Ethics of undisclosed payments to doctors recruiting patients in clinical trials.
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Biomedical subjects
Publications and source records attributed to L J Sant Cassia.
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The records of 208 women were reviewed to quantify the long-term treatment failures of large loop excision of the transformation zone (LLETZ) in the treatment of cervical intraepithelial neoplasia (CIN) grade III. The rate of dyskariotic smears fell from 8% at 6 months to 2.3% at 48 months. The excision was considered incomplete in 84 cases (40.3%) of which 40 had endocervical margins involved. Thirty-five per cent of women with incomplete excision of CIN at the endocervical margin and 9% with complete excision had a dyskariotic smear within 4 years following LLETZ. These findings were statistically significant (P = 0.003 and 0.02 respectively). However, 5% only of women in the former group had cytological treatment failure at 6 months. There was no significant association between age and incidence of treatment failure. Further data are required to determine the risk of recurrence beyond 4 years before recommendations could be made about the duration of annual screening.
Management of early endometrial carcinoma is controversial in regard to timing and indication of adjunctive radiation therapy. Two hundred eighty patients with stage I carcinoma of the endometrium are analyzed: 135 patients were treated with surgery only and 61 patients underwent preoperative and 83 patients postoperative radiation therapy. The overall survival was 94%. Recurrence rates in all three treatment arms were equal. Tumor grade was found to change from the diagnostic D&C specimen to the definite surgical specimen in 31% of all cases and in 50% of all grade 3 lesions. As only 39% of all patients required postoperative radiation therapy with equal survival, a primary surgical approach spares the majority of patient unnecessary treatment and preserves prognostically important histology.
Seventy-nine patients with evaluable epithelial ovarian cancer following primary laparotomy and treated with one of three primary cis-platinum-containing regimens were studied to determine the rate at which clinical cytoreduction occurred and whether a rapid response to treatment was of prognostic significance by improving progression free interval (PFI) or survival. A rapid response to treatment improved PFI in patients treated with single agent cis-platinum (P = 0.04) and increased survival in patients treated with a sequential cis-platinum based combination regimen (P = 0.03). The rate of cytoreduction was not a significant variable, however, in a multiple regression analysis of prognostic factors. Over 75% of all clinical responses, regardless of the regimen, had begun by the completion of the third course of chemotherapy. We conclude that response to active chemotherapy is a rapid phenomenon in ovarian cancer and this has important implications in both the decision to change drug therapy and the timing of further surgical effort.
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