Rosalind A Eeles1, James P Morden2, Martin Gore2, Janine Mansi2, John Glees2, Miklos Wenczl2, Christopher Williams2, Henry Kitchener2, Richard Osborne2, David Guthrie2, Peter Harper2, Judith M Bliss2. 1. Rosalind A. Eeles, James P. Morden, and Judith M. Bliss, The Institute of Cancer Research; Martin Gore, The Royal Marsden Hospital; Janine Mansi, St George's Hospital; Peter Harper, Guy's Hospital, London; John Glees, Epsom Hospital, Epsom, and The Royal Marsden Hospital, Sutton; Christopher Williams, Southampton General Hospital, Southampton; Henry Kitchener, Aberdeen Royal Infirmary, Aberdeen; Richard Osborne, Addenbrookes Hospital, Cambridge; David Guthrie, Derbyshire Royal Infirmary, Derby, United Kingdom; and Miklos Wenczl, Markusovszky Teaching Hospital, Szombathely, Hungary. ros.eeles@icr.ac.uk. 2. Rosalind A. Eeles, James P. Morden, and Judith M. Bliss, The Institute of Cancer Research; Martin Gore, The Royal Marsden Hospital; Janine Mansi, St George's Hospital; Peter Harper, Guy's Hospital, London; John Glees, Epsom Hospital, Epsom, and The Royal Marsden Hospital, Sutton; Christopher Williams, Southampton General Hospital, Southampton; Henry Kitchener, Aberdeen Royal Infirmary, Aberdeen; Richard Osborne, Addenbrookes Hospital, Cambridge; David Guthrie, Derbyshire Royal Infirmary, Derby, United Kingdom; and Miklos Wenczl, Markusovszky Teaching Hospital, Szombathely, Hungary.
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.
RCT Entities:
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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