Table 2. Patient, disease and treatment characteristics at T0.
|
OFS |
Tam |
All |
|||||
|---|---|---|---|---|---|---|---|
| Characteristic | N | % | N | % | N | % | P-valuea |
| N patients | 54 | 20 | 74 | — | |||
| Age at randomisation | 0.56 | ||||||
| Mean (range) | 44 | (28–58) | 46 | (38–53) | 45 | (28–58) | |
| <35 | 5 | 9.3 | — | — | 5 | 6.8 | |
| 35–39 | 4 | 7.4 | 2 | 10.0 | 6 | 8.1 | |
| 40–44 | 15 | 27.8 | 5 | 25.0 | 20 | 27.0 | |
| 45–49 | 21 | 38.9 | 7 | 35.0 | 28 | 37.8 | |
| 50+ | 9 | 16.7 | 6 | 30.0 | 15 | 20.3 | |
| Education | 1.00 | ||||||
| Primary/secondary education | 9 | 16.7 | 3 | 15.0 | 12 | 16.2 | |
| Additional education | 31 | 57.4 | 12 | 60.0 | 43 | 58.1 | |
| Academic education | 14 | 25.9 | 5 | 25.0 | 19 | 25.7 | |
| Body mass index | 0.94 | ||||||
| Normal (<25) | 30 | 55.6 | 11 | 55.0 | 41 | 55.4 | |
| Overweight (25–<30) | 13 | 24.1 | 4 | 20.0 | 17 | 23.0 | |
| Obese (⩾30) | 9 | 16.7 | 4 | 20.0 | 13 | 17.6 | |
| Unknown | 2 | 3.7 | 1 | 5.0 | 3 | 4.1 | |
| Menstruation | 0.79 | ||||||
| Normal | 36 | 66.7 | 13 | 65.0 | 49 | 66.2 | |
| Irregular (but cycles continuing) | 7 | 13 | 4 | 20.0 | 11 | 14.9 | |
| Persistent amenorrhoea | 11 | 20.4 | 3 | 15.0 | 14 | 18.9 | |
| Performance status | 1.00 | ||||||
| Fully active (K90–100) | 48 | 88.9 | 18 | 90.0 | 66 | 89.2 | |
| Restricted (K70–80) | 6 | 11.1 | 2 | 10.0 | 8 | 10.8 | |
| History and/or treatment of depression/anxiety | 0.41 | ||||||
| No | 33 | 61.1 | 15 | 75.0 | 48 | 64.9 | |
| Yes | 21 | 38.9 | 5 | 25.0 | 26 | 35.1 | |
| Nodal status | 0.75 | ||||||
| Negative | 42 | 77.8 | 17 | 85.0 | 59 | 79.7 | |
| Positive | 12 | 22.2 | 3 | 15.0 | 15 | 20.3 | |
| Local-regional treatment | 0.92 | ||||||
| Mastectomy, no radiation | 13 | 24.1 | 4 | 20.0 | 17 | 23.0 | |
| Mastectomy with radiation | 6 | 11.1 | 2 | 10.0 | 8 | 10.8 | |
| Breast-conserving with radiation | 35 | 64.8 | 14 | 70.0 | 49 | 66.2 | |
| Weeks from randomisation to completion of radiation if received, median (interquartile range) | 7.4 | (1.9–9.7) | 7 | (2.1–13.4) | 7.4 | (1.9–10.0) | |
| Prior chemotherapy | 0.78 | ||||||
| No | 38 | 70.4 | 15 | 75.0 | 53 | 71.6 | |
| Yes | 16 | 29.6 | 5 | 25.0 | 21 | 28.4 | |
| Months from last dose of chemotherapy, median (interquartile range) | 2.1 | (1.7–2.8) | 2.1 | (1.9–2.4) | 2.1 | (1.8–2.7) | |
| HER2 status and therapy | 1.00 | ||||||
| Not HER2+ | 51 | 94.4 | 19 | 95.0 | 70 | 94.6 | |
| HER2+/HER2-directed therapy | 3 | 5.6 | 1 | 5.0 | 4 | 5.4 | |
| Type of OFS during year 1 | NA | ||||||
| GnRH agonist only | 49 | 90.7 | NA | — | |||
| GnRH agonist followed by oophorectomy | 4 | 7.4 | NA | — | |||
| Oophorectomy only | 1 | 1.9 | NA | — | |||
Abbreviations: NA=not applicable; OFS=ovarian function suppression.
a
Patient, disease and prior treatment characteristics were compared between groups using Fisher's exact tests for categorical variables.