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Abstract
Purpose To assess the effects of adjuvant hormone therapy (AHT) on survival and disease outcome in women with epithelial ovarian
cancer.
Patients and Methods
Participants were premenopausal and postmenopausal women who had been
diagnosed with epithelial ovarian cancer (any International
Federation of Gynecology and Obstetrics stage) 9
or fewer months previously. Ineligible patients included those with
deliberately
preserved ovarian function, with a history of a
hormone-dependent malignancy, or with any contraindications to
hormone-replacement
therapy. Patients were centrally randomly
assigned in a 1:1 ratio to either AHT for 5 years after random
assignment or no
AHT (control). Main outcome measures were
overall survival (OS), defined as time from random assignment to death
(any cause),
and relapse-free survival, defined as time from
random assignment to relapse or death (any cause). Patients who
continued,
alive and relapse free, were censored at their
last known follow-up.
Results A total of 150
patients (n = 75, AHT; n = 75, control) were randomly assigned from
1990 to 1995 from 19 centers in the United
Kingdom, Spain, and Hungary; all patients were
included in intention-to-treat analyses. The median follow-up in alive
patients
is currently 19.1 years.
Of the 75 patients with
AHT, 53 (71%) have died compared with 68 (91%) of 75 patients in the
control
group. OS was significantly improved in patients
who were receiving AHT (hazard ratio, 0.63; 95% CI, 0.44 to 0.90; P = .011). A similar effect was seen for relapse-free survival (hazard ratio, 0.67; 95% CI, 0.47 to 0.97; P = .032). Effects remained after adjustment for known prognostic factors.
Conclusion These
results show that women who have severe menopausal symptoms after
ovarian cancer treatment can safely take hormone-replacement
therapy, and this may, in fact, infer benefits
in terms of OS in addition to known advantages in terms of quality of
life.
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