Five-year changes in ovarian function restoration in premenopausal patients with breast cancer taking tamoxifen after chemotherapy: An ASTRRA study report

Kim, Hee J.; Noh, Woo Chul; Nam, Seok Jin; Park, Byeong Woo; Lee, Eun S.; Im, Seock Ah; Jung, Yuh‐Seog; Yoon, Jung Han; Kang, Sung Soo; Park, Kyong H.; Lee, Soo Jung; Lee, Jeong Eon; Lee, Min Hyung; Cho, Se H.; Kim, Sung Young; Kim, Hyun Ah; Han, Se Hwan; Han, Wonshik; Hur, Min; Kim, Seon‐Ok

doi:10.1016/j.ejca.2021.03.017

Cited by 10 publications

(10 citation statements)

References 24 publications

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“…12 The recovery of ovarian function after chemotherapy is largely determined by age. 18 Therefore, the starting point of OFS can differ with the patient's age. That is, starting OFS concurrently or immediately after chemotherapy in patients younger than 40 years would be beneficial, as in the SOFT/TEXT.…”

Section: Discussionmentioning

confidence: 99%

“…However, we found no significant differences in the HR by random assignment visit in any age group (Data Supplement, Table S5). Older patients experience longer ovarian function recovery time after cancer treatment compared with younger patients 18,22 and are estimated to experience longer ovarian recovery even after 2 years of ovarian suppression. Therefore, these patients are expected to have a longer period of amenorrhea, potentially resulting in greater survival benefits.…”

Section: Discussionmentioning

confidence: 99%

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Adding Ovarian Suppression to Tamoxifen for Premenopausal Women With Hormone Receptor–Positive Breast Cancer After Chemotherapy: An 8-Year Follow-Up of the ASTRRA Trial

Baek,

Noh,

Ahn

et al. 2023

JCO

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PURPOSE To determine the updated long-term outcomes of the Addition of Ovarian Suppression to Tamoxifen in Young Women With Hormone-Sensitive Breast Cancer Who Remain Premenopausal or Regain Vaginal Bleeding After Chemotherapy (ASTRRA) trial. PATIENTS AND METHODS This study is a post-trial follow-up of the ASTRRA trial, involving 1,483 premenopausal women younger than 45 years treated with definitive surgery after completing adjuvant or neoadjuvant chemotherapy for estrogen receptor–positive breast cancer. Patients were randomly assigned in a 1:1 ratio to complete 5 years of tamoxifen (TAM) alone (TAM-only) or 5 years of TAM with ovarian function suppression (OFS) for 2 years (TAM + OFS). The primary end point was disease-free survival (DFS), and the secondary end point was overall survival (OS). RESULTS At 106.4 months of median follow-up, there was a continuous significant reduction in the DFS event rate in the TAM + OFS group. The 8-year DFS rate was 85.4% in the TAM + OFS group and 80.2% in the TAM-only group (hazard ratio [HR], 0.67; 95% CI, 0.51 to 0.87). There were no significant differences in OS between the two groups. The OS rate was 96.5% in the TAM + OFS group and 95.3% in the TAM-only group (HR, 0.78; 95% CI, 0.49 to 1.25). CONCLUSION Adding OFS for 2 years to adjuvant TAM with a longer follow-up resulted in consistent DFS benefits, suggesting that adding OFS to TAM should be considered for patients who remain in a premenopausal state or resume ovarian function after chemotherapy.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Adding Ovarian Suppression to Tamoxifen for Premenopausal Women With Hormone Receptor–Positive Breast Cancer After Chemotherapy: An 8-Year Follow-Up of the ASTRRA Trial

Baek,

Noh,

Ahn

et al. 2023

JCO

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“…Finally, we did not consider the effects of ovarian function suppression because this was a retrospective analysis based on electronic medical records, and we could not obtain reliable data on such treatment. Given that higher clinical risk patients show more benefit from additional ovarian function suppression based on an analysis of the TEXT and SOFT trial populations, and that the randomized ASTRRA trial demonstrated the benefit of additional ovarian function suppression in premenopausal women who resumed menstruation after adjuvant chemotherapy, whether the premenopausal women received ovarian function suppression or not may be crucial for their outcomes 24–27 . Despite the limitations, our study included a fairly large population of premenopausal women who had 21‐gene expression assay results, reflecting the real‐world implications of the RS in the prognostication of the patients, and our results provide topics to be investigated in prospective future trials.…”

Section: Discussionmentioning

confidence: 99%

“…7,8 The predictive role of the RS for chemotherapy benefit is different according to menopausal status among those with low to intermediate RS (<26). [9][10][11] For postmenopausal women (age >50 years), there is no benefit of chemoendocrine therapy compared to endocrine therapy alone among patients with RS <26, while the addition of chemotherapy is beneficial for premenopausal women with RS <26 and pN1 stage and intermediate RS (16)(17)(18)(19)(20)(21)(22)(23)(24)(25) and pN0 stage. [9][10][11][12] As the treatment recommendations and predictive role of the RS differ based on menopausal status, the role of the RS according to menopausal status should be studied.…”

