Summary Forty-eight patients with advanced breast carcinoma who had not received prior chemotherapy (minimum follow up 21 months) were randomised to receive either adriamycin 70 mgm 2 i.v. 3-weekly for 8 cycles (Regimen A) or adriamycin 35 mgm-2 i.v. 3-weekly for 16 courses (Regimen B). Objective responses were seen in 14/24 (58%) patients with regimen A (4 complete) and 6/24 (25%) with regimen B (1 complete) (P<0.02). The median duration of response was 14 months with regimen A and 6.5 months with regimen B. The median duration of survival was 20 months and 8 months respectively (P<0.01). The toxicity was similar with each regimen. There was no evidence of deterioration in left ventricular ejection fraction nor congestive heart failure in any patient. It is concluded that when given at 3-weekly intervals adriamycin is a more effective treatment for advanced breast cancer at higher rather than lower dosage.
A total of 40 patients with metastatic breast cancer were treated with 120 mg/m2 i.v. epirubicin every 3 weeks for a maximum of 10 cycles. Nine achieved a complete response and 17 showed a partial response, for an objective response rate of 65% (95% confidence interval, 47%-83%); the median duration of response was 7 months (range, 1-15 months) and median survival amounted to 13 months (range, 2-20 months). Leucopenia (grade 2 or 3) was seen in 14 patients on day 21 of the cycle. A subset of nine patients underwent blood counts on day 10, when all had marked neutropenia (less than 1 x 10(9)/l). Other toxicity was frequent and included nausea/vomiting (80%), alopecia (95%) and stomatitis (35%). Five patients showed a significant fall in cardiac output, but this reverted to normal after treatment. Epirubicin should have a role in the development of high-dose regimens for the treatment of advanced breast cancer.
Fifty-seven evaluable patients with advanced ovarian carcinoma were randomized to receive either a combination of hexamethylmelamine, cyclophosphamide, methotrexate and 5-fluorouracil (Hexa-CAF) or high-dose cyclophosphamide alone given intravenously intermittently. Objective responses were seen in 62% of patients receiving cyclophosphamide alone, and 36% of patients in the Hexa-CAF regimen, this difference being statistically significant (P less than 0.05). The median duration of objective response (10 months vs. 9 months) and the median survival (11 months vs. 10 months) were greater in the cyclophosphamide group, but these differences were not statistically significant. It is concluded that there is no therapeutic advantage for the Hexa-CAF protocol over the alkylating agent used alone.
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