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Table 1 Disease progression due to new metastasis as a risk factor of overall survival (intent-to-treat population)

From: “New” metastases are associated with a poorer prognosis than growth of pre-existing metastases in patients with metastatic breast cancer treated with chemotherapy

  Study 301 Study 305/EMBRACE
  Stratified by treatment group Not stratified Stratified by treatment group Not stratified
Compared with all othera subjects
Patients, n 1102 762
HR (95 % CI) 1.98 (1.71, 2.29) 1.96 (1.70, 2.27) 2.25 (1.79, 2.83) 2.27 (1.80, 2.85)
Wald p value <0.0001 <0.0001 <0.0001 <0.0001
Compared with those whose disease progressed due to an increase in the size of pre-existing lesion(s)
Patients, n 663 469
HR (95 % CI) 1.81 (1.54, 2.14) 1.80 (1.53, 2.13) 2.09 (1.63, 2.68) 2.12 (1.65, 2.72)
Wald p value <0.0001 <0.0001 <0.0001 <0.0001
Compared with those with no reported disease progressionb
Patients, n 859 500
HR (95 % CI) 2.20 (1.88, 2.57) 2.16 (1.85, 2.53) 2.61 (2.03, 3.37) 2.60 (2.02, 3.34)
Wald p value <0.0001 <0.0001 <0.0001 <0.0001
  1. Tumor progression due to new metastasis is fitted as a time-dependent variable in the Cox regression model
  2. CI confidence interval, EMBRACE Eisai Metastatic Breast Cancer Study Assessing Physician’s Choice Versus E7389, HR hazard ratio
  3. ai.e., progression due to growth of pre-existing lesion(s), or those with no reported disease progression (including death, clinical deterioration or censoring)
  4. bPatients with no reported disease progression included death, clinical deterioration, or censoring