| Level of Evidence | Study | n | Setting | Treatments | Outcome | Results |
|---|---|---|---|---|---|---|
| RCT stratified on HER2 status/HER2-guided vs. non-HER2-guided | ||||||
| RCT prespecified MV SGA | ||||||
| RCT post-hoc MV SGA | Von Minckwitz 2007 | 194 | Neoadjuvant tumor≥3cm, age 18–70 | doxorubicin+ docetaxel + tamoxifen (TAM) | pCR | Univariate: Not reported; |
| Log reg: IHC HER2 as predictor of pCR p=0.126; HER2*TAM not reported | ||||||
| Rasmussen 2008 | 3533 | Adjuvant postmen HR+ | tamoxifen vs. letrozole | DFS | Univariate : FISH/IHC HER2+ vs. HER2- p<.0001 | |
| Coxa: FISH/IHC HER2*Tx, p=.60 | ||||||
| TTR | Cox: FISH/IHC HER2*Tx NS | |||||
| Dowsett 2008 | 1782 | Adjuvant postmen HR+ | tamoxifen vs. anastrozole (ANA) for 5 yrs | TETR | Univariate: FISH/IHC HER2 - vs. + ANA:p<0.0001, TAM:p=.002 | |
| Cox: FISH/IHC HER2 - vs. + ANA:p<0.001, TAM:p=.014 | ||||||
| “no indication” of greater differential benefit of ANA vs. TAM but | ||||||
| no statistics provided and only 44 HER2+ pts so CIs wide | ||||||
| Ryden 2005, 2007 | 470 | Adjuvant, Stage II, Premen or <50 years | tamoxifen vs. observation | RFS | Univariate: IHC HER2- Tx vs. Cx p=.07 (ER+) | |
| IHC HER2+ Tx vs. Cx p=.2 (ER+) | ||||||
| FISH HER2- or HER2+ Tx vs. Cx p=.14 (ER+) | ||||||
| Cox regression: IHC HER2*TAM p=.4 (ER+); p=.3 (ER+/PR+) | ||||||
| FISH/IHC HER2*TAM p=.95 (unclear if ER+ only) | ||||||
| Knoop 2001 | 1515 | Adjuvant, High risk, Postmen | tamoxifen vs. observation | DFS | Univariate: IHC HER2 lo+ or - Tx vs. Cx p=.0001 (HR+) | |
| IHC HER2 hi+ Tx vs. Cx p=.5 (HR+) | ||||||
| Cox regression: IHC HER2 and HER2*TAM not significant (HR+) | ||||||
| RCT treatment by HER2 SGA | ||||||
| 1-arm prespecified MV analysis | ||||||
| 1-arm post-hoc MV analysis | Arpino 2004 | 136 | Metastatic, 1st line Tx | tamoxifen | ORR | No stat signif diff FISH HER2 + vs. - in CR+PR+SD |
| TTF | univariate: FISH HER2 - vs. + p=.007 | |||||
| Cox regression: HER2+ as predictor TTF p=.54 | ||||||
| OS | univariate: FISH HER2 - vs. + p=.07 | |||||
| 1-arm UV analysis | Cox regression: HER2+ as predictor OS p=.97 | |||||
Stratified for randomization group and chemotherapy
Abbreviations: DFS: disease-free survival; HR: hazard ratio; MV: multivariate; ORR: overall response rate; OS: overall survival; pCR: pathologic complete response; RCT: randomized, controlled trial; RFS: recurrence-free survival; SGA: subgroup analysis; TETR: time to early tumor recurrence; TTF: time to treatment failure; TTR: time to tumor recurrence; Tx: treatment; UV: univariate analysis;
From: 3, Results and Conclusions
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