A prospective phase III trial comparing anastrozole with tamoxifen as first-line therapy in postmenopausal, hormone-dependent, advanced breast cancer (ABC). Patients were randomized to anastrozole 1 mg daily (n = 121) or tamoxifen 40 mg daily (n = 117). Efficacy and tolerability were evaluated after 3 months' therapy, and survival was evaluated at median time of follow-up. At a median follow-up of 13.3 months, clinical benefit (CB) was achieved in 83% and 56% of anastrozole and tamoxifen patients, respectively (p < 0.001); median time to disease progression (TTP) in patients achieving CB was 18.0 months and 7.0 months, respectively, (hazard ratio [HR] = 0.13, 95% CI = 0.08-0.20, p < 0.01). At data cutoff, 89% of tamoxifen patients had died, compared with 60% of anastrozole patients; median time to death was 17.4 months and 16.0 months, respectively (HR = 0.64, 95% CI = 0.47-0.86, p = 0.003). Therapy was well tolerated in both groups. Anastrozole showed significant advantages over tamoxifen for CB, median TTP in patients gaining CB, and survival. These data further support routine use of anastrozole as first-line treatment for postmenopausal hormone-dependent ABC.

A prospective phase III trial comparing anastrozole with tamoxifen as first-line therapy in postmenopausal, hormone-dependent, advanced breast cancer (ABC). Patients were randomized to anastrozole 1 mg daily (n = 121) or tamoxifen 40 mg daily (n = 117). Efficacy and tolerability were evaluated after 3 months' therapy, and survival was evaluated at median time of follow-up. At a median follow-up of 13.3 months, clinical benefit (CB) was achieved in 83% and 56% of anastrozole and tamoxifen patients, respectively (p < 0.001); median time to disease progression (TTP) in patients achieving CB was 18.0 months and 7.0 months, respectively, (hazard ratio [HR] = 0.13, 95% CI = 0.08-0.20, p < 0.01). At data cutoff, 89% of tamoxifen patients had died, compared with 60% of anastrozole patients; median time to death was 17.4 months and 16.0 months, respectively (HR = 0.64, 95% CI = 0.47-0.86, p = 0.003). Therapy was well tolerated in both groups. Anastrozole showed significant advantages over tamoxifen for CB, median TTP in patients gaining CB, and survival. These data further support routine use of anastrozole as first-line treatment for postmenopausal hormone-dependent ABC.

Our data suggest that TOR is an efficient and well-tolerated agent for the therapy of postmenopausal women with hormonal positive receptors advanced breast cancer, and must be considered an alternative to TAM as first line therapy for ER+ advanced breast cancer patients and as well as an adjuvant treatment.

On the basis of preclinical and clinical data, we designed a phase II study to determine the efficacy and feasibility of high-dose epirubicin plus docetaxel (Taxotere) with lenograstim support, as first-line therapy for patients with advanced breast cancer. Patients with histologic evidence of metastatic breast cancer, without previous chemotherapy, adequate organ functions, Eastern Cooperative Oncology Group performance status less than 2, and signed informed consent entered in the trial. Treatment consisted of premedication the day before the treatment day for 3 consecutive days (dexamethasone 16 mg o.r. and 5-HT3 antagonists). On the treatment day 1, epirubicin 130 mg/m2 was administered as a 15-minute intravenous infusion followed 1 hour later by 1-hour intravenous infusion of docetaxel 100 mg/m2. Cycles were repeated every 21 days, for a maximum of 8 cycles. Lenograstim (5 microg/kg, s.c.) was started 48 hours later (day 4) and was given daily for 10 consecutive days. Response evaluation was made after the third cycle was applied, following World Health Organization criteria. Responding patients received five additional cycles. Median time to progression and survival were calculated according to the Kaplan-Meier method. A total of 32 patients have been included in the study. A total of 236 courses were delivered. A total response rate of 87.5% (95% confidence interval [CI] of 77-98) was obtained. There were 11 complete responses and 17 partial responses. Toxicity was mild, with a low incidence of undesirable effects (7 cycles, 2.9% were delayed from 3 to 6 days because of neutropenia). After a median follow-up time of 490 days (range, 131-966 days), the median time to progression was 490 days (95% CI 314-575), and the median survival was 604 days (95% CI 513-785). This epirubicin plus docetaxel regimen is an efficient treatment for patients with advanced breast cancer. The lenograstim support allows the administration of such a chemotherapy regimen with a modest incidence of side effects. A larger number of patients need to be evaluated.

No abstract