Table 1 Patient baseline characteristics
Characteristic | Part 1 (n = 46) | Part 2 (n = 16) | Total (n = 62) |
|---|---|---|---|
Median age, years [range] | 59.5 [20, 77] | 59.5 [20, 77] | 59.5 [20, 77] |
Sex, n (%) | |||
Female | 18 (39) | 7 (44) | 25 (40) |
Male | 28 (61) | 9 (56) | 37 (60) |
Histological type, n (%) | |||
Adenocarcinoma | 35 (76) | 11 (69) | 46 (74.2) |
Adenosquamous Carcinoma | 0 | 1 (6) | 1 (1.6) |
Alveolar Rhabdomyosarcoma | 0 | 1 (6) | 1 (1.6) |
Basal Cell Carcinoma | 0 | 1 (6) | 1 (1.6) |
Low Grade Endometrioid Adenocarcinoma | 0 | 1 (6) | 1 (1.6) |
Mesothelioma | 1 (2) | 0 | 1 (1.6) |
Metastatic Melanoma | 1 (2) | 0 | 1 (1.6) |
Sarcoma | 1 (2) | 0 | 1 (1.6) |
Spindle Cell Carcinoma | 1 (2) | 0 | 1 (1.6) |
Squamous Cell | 4 (9) | 0 | 4 (6.5) |
Undifferentiated | 0 | 1 (6) | 1 (1.6) |
Histology not specified | 3 (7) | 0 | 3 (4.8) |
Performance Status, n (%) | |||
0 | 23 (50) | 7 (44) | 30 (48) |
1 | 23 (50) | 9 (56) | 32 (52) |
Cancer Type, n (%) | |||
Colon | 16 