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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