The affect of goserelin on the QoL of women having chemotherapy for EBC: Results from the OPTION trial

Abstract

Background The OPTION trial results showed that premenopausal women with early stage breast cancer (EBC) receiving chemotherapy benefited from ovarian function protection with goserelin. The impact of treatments on patient reported Quality of Life (QoL) were also examined. Patients and methods 227 pre-menopausal women with EBC, were randomly assigned to chemotherapy±goserelin (C±G); 132 (58%) were ER-ve. Patients were stratified by age (≤40 years and >40 years). QoL was assessed with the Functional Assessment of Cancer Therapy – Breast, and Endocrine Symptom checklist at baseline (pre-treatment), 3, 6, 12, 18 and 24 months, then annually to 5 years. Treatment Outcome Index (TOI) score was the primary outcome. Results 213 patients were available for QoL analysis. There was a significant decrease in TOI scores for both treatment groups at 3 and 6 months that returned to pre-treatment levels at 12 months, then continued to increase reflecting improved QoL. By 3 months there was a significant difference from baseline in both groups for menopausal symptoms, and between groups in the proportion experiencing hot flushes at any time. The C + G group experienced higher levels of vasomotor symptoms generally during the treatment phase; by 24 months, the short-term negative effect of goserelin was reversed, with hot flushes twice as frequent in the chemotherapy only group (40.9% vs 21.3%). Conclusions These results show that young women diagnosed with breast cancer experienced only a short-term decrease in QoL from the addition of goserelin, in order to preserve ovarian function during chemotherapy treatment.

Gonadotropin-Releasing Hormone Agonists during Gonadal Chemotherapy for the Effect on Pregnancy Outcome and Ovarian Function in Premenopausal Patients with Breast Cancer: A Systematic Review and Meta-Analysis

“…Four studies documented the rate of amenorrhea one to 2 years after chemotherapy; there was no significant heterogeneity between studies ( p = 0.49; I 2 = 0%) [11, 17, 21]. As a result, a fixed-effect model was used for analysis.…”

Ovarian Function Suppression With Luteinizing Hormone-Releasing Hormone Agonists for the Treatment of Hormone Receptor-Positive Early Breast Cancer in Premenopausal Women

“…However, recently reported results from the OPTION trial suggest that when goserelin is added to chemotherapy to provide ovarian function protection in premenopausal women with early breast cancer the detrimental effects experienced on quality of life are shortlived. Within 24 months, the majority of patient-reported outcomes in individuals receiving goserelin with chemotherapy did not differ from those receiving chemotherapy alone (78).…”

“…When determining the most appropriate adjuvant endocrine therapy for individual patients, the potential benefits of the addition of LHRHa must be weighed against increased rates of side effects and practical aspects of using these drugs. The effects of addition of OFS to tamoxifen or AIs on adverse events and patient-reported outcomes have been reported in the E-3193, SOFT, ZIPP, and OPTION trials (46,(75)(76)(77)(78). Overall, evidence from these trials suggests that, in premenopausal patients, addition of LHRHa to tamoxifen is associated with worse FIGURE 2 | Overview of evidence supporting the addition of OFS to endocrine therapy in premenopausal women with HR+ breast cancer.…”