scholarly journals Adding Ovarian Suppression to Tamoxifen for Premenopausal Breast Cancer: A Randomized Phase III Trial

2020 ◽  
Vol 38 (5) ◽  
pp. 434-443 ◽  
Author(s):  
Hyun-Ah Kim ◽  
Jong Won Lee ◽  
Seok Jin Nam ◽  
Byeong-Woo Park ◽  
Seock-Ah Im ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Ovarian Function ◽  
Disease Free Survival ◽  
Premenopausal Women ◽  
Hazard Ratio ◽  
Phase Iii ◽  
Premenopausal Breast Cancer ◽  
Ovarian Function Suppression ◽  
Beneficial Effects ◽  
Positive Breast Cancer

PURPOSE The addition of ovarian function suppression (OFS) for 5 years to tamoxifen (TAM) for treatment of premenopausal patients with breast cancer after completion of chemotherapy has beneficial effects on disease-free survival (DFS). This study evaluated the efficacy of adding 2 years of OFS to TAM in patients with hormone receptor–positive breast cancer who remain in a premenopausal state or resume ovarian function after chemotherapy. PATIENTS AND METHODS We enrolled 1,483 premenopausal women (age ≤ 45 years) with estrogen receptor–positive breast cancer treated with definitive surgery after completing adjuvant or neoadjuvant chemotherapy. Ovarian function was assessed every 6 months for 2 years since enrollment on the basis of follicular-stimulating hormone levels and vaginal bleeding history. If ovarian function was confirmed to be premenopausal at each visit, the patient was randomly assigned to complete 5 years of TAM alone (TAM-only) group or 5 years of TAM with OFS for 2 years that involved monthly goserelin administration (TAM + OFS) group. DFS was defined from the time of enrollment to the time of the first event. RESULTS A total of 1,293 patients were randomly assigned, and 1,282 patients were eligible for analysis. The estimated 5-year DFS rate was 91.1% in the TAM + OFS group and 87.5% in the TAM-only group (hazard ratio, 0.69; 95% CI, 0.48 to 0.97; P = .033). The estimated 5-year overall survival rate was 99.4% in the TAM + OFS group and 97.8% in the TAM-only group (hazard ratio, 0.31; 95% CI, 0.10 to 0.94; P = .029). CONCLUSION The addition of 2 years of OFS to TAM significantly improved DFS compared with TAM alone in patients who remained premenopausal or resumed ovarian function after chemotherapy.

scholarly journals Impact on disease-free survival of the duration of ovarian function suppression, as postoperative adjuvant therapy, in premenopausal women with hormone receptor-positive breast cancer: a retrospective single-institution study

Breast Cancer ◽  
2018 ◽  
Vol 25 (3) ◽  
pp. 343-349 ◽  
Author(s):  
Yukinori Ozaki ◽  
Yuko Tanabe ◽  
Nobuko Tamura ◽  
Takuya Ogura ◽  
Chihiro Kondoh ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Hormone Receptor ◽  
Ovarian Function ◽  
Disease Free Survival ◽  
Premenopausal Women ◽  
Ovarian Function Suppression ◽  
Hormone Receptor Positive ◽  
Significant Difference ◽  
Premenopausal Patients ◽  
Positive Breast Cancer

Abstract Introduction Although tamoxifen (TAM) plus ovarian function suppression (OFS) is considered as a standard adjuvant treatment for premenopausal women with hormone receptor-positive breast cancer, the optimal duration of OFS has not yet been established. This retrospective study was designed to assess the duration of OFS and the impact of the duration of OFS on the DFS in these patients. Methods We retrospectively reviewed the data of premenopausal patients with breast cancer who received TAM + OFS (goserelin or leuprorelin) as adjuvant therapy between February 2004 and June 2015. The primary analysis was a comparison of the disease-free survival (DFS) between patients who received OFS for 3 years or less (OFS ≤ 3 years group) and those who received OFS for longer than 3 years (OFS > 3 years group). Results We analyzed the data of 215 premenopausal patients diagnosed as having hormone receptor-positive breast cancer. A propensity score-matched model showed the absence of any significant difference in the DFS between the OFS ≤ 3 years group and OFS > 3 years group (6-year DFS rate, 93.2 vs. 94.0%; log-rank test p = 0.767). Conclusions Our data showed that among premenopausal women with hormone receptor-positive breast cancer who received TAM + OFS as adjuvant endocrine therapy, there was no significant difference in the DFS between the OFS ≤ 3-year group and OFS > 3-year group. A randomized trial is needed to establish the optimal duration of OFS for these patients.

