Table 2. Summarize of RECIST criteria as reported by several trials in both treatment groups. All trials (cumulative) analysis had been adjusted according to the most appropriate model based on the heterogeneities. The fixed-effect model (FEM) analysis in trials-specific outcomes were implemented thoroughly considering the number of studies of each trial.
| A. Intention-to-treat groups | ||||||
| RECIST Parameter (ITT) | All Trials RR (Total)α | Analysis models | P value (Total analysis) | Trials-specific RR* in FEM | ||
| MONALEESA | MONARCH | PALOMA | ||||
| Overall Response Rate (ORR) | 1.59 [1.37, 1.86] | REM | <.05 | 1.45 [1.27, 1.65] | 2.03 [1.70, 2.42] | 1.34 [1.13, 1.59] |
| Clinical Benefit Rate (CBR) | 1.22 [1.13, 1.32] | REM | <.05 | 1.12 [1.06, 1.18] | 1.26 [1.16, 1.35] | 1.35 [1.24, 1.47] |
| Complete Response (CR) | 1.46 [0.93, 2.31] | FEM | >.05 | 1.55 [0.80, 3.01] | 4.16 [1.26, 13.70] | 0.58 [0.25, 1.33] |
| Partial Response (PR) | 1.55 [1.32, 1.81] | REM | <.05 | 1.44 [1.25, 1.65] | 1.75 [1.49, 2.07] | 1.40 [1.17, 1.68] |
| Stable Disease (SD) | 0.90 [0.79, 1.02] | REM | >.05 | 0.93 [0.80, 1.08] | 0.78 [0.70, 0.86] | 1.14 [0.98, 1.32] |
| Stable Disease (SD) >24 Weeks | 1.04 [0.90, 1.20] | REM | >.05 | - | 0.89 [0.77, 1.02] | 1.20 [1.05, 1.36] |
| Progressive Disease (PD)β | 0.46 [0.39, 0.54] | FEM | <.05 | 0.52 [0.40, 0.67] | 0.40 [0.30, 0.54] | 0.44 [0.32, 0.60] |
| *Grey area of the table in the trial specific section indicates the significant analysis result (P <.05) αPositive value of the RR are favoring the outcomes in the treatment arm βOnly in the PD outcomes, the RR value as inversely applied therefore negative value are favoring the results in the treatment arm | ||||||
| B. Measurable disease groups | ||||||
| RECIST Parameter (Measurable disease) | All Trials RR (Total)α | Analysis models | P value (Total analysis) | Trials-specific RR* in FEM | ||
| MONALEESA | MONARCH | PALOMA | ||||
| Overall Response Rate (ORR) | 1.51 [1.29, 1.77] | REM | <.05 | 1.41 [1.21, 1.66] | 1.75 [1.44, 2.14] | 1.39 [1.19, 1.63] |
| Clinical Benefit Rate (CBR) | 1.23 [1.13, 1.34] | REM | <.05 | 1.15 [1.08, 1.23] | 1.27 [1.14, 1.41] | 1.35 [1.22, 1.50] |
| Complete Response (CR) | 1.57 [0.96, 2.58] | FEM | >.05 | 1.47 [0.73, 2.92] | 10.65 [1.44, 78.76] | 0.65 [0.09, 4.83] |
| Partial Response (PR) | 1.46 [1.27, 1.68] | REM | <.05 | 1.41 [1.24, 1.60] | 1.57 [1.31, 1.88] | 1.45 [1.23, 1.70] |
| Stable Disease (SD) | 0.85 [0.73, 0.99] | REM | <.05 | 0.88 [0.79, 0.99] | 0.68 [0.57, 0.81] | 1.13 [0.92, 1.40] |
| Stable Disease (SD) >24 Weeks | 0.97 [0.84, 1.11] | FEM | >.05 | - | 0.79 [0.62, 1.01] | 1.09 [0.92, 1.29] |
| Progressive Disease (PD)β | 0.45 [0.38, 0.55] | FEM | <.05 | 0.48 [0.36, 0.64] | 0.43 [0.29, 0.63] | 0.44 [0.32, 0.61] |
*Grey area of the table in the trial specific section indicates the significant analysis result (P <.05)
αPositive value of the RR are favoring the outcomes in the treatment arm
βOnly in the PD outcomes, the RR value as inversely applied therefore negative value are favoring the results in the treatment arm