Table 4

Anti-HER2 therapies: adjuvant trastuzumab

StudyTrial nameSettingPrimary outcomeMedian follow-upDFS controlDFS gainDFS HR*OS controlOS gainOS HR*ESMO-MCBS V.1.1Reference
Chemotherapy±trastuzumabHERAAdjuvant or neoadjuvant HER2+tumoursDFS2 yearsDFS 77.4%8.4%0.54 (0.43–67)Early crossover at interim analysisA34
AC-P vs AC-PH or TCaHBCIRG006Adjuvant HER2+tumoursDFS65 months75.0%AC-PH-9%0.6387.0%AC-PH-5%0.75A36
AC-P vs AC-PH or TCaHBCIRG006Adjuvant HER2+tumoursDFS65 months75.0%TCH-6%0.75TCaH-4%0.77B{Slamon, 2011 #1663;Slamon, 2011 #166336 }
AC-P vs AC-PHNSABP B31-NCCTGAdjuvant HER2+ tumoursDFS8.4 years10 years DFS 62.211.5%0.60 (0.53–0.68)10 years OS 75.2%8.80%0.63 (0.54–0.73)A{Perez, 2014 #166835 }
Adjuvant chemo±trastuzumabMeta-analysisHER2+, <2 cm stratified for HR and nodal statusDFS and OS HR+all8 years75.7%7.0%0.70 (0.59–0.85)88.4%3.8%0.68 (0.52–0.89)B{O'Sullivan, 2015 #181184 }
Adjuvant chemo±trastuzumabMeta-analysisHER2+, <2 cm stratified for HR and nodal statusDFS and OS HR+<1 node8 years81.6%3.8%0.64 (0.47–0.83)92.6%2.1%0.68 (0.42–1.10)NEB{O'Sullivan, 2015 #1811}
Adjuvant chemo±trastuzumabMeta-analysisHER2+, <2 cm stratified for HR and nodal statusDFS and OS HR− all8 years66.4%9.4%0.66 (0.49–0.88)78.8%8.8%0.59 (0.47–0.74)A{O'Sullivan, 2015 #1811}
Adjuvant chemo±trastuzumabMeta-analysisHER2+, <2 cm stratified for HR and nodal statusDFS and OS HR− <1 node8 years73.7%5.9%0.77 (0.59–1.00)87.8%4.0%0.69 (0.66–1.04)NEB{O'Sullivan, 2015 #1811}
  • Chart blanks—relevant variables not available in manuscript.

  • *HR values in parentheses refer to 95% CI.

  • A, doxorubicin; C, cyclophosphamide; Ca, carboplatin; chemo, chemotherapy; DFS, disease-free survival; ESMO-MCBS, The European Society for Medical Oncology-Magnitude of Clinical Benefit Scale; H, trastuzumab; HER2+, HER2 overexpression; HR+, hormone receptor-positive; NEB, no evaluable benefit; OS, overall survival; P, paclitaxel; T, docetaxel.