The cost-effectiveness of community care for former long-stay psychiatric hospital patients.
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Biomedical subjects
Publications and source records attributed to J Beecham.
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Twenty-eight patients with advanced, measurable squamous carcinoma of the uterine cervix were treated with 62 courses of esorubicin at doses ranging from 20-35 mg/m2 every three weeks. All patients were evaluable for response and toxicity. All patients had received prior therapy including radiation therapy in 28, chemotherapy in 23, and surgery in 11. All patients were Gynecologic Oncology Group (GOG) performance status 0, 1 or 2. There were no responses seen. Severe (grade 3 or 4) leukopenia, thrombocytopenia, and anemia were seen in 13, 3, and 9 patients, respectively. Gastrointestinal toxicity as well as alopecia were the other adverse effects. Mucositis and phlebitis were not seen. Neither clinical congestive cardiomyopathy nor decrement in left ventricular ejection fraction was observed. Lack of response in association with moderate toxicity using this dose and schedule of esorubicin in squamous carcinoma of the cervix previously treated with chemotherapy makes further study as a salvage agent unwarranted.
One hundred eighty-six patients with minimal residual Stage III ovarian cancer (tumor mass less than or equal to 3 cm) were treated in a prospective randomized protocol (melphalan with or without Corynebacterium parvum). As per protocol 84 patients were eligible and underwent a second-look laparotomy with 41 (49%) having negative findings for persistent malignancy. Factors which affected survival after second look were presence or absence of macroscopic disease, age, and grade. Depending upon these prognostic factors, survival at 4 years after second look ranged from 31 to 100%. The role of second-look laparotomy is examined relative to these results.
Peritoneal cytology has been shown to be one of the prognostic factors in endometrial cancer. A series of 134 patients was seen between January 1977 and March 1985 with clinical Stage I (or treated as a clinical Stage I) endometrial adenocarcinoma at the University of Rochester Cancer Center. The majority of patients underwent extrafascial hysterectomy with the majority of washings obtained at the time of surgery. Fourteen percent (19/134) of the patients were found to have positive cytology. Eleven patients with positive cytology (11/19) were treated with local-regional pelvic treatment; the other eight patients received whole abdominal therapy. The recurrence rates were less with the local treatment than with the whole abdominal treatment groups (9.1% vs. 25%) in those patients having positive cytology. There was no statistical difference in recurrence rates between the pathologic Stage I patients with positive cytology (10%) versus those patients having negative cytology (5%), nor was there statistical difference in survival between pathologic Stage I positive or negative cytology patients. It is suggestive from this non-randomized study that positive cytology in endometrial cancer is not an independent prognostic factor and that whole abdominal irradiation did not influence outcome.
In patients with stage IB cervical carcinoma (carcinoma confined to the cervix), accurate staging is essential in order to determine the best treatment strategy--that is, whether to use surgery alone or surgery in combination with pre- or postsurgical radiation therapy. Currently, decisions regarding the management of patients are made on the basis of clinical staging that has an error rate of 34-39% (when surgical staging is used as the standard). To investigate the value of MR in staging patients with IB cervical cancer, we performed prospective MR examinations in 27 patients who had cervical carcinoma. Of these, 10 were clinically staged as having IB cervical carcinoma and underwent radical hysterectomy, providing specimens for pathologic correlation. In six of these 10 patients, the extent of disease had been underestimated during clinical examination under anesthesia. These six patients would have received radiation therapy before surgery had the MR information been used at the treatment-planning stage. MR imaging correlated better with surgical pathology than did clinical examination under anesthesia in determining the location and extent of tumor. MR imaging should be used in conjunction with clinical staging to determine appropriate therapy in patients with stage IB cervical carcinoma.
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Murine monoclonal antibodies (MCAs) against human ovarian tumor associated antigen NB/70K have been prepared. One of these MCAs, NB12123, was chosen for the development of a radioimmunoassay for measuring serum NB/70K levels. In this assay, the average NB/70K level in 75 normal, healthy controls was 11.9 activity units (AU) with an SD of 14.9 AU. The normal cut off value for this assay was set at 45 AU (mean +2 SD). 24 of 46 (52%) ovarian cancer patients, 7 of 18 (39%) patients with benign ovarian cysts or tumors and 3 of 85 (4%) control samples had elevated serum NB/70K levels. Comparison of NB/70K levels measured in the NB12123 assay with levels measured in an assay using a polyclonal antiNB/70K previously developed in our laboratory [13] indicated that although both assays had approximately the same percentage of positive ovarian cancer patient samples, there appeared to be no correlation between the absolute NB/70K levels measured by the two assays. The rank of ovarian cancer patient samples was also different for the two assays. Also, almost 40% of patients with benign ovarian cysts and tumors had elevated serum NB/70K levels as measured by the NB12123 assay as compared to 0% for the polyclonal assay. Reciprocal cross-blocking experiments, absorption studies, and immune precipitate analysis indicated that both the monoclonal NB12123 assay and the polyclonal antiNB/70K assay measured the same population of NB/70K molecules. However, the polyclonal antibody recognizes epitopes in addition to that recognized by NB12123. Taken together, these results suggest that the epitope recognized by NB12123 is not as specific for malignant ovarian tumors as the epitope(s) recognized by polyclonal antiNB/70K and/or that more than the one epitope detected by the MCA is responsible for the specificity for ovarian cancer of the polyclonal NB/70K assay. In spite of this, the greater sensitivity and range of the monoclonal NB12123 assay make it possible to monitor serum NB/70K levels in ovarian cancer patients. In four patients examined, the fluctuating serum NB/70K levels appeared to correlate well with clinical status.
