Table 1.

Patient demographics and baseline characteristics (comparison between arms)

VariableP600 (n = 47)P900 (n = 45)
Median age (range)56 (35-81)61 (33-78)
Disease stage, n (%)
    Locally advanced (M0)1 (2.1)4 (8.9)
    Metastatic (M1)46 (97.9)41 (91.1)
Number of disease sites, n (%)
    12 (4.3)3 (6.7)
    29 (19.1)7 (15.6)
    ≥336 (76.6)35 (77.8)
Site of disease, n (%)
    Visceral31 (66.0)29 (64.4)
    Lung14 (29.8)17 (37.8)
    Liver19 (40.4)17 (37.8)
    Other2 (4.3)0
    Nonvisceral38 (80.9)37 (82.2)
ECOG performance status, n (%)
    025 (53.2)25 (55.6)
    118 (38.3)20 (44.4)
    23 (6.4)0
    Unknown1 (2.1)0
Prior treatment
    Surgery38 (80.9)41 (91.1)
    Chemotherapy (adjuvant or neoadjuvant)28 (59.6)29 (64.4)
    Radiotherapy34 (72.3)32 (71.1)
    Hormonal*23 (48.9)27 (60.0)
ER/PR
    +/+12 (25.5)18 (40.0)
    −/−18 (38.3)9 (20.0)
    +/− or −/+7 (14.9)7 (15.6)
    Unknown10 (21.3)11 (24.4)
  • Abbreviations: ECOG, Eastern Cooperative Oncology Group; ER, estrogen receptor; PR, progesterone receptor.

  • * All patients who received prior hormonal therapy did so in an adjuvant setting, except one patient in each treatment arm. Three patients in each arm received prior hormonal therapy in a locally advanced setting.