5-Fluorouracil, adriamycin and cyclophosphamide combined with high-dose medroxyprogesterone acetate in advanced breast cancer.

Seventy-six patients with metastatic breast cancer were treated with fluorouracil, adriamycin (doxorubicin) and cyclophosphamide (FAC) plus high-dose medroxyprogesterone acetate (HD-MPA). MPA was given for 21 days at the dose of 500 mg/day i.m., then on a randomized basis, either 500 mg/week i.m. (FAC+HD-MPA i.m.) or 300 mg/day p.o. (FAC+HD-MPA p.o.). Objective response rates were 79% in 39 patients on FAC+HD-MPA i.m. and 73% in the 37 patients on FAC+HD-MPA p.o. There was no significant difference in the median duration of response and median survival for the 2 regimens (respectively, 17 months and 22 months, and 15 months and 21 months for FAC+HD-MPA i.m. and FAC+HD-MPA p.o.). Toxicity was mild and similar in both groups. Although FAC+HD-MPA was highly effective, at present it is difficult to select which regimen provides the best initial treatment for metastatic breast cancer.

Cyproterone acetate in advanced male breast cancer.

Three male patients of 55, 63 and 71 years of age, with metastatic breast cancer, were treated with cyproterone acetate. Two patients showed complete remission, one lasting 21 months, another 51+ months and a third achieved partial remission lasting 9 months. These results suggest that cyproterone acetate may be useful in the treatment of advanced male breast cancer.

Congenital ichthyosis and endodermal sinus tumor of the ovary in a ten-year-old child.

Acquired ichthyosis is very likely to be associated with a malignancy, especially with Hodgkins disease. The association of congenital ichthyosis with malignant tumors has been so far reported only in two instances. Herein we report on a third case. Due to the small number of cases, no conclusion can be drawn about the correlations between the two diseases.

Serum I-K (immunoconglutinins) in Hodgkin's disease.

An increase of C'3 fraction, already observed in Hodgkin's disease has been confirmed, and is here described in a group of 33 patients at various clinical stages of Hodgkin's disease. It is consistently higher than those found in a group of 26 normal subjects. Conglutinins present in Hodgkin's disease patients, as far as their behaviour is concerned, may be considered as immunoconglutinins (I-K).

Mitomycin C in patients with metastatic breast cancer refractory to hormone therapy and chemotherapy.

43 patients with advanced breast cancer, resistant to conventional therapies, were treated with mitomycin C at a dose of 20 mg/m2 i.v. every 6 weeks. No response was observed. The most common side effect was myelotoxicity. Leukopenia occurred in 63% of the patients, thrombocytopenia in 67%, and anemia in 14%. Two episodes of acute dyspnea were observed which were thought to be pulmonary hypersensitivity reactions. This study does not suggest that mitomycin C is of value as second- or third-line treatment in metastatic breast cancer. It is likely that the drug could play a more important role in combination with other chemotherapeutic agents.

Phase II study of epirubicin in advanced malignant melanoma.

Twenty patients with advanced malignant melanoma refractory to conventional chemotherapy, were entered into a Phase II study of epirubicin, one of the new doxorubicin analogues. The drug was given at a dose of 90 mg/m2 IV every 3 weeks. One partial response and three disease stabilizations were observed. Nausea and vomiting and alopecia were common. Mild to moderate leukopenia occurred in 6 patients. Three cases of reversible ST-T changes were recorded. The observed response rate of 5% with a 39.2% probability of a true response rate greater than or equal to 10%, does not suggest that epirubicin, in the dose and schedule chosen, is active in metastatic malignant melanoma.

Controlled study of DTIC versus DTIC plus epirubicin in metastatic malignant melanoma.

Forty-two previously untreated patients with metastatic malignant melanoma were randomized to receive DTIC at a dose of 250 mg/m2/day 4 IV on days 1-5 or the same drug plus epirubicin (Epi-DX) at a dose of 90 mg/m2 on day 1. Cycles were repeated every 3 weeks. Partial responses were observed in two out of 22 patients (9.1%) treated with DTIC, and in four out of 19 evaluable patients (21.1%) treated with Epi-DX + DTIC. Overall, Epi-DX + DTIC combination was well tolerated, thus permitting administration after a 3-week interval of the full drug dosages in all but two patients. No major cardiotoxicity was observed. Although patients in the Epi-DX + DTIC group had a better response rate than those in the DTIC group, the difference was not statistically significant, and the 21.1% response rate observed with the two-drug combination does not differ from that reported with DTIC used alone.

Early observations on the administration of Lonidamine in cancer patients.

Lonidamine was studied in advanced cancer patients. The drug was given orally by single or repeated administrations. Single doses ranged from 150 to 450 mg. Repeated administrations were performed with progressively increasing doses: 450-900 mg daily. Lonidamine lacked severe toxic effects after both single and prolonged administrations. The most common side effect was myalgia; gastrointestinal discomfort was also reported. 1 patient with lung cancer experienced an episode of arrhythmia which subsided upon discontinuation of treatment and did not reoccurr++ when treatment was reinstated. 1 partial and 2 minor responses were observed in the 6 patients with breast cancer.

Treatment of carcinoid syndrome with recombinant interferon alpha-2a.

The prognosis and the quality of life of patients with carcinoid tumors is related either to symptoms from the substances secreted or to progressive tumor growth. Medical treatment with cytotoxic agents is of marginal value for increasing life expectancy and reducing clinical symptoms. Recent studies with interferon have shown interesting results. In the present investigation, 22 patients with carcinoid tumors and syndrome were treated with recombinant interferon alpha-2a (r-IFN alpha-2a) at the dose of 6 x 10(6) IU intramuscularly daily for 8 weeks and three times weekly thereafter. The primary tumor was localized in the foregut (n = 11), midgut (n = 7), hindgut (n = 1), and unknown site (n = 3). Most cases had liver metastasis. Seventeen patients had elevated 5-hydroxyindoloacetic acid (5-HIAA) excretion and 5 had flushing and/or diarrhea as the only clinical manifestation. Six cases presented a complete syndrome (flushing, diarrhea and 5-HIAA excretion). Control of symptoms was obtained in 80% and a 5-HIAA level reduction in 58% of the patients. The interferon treatment was more effective for control of the carcinoid syndrome than for control of tumor growth. The treatment was well tolerated and fever, myalgia, anorexia and fatigue were the most frequent side-effects.