Table 1

Patient demographics and baseline disease characteristics (modified intent-to-treat population)

CharacteristicAS/OBI-821
(N=224)
Placebo
(N=124)
Median age, years (range)53 (30–87)52 (30–82)
Ethnicity, n (%)
 Asian185 (82.6)97 (78.2)
 Caucasian39 (17.4)27 (21.8)
Country, n (%)
 Taiwan121 (54.0)63 (50.8)
 USA44 (19.6)27 (21.8)
 South Korea42 (18.8)24 (19.4)
 Hong Kong13 (5.8)7 (5.6)
 India4 (1.8)3 (2.4)
ECOG performance status, n (%)
 0165 (74.0)*92 (74.2)
 158 (26.0)32 (25.8)
Median time from first metastatic diagnosis to day 1, months (range)12 (1–87)13.5 (3–151)
Metastatic disease, n (%)
 De novo72 (32.1)37 (29.8)
 Relapsed152 (67.9)87 (70.2)
Disease-free interval(n=152)(n=87)
 Median, months (range)52 (0.5–298)50 (0.5–239)
 >24 months, n (%)119 (78.3)61 (70.1)
 12–24 months, n (%)17 (11.2)15 (17.2)
 <12 months, n (%)16 (10.5)11 (12.6)
Number of progression events after diagnosis of metastatic disease, n (%)
 0137 (61.2)77 (62.1)
 167 (29.9)37 (29.8)
 220 (8.9)10 (8.1)
Disease status, n (%)
 Measurable104 (46.4)49 (39.5)
 Evaluable91 (40.6)57 (46.0)
 No evident disease29 (12.9)18 (14.5)
Number of sites of disease, n (%)
 033 (14.7)19 (15.3)
 181 (36.2)38 (30.6)
 267 (29.9)42 (33.9)
 ≥343 (19.2)25 (20.2)
Sites of disease, n (%)
 Bone91 (40.6)71 (57.3)
 Visceral108 (48.2)60 (48.4)
 Nodes70 (31.3)34 (27.4)
 Breast33 (14.7)10 (8.1)
 Soft tissue/skin20 (8.9)6 (4.8)
Biologic subtypes, n (%)
 HR+, HER2–161 (71.9)84 (67.8)
 Triple negative28 (12.5)17 (13.7)
 HER2+35 (15.6)23 (18.5)
Prior treatments for metastatic disease (n/N,† %)
 Chemotherapy199/224 (88.8)110/124 (88.7)
 Hormone therapy134/161 (83.2)73/84 (86.9)
 HER2− targeted therapy26/35 (74.3)17/23 (73.9)
 mTOR inhibitor0/161 (0.0)1/84 (1.2)
Stratification factors, n (%)
 HT with PR/SD129 (57.6)68 (54.8)
 HT with CR11 (4.9)8 (6.5)
 No HT with PR/SD73 (32.6)42 (33.9)
 No HT with CR11 (4.9)6 (4.8)
Globo H expression by IHC, n (%)(n=159)(n=84)
 044 (27.7)25 (29.8)
 1+57 (35.8)30 (35.7)
 2+27 (17.0)10 (11.9)
 3+31 (19.5)19 (22.6)
  • *One patient had a missing assessment.

  • †N=patients for whom treatment would be appropriate (HT, mTOR inhibitor for patients with HR+ tumors; HER2− targeted therapy for patients with HER2+ tumors).

  • CR, complete response; ECOG, Eastern Cooperative Oncology Group; HER2, human epidermal growth factor receptor 2; HER2−, HER2-negative; HER2+, HER2-positive; HR+, hormone receptor-positive; HT, hormone therapy; IHC, immunohistochemistry; mTOR, mammalian target of rapamycin; PR, partial response; SD, stable disease.