A randomized prospective therapy trial in patients with stage III optimal epithelial carcinoma of the ovary was accomplished by the Gynecologic Oncology Group. Therapy with melphalan or melphalan plus immuno-adjuvant, Corynebacterium parvum (C. parvum), was utilized as adjuvant treatment following surgical therapy. One hundred eight-five patients were eligible for evaluation with 87 patients in the melphalan group and 98 patients in the melphalan plus C. parvum group. The comparison of the treatment regimens showed no differences with respect to either progression-free interval or survival. However, it should be noted that a 50% 3-year survival was obtained. A group was identified, using four prognostic factors that had 80% survival at 3 years. Maximum size of the residual tumor, as well as performance status, was not prognostically significant. This study demonstrates a lack of efficacy of the addition of C. parvum to melphalan for this patient population.
The defined, purified ovarian cancer-associated antigen, NB/70K, was used as tumor antigen in the humoral leukocyte adherence inhibition (H-LAI) assay. Bell-shaped dose-response relationships were obtained with increasing concentrations of NB/70K and constant serum concentration from ovarian cancer patients. The concentrations of NB/70K used in this study were 100-250 times less than what had been used in previous H-LAI studies with crude antigen extracts. The response rate of ovarian cancer patients was greatly influenced by the stage of the disease. Thus 75% (6/8) of the patients with disease restricted to the pelvis (stages I and II) reacted while only 20% (5/24) of the patients with more advanced stages (stages III and IV) gave response. Of patients with other gynecological cancers, 17% (1/6) were positive and only 8% (1/13) of patients with other malignant diseases reacted. One of the 11 controls (9%) was found to give positive response. The importance of the present investigation was the finding that a defined, purified, cancer-associated antigen elicited reactivity in the H-LAI assay and that a high sensitivity for detection of early stages of ovarian cancer was obtained with this antigen. The results suggest that TAAs involved in immune recognition of cancer can be identified by the H-LAI assay.
After hysterectomy, 156 evaluable patients with stage I (limited to the corpus) or stage II (limited to the corpus and cervix) uterine sarcomas were randomly assigned to adjuvant chemotherapy with Adriamycin (Adria Laboratories, Columbus, Ohio) for six months or to no further treatment. Pelvic irradiation (external or intracavitary) was optional before randomization. Of 75 patients receiving Adriamycin, 31 have suffered recurrences compared with 43 of 81 receiving no adjuvant chemotherapy. This difference is not statistically significant. Moreover, there is no difference in progression-free interval or survival. The optional radiotherapy did not influence the outcome although there was a suggestion that vaginal recurrence was decreased by pelvic radiotherapy. The recurrence rates in specific cell types (leiomyosarcoma, homologous mixed mesodermal sarcoma, or heterologous mixed mesodermal sarcoma) were not significantly different although the pattern of recurrence differed, with pulmonary metastases being more common in leiomyosarcoma and extrapulmonary recurrence being more common in mixed mesodermal sarcoma. The outcome with respect to chemotherapy was not altered even after adjusting for maldistribution of cases. Thus, we could not show a benefit for this dose schedule of Adriamycin as adjuvant treatment for uterine sarcomas.
Thirty-six patients with advanced carcinoma of the cervix received PALA at a dosage of 5 gm/m2 every three weeks. Thirty-three patients had received prior irradiation therapy and chemotherapy. No complete or partial responses were seen. The major toxicity was dermatologic and occurred in 16/36 (44%) of patients. Three patients experienced dose limiting disorientation or confusion. PALA was not associated with any antitumor activity in patients with advanced carcinoma of the cervix who had received prior chemotherapy. The results of this study indicate that PALA has no substantial activity in patients with advanced squamous carcinoma of the cervix who have previously received chemotherapy.
Twenty-nine patients with advanced ovarian carcinoma were entered into a Gynecologic Group Phase II study of Baker's Antifol. Of these, 26 were eligible for evaluation of toxicity and 25 for evaluation of response. The evaluable patients constituted an unusually favorable group for a Phase II study in a chemotherapy-sensitive tumor; although all have received prior chemotherapy, eight had had treatment with only a single alkylating agent and the median performance status of the study population was two (ambulatory, capable of self-care). No complete responses were seen. Two patients had regression of abdominal tumor masses sufficient to qualify as partial responders (PR 8%). Dose-limiting toxicity, as expected, was found to be gastrointestinal. Significant mucositis and dermatitis were also observed. No episodes of hypotension during infusion occurred with a 60-120 min time of administration. Baker's antifol has only limited activity against ovarian carcinoma previously treated with chemotherapy and is not likely to contribute to improved therapy, either as a single agent or in combination.
Numerous specimens of a mite, Ursicoptes americanus Fain and Johnston, 1970 (Acari: Audycoptidae), were found in skin scrapings from an aged female black bear, Ursus americanus, afflicted with a severe generalized mange. The mite had not been found previously in association with clinical dermatitis. The male, nymph and larva of Ursicoptes americanus, heretofore unknown, are described and the generic diagnosis is amplified. Discovery of the male aids in resolving the questionable taxonomic status of the family Audycoptidae.
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Glucose, insulin, glucagon and fructosamine were measured in the plasma of control (n = 34) and of Rh fetuses (n = 22) before the first and subsequent transfusion. Prior to treatment, Rh fetuses, compared to controls, had raised concentrations of glucose (p = 0.01), glucagon (p = 0.04) and fructosamine (p = 0.004). Fetal insulin levels were not significantly different. Before subsequent transfusion, despite correction of anemia, Rh fetuses were clearly hyperinsulinemic even after correction for gestation (p = 0.002) and had low glucagon concentrations (p = 0.01) when compared with values at the first transfusion. This metabolic milieu appears similar to that of fetuses of diabetic mothers which have increased plasma glucose and insulin during most of the last third of gestation.