Table 4. Cardiac end points.
|
12-months patients |
6-months patients |
|||||
|---|---|---|---|---|---|---|
| Overall | In 1st 6 months | In 2nd 6 months | Overall | In 1st 6 months | In 2nd 6 months | |
|
Number of patients reporting at least one of the followinga | ||||||
| PERSEPHONE defined cardiac end points | ||||||
| Clinical cardiac dysfunctionb | 140/1214 (12%) | 102/1214 (8%) | 91/1196 (8%) | 105/1216 (9%) | 84/1216 (7%) | 62/1174 (5%) |
| Symptoms of CHFc | 78 | 55 | 41 | 53 | 41 | 22 |
| Signs of CHF | 27 | 21 | 12 | 17 | 15 | 7 |
| New medication for cardiac disease | 97 | 65 | 72 | 75 | 62 | 52 |
| Low LVEFd | 146/1249 (12%) | 91/1249 (7%) | 101/1201 (8%) | 117/1249 (9%) | 96/1249 (8%) | 59/1114 (5%) |
| Cardiac deathe | 3/1251 | 0/1251 | 0/1234f | 1/1249 | 0/1249 | 0/1230f |
| Significant LVEF falls | ||||||
| An absolute decrease from baseline of ⩾10% to below 50% | 106/1204 (9%) | 63/1198 (5%) | 68/1162 (6%) | 89/1216 (7%) | 68/1214 (6%) | 43/1086 (4%) |
| An LVEF<50% after a baseline of ⩾59% | 68/1204 (6%) | 37/1198 (3%) | 47/1162 (4%) | 57/1216 (5%) | 46/1214 (4%) | 23/1086 (2%) |
|
Number of LVEF tests reported as low | ||||||
| Incidence of low LVEF testsg | 305/6342 (5%) | 146/3850 (4%) | 159/2492 (6%) | 242/5805 (4%) | 155/3790 (4%) | 87/2015 (4%) |
| MUGA | 117/1104 (11%) | 61/641 (10%) | 56/463 (12%) | 96/959 (10%) | 67/606 (11%) | 29/353 (8%) |
| ECHO | 185/4479 (4%) | 84/2475 (3%) | 101/2004 (5%) | 142/4119 (3%) | 85/2474 (3%) | 57/1645 (3%) |
| Unknown | 3/759 (<1%) | 1/734 (<1%) | 2/25 (8%) | 4/727 (<1%) | 3/710 (<1%) | 1/17 (6%) |
Abbreviations: ECHO=echocardiography; LVEF=left ventricular ejection fraction; MUGA=multi-gated acquisition.
Patients could experience a cardiac endpoint in both of the 6-month intervals.
Clinical cardiac dysfunction=symptoms of cardiac disease, or signs of congestive heart failure or new medication for cardiac disease.
CHF=congestive heart failure.
Low LVEF=LVEF<50%, or % unknown but classified on report as abnormal.
Four deaths have been reported with a ‘cardiac' cause (three in 12-month patients, one in 6-month patients). None occurred during the first 12 months after starting trastuzumab treatment. Three patients reported with a cardiac cause contributing to death (two of the patients on the 12-month arm, and the patient on the 6-month arm) also had widespread metastatic disease at the time of death. It is likely that only one death is potentially attributable to cardiac complications of treatment (12-month arm).
Denominators reduced from entire patient set due to either deaths due to non-cardiac reasons or withdrawal of consent for further follow-up within the first 6-month period.
Incidence of low LVEF tests out of the total number of tests in the time period.