Table 2.

Table 2 shows the pCR rates according to LAR and non-LAR groups for 13 neoadjuvant chemotherapy (NAC) treatment arms across seven clinical trials. Within the LAR group, the pCR response rates ranged from 13.3% to 45.5%, while within the non-LAR group, the pCR rates ranged from 35.6% to 71.7%. The sample size within the LAR group was small for many of the NAC treatment arms; however, in 11 of the 13 NAC treatment arms, the pCR rate was higher in the non-LAR group than in the LAR group. We performed a meta-analysis to summarize the LAR effect across the 13 NAC treatment arms, as measured by the odds ratio [non-LAR vs LAR]. A random-effects logit model was adopted [1]. In the model, the NAC treatment arm effects were treated as random as opposed to fixed to better capture the variability inherent in the system more realistically; furthermore, the model included random LAR effects such that the LAR effect was not constrained to be identical in each trial arm stratum. The odds ratio's expected or average value [95% CI] was 2.11 [1.33, 2.89]. There was strong evidence of a LAR effect such that within the non-LAR group, the odds of achieving a pCR was 2.11 times the odds within the LAR group

pCR
IdTrialNAC TreatmentArmGroupYesNoTotal% YesOdds Ratio
AGSE106977Taxane + ACALAR2131513.33%5.68
non-LAR34397346.58%
Taxane + Carboplatin+A/CBLAR16714.29%3.60
non-LAR9152437.50%
BGSE25055Taxane + AC-LAR4172119.05%2.45
non-LAR34599336.56%
CGSE25065Taxane + AC-LAR18911.11%2.52
non-LAR18274540.00%
DGSE32646Taxane + FEC-LAR24633.33%1.33
non-LAR8122040.00%
EBrightNessTaxane + Veliparib + Carboplatin+A/CALAR15254037.50%2.20
non-LAR1128519756.85%
BrightNessTaxane + Carboplatin + A/CBLAR10122245.45%1.73
non-LAR594110059.00%
BrightNessTaxane + ACCLAR4182218.18%2.49
non-LAR366510135.64%
FCALGB 40603Taxane + AC1LAR661250.00%0.63
non-LAR20325238.46%
CALGB 40603Taxane + Bevacizumab + A/C2LAR581338.46%1.52
non-LAR20214148.78%
CALGB 40603Taxane + Carboplatin + A/C3LAR661250.00%1.00
non-LAR23234650.00%
CALGB 40603Taxane + Carboplatin + Bevacizumab + A/C4LAR571241.67%3.55
non-LAR38155371.70%
GBeautyTaxane + AC-LAR27922.22%6.13
non-LAR21123363.64%
pCR
IdTrialNAC TreatmentArmGroupYesNoTotal% YesOdds Ratio
AGSE106977Taxane + ACALAR2131513.33%5.68
non-LAR34397346.58%
Taxane + Carboplatin+A/CBLAR16714.29%3.60
non-LAR9152437.50%
BGSE25055Taxane + AC-LAR4172119.05%2.45
non-LAR34599336.56%
CGSE25065Taxane + AC-LAR18911.11%2.52
non-LAR18274540.00%
DGSE32646Taxane + FEC-LAR24633.33%1.33
non-LAR8122040.00%
EBrightNessTaxane + Veliparib + Carboplatin+A/CALAR15254037.50%2.20
non-LAR1128519756.85%
BrightNessTaxane + Carboplatin + A/CBLAR10122245.45%1.73
non-LAR594110059.00%
BrightNessTaxane + ACCLAR4182218.18%2.49
non-LAR366510135.64%
FCALGB 40603Taxane + AC1LAR661250.00%0.63
non-LAR20325238.46%
CALGB 40603Taxane + Bevacizumab + A/C2LAR581338.46%1.52
non-LAR20214148.78%
CALGB 40603Taxane + Carboplatin + A/C3LAR661250.00%1.00
non-LAR23234650.00%
CALGB 40603Taxane + Carboplatin + Bevacizumab + A/C4LAR571241.67%3.55
non-LAR38155371.70%
GBeautyTaxane + AC-LAR27922.22%6.13
non-LAR21123363.64%
Table 2.

