CA 15.3 and CEA plasma level monitoring in patients with breast cancer.

CA 15.3 and CEA were determined in the serum of 217 patients with early and advanced breast carcinoma. CA 15.3 was high (greater than 30 U/ml) in 1/6 (17%) patients with stage I-II primary tumor, in 4/77 (5%) patients without clinical signs of disease after mastectomy, in 67/102 (65%) patients with advanced disease in progression, and in 13/32 (41%) patients with advanced disease not in progression and undergoing therapy. The corresponding incidences of pathological CEA values (greater than 2.5 ng/ml) were 33, 8, 55 and 14%. The combination of the two markers brings about a certain improvement in the sensitivity for recognising patients with advanced disease in progression (79/102 = 77%). The presence of high values of CA 15.3 is statistically correlated to the prevalent site of metastases (bone and viscera greater than soft tissues). Monitoring the two markers during antitumor therapy in 36 patients showed good accordance (56%) between CA 15.3 changes and response to therapy. The decrease of the marker in patients who achieved partial remission was statistically significant. In conclusion, CA 15.3 is more sensitive than CEA in recognising patients with advanced disease in progression and gives better accordance with the response to therapy. The simultaneous use of the two markers may be useful in the follow-up of operated patients and in monitoring the disease during treatment.

5-Fluorouracil, epirubicin and cyclophosphamide (FEC combination) in advanced breast cancer.

Thirty patients with advanced breast cancer, not pretreated with chemotherapy for advanced disease, received a polychemotherapy regimen containing 5-fluorouracil (500 mg/m2 iv), epirubicin (50 mg/m2 iv) and cyclophosphamide (500 mg/m2 iv) every four weeks. All patients were evaluable for response and for toxicity. No complete remissions were observed, while 13 patients (43.5%) achieved a partial remission for a median duration of 46 weeks. The main side-effects were alopecia (grade 2-3 in 57%), leukopenia (grade 3-4 in 33%) and nausea/vomiting (grade 3-4 in 27%). In three cases we observed laboratory signs of cardiotoxicity without clinical symptoms.

Cisplatinum plus epirubicin alternated with cyclophosphamide plus 5-fluorouracil in ovarian cancer.

Fifty-two patients with ovarian cancer (post surgical residual tumor) were treated with the combination of platinum + epirubicin (PE) (P 50mg/m2, E 60 mg/m2) alternated with cyclophosphamide + 5-fluorouracil (CF) (C 800 mg/m2, F 600 mg/m2). The treatment was repeated every 28 days for a maximum of 10 cycles. Forty-three patients were evaluable for response. Complete remission (CR) was achieved in 13 (30%) patients (evaluated by second-look), while partial remission (PR) was achieved in 6 (14%) patients for a mean duration of 27 and 14 months, respectively. Eleven out of 13 patients with CR and 5 out of the nonevaluable patients are alive and do not show signs of disease after a mean follow-up of 29 + months (range 19-36). The main factors that conditioned complete remission were the tumor residue and performance status of the patient.

Mitoxantrone, 5-fluorouracil and cyclophosphamide in advanced breast cancer.

Thirty patients with advanced breast cancer, not pretreated with chemotherapy, received a polychemotherapy regimen containing mitoxantrone, fluorouracil and cyclophosphamide at the dose of 10 mg/m2, 500 mg/m2 and 500 mg/m2 i.v. respectively every 28 days. Out of 25 patients evaluable for response 9 patients achieved a partial remission (36%) for a median duration of 20.5 weeks. The main side effects were leukopenia (grade 3-4 in 70%) and nausea-vomiting (grade 3-4 in 27%). Alopecia was present only in 5 patients (17%). Three patients demonstrated instrumental signs of cardiotoxicity without clinical symptoms.

Combination chemotherapy with cyclophosphamide, fluorouracil, and either epirubicin or mitoxantrone: a comparative randomized multicenter study in metastatic breast carcinoma.

From February 1987 to January 1989, 60 patients with advanced breast cancer and no prior chemotherapy for advanced disease were randomized and studied, with 31 treated with fluorouracil, epirubicin, and cyclophosphamide (FEC) and 29 patients with fluorouracil, mitoxantrone, and cyclophosphamide (FNC). Doses were 500 mg/m2 fluorouracil, 500 mg/m2 cyclophosphamide, and 50 mg/m2 epirubicin2 or 10 mg/m mitoxantrone, i.v. Day 1 every 3 weeks. There were no statistically significant differences in pretreatment patient characteristics between the groups. Fifty-six patients were evaluable for response (29 in the FEC arm and 27 in the FNC arm). The response rates were 48.2% for the FEC group (complete response (CR) 10.3% and partial response (PR) 37.9%) and 40.7% for the FNC group (CR 3.7% and PR 37%) (not significantly different, NS). The median response duration was 247 and 267 days, respectively (NS), the median time to progression and time to treatment failure was 244 and 155.5 days for the FEC group and 86 and 98 days for the FNC group, respectively (NS). The incidence of nausea/vomiting was 87.1% in the FEC group and 79.3% in the FNC group, with comparable severity. Alopecia occurred in 80.6% of FEC patients and 44.8% of FNC patients (p less than 0.05). The incidences and degrees of severity of leukopenia, anemia, and cardiotoxicity were comparable in the two treatment groups. Efficacy and toxicity of the two regimens were quite similar. FNC can improve the quality of life of patients by providing significantly less alopecia.