The antitumor efficacy of calusterone, 200 mg/day by mouth, against objectively progressing advanced breast cancer was evaluated by the Cooperative Breast Cancer Group criteria in 117 women. In 41, calusterone was the first treatment for advanced breast cancer, in 49 it was given as secondary steroidal therapy, and in 27 it followed cytotoxic chemotherapy. Part of the study included comparison by the double-blind technique of calusterone in 23 women with Δ¹-testololactone, 1,000 mg/day by mouth, in 25 similar patients randomly distributed for site of most significant metastasis and for age with respect to the menopause. Calusterone produced objective regressions lasting an average of 9.8 months in 51% of patients in whom it was primary or secondary hormonal therapy, but in only 19% of patients with previous cytotoxic chemotherapy. In the last group, regressions lasted only 6 months. Calusterone was equally effective in women with or without visceral metastasis, in all age groups, and in castration failures. In the double-blind study, calusterone produced regressions in 52% and Δ¹-testololactone in 32% of patients. In the crossover, patients who had not responded to calusterone also failed to respond to Δ¹-testololactone, while 33% of Δ¹-testololactone failures or responders obtained regression on calusterone therapy. Calusterone is a weak androgen, and, like other 17α-alkylated steroids, produces nausea in 28 % of patients and BSP retention almost uniformly. There was no cholestatic jaundice or hepatocellular damage. Nausea was usually transient, but of sufficient severity in five patients to necessitate termination of therapy. Unlike other androgens, calusterone causes no rise in hematocrit, but a striking increase in the platelet count and a slight rise in the white blood cell count. By the rigorous criteria of the Cooperative Breast Cancer Group, calusterone is the most effective antitumor steroid thus far identified in a statistically adequate sample.

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Calusterone, 200 mg daily by mouth, significantly raised platelet counts of 80 women with advanced breast cancer. It showed no erythropoietic activity. Simultaneous measurements in 27 patients receiving Δ1-testoloactone, 1000 mg a day, were not significantly different from those of 21 untreated patients. Calusterone is clinically well tolerated, is weakly androgenic, and, like other 17-alpha alkylated steroids, causes bromsulphalein retention but no hepatocellular damage or jaundice. Its thrombocytopoietic effect in women with advanced breast cancer warrants investigation in patients with thrombocytopenic purpura or aplastic anemia and in patients undergoing chemotherapy.

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To determine whether parathyroid hormone is required for renal response to phosphorus loading, the effects of ingestion of 3100 mg of phosphorus daily for 3 days were compared in 5 treated hypoparathyroid patients and 5 normal control subjects of comparable age and sex. In both normal and hypoparathyroid subjects the response to phosphorus loading was characterized by an increase in urinary excretion of phosphorus without a concomitant increase in the rate of glomerular filtration of phosphorus. Some mechanism other than changes in rates of parathyroid hormone secretion probably accounts for renal responses to changes in phosphorus intake. The timing of urine and serum collections with regard to food intake and the total amount of phosphorus in the diet were found to affect the assessment of renal handling of phosphorus. The finding that a 3-day period of oral phosphorus loading did not increase the serum phosphorus level in the hypoparathyroid patients suggests that phosphorus restriction is not always necessary in the treatment of hypoparathyroidism. The addition of one more condition to the list of those that may affect the percentage of renal tubular resorption of phosphorus in no way decreases the usefulness of this determination in the diagnosis of hyperparathyroidism.