Table 1: Summary of the five adjuvant Herceptin® trials reported to date
| Trial | No. | Design | Median Follow-up | HR for DFS | HR for OS | Cardiac Toxicity |
|---|---|---|---|---|---|---|
| N9831 + NSABP B-31 |
3,351 | AC → P ±H | 24 months | 0·48 | 0·67 | 3·3% |
| 4·1% | ||||||
| N9831 | 1,964 | AC → P → ±H | 18 months | 0·87 | 0·85 | 2·2% |
| HERA | 3,387 | Chemo → ±H | 12 months | 0·54 | 0·76 | 2·3% |
| 24 months | 0·64 | 0·66 | ||||
| BCIRG 006 | 2,147 | AC → T ±H | 23 months | 0·49 | 36 vs 20 | 2% |
| 2,148 | CarboTH | 0·61 | 36 vs 28 | 0·5% | ||
| FinHer | 231 | T(V)H → FEC | 36 months | 0·43 | 0% |
Notes
All Herceptin® was given for 1 year, except for Finher where it was only for 9 weeks.
Non-significant differences are shown in italics [query with author – italics not visible in table]
Control arm patients are counted twice for N9831 and BCIRG 006, as two different analyses of treatment are presented.
Cardiac toxicity includes cardiac death, grade 3/4 cardiac failure, but NOT arrythmias (as data on arrythmias only available for BCIRG006)
Control arm cardiotoxicity rates were all around 0·1% – 0·3%
AC (Adriamycin + Cyclophosphamide)
P (Paclitaxel)
CarboTH (Carboplatin +Taxotere with Herceptin® starting with the first cycle of chemotherapy)
T (Taxotere) V (Vinorelbine) FEC (5-FU, Epirubicin, Cyclophosphamide)
AC→P±H means AC chemotherapy followed by Paclitaxel with patients randomized to commence (or not) Herceptin® with the paclitaxel
AC→P→±H means AC chemotherapy followed by Paclitaxel with patients randomised to commence (or not) Herceptin® after the paclitaxel