Evaluation of Adjuvant! Online to predict the effect of optimal endocrine therapy (ovarian function suppression plus tamoxifen) for premenopausal breast cancer patients with estrogen-receptor-positive breast cancer

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. 585-585
Author(s):  
R. J. Paridaens ◽  
S. Gelber ◽  
B. F. Cole ◽  
R. D. Gelber ◽  
B. Thürlimann ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Estrogen Receptor ◽  
Endocrine Therapy ◽  
Ovarian Function ◽  
Premenopausal Women ◽  
Free Survival ◽  
Ovarian Function Suppression ◽  
Estrogen Receptor Positive ◽  
Chemoendocrine Therapy ◽  
Positive Breast Cancer

585 Background: Adjuvant! Online (AOL) is a user-friendly, web-based tool that provides estimates of adjuvant therapy outcomes for individual patients. While reliable evidence underpins estimates for most patient cohorts, there is a paucity of data on the effect of adding chemotherapy to complete estrogen blockade for premenopausal women with estrogen-receptor positive breast cancer. Methods: International Breast Cancer Study Group (IBCSG) Trial 11–93 enrolled 174 premenopausal women with estrogen-receptor positive, node-positive breast cancer from 1993 to 1998. Fifty percent of patients had 1 positive axillary lymph node and 97% had between 1 and 3 positive nodes. Patients were randomized to receive ovarian function suppression plus five years of tamoxifen with or without chemotherapy. The estimated hazard rates and corresponding 10-year relapse-free survival percents obtained from Trial 11–93 data (Breast Cancer Res Treat. 2009;113:137–144) were compared with those predicted using AOL. Results: The 10-year relapse-free survival percents predicted from AOL were 64.4% (95% CI, 61.9% to 67.2%) for endocrine therapy alone and 74.9% (95% CI, 73.1% to 76.8%) for chemoendocrine therapy. By contrast, these estimates in Trial 11–93 were 76.4% (95% CI, 65.8% to 84.0%) for endocrine therapy alone and 74.9% (95% CI, 64.5% to 82.7%) for chemoendocrine therapy. The AOL estimate for the endocrine alone control group is lower than that observed in Trial 11–93 (p = 0.03), while the estimates for the two chemoendocrine therapy groups are similar. Conclusions: AOL appears to underestimate the effectiveness of adjuvant endocrine therapy alone for premenopausal women with endocrine responsive breast cancer, thus overestimating the added benefit - if any - from chemotherapy for this patient population. Prospective clinical trials addressing the question are warranted. No significant financial relationships to disclose.

scholarly journals International Breast Cancer Study Group (IBCSG)

2006 ◽  
Vol 9 (S1) ◽  
pp. 226-280
Author(s):  
Keyword(s):  
Breast Cancer ◽  
Adjuvant Therapy ◽  
Endocrine Therapy ◽  
Ovarian Function ◽  
Premenopausal Women ◽  
Phase Iii ◽  
Phase Iii Trial ◽  
Node Positive ◽  
Positive Breast Cancer