Table 2 shows the pCR rates according to LAR and non-LAR groups for 13 neoadjuvant chemotherapy (NAC) treatment arms across seven clinical trials. Within the LAR group, the pCR response rates ranged from 13.3% to 45.5%, while within the non-LAR group, the pCR rates ranged from 35.6% to 71.7%. The sample size within the LAR group was small for many of the NAC treatment arms; however, in 11 of the 13 NAC treatment arms, the pCR rate was higher in the non-LAR group than in the LAR group. We performed a meta-analysis to summarize the LAR effect across the 13 NAC treatment arms, as measured by the odds ratio [non-LAR vs LAR]. A random-effects logit model was adopted [1]. In the model, the NAC treatment arm effects were treated as random as opposed to fixed to better capture the variability inherent in the system more realistically; furthermore, the model included random LAR effects such that the LAR effect was not constrained to be identical in each trial arm stratum. The odds ratio's expected or average value [95% CI] was 2.11 [1.33, 2.89]. There was strong evidence of a LAR effect such that within the non-LAR group, the odds of achieving a pCR was 2.11 times the odds within the LAR group

pCR
IdTrialNAC TreatmentArmGroupYesNoTotal% YesOdds Ratio
AGSE106977Taxane + ACALAR2131513.33%5.68
non-LAR34397346.58%
Taxane + Carboplatin+A/CBLAR16714.29%3.60
non-LAR9152437.50%
BGSE25055Taxane + AC-LAR4172119.05%2.45
non-LAR34599336.56%
CGSE25065Taxane + AC-LAR18911.11%2.52
non-LAR18274540.00%
DGSE32646Taxane + FEC-LAR24633.33%1.33
non-LAR8122040.00%
EBrightNessTaxane + Veliparib + Carboplatin+A/CALAR15254037.50%2.20
non-LAR1128519756.85%
BrightNessTaxane + Carboplatin + A/CBLAR10122245.45%1.73
non-LAR594110059.00%
BrightNessTaxane + ACCLAR4182218.18%2.49
non-LAR366510135.64%
FCALGB 40603Taxane + AC1LAR661250.00%0.63
non-LAR20325238.46%
CALGB 40603Taxane + Bevacizumab + A/C2LAR581338.46%1.52
non-LAR20214148.78%
CALGB 40603Taxane + Carboplatin + A/C3LAR661250.00%1.00
non-LAR23234650.00%
CALGB 40603Taxane + Carboplatin + Bevacizumab + A/C4LAR571241.67%3.55
non-LAR38155371.70%
GBeautyTaxane + AC-LAR27922.22%6.13
non-LAR21123363.64%
pCR
IdTrialNAC TreatmentArmGroupYesNoTotal% YesOdds Ratio
AGSE106977Taxane + ACALAR2131513.33%5.68
non-LAR34397346.58%
Taxane + Carboplatin+A/CBLAR16714.29%3.60
non-LAR9152437.50%
BGSE25055Taxane + AC-LAR4172119.05%2.45
non-LAR34599336.56%
CGSE25065Taxane + AC-LAR18911.11%2.52
non-LAR18274540.00%
DGSE32646Taxane + FEC-LAR24633.33%1.33
non-LAR8122040.00%
EBrightNessTaxane + Veliparib + Carboplatin+A/CALAR15254037.50%2.20
non-LAR1128519756.85%
BrightNessTaxane + Carboplatin + A/CBLAR10122245.45%1.73
non-LAR594110059.00%
BrightNessTaxane + ACCLAR4182218.18%2.49
non-LAR366510135.64%
FCALGB 40603Taxane + AC1LAR661250.00%0.63
non-LAR20325238.46%
CALGB 40603Taxane + Bevacizumab + A/C2LAR581338.46%1.52
non-LAR20214148.78%
CALGB 40603Taxane + Carboplatin + A/C3LAR661250.00%1.00
non-LAR23234650.00%
CALGB 40603Taxane + Carboplatin + Bevacizumab + A/C4LAR571241.67%3.55
non-LAR38155371.70%
GBeautyTaxane + AC-LAR27922.22%6.13
non-LAR21123363.64%
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