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. 2015 Sep 15;107(11):djv253. doi: 10.1093/jnci/djv253

Table 2.

Meta-analysis (univariate and multivariate) using random effects model according to trial characteristics (including personalized vs non-personalized drugs) in randomized registration trials

Characteristic Relative response rate ratio PFS OS
N RRR (95% CI) N HR (95% CI) N HR (95% CI)
Personalized status
 Personalized 14 3.82 (2.51 to 5.82) 13 0.41 (0.33 to 0.51) 13 0.71 (0.61 to 0.83)
 Non-personalized 37 2.08 (1.76 to 2.47) 38 0.59 (0.53 to 0.65) 33 0.81 (0.77 to 0.85)
P (univariate) .009 .004 .11
P (meta-regression)*,† .03 <.001 .07
Control arm
 Placebo 16 7.03 (4.27 to 11.58) 15 0.42 (0.37 to 0.48) 15 0.81 (0.74 to 0.90)
 Active treatment 35 2.08 (1.75 to 2.47) 36 0.60 (0.54 to 0.67) 31 0.78 (0.74 to 0.83)
P (univariate) † <.001 <.001 .51
P (meta-regression) *,† <.001 <.001 NA
Tumor type
 Solid 43 2.27 (1.92 to 2.69) 44 0.56 (0.50 to 0.62) 41 0.81 (0.77 to 0.85)
 Hematologic 8 3.30 (1.93 to 5.63) 7 0.42 (0.33 to 0.54) 5 0.60 (0.49 to 0.73)
P (univariate) † .2 .04 .004
P (meta-regression) *,† NA .004 .006
Treatment status
 Naïve 22 2.23 (1.76 to 2.83) 23 0.54 (0.46 to 0.63) 20 0.77 (0.71 to 0.84)
 Pretreated 29 2.70 (2.09 to 3.50) 28 0.54 (0.47 to 0.61) 26 0.81 (0.76 to 0.87)
P (univariate) † .29 .99 .37
Cross-over allowed
 Yes 23 3.67 (2.86 to 4.69) 22 0.42 (0.37 to 0.47) 21 0.76 (0.68 to 0.85)
 No 28 1.68 (1.45 to 1.95) 29 0.65 (0.58 to 0.72) 25 0.80 (0.76 to 0.84)
P (univariate) † <.001 <.001 .48
P (meta-regression)*,† NA NA .32

* Meta-regression analysis was performed including only factors considered statistically significant in univariate analysis. In the case of allowance for crossover for RRR and PFS analysis, meta-regression was not performed because crossover occurred after progression and could therefore not confound responses or PFS. HR = hazard ratio; N = number of trials included; NA = not applicable; OS = overall survival; PFS = progression-free survival; RRR = relative response rate ratio.

P values were two-sided.