Background
Methods
Results
Topic | Statement | Level of agreement/disagreement | Positive Consensusa | ||||
---|---|---|---|---|---|---|---|
Completely disagree | Slightly disagree | Partially agree | Agree | Completely agree | |||
Prognostic groups | 1. The risk of recurrence in premenopausal women with HR-positive EBC depends on prognostic factors. | ||||||
The following prognostic factors should be considered for risk assessment: | |||||||
A. Tumor stage (T and N) | 0% | 0% | 10% | 32% | 58% | 100% | |
B. Tumor grade | 0% | 0% | 16% | 39% | 45% | 100% | |
C. HER2 overexpression | 0% | 0% | 0% | 23% | 77% | 100% | |
D. Age | 3% | 3% | 39% | 32% | 23% | 94% | |
E. Gene expression profile | 0% | 3% | 39% | 42% | 16% | 97% | |
F. Ki-67 | 0% | 0% | 10% | 39% | 51% | 100% | |
G. ER and PgR expression levels | 0% | 3% | 7% | 35% | 55% | 97% | |
H. Histology (ductal vs. lobular) | 38% | 52% | 5% | 0% | 5% | 10% | |
2. Predictive and prognostic factors guide the choice of adjuvant endocrine treatment in premenopausal women with HR-positive EBC. | |||||||
The following factors guide the choice of treatment in premenopausal patients who are candidates for adjuvant endocrine therapy: | |||||||
A. Tumor stage (T and N) | 0% | 6% | 20% | 29% | 45% | 94% | |
B. Tumor grade | 3% | 7% | 16% | 52% | 22% | 90% | |
C. HER2 overexpression | 0% | 10% | 12% | 39% | 39% | 90% | |
D. Age | 0% | 10% | 19% | 39% | 32% | 90% | |
E. Gene expression profile | 0% | 13% | 32% | 42% | 13% | 87% | |
F. Ki-67 | 0% | 3% | 23% | 39% | 35% | 97% | |
G. ER and PgR expression levels | 0% | 3% | 6% | 39% | 52% | 97% | |
H. Histology (ductal vs. lobular) | 33% | 52% | 5% | 0% | 10% | 15% | |
Therapeutic strategy | 3. For premenopausal women with HR-positive EBC at low risk of recurrence, adjuvant tamoxifen is the recommended adjuvant treatment. | ||||||
A. The addition of OFS to tamoxifen or exemestane did not show clinical benefit in terms of DFS, DDFS, BCFI and OS in low–risk patients. | 6% | 10% | 13% | 45% | 26% | 84% | |
B. The addition of OFS to standard endocrine therapy could be associated with worse adverse effects, according to patients’ age. | 3% | 10% | 32% | 36% | 19% | 87% | |
C. If tamoxifen is contraindicated, OFS with or without exemestane should be considered. | 0% | 0% | 6% | 42% | 52% | 100% | |
4. The addition of OFS to standard adjuvant endocrine therapy is recommended for premenopausal women with HR–positive EBC at intermediate or high risk of recurrence. | |||||||
A. The addition of OFS to tamoxifen reduces the risk of breast cancer recurrence. | 0% | 3% | 13% | 52% | 32% | 97% | |
B. OFS plus exemestane reduced the risk of breast cancer recurrence compared to OFS plus tamoxifen. | 0% | 0% | 23% | 45% | 32% | 100% | |
C. OFS plus exemestane reduced the risk of breast cancer recurrence compared to tamoxifen alone. | 0% | 3% | 6% | 52% | 39% | 97% | |
D. The combination of OFS and tamoxifen may be an alternative to OFS plus AIs for patients at intermediate risk of breast cancer recurrence. | 0% | 3% | 45% | 32% | 20% | 97% | |
Ovarian function suppression | 5. The standard duration of adjuvant OFS for premenopausal women with HR-positive EBC is 5 years, with LHRHa therapy administered on a monthly basis. | ||||||
A. Available data on OFS come from clinical trials in which LHRHa therapy was administered on a monthly basis. | 0% | 0% | 6% | 55% | 39% | 100% | |
B. Adjuvant endocrine treatment with LHRHa therapy plus AIs may result in incomplete ovarian suppression. | 0% | 26% | 16% | 32% | 26% | 74% | |
C. Potential predictive factors for suboptimal ovarian suppression are high BMI, no prior chemotherapy, low baseline FSH and LH levels. | 0% | 13% | 23% | 45% | 19% | 87% | |
D. Surgical oophorectomy could be an alternative to LHRHa therapy, according to patients’ preferences. | 3% | 7% | 16% | 39% | 35% | 90% | |
E. LHRHa therapy should start preferably on the second day of the menstrual cycle. | 0% | 19% | 13% | 42% | 26% | 81% | |
F. AIs should be administered at least 4 weeks after the first dose of LHRHa therapy, when associated with OFS. | 0% | 4% | 32% | 32% | 32% | 96% | |
G. Perimenopausal patients with chemotherapy-induced amenorrhea should receive OFS if baseline FSH and E2 levels are not in the postmenopausal range. | 6% | 6% | 0% | 28% | 60% | 88% |