Table 1.
Change in LVEF in Patients Who Proceeded to Post-AC Therapy and Who Consented to LVEF Evaluation at 6 Years
| LVEF Variable | No. (%) of Patients by Arm |
||
|---|---|---|---|
| A (n = 664) | B (n = 710) | C (n = 570) | |
| All patients on the N9831 cohort (N = 1944) with LVEF decrease* | |||
| By ≥ 10 points | 174 (26.2) | 251 (35.3) | 227 (39.8) |
| By ≥ 15 points | 64 (9.6) | 104 (14.6) | 107 (18.7) |
| To below the LLN | 80 (12) | 119 (16.7) | 136 (23.8) |
| Patients on the N9831 cohort who had a 6-year LVEF evaluation (n = 651) | 205 | 234 | 212 |
| With LVEF decrease by ≥ 10 points | 42 (20.5) | 46 (19.6) | 48 (22.6) |
| With LVEF decrease by ≥ 15 points | 19 (9.2) | 17 (7.3) | 19 (8.9) |
| With LVEF decrease to below the LLN | 13 (6.3) | 11 (4.7) | 10 (4.7) |
Abbreviations: AC, doxorubicin plus cyclophosphamide; LLN, lower limit of normal; LVEF, left ventricular ejection fraction.
*
Multigated acquisition scan or echocardiography to evaluate LVEF was performed at baseline (within 3 weeks before registration), at 3, 6, and 9 months after registration, and after completion of chemotherapy (18 months for arms A and C and 21 months for arm B).