Section: Introductionmentioning

confidence: 99%

21‐gene expression assay and clinical outcomes of premenopausal patients with hormone receptor‐positive breast cancer

Hyung,

Lee,

Kim

et al. 2023

Intl Journal of Cancer

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The prognostic role of the recurrence score (RS) based on the 21‐gene expression assay in premenopausal women is not well delineated, and we investigated the association of outcomes and the RS in premenopausal patients who had 21‐gene expression assay at Asan Medical Center, Seoul, Korea, between June 2005 and July 2018. Invasive breast cancer‐free survival (IBCFS) by STEEP version 2.0 was compared according to the RS and clinical risk factors. A total of 554 patients were included in our study and 116 patients (20.9%) had age <40 years, 238 patients (43.0%) had luminal B subtype (Ki67 ≥ 20%), and 83 patients (15.0%) had RS >25. All patients received adjuvant tamoxifen ± chemotherapy. Overall, patients with RS >25 showed trend toward worse IBCFS from multivariable analysis (adjusted HR 1.89 [95% CI: 0.95‐3.73], P = .069). When comparing outcomes according to age and luminal subtypes, patients with luminal B subtype and age <40 years (n = 60) showed significantly worse outcomes compared to the others (luminal A or luminal B + age ≥40 years, n = 494; adjusted HR 2.95 [95% CI: 1.49‐5.82], log‐rank P < .001). Among patients with luminal B subtype and age <40 years, there was no significant association observed between IBCFS and the RS (log‐rank P = .51). In conclusion, while RS >25 showed association with poor outcomes in premenopausal women, it may have less prognostic significance among those with luminal B subtype and age <40 years.

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“…С практической точки зрения определение концентрации эстрадиола и ФСГ позволяет оценить функцию яичников и выявить ее возобновление после индуцированной ХТ-лечением аменореи. На возобновление функции яичников в таком случае указывает уровень ФСГ в сыворотке крови менее 30 мМЕ/мл, эстрадиола -более 40 пг/мл [23].…”

Section: гиперэстрогения как следствие индукции стероидогенеза в яичн...unclassified

Induction of ovarian steroidogenesis as an additional potential risk factor for progression in premenopausal patients with hormone-receptor-positive breast cancer receiving tamoxifen as adjuvant therapy

et al. 2022

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Introduction. Patients with hormone-receptor-positive (HR+) breast cancer (BC) over 40 years old who take tamoxifen are not subject to mandatory castration. However this cohort of patients is not homogeneous.Aim. The present study is aimed at studying the features of ovarian steroidogenesis in perimenopausal breast cancer patients receiving adjuvant hormone therapy (HT) with tamoxifen.Materialy and methods. The study included 82 patients aged 42 to 53 years with GH+BC who received HT with tamoxifen 20 mg daily. Within 9 months from the start of HT in patients, the levels of estradiol and follicle-stimulating hormone in the peripheral blood were studied every 3 months.Results. In 66.7% of patients who received chemotherapy (CT), the development of amenorrhea was noted. Half of the patients in the HT-only group demonstrated amenorrhea. Oligomenorrhea was observed in 20.8% and 16.7% in each group, respectively. The incidence of amenorrhea in women treated with chemotherapy was higher (OR 2.02; 95% CI: 0.73-5.67), but the differences were not statistically significant (p = 0.1766). In the general cohort, in 15.7-16.8% of patients, the level of estradiol exceeded 251 pg / ml - the upper limit of the norm of the follicular phase of the menstrual cycle. Differences between groups in the incidence of estradiol levels > 251 pg/ml were statistically significant (p = 0.0293). 3.4-5.6% of patients in the total cohort (depending on the period of observation) had an estradiol level > 649 pg / ml, which corresponded to the highest ovulatory value.Conclusions. Against the background of HT with tamoxifen in some perimenopausal patients hyperestrogenism is observed which indicates the implementation of the effect of induction of ovarian steroidogenesis and can be considered as an additional potential risk factor for the progression of HR+BC. Amenorrhea after CT is not a reliable marker of ovarian suppression.

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Five-year changes in ovarian function restoration in premenopausal patients with breast cancer taking tamoxifen after chemotherapy: An ASTRRA study report

Cited by 10 publications

References 24 publications

Adding Ovarian Suppression to Tamoxifen for Premenopausal Women With Hormone Receptor–Positive Breast Cancer After Chemotherapy: An 8-Year Follow-Up of the ASTRRA Trial

Adding Ovarian Suppression to Tamoxifen for Premenopausal Women With Hormone Receptor–Positive Breast Cancer After Chemotherapy: An 8-Year Follow-Up of the ASTRRA Trial

21‐gene expression assay and clinical outcomes of premenopausal patients with hormone receptor‐positive breast cancer

Induction of ovarian steroidogenesis as an additional potential risk factor for progression in premenopausal patients with hormone-receptor-positive breast cancer receiving tamoxifen as adjuvant therapy

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