Table 1.

Summary of selected baseline characteristics (ITT population: study 305)

Treatment groupTotal
ParameterEribulin N = 508, n (%)TPC N = 254, n (%)N = 762, n (%)
Time since original diagnosis, y
 Median5.45.15.2
Tumor sites in >10% patients overall, n (%)
 Bone306 (60.2)158 (62.2)464 (60.9)
 Liver296 (58.3)159 (62.6)455 (59.7)
 Lymph nodes220 (43.3)118 (46.5)338 (44.4)
 Lung197 (38.8)95 (37.4)292 (38.3)
 Pleura87 (17.1)42 (16.5)129 (16.9)
 Breast54 (10.6)24 (9.4)78 (10.2)
Number of organs involved, n (%)a
 185 (16.7)35 (13.8)120 (15.7)
 2172 (33.9)82 (32.3)254 (33.3)
 3145 (28.5)77 (30.3)222 (29.1)
 471 (14.0)37 (14.6)108 (14.2)
 524 (4.7)16 (6.3)40 (5.2)
 ≥69 (1.8)7 (2.8)16 (2.1)
HER2/neu status (combined FISH and IHC tests), n (%)b
 Positive83 (16.3)40 (15.7)123 (16.1)
 Negative373 (73.4)192 (75.6)565 (74.1)
 Unknown4 (0.8)0 (0)4 (0.5)
 Not done48 (9.4)22 (8.7)70 (9.2)
ER status, n (%)
 Positive336 (66.1)171 (67.3)507 (66.5)
 Negative143 (28.1)72 (28.3)215 (28.2)
 Unknown1 (0.2)0 (0)1 (0.1)
 Not done28 (5.5)11 (4.3)39 (5.1)
PgR status, n (%)
 Positive254 (50.0)123 (48.4)377 (49.5)
 Negative197 (38.8)102 (40.2)299 (39.2)
 Unknown1 (0.2)0 (0)1 (0.1)
 Not done56 (11.0)29 (11.4)85 (11.2)
Negative for ER, PgR, and HER2/neu, n (%)
 Yes93 (18.3)51 (20.1)144 (18.9)
 No380 (74.8)192 (75.6)572 (75.1)
 Unknownc35 (6.9)11 (4.3)46 (6.0)
Cancer stage at diagnosis
 02 (0.4)0 (0)2 (0.3)
 I62 (12.2)30 (11.8)92 (12.1)
 II213 (41.9)89 (35.0)302 (39.6)
 III142 (28.0)71 (28.0)213 (28.0)
 IV81 (15.9)59 (23.2)140 (18.4)
 Not available8 (1.6)5 (2.0)13 (1.7)

Abbreviations: ER, estrogen receptor; HER2/neu, human epidermal growth factor receptor 2; IHC, immunohistochemistry; ITT, intent to treat; PgR, progesterone receptor.

  • aThe number of organs involved is based on the local evaluation.

  • bFor patients who were tested with FISH their status is derived from the FISH test irrespective of IHC results even if the FISH test yielded a result of unknown. Results from the IHC tests are used only when the FISH test was not conducted. For these patients, a result of 3+ indicates that the patient was Her2/neu positive.

  • cIncludes patients whose results were ER and PgR negative and who were never tested for their Her2 status (n = 26 and 10 for eribulin and TPC, respectively).