estramustine and Melanoma

Eighty-two patients with invasive malignant melanoma and no distant metastases were prospectively randomized following their surgical treatment to 1) observation; 2) chemotherapy with Dacarbazine (DTIC) 200 mg/M2 I.V. daily X 5 every 4 weeks and Estracyt 15 mg/kg orally daily for 1 year; and 3) immunotherapy with TICE BCG 1 ml to an area of scarification near the primary site, every 4 weeks for 1 year. At a median follow-up of 73.4 months 31 patients (38%) have relapsed. There was no significant difference in survival according to the treatment, but a weak effect on the course of the disease by either of the treatment protocols cannot be ruled out due to the small sample of patients. Survival and disease-free interval varied significantly according to the histologic status of the regional nodes. The estimated 5-year disease-free rate of patients with negative nodes was 85% and for those with positive nodes it was 35% (P less than 0.0001).

Topics: Administration, Oral; Adult; Aged; BCG Vaccine; Combined Modality Therapy; Dacarbazine; Estramustine; Female; Humans; Injections, Intravenous; Male; Melanoma; Middle Aged; Nitrogen Mustard Compounds; Prospective Studies; Random Allocation

Twenty-six patients with measurable metastatic melanoma were treated with estramustine phosphate (12 mg/mg body wt) orally every day. Tumor biopsies were assessed for estrogen receptors (ER) in 14 patients and for estramustine binding sites (EMBS) in 13 patients. ER and EMBS were measured with isoelectric focusing in polyacrylamide gels. Three partial responses (PR) (12%) and three no changes (NC) (12%) according to WHO criteria were registered. In one patient with NC and in four patients with progressive disease (PD) the tumors were ER positive. EMBS was found in one patient with PR and in two patients with PD. Because of the low frequency of antitumor activity and the low number of patients with ER and/or EMBS the number of patients is too low for any correlation between tumor response and ER and/or EMBS status.

Topics: Adult; Aged; Binding Sites; Drug Evaluation; Estramustine; Female; Humans; Male; Melanoma; Middle Aged; Nitrogen Mustard Compounds; Receptors, Estrogen

Thirty-five patients with advanced cancers were treated with estramustine phosphate tablets (Estracyt). Doses ranged between 420 mg and 700 mg daily. One partial response was documented in a hormone resistant prostatic cancer patient. Four minor responses (less than 50% responses, or less than one month more than 50% response) were obtained; one in a hormone resistant prostatic cancer, two in metastatic colorectal cancers; and another in a malignant melanoma. Toxicity phenomena included nausea (9/35 - 25%), water retention (4/35 - 11.5%) and mild elevation of alkaline phosphatase (2/35 - 6%). Other toxicity effects were vaginal bleeding in two women, acne in one woman and mild pruritus in another patient. Myelosuppression and immune suppression were not significantly detected.

Topics: Adult; Aged; Colonic Neoplasms; Drug Evaluation; Drug Resistance; Estramustine; Female; Humans; Male; Melanoma; Middle Aged; Neoplasms; Nitrogen Mustard Compounds; Prostatic Neoplasms; Rectal Neoplasms

Chemotherapy was administered in the immediate postoperative period to seventy patients (52 with melanomas and 18 with sarcomas) after a total of eighty-seven major operations, with no morbidity or mortality traceable to the chemotherapy. There was no apparent interference with wound healing or what would be considered a normal postoperative course. Fourteen of these patients (5 with melanomas and 9 with sarcomas) received a combination of radiation anc chemotherapy initiated in the postoperative period, and it was tolerated well. This combination appears to be safe, provided the field of radiation is not so large that is may add significantly to the myelosuppressive effect of chemotherapy and the dosage of concomitantly administered radiopotentiating agent(s) is reduced. Sixteen patients had Bacillus Calmette-Gúerin (BCG) immunotherapy in the immediate postoperative period without complications. This policy of a tight interweaving of modalities is safe, has the theoretic advantage of an earlier concerted attack on microscopic residual tumor, and appears particularly promising in sarcomas.

Topics: BCG Vaccine; Dacarbazine; Estramustine; Humans; Melanoma; Melphalan; Radiotherapy Dosage; Sarcoma; Skin Neoplasms

Twenty-six patients (14 men and 12 women) with histologically proven advanced malignant melanoma, who previously had not responded to DTIC, methyl-CCNU, and procarbazine, received estramustine phosphate (estracyt) (15 mg/m2) in daily divided doses. All patients had measurable disease. One patient developed a complete remission and one patient had improvement in liver function without measurable regression in the tumor. In three other patients (11%), the disease remained static for a period of 3--5 months. The mean survival time from the beginning of therapy was 16.8 months for the patients with a response or static disease and 2.18 months for those who had no response. Gastrointestinal toxicity was minimal; no hematologic toxicity was observed. It appears that estramustine phosphate used as a single agent for treating advanced malignant melanoma after patients failed to respond to DTIC and to the combination of methyl-CCNU and procarbazine has a poor response rate.

Topics: Adult; Aged; Drug Evaluation; Estramustine; Female; Humans; Male; Melanoma; Middle Aged; Nitrogen Mustard Compounds; Remission, Spontaneous; Time Factors