This section provides current contact details and a summary of recent or ongoing clinical trials being coordinated by International Breast Cancer Study Group (IBCSG). Clinical trials include: CMF with or without prednisone for pre/perimenopausal patients with breast cancer and 1–3 positive nodes. Ludwig/IBCSG Trial ICMF + prednisone combined with or without oophorectomy for pre/perimenopausal patients with breast cancer and 4 or more positive nodes. Ludwig/IBCSG Trial IIAdjuvant therapy for postmenopausal elderly patients (older than 65): observation versus prednisone tamoxifen. Ludwig/IBCSG Trial IIIAdjuvant therapy for postmenopausal, 65 years or younger, node-positive breast cancer patients: observation versus prednisone + tamoxifen versus CMF + prednisone + tamoxifen. Ludwig/IBCSG Trial IVAdjuvant perioperative chemotherapy. Ludwig/IBCSG Trial VAdjuvant therapy in node-positive pre/perimenopausal breast cancer patients: CMF 3 versus 6 with or without reintroduction of chemotherapy. IBCSG Trial VIAdjuvant chemotherapy in node-positive postmenopausal breast cancer patients: endocrine versus chemo-endocrine versus chemo-endocrine with delayed chemotherapy. IBCSG Trial VIIAdjuvant therapy in pre- and perimenopausal patients with node-negative breast cancer. Observation versus LH-RH analogue versus CMF versus CMF + LN-RH analogue. IBCSG Trial VIIIAdjuvant therapy in postmenopausal patients with node-negative breast cancer. Tamoxifen versus CMF followed by tamoxifen. IBCSG Trial IXSurgical therapy with or without axillary node clearance for breast cancer in elderly patients who receive adjuvant therapy with tamoxifen. IBCSG Trial 10–93Adjuvant therapy for premenopausal patients with node-positive breast cancer who are suitable for endocrine therapy alone. IBCSG Trial 11–93Adjuvant therapy for post/perimenopausal patients with node-positive breast cancer who have estrogen-receptor-positive tumors. IBCSG Trial 12–93Adjuvant therapy for premenopausal patients with node-positive breast cancer who are not suitable for endocrine therapy alone. IBCSG Trial 13–93Adjuvant therapy for post perimenopausal patients with node-positive breast cancer who are not suitable for endocrine therapy alone. IBCSG Trial 14–93High dose EC × 3 supported by PBSC versus EC/AC × 4 followed by CMF as adjuvant treatment for high-risk operable Stage II and Stage III breast cancer in premenopausal and young postmenopausal (<65 years) patients. IBCSG Trial 15–95Adjuvant therapy for postmenopausal patients with operable breast cancer who have estrogen-receptor or progesterone-receptor-positive tumors. Tamoxifen versus letrozole versus tamoxifen followed by letrozole versus letrozole followed by tamoxifen. BIG 1–98 / IBCSG Trial 18–98Maintenance chemotherapy in hormone non-responsive breast cancer: low-dose cytotoxics as “anti-angiogenesis treatment” following adjuvant induction chemotherapy for patients with ER-negative and PgR-negative breast cancer. IBCSG Trial 22–00A randomized trial of axillary dissection versus no axillary dissection for patients with clinically node-negative breast cancer and micrometastases in the sentinel node. IBCSG Trial 23–01Suppression of Ovarian Function Trial (SOFT). A Phase III trial evaluating the role of ovarian function suppression (OFS) and the role of exemestane as adjuvant therapies for premenopausal women with endocrine-responsive breast cancer. Tamoxifen versus OFS + tamoxifen versus OFS + exemestane. BIG 2–02/IBCSG Trial 24–02Tamoxifen and Exemestane Trial (TEXT). A Phase III trial evaluating the role of exemestane plus GnRH analogue as adjuvant therapy for premenopausal women with endocrine-responsive breast cancer. Ovarian function suppression + tamoxifen versus ovarian function suppression + exemestane. BIG 3–02/IBCSG Trial 25–02Premenopausal Endocrine Responsive Chemotherapy Trial (PERCHE) A Phase III trial evaluating the role of chemotherapy as adjuvant therapy for premenopausal women with endocrine-responsive breast cancer who receive endocrine therapy.Chemotherapy + OFS + tamoxifen/exemestane versus OFS + tamoxifen/ exemestane. BIG 4–02/IBCSG Trial 26–02Chemotherapy for radically resected loco-regional relapse. BIG 1-02/IBCSG Trial 27–02/NSABP Protocol B-37Chemotherapy adjuvant study for women at advanced Age (CASA) Phase III trial evaluating the role of adjuvant pegylated liposomal doxorubicin (PLD) for women (age 66 years or older) with endocrine non-responsive breast cancer who are not suitable for being offered a “standard chemotherapy regimen”. BIG 1–05/IBCSG Trial 32–05

scholarly journals The Modern Landscape of Endocrine Therapy for Premenopausal Women with Breast Cancer

Breast Care ◽  
2015 ◽  
Vol 10 (5) ◽  
pp. 312-315 ◽  
Author(s):  
Lorenzo Rossi ◽  
Olivia Pagani
Keyword(s):  
Breast Cancer ◽  
Endocrine Therapy ◽  
Ovarian Function ◽  
Treatment Options ◽  
Endocrine Resistance ◽  
Premenopausal Women ◽  
New Drugs ◽  
Fine Tuning ◽  
Individual Risk ◽  
Ovarian Function Suppression

The optimal endocrine therapy for premenopausal women with early and advanced breast cancer still remains an important and controversial issue. For over 30 years, tamoxifen has been the gold standard in the adjuvant setting. New therapeutic options, such as the addition of ovarian function suppression to oral endocrine therapy (either tamoxifen or aromatase inhibitors), can improve outcomes over tamoxifen alone in well-selected patients. Treatment duration has also been revisited, and extended therapy is becoming a new standard of care, especially in high-risk patients. Endocrine therapy for advanced disease still represents a challenge and a research priority. New drugs and combinations able to overcome endocrine resistance are at the horizon, and their role in premenopausal women should be better elucidated. Side effects and quality of life (including family planning considerations) play an important role in treatment selection and in the patients' treatment adherence and should always be discussed before start of treatment. The paper will specifically focus on how to integrate all new treatment options in the current armamentarium of endocrine therapy of premenopausal women, with the aim of best fine-tuning treatment selections according to the individual risk/benefit evaluation.

Ovarian Function Suppression in Premenopausal Women with Early-Stage Breast Cancer

2017 ◽  
Vol 18 (1) ◽  
Author(s):  
Matteo Lambertini ◽  
Lucia Del Mastro ◽  
Giulia Viglietti ◽  
Noam F. Pondé ◽  
Cinzia Solinas ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Ovarian Function ◽  
Early Stage ◽  
Premenopausal Women ◽  
Early Stage Breast Cancer ◽  
Ovarian Function Suppression
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