Table 3.
Summary of treatment discontinuation, dose reduction and interruption during study treatment
| Status/reason | EVE esc n = 79 n (%) | EVE 10mg n = 77 n (%) | Overall n = 156 n (%) | P value |
|---|---|---|---|---|
| Discontinued everolimus | ||||
| Within the first 3 weeks (escalation phase) | 5 (6.3) | 12 (15.8) | 17 (10.9) | 0.073 |
| Disease progression | 1 (1.3) | 1 (1.3) | 2 (1.3) | |
| Death | 0 (0.0) | 2 (2.6) | 2 (1.3) | |
| AE | 1 (1.3) | 5 (6.6) | 6 (3.8) | |
| Patient’s or investigator’s decision | 3 (3.8) | 4 (5.2) | 7 (4.5) | |
| Within the first 12 weeks | 37 (46.3) | 25 (32.9) | 62 (39.7) | 0.103 |
| Disease progression | 25 (31.3) | 7 (9.2) | 32 (20.5) | |
| Death | 0 (0.0) | 3 (3.9) | 3 (1.9) | |
| AE | 5 (6.3) | 7 (9.2) | 12 (7.7) | |
| Patient’s or investigator’s decision | 7 (8.8) | 8 (10.5) | 15 (9.6) | |
| Within 24 weeks | 58 (72.5) | 50 (65.8) | 108 (69.2) | 0.390 |
| Disease progression | 39 (48.8) | 25 (32.9) | 64 (41.0) | |
| Death | 1 (1.3) | 3 (3.9) | 4 (2.6) | |
| AE | 8 (10.0) | 10 (13.2) | 18 (11.5) | |
| Patient’s or investigator’s decision | 10 (12.6) | 12 (15.8) | 22 (14.1) | |
| Discontinued exemestane | 23 (28.8) | 22 (28.9) | 45 (28.8) | >0.99 |
| Disease progression | 38 (47.5) | 29 (38.2) | 67 (42.9) | |
| Death | 3 (3.8) | 3 (3.9) | 6 (3.8) | |
| AE | 4 (5.0) | 2 (2.6) | 6 (3.8) | |
| Patient’s or investigator’s decision | 12 (15.0) | 20 (26.3) | 32 (20.5) | |
| Dose reduction everolimus | ||||
| Patients with everolimus reduced to 5 mg | 23 (31.5) | 24 (36.4) | 47 (33.8) | 0.593 |
| Haematological AE related to study medication | 4 (5.1) | 2 (2.6) | 6 (3.8) | 0.681 |
| Nonhaematological AE related to study medication | 16 (20.3) | 14 (18.2) | 30 (19.2) | 0.840 |
| AE not related to study medication | 0 (0.0) | 3 (3.9) | 3 (1.9) | 0.118 |
| Other reason | 1 (1.3) | 1 (1.3) | 2 (1.3) | >0.99 |
| Unknown reason | 3 (3.8) | 4 (5.2) | 7 (4.5) | 0.718 |
| Interruption everolimus | ||||
| Patients with at least one treatment interruption | 47 (59.5) | 43 (55.8) | 90 (57.7) | 0.746 |
| Haematological AE related to study medication | 6 (7.6) | 6 (7.8) | 12 (7.7) | >0.99 |
| Nonhaematological AE related to study medication | 26 (32.9) | 29 (37.7) | 55 (35.3) | 0.616 |
| AE not related to study medication | 10 (12.7) | 14 (18.2) | 24 (15.4) | 0.381 |
| Patient’s noncompliance | 7 (8.9) | 6 (7.8) | 13 (8.3) | >0.99 |
| Organisational reason | 5 (6.3) | 1 (1.3) | 6 (3.8) | 0.210 |
| Other reason | 9 (11.4) | 6 (7.8) | 15 (9.6) | 0.589 |
Note that one patient who was randomised to the EVE esc arm received 10mg everolimus during the escalation phase of 3 weeks, and was therefore analysed in the EVE 10mg arm.
AE, adverse event; EVE, everolimus; esc, escalated.