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Table 1 Delphi model results

From: An Italian Delphi study to evaluate consensus on adjuvant endocrine therapy in premenopausal patients with breast cancer: the ERA project

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%
  1. Abbreviations: HR hormone receptors, EBC early breast cancer, HER2 Human epidermal growth factor receptor 2, ER estrogen receptor, PgR progesterone receptor, OFS, ovarian function suppression, DFS disease-free survival, DDFS distant disease-free survival, BCFI breast cancer-free interval, OS overall survival, AIs aromatase inhibitors, LHRHa luteinizing hormone-releasing hormone analogs, BMI body mass index, FSH follicle-stimulating hormone, LH luteinizing hormone, E2 beta-2-estradiol
  2. aA consensus was deemed as achieved if either the sum of answers 1 and 2 (negative), or 3, 4 and 5 (positive) exceeded 66%