TOULOUSE, France-Accrual problems continue to plague clinical trials, most recently a French study attempting to compare complete hormonal blockade with luteinizing hormone–releasing hormone (LHRH) to chemotherapy in premenopausal early-stage breast cancer. Patients in the study were hormone-receptor positive and had one to three positive lymph nodes.
TOULOUSE, FranceAccrual problems continue to plague clinical trials, most recently a French study attempting to compare complete hormonal blockade with luteinizing hormonereleasing hormone (LHRH) to chemotherapy in premenopausal early-stage breast cancer. Patients in the study were hormone-receptor positive and had one to three positive lymph nodes.
Investigators were clearly reluctant to enroll patients, because hormonal blockade with LHRH was seen as inferior to chemotherapy, Henri Hubert Roche, MD, of Centre Claudius Regaud, Toulouse, France, told participants at the ASCO meeting.
As a result, the study enrolled only about 300 of the 500 patients needed to detect a 10% or better difference in the treatment arms.
In the study, FASG-06, there was a trend favoring tamoxifen (Nolvadex)/LHRH complete hormonal blockade over epirubicin (Ellence)-based chemotherapy in time to relapse and disease-free survival.
Between 1990 and 1998, 333 premenopausal operable breast cancer patients with estrogen-receptorpositive or progesterone-receptorpositive breast cancer and 1 to 3 positive nodes were randomized.
Patients in arm A (n = 164) received tamoxifen (30 mg/day) plus intramuscular triptoreline (Decapeptyl) (3.75 mg every months for 3 years). Patients in arm B (n = 169) received FEC 50 (fluorouracil 500 mg/m², epirubicin 50 mg/m², cyclophosphamide 500 mg/m²) every 21 days for 6 cycles.
Dr. Roche said that at median follow-up of 54 months, relapse occurred in 22 of 164 patients (13.5%) in arm A and 32 of 169 patients (19%) in arm B. Disease-free survival was 91.7% in arm A and 80.9% in arm B (P = .12). Deaths occurred in 7 patients (4.3%) in arm A and 13 patients (7.7%) in arm B, with overall survival rates of 97% and 92.9% (P = .18).
The trial showed that 3-year complete hormonal blockade is feasible, since the dropout rate due to toxicity was only 8%, Dr. Roche concluded.
Temporary castration might be an alternative to chemotherapy in this hormone-sensitive population, he said. He recommended that future trials also include quality-of-life assessments.
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