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Vaginal cytology as an aid to hormone therapy in postmenopausal cancer of the breast.
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The thermoprofile as an early indicator of breast cancer response to hormonal therapy.
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Acute leukemia complicating metastatic breast cancer.
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Plasma prolactin responses to thyrotropin-releasing hormone in patients with breast cancer.
Plasma human prolactin levels were measured by homologous radioimmunoassay in patients with primary breast cancer and in normal women of similar age. In normal controls mean (+/- SEM) basal plasma prolactin levels were 11.9 +/- 1.5 ng/ml and intravenous injection of synthetic thyrotropin-releasing hormone (TRH), 500 mug, caused a significant rise in plasma prolactin in all subjects examined with a maximum response of 52.6 +/- 3.3 ng/ml (mean +/- SEM). Markedly high plasma prolactin levels and exaggerated plasma prolactin responses to TRH were demonstrated in some patients with breast cancer. However, mean basal plasma prolactin levels and mean plasma prolactin increments following TRH in patients with breast cancer did not differ significantly from those in normal subjects. Plasma prolactin responses to TRH were slightly blunted during the administration of androgen in patients with breast cancer. These results suggest that some of the patients with primary breast cancer have abnormal prolactin secretion.
Vinblastine, adriamycin, thiotepa, and halotestin (VATH): therapy for advanced breast cancer refractory to prior chemotherapy.
Nineteen postmenopausal patients with metastatic breast cancer refractory to conventional combination chemotherapy were treated with monthly cycles with the combinations of vinblastine, adriamycin, thiotepa and halotestin. Ten patients (52%) responded with a greater than 50% regression of measurable tumor. The median duration of response was 11.5 months, with 5/10 patients still responding at a mean follow-up of 10 months. Only 2/10 responders have died with a mean follow-up of 13.8 months. In contrast, 8/9 nonresponders have died (median survival 6.0 months). Response to therapy was neither influenced by site of disease, time interval from diagnosis to primary chemotherapy nor duration of response to primary chemotherapy. No patient was hospitalized because of drug induced toxicity. This combination of drugs is a tolerable effective regimen for patients relapsing after adjuvant chemotherapy or after primary combination chemotherapy for grossly metastatic disease.
Comparison of sex steroid receptor analyses and carcinoembryonic antigen with clinical response to hormone therapy.
This study corroborates previous reports which suggested the efficacy of estrogen receptor (ER) analysis in predicting responses of patients with metastatic mammary carcinoma to hormonal therapeutic manipulation. The predictive value of multiconcentration titration and sucrose density gradient analyses of ERs and progesterone receptors (PRs) are compared. The predictive value of ER analyses can be improved by the discrimination of 8S versus 4S binding species or by the use of PR analysis in combination with ER analysis. The tumor-associated antigen, carcinoembryonic antigen (CEA), is evolving as an important quantitative aid in evaluating the clinical responses to patients receiving hormonal therapy.
Histochemical assay of estrogen and progesterone receptors in breast cancer: correlation with biochemical assays and patients' response to endocrine therapies.
Estrogen (ER) and progesterone (PgR) receptors were assayed by histochemistry in primary, recurrent, and metastatic breast cancer. Ligand-conjugates composed of 17 beta-estradiol and 11 alpha-hydroxyprogesterone covalently linked to bovine serum albumin and labelled with fluorescein isothiocyanate were employed. Results were compared with those of conventional biochemical receptor assays and correlated for ER in 92% of 314 tumors and for PgR in 86% of 86 specimens. ER and PgR determinations by both assay systems were correlated with clinical response to various endocrine therapies in 40 women with Stage IV disease. The histochemical assay enabled successful prediction of response in 80% of cases including eight which could not be fully analyzed biochemically.
One-day VATH (vinblastine, Adriamycin, thiotepa, and Halotestin) therapy for advanced breast cancer refractory to chemotherapy.
Twenty-nine postmenopausal patients with metastatic breast cancer refractory to conventional combination chemotherapy underwent treatment with a combination of vinblastine, Adriamycin, thiotepa, and Halotestin given once every 21 days. Thirteen patients (45%) responded with a greater than 50% regression of measurable tumor. Responses occurred in nine of 12 patients (75%) with visceral dominant disease and were recognized in four of 15 (27%) with osseous dominant disease (another 5 improved for a total improvement of 60%). The median duration of response was 11 months. The median survival times were 16 months for responders and eight months for those with progressive disease. Response rate was not affected by age, number of years after menopause, number of metastatic sites involved, or number of systemic treatment modalities previously used, but may have been adversely affected by late stage at original diagnosis, short time from diagnosis, poor response to primary chemotherapy, and dose modification. This combination of drugs is a convenient, tolerable, and effective regimen for treating breast cancer refractory to primary chemotherapy regimens currently in use.
