Accrual Problems Continue to Confound French Study of Hormonal Blockade vs Chemotherapy for Breast Cancer

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.

“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-receptor–positive or
progesterone-receptor–positive 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.