Background
Adjuvant trial of timing of surgical oophorectomy
Methods
Statistical methods
Results
All randomized patientsa | Original cohort of randomized patientsa | |||||||
---|---|---|---|---|---|---|---|---|
Immediate/follicular phase | Scheduled/luteal phase | Immediate/follicular phase | Scheduled/luteal phase | |||||
Total randomized | 255 | 244 | 167 | 167 | ||||
Year | Total (Failures) | Failure probability (95% CI) | Total (Failures) | Failure probability (95% CI) | Total (Failures) | Failure probability (95% CI) | Total (Failures) | Failure probability (95% CI) |
1 | 246 (10) | 0.04 (0.02, 0.07) | 226 (18) | 0.07 (0.05, 0.11) | 163 (5) | 0.03 (0.01, 0.07) | 157 (11) | 0.07 (0.4, 0.12) |
3 | 210 (36) | 0.18 (0.14, 0.23) | 178 (45) | 0.26 (0.21, 0.32) | 137 (26) | 0.19 (0.13, 0.25) | 124 (31) | 0.25 (0.19, 0.33) |
5 | 118 (26) | 0.29 (0.24, 0.36) | 102 (20) | 0.36 (0.30, 0.43) | 116 (17) | 0.29 (0.23, 0.36) | 102 (18) | 0.36 (0.29, 0.44) |
Total eventsb | 78 | 85 | 54 | 62 | ||||
Average follow up time, years (SD) | 4.41(1.5) | 4.08 (1.8) | 4.77 (1.6) | 4.42 (1.9) | ||||
Event rateb | 69.4 | 85.4 | 67.8 | 83.9 | ||||
HRb (95% CI) | 1.24 (0.91, 1.68) | 1.25 (0.86, 1.79) |
Time (years) | Prior trial data | Estimates from trial design | Estimated by SSRE procedurea | Final for SSRE cohort (95% CI) | Final for all randomized (95% CI) | |
---|---|---|---|---|---|---|
Median (5%, 95%) | Estimates used in SSREb | |||||
3 | 0.16 | 0.28 | 0.30 (0.22, 0.39) | 0.24 | 0.22 (0.16, 0.30) | 0.18 (0.14, 0.23) |
5 | 0.26 | 0.40 | 0.49 (0.35, 0.67) | 0.40 | 0.33 (0.26, 0.41) | 0.29 (0.24, 0.36) |
Included in SSRE (n = 272)a | Recruited after SSRE (n = 227) | 95% CI for the difference | |
---|---|---|---|
Age, years | 42.1 (4.6) | 42.5 (4.5) | −0.46 (− 1.27, 0.35) |
Immediate/follicular-phase surgery | 50.7% (138) | 51.5% (117) | − 1.0% (− 9.6%, 8.0%) |
Worse prognostic classb | 22.1% (58) | 19.0% (43) | 3.0% (−4.1%, 10.2%) |
Positive axillary nodes | 60.5% (159) | 55.3% (125) | 5.1% (−3.6%, 13.9%) |
Pathologic stage III-IV cancer | 40.9% (110) | 38.8% (88) | 1.7% (−6.9%, 10.3%) |
Radiotherapy given after mastectomy | 40.2% (108) | 38.8% (88) | 1.4% (−7.2%, 10.0%) |
Recruitment site | |||
A | 34.6% (94) | 33.5% (76) | 1.1% (−7.3%, 9.4%) |
B | 42.3% (115) | 44.1% (100) | −1.8% (−10.5%, 7.0%) |
Other | 23.2% (63) | 22.5% (51) | 0.7% (−6.7%, 8.1%) |