Phase II trial of 6-thioguanine in metastatic breast cancer.
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Biomedical subjects
Publications and source records attributed to J Crowley.
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Groups of female Fischer rats received 500 rads of gamma-irradiation and were maintained in hormone states that promoted or inhibited lactation. Chronically lactating rats developed no mammary tumors. Rats did not lactate or lactated acutely during the period surrounding irradiation developed similar numbers of carcinomas.
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The shape of the curve relating carcinogen dose to the number of animals developing neoplasms is reexamined; a family of curves relating expected tumor incidence to carcinogen dose, if tumors arose from one cell or two or more interacting cells, is calculated; and how closely these curves correspond to reported radiation dose inrelation to mammary tumor incidence is tested. The results are in conflict with the conclusion of Rossi and Kellerer that the induction of mammary tumors in Sprague-Dawley rats is dependent on the action of neutron radiation on more than one cell. Indeed, there appears to be no reason to reject the simplest hypothesis that one transformed cell is sufficient to produce a mammary tumor.
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This note presents theoretical and numerical calculations which investigate the adequacy of the sigma(0 -- E)2/E approximation (Peto and Pike [1973]) when applying the Mantel/Haenszel summary chisquare statistic to the comparison of r life tables in the manner suggested by Mantel [1966], Peto and Peto [1972], and Cox [1972]. These indicate that conservatism is mild unless there are marked differences in the withdrawal patterns in the r tables. Such differences may, however, be anticipated in the case of a generalization of the life table procedure suggested by Crowley [1973], Mantel and Byar [1974], and Turnbull, Brown, and Hu [1974], wherein individuals are moved from one life table to another according to changes in their treatment (or other) statuses.
We have described the isolation of Mycobacterium chelonei subspecies abscessus which on two occasions grew out within 4 days in routine cultures after inoculation with purulent material from injection abscesses in a patient with diabetes mellitus. Media isolation and culture characteristics of this organism in comparison to others in the Mycobacterium fortuitum complex are described. Mycobacteria in routine laboratory media can be mistaken for diphtheroids or other "contaminants" or can be overlooked entirely. The possibility of clinical infection of mycobacterial species should be kept in mind when confronted with "sterile" abscesses at injection sites.
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Data Monitoring Committees in the Southwest Oncology Group comprise the study leadership and the leadership of the Group, augmented by some outside representation. The early stopping guidelines used by these committees are explicit in each protocol, and can be characterized as specifying a few interim analyses at conservative statistical levels. We describe our ten years of experience with this system, and give examples of different trials which have stopped either for positive or negative results.
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