Summary Results using the same drug in phase II studies of treatment in ovarian cancer vary widely. An analysis of five phase II studies with a total of 93 patients was carried out to determine whether factors other than the efficacy of the drug affect response. The drugs for the phase II studies were chosen on the basis of in vitro activity or previous activity in humans. Univariate analysis showed that several factors were of significance in predicting response. The most significant was interval from the end of previous treatment to entry into a phase II study. Others were the original presenting stage of the patient, the second line treatment given and the best previous response to therapy. In multivariate analysis, however, only two factors were shown to be of importance which were interval and the FIGO stage of the patient. Using these two variables the discriminant analysis predicted 89% of those who did not respond and 75% of those who did, with an overall correct prediction of 85%. The importance of interval is emphasised by the observation that the response rate for those patients who progressed on treatment or who relapsed within 3-6 months of primary therapy had a response rate of <10%. Future phase II studies should probably exclude patients in this category, since the chance of their responding is very low.The outlook for patients suffering from advanced ovarian cancer is poor, with fewer than 20% of patients with stage 3 or stage4 disease surviving more than 5 years (Katz et al., 1981). The disease is sensitive to chemotherapy but in advanced disease the role of chemotherapy is palliation in the majority of patients (Neijt et al., 1986).Since the majority of patients will respond to established chemotherapy agents, it is difficult ethically to evaluate new agents as first line treatment. Evaluation of new agents is confined to patients relapsing or progressing at the end of primary therapy. Studies of a wide range of chemotherapeutic agents have shown widely varying results (Ozols & Young, 1984). In studies of cisplatinum, for example, response rates in the range of 15-50% have been observed (Thigpen & Blessing, 1985) and in evaluations of the anthracenedione mitoxantrone response rates from 0 to 28% have been seen (Lawton et al., 1978a;Muss et al., 1984;Hilgers et al., 1984).Such variations in response rates suggest that factors other than the activity of the drug may be involved in determining whether a patient is likely to show response to a new drug. This has implications for the evaluation of new drugs, and may explain why some studies have failed to detect active drugs.In an attempt to identify whether such factors exist we have examined retrospectively a group of patients from this centre treated in a number of phase II studies over a period of 4 years. We have aimed to identify factors which predict patients who will respond to chemotherapy. Patients and methodsA total of 92 patients were entered into five phase II chemotherapy trials from 1983 to 1987 (Lawton et al., 1985(Lawton et al., ,...
Drugs that affect the angiogenic activity of platelet-derived endothelial cell growth factor offer a potential route for therapeutic intervention.
We compared endometrial thickness and volume in patients with postmenopausal bleeding, and examined the value of each parameter in differentiating between benign and malignant endometrial pathology. A total of 103 patients with a history of postmenopausal bleeding were recruited into the study. Patients who were taking hormone replacements therapy or other hormonal preparations with a known effect on the endometrium were excluded. Each patient underwent three-dimensional ultrasonography for the measurement of endometrial thickness and volume. In 97 cases both of these measurements were obtained and the results were compared to the histological diagnosis after endometrial biopsy or dilatation and curettage. Endometrial cancer was diagnosed in 11 patients. The mean endometrial thickness was 29.5 mm (SD 12.59) and the mean volume was 39.0 ml (SD 34.16). In the remaining 86 patients there were eight cases with endometrial hyperplasia and seven with endometrial polyps. The endometrial thickness and volume in patients with benign pathology was 15.64 mm (SD 5.26) and 5.47 ml (SD 6.32), respectively. In 71 patients with atrophic or normal endometrium the mean thickness and volume was 5.29 mm (SD 3.97) and 0.91 ml (SD 1.71), respectively. Receiver operating characteristic curves showed endometrial volume to be superior to endometrial thickness for the diagnosis of endometrial cancer. The optimal cut-off value of endometrial thickness for the diagnosis of cancer was 15 mm, with the test sensitivity of 83.3% and positive predictive value of 54.5%. With the cut-off level of 13 ml for endometrial volume measurement the sensitivity was 100% and the positive predictive value 91.7%. Both the thickness and volume were higher in patients with advanced and less differentiated cancers. The measurements of endometrial volume was superior to that of endometrial thickness as a diagnostic test for the detection of endometrial cancer in symptomatic postmenopausal women.
Objective To study whether intervention debulking surgery improves survival in patients with Design A prospective multicentre randomised study.Setting Hospitals in the West Midlands. Subjects Ovarian cancer patients with bulky residual disease after primary surgery who areMethods Eligible patients were randomised to receive combination chemotherapy alone or Main outcome measure Survival was assessed using product limit method and log-rank test.Results Seventy-nine patients were entered into the study. Thirty-seven patients were randomised to intervention debulking surgery, 25 (67 %) of whom underwent intervention debulking surgery, which was performed a median of 13 weeks after primary surgery. The median survival for the intervention debulking surgery group was 15 months (95 % CI 10-20 mo) and that of those randomised to chemotherapy alone, which was 12 months (95% CI 8-16 mo), were not significantly different (hazard ratio = 0.71; 95% CI 04-1.13). Conclusion Intervention debulking surgery may not improve survival in patients with advanced ovarian cancer.advanced ovarian cancer who have bulky (> 2 cm) residual disease after primary surgery.considered well enough to receive cis-platinum based chemotherapy and further surgery.combined with intervention debulking surgery.
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