VIENNA, AustriaIn a group of estrogen- or progesterone-positive
breast cancer patients, combination endocrine treatment using
goserelin (Zoladex) and tamoxifen (Nolvadex) significantly reduced
the number of recurrences and increased disease-free survival,
compared with CMF, after a median follow-up of 4 years, said Reimond
Jakesz, MD, of the Department of General Surgery, University of
Most significant is a reduction in the number of local
recurrences by more than 50% after endocrine treatment, especially
since 60% of the patients in the study had breast-conserving
surgery, Dr. Jakesz said at the 35th annual meeting of the
American Society of Clinical Oncology (ASCO) in Atlanta.
Dr. Jakesz reported results of the Austrian Breast Cancer Study Group
(ABCSG) Trial 5, a trial involving 1,045 premenopausal breast cancer
patients with hormone-responsive stage I and II disease. The trial
was conducted at 65 centers throughout Austria.
The study, initiated in 1990, randomized patients to receive the
endocrine combinationtamoxifen (20 mg orally) for 5 years plus
goserelin (3.6 mg subcutaneously) every 28 days for 3 yearsor
six cycles of standard CMFcyclophosphamide, 600 mg/m2;
methotrexate, 40 mg/m²; and fluorouracil, 600 mg/m²IV
on days 1 and 8. They were observed for a median of 4 years.
A total of 167 recurrences (53 local) and 68 deaths were recorded
within the follow-up period. Roughly 14% of the patients on the
tamoxifen/goserelin combination experienced a recurrence, compared
with 18% in the CMF group. Four patients on tamoxifen/goserelin had a
contralateral breast cancer, compared with nine in the CMF group. In
the endocrine combination group, 3.1% had a local recurrence vs 7.1%
on CMF. Also, there were 29 deaths on the endocrine combination,
compared with 39 on CMF.
To sum up, Dr. Jakesz noted that patients treated with the
combination of goserelin and tamoxifen showed a significantly
improved disease-free survival, compared with CMF (P < .02). The
trend favoring the endocrine combination was not statistically
significant for overall survival, however.
Patients treated with breast conservation surgery and radiation
(about 60% of the patients) had a 4.6-fold risk of developing a local
recurrence if taking CMF, compared with the patients on endocrine
treatment. We saw excellent local control of patients treated
by endocrine therapy, Dr. Jakesz said.
With respect to progesterone-receptor levels, analysis showed that
patients with a higher number of progesterone receptors had about one
third the risk of developing a recurrence, compared with other
progesterone groups, he said. There was no such interaction in the
Endocrine Therapy Less Toxic
Patients reported a total of 21,000 episodes of side effects during
outpatient visits. According to Dr. Jakesz, these were as expected:
stomatitis, nausea, diarrhea, fever, and infection in the CMF group;
and headache, vertigo, and hot flashes among patients on the
tamoxifen/goserelin combination. Dr. Jakesz said, The endocrine
treatment appears to be less toxic and better tolerated than
chemotherapy, with significantly better treatment adherence.
Dr. Jakesz underscored that although these findings are preliminary,
the data indicate a significant benefit for the tamoxifen/goserelin
combination, compared with CMF.