Hairy cell leukemia. Durability of response to splenectomy in 26 patients and treatment of relapse with androgens in six patients.
Twenty-three of 26 patients with hairy cell leukemia evaluable for response to splenectomy had significant improvement in anemia, thrombocytopenia, and/or neutropenia. Eight of the 23 had a recurrence of cytopenia after a median response duration of 4 to 5 months (range, 1-22). The remaining 15 patients did not have a recurrence of cytopenia at 20 months median follow-up (range, 1-76). Six patients with postsplenectomy cytopenia were given androgenic steroids. Two of the six had an improvement in anemia and thrombocytopenia, and a third patient had an improvement in neutropenia. It was concluded that, although most patients with hairy cell leukemia have initial improvement in cytopenia with splenectomy, a significant number of them either fail to respond or have recurrent cytopenia after initial response to splenectomy. A trial of androgenic steroids is a reasonable therapeutic option in these patients. Alternative therapies are reviewed and recommendations made.
Chemotherapy of malignant thymoma. Case report and review of the literature.
The authors report the case of a patient with malignant thymoma unresponsive to combination chemotherapy (cyclophosphamide, doxorubicin, vincristine, and prednisone [CHOP] and cisplatin/VP-16) who subsequently achieved clinical response to continuous daily prednisone. A review of the literature indicates that prednisone and cisplatin are the most active agents in the treatment of malignant thymoma.
Immunohistochemical estrogen receptor determination in paraffin-embedded tissue. Prediction of response to hormonal treatment in advanced breast cancer.
A new immunohistochemical assay using a monoclonal estrogen receptor (ER) antibody (H222, Abbott Laboratories, North Chicago) for determination of ER in formalin-fixed paraffin-embedded tissue was applied to evaluate its clinical value in a group of 145 previously untreated patients with advanced breast cancer. Suitable histologic material was accessible in 137 of these patients, of whom 70% had ER-positive tumors. The ER-positive patients had a significantly longer median overall survival than ER-negative patients (67 versus 32 months, P much less than 0.001) and this was an effect of both a prolonged disease-free interval (27 versus 17 months, P less than 0.05) and a prolonged survival after recurrence (41 versus 15 months, P much less than 0.001). Response to endocrine therapy was obtained in 49% of the patients with ER-positive tumors and in 7% with ER-negative tumors (P much less than 0.001). Relationship between response and semiquantified individual staining features could not be established. It is concluded that ER analysis in formalin-fixed paraffin-embedded tissue offers clinically useful information for allocation of patients to endocrine therapy.
Superior sagittal sinus thrombosis associated with androgen therapy for hypoplastic anemia.
Of 27 patients with hypoplastic anemia treated between 1971 and 1974 with male hormone and protein-assimilating hormone, 3 developed superior sagittal sinus thrombosis (SSST). The clinical symptoms and signs and angiographic findings of SST were characteristic enough to allow an early diagnosis. Signs related to SST were seizures, hemiplegia, facial palsy, stupor, and coma, with the most important prodrome and consistent subjective complaint being headache. Following discontinuation of the hormone therapy, neurological signs and symptoms related to SSST gradually subsided. In all cases, the hematological picture improved with discontinuation of the hormone therapies. It appears that administration of male hormone can be associated with the development of SSST. If neurological symptoms and signs of SSST appear, administration of the hormones should be discontinued.
Seminal acid phosphatase content in the clinical bioassay of androgens and antiandrogens.
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Androgens and erythropoiesis.
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Prevention of digitoxin poisoning by various steroids.
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Sample size calculations for the two-sample problem using the multiplicative intensity model.
In this paper we propose formulae for calculating the expected number of events or, alternatively, the required trial duration, for clinical trials involving two treatment groups in which patients may potentially experience multiple events and the data will be analysed using a multiplicative intensity (MI) model. We use a partial likelihood-based approach and examine in detail two MI models: one that includes a binary treatment variable as the only covariate and a three-state Markov process model in which a binary time-varying covariate is added to the previous model. For the simpler model, our formula coincides with those derived by Cook using full likelihood methods. We present applications of the derived formulae to chronic granulomatous disease and breast cancer data sets.
Maintenance tamoxifen after induction postoperative chemotherapy in node-positive breast cancer patients: the Eastern Cooperative Oncology Group Trials.
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