cell images were processed by the analytical cytodiagnostic programs of the TICAS system. Cells were sorted into two control groups and five groups of increasing atypia ranging from normal epithelium to invasive squamous cell carcinoma. Standard statistical tests, including Wilk's Lambda, Rao's V, and the Kruskal-Wallis tests are performed on these subsets of cell image features. This study demonstrates that discriminant analyses permit differentiation between normal cells and those from marked atypia or carcinoma and that the classification achieves a high degree of agreement with visual assignment.

Animals↗
PubMed1995

The influence of history on interobserver agreement for diagnosing actinic keratoses and malignant skin lesions.

BACKGROUND: Quantifying interobserver diagnostic agreement is necessary to evaluate skin cancer screening programs, but estimates of variability are incomplete. OBJECTIVE: We sought to measure agreement between dermatologists for diagnosing actinic keratoses (AKs) and malignant skin lesions and to determine the way in which blinding examiners to patient history affects agreement. METHODS: We varied the amount of historical information available to examiners in two consecutive patient series (n = 50) presenting to a Veterans Affairs Medical Center dermatology clinic. Two dermatologists examined each patient independently. RESULTS: Assessing historical features increased the kappa statistic for malignancy recognition from -0.04 to 0.76. kappa Statistics for diagnosing single AKs were 0.17 and 0.15, respectively, and 0.62 and 0.55 for multiple AKs. CONCLUSION: Agreement was high for diagnosing malignant skin lesions when history was included in the evaluation. Agreement for multiple AKs was higher than for single AKs, although neither was influenced by inclusion of historical features.

Aged↗
PubMed1989

Grading of soft tissue sarcomas: necrosis as a determinant of survival.

All cases of sarcomas of soft tissue occurring in males age 20-79 in Western Washington from 1981 to 1984 were studied with respect to the influence of multiple clinical, gross, and histologic parameters in predicting survival. Among histologic parameters studied, a strong and statistically significant association of necrosis of more than 15% of the tumor with death was observed. This effect was seen even when controlling for the influence of histology, site, stage of disease, and other factors. It is concluded that necrosis can serve as a prognostically relevant criterion for separating aggressive (nongrade 1) soft tissue sarcomas into intermediate grade (grade 2) and high grade (grade 3) tumors.

Adult↗
PubMed2003

Rectal resection with low anastomosis: functional outcome.

OBJECTIVE: Function after anterior, low anterior and intersphincteric resection for rectal cancer was studied. METHOD: Of 139 patients 122 responded to a standardized questionnaire (Cleveland Clinic Continence Score) 108 +/- 46 weeks postoperatively and 70 underwent anorectal manometry at 26 +/- 15 weeks. RESULTS: The postoperative continence score was dependent on the procedure (anterior resection 4.1 +/- 4.6, low anterior resection 6.9 +/- 5.6, intersphincteric resection 11.5 +/- 5.2; P < 0.0001). It was poorer after radiochemotherapy (9.0 vs. 5.7; P = 0.030), but after colonic pouch reconstruction there was no significant difference between low anterior resection (5.6 vs. 7.3) and intersphincteric resection (10.0 vs. 12.5). Mean and maximal resting pressures were significantly reduced after intersphincteric resection (24 +/- 9 and 40 +/- 13 mmHg, respectively, P < 0.001) and further reduced by radiochemotherapy. Squeeze pressure was unaffected by the operative procedures and radiochemotherapy. Maximum tolerable volume and rectal compliance were reduced, after both low anterior and intersphincteric resection. Statistical correlation between continence score and maximal resting pressure (P = 0.014), mean resting pressure (P = 0.002), urge volume (P = 0.037), and neorectal compliance (P = 0.0018) reached significance. Satisfaction with the functional outcome was expressed by 71% of patients. CONCLUSION: After rectal resection the degree of impaired continence depended on the operative procedure and the form of reestablishment of intestinal continuity. Radiochemotherapy affected the outcome adversely. Despite reduced function, overall patient satisfaction was high.

Adenocarcinoma↗
PubMed1964

A STATISTICAL REVIEW OF CARCINOMA OF THE LIP.

Among 3166 patients with microscopically confirmed squamous cell carcinoma of the lip registered at The Ontario Cancer Treatment and Research Foundation's Regional Clinics in 1938-1955, the five-year crude survival rate was 65%, and the five-year net survival rate 89%. Survival was influenced by age, site and size of primary lesion, local and regional invasion, long delay, and treatment method. The initial treatment appeared to control the primary lesion in 84% of cases and involved lymph nodes in 58%. The net survival rates improved over the survey period. Findings confirm the usefulness of the proposed TNM staging.

Biomedical Research↗