Table 1.

Baseline demographic and disease characteristics (FAS)

CharacteristicEverolimus 70 mg/wk (n = 99)Everolimus 10 mg/d (n = 100)
Age, median (range), y61.0 (32–81)61.5 (25–84)
Sex, n (%)
 Male52 (52.5)52 (52.0)
 Female47 (47.5)48 (48.0)
WHO PS, n (%)
 045 (45.5)50 (50.0)
 152 (52.5)44 (44.0)
 22 (2.0)5 (5.0)
 ≥154 (54.5)49 (49.0)
 Missing01 (1.0)
Primary site of cancer, n (%)
 Colon72 (72.7)76 (76.0)
 Rectum21 (21.2)14 (14.0)
 Othera6 (6.1)10 (10.0)
Histology/cytology, n (%)
 Adenocarcinoma93 (93.9)95 (95.0)
 Mucinous adenocarcinoma6 (6.1)4 (4.0)
 Other01 (1.0)
Histologic grade, n (%)
 Well differentiated9 (9.1)13 (13.0)
 Moderately differentiated78 (78.8)64 (64.0)
 Poorly differentiated11 (11.1)17 (17.0)
 Unknown1 (1.0)6 (6.0)
Time since initial diagnosis, n (%)
 ≤12 mo2 (2.0)3 (3.0)
 >12 to ≤24 mo23 (23.2)23 (23.0)
 >24 mo74 (74.7)74 (74.0)
Number of organs involved, n (%)
 ≤247 (47.5)52 (52.0)
 >252 (52.5)48 (48.0)
Visceral involvement, n (%)97 (98.0)100 (100)
PIK3CA, n (%)
 Wild-type76 (76.8)76 (76.0)
 Mutation3 (3.0)5 (5.0)
 Missing20 (20.2)19 (19.0)
PTEN expression, n (%)
 Low43 (43.4)26 (26.0)
 Normal30 (30.3)46 (46.0)
 Missing26 (26.3)28 (28.0)
KRAS, n (%)
 Wild-type46 (46.5)40 (40.0)
 Mutation33 (33.3)41 (41.0)
 Missing20 (20.2)19 (19.0)
BRAF, n (%)
 Wild-type71 (71.2)72 (72.0)
 Mutation8 (8.1)7 (7.0)
 Missing20 (20.2)21 (21.0)

Abbreviations: PIK3CA, phosphoinositide 3-kinase catalytic subunit; PTEN, phosphatase and tensin homolog; WHO PS, World Health Organization performance status.

  • aIncludes cecum (n = 5), colon and rectum (n = 3), rectosigmoid (n = 4), sigmoid colon (n = 2), colorectal (n = 1), and splenic colon corner (n = 1).