After a 19-year follow up, women who were diagnosed with ovarian cancer and randomly assigned to receive adjuvant hormone therapy (AHT) had significantly improved overall survival and relapse-free survival compared with control patients who did not receive AHT, researchers reported. The results were published online Sept. 28 in Journal of Clinical Oncology.
Despite the fact that 46 out of 72 patients discontinued taking the hormone therapy, (median 1.14 years of treatment), the benefits of treatment were apparent. Improved survival was observed in the AHT group as early as 5 years after assignment and persisted for 20 years.
Of 121 (81%) patients who died during follow up, 53 (71%) were in the AHT group and 68 (91%) in the control group (HR, 0.63; 95% CI, 0.44-0.90; P = .011) (J Clin Oncol. 2015 Sep 28. doi:10.1200/JCO.2015.60.9719).
“This trial has shown that women who have severe menopausal symptoms after ovarian cancer treatment can safely take HRT without compromising their survival by doing so,” wrote Dr. Rosalind Eeles, professor of oncogenetics and consultant in cancer genetics and clinical oncology at The Institute of Cancer Research, Sutton, London, and colleagues. Their findings from this prospective randomized trial confirmed the survival benefit previously reported in a retrospective study, “so administration of HRT for QOL [quality of life] and survival benefit should be considered in patients with ovarian cancer,” they said.
The phase III nonblinded, controlled trial randomized 150 patients, median age 59 years, who were diagnosed with epithelial ovarian cancer less than 9 months prior. In total, 77% of the patients were postmenopausal, and 63% were FIGO disease stage III or IV. Most of the patients (83%) were recruited from 17 centers in the United Kingdom, with 8% and 9% recruited from single centers in Spain and Hungary, respectively.
Long-term OS was superior in the AHT group. The hazard ratio, adjusted for stratification factors of treating center, menopausal status (pre vs. post), FIGO stage (I and II vs. III and IV), and additional prognostic factors, was 0.45 (95% CI, 0.30-0.69; P less than .001).
Relapse-free survival also was superior in the AHT group compared with the control group (HR, 0.67; 95% CI, 0.47-0.97; P = .032). The RFS benefit increased after adjustment for prognostic factors, as above (adjusted HR, 0.53; 95% CI, 0.34-0.81; P = .004).
Adverse event rates were low, and similar for both groups.
Dr. Eeles reported honoraria from Janssen-Cilag and expenses from Genprobe, Vista, and Illumina. Two of her coauthors reported ties to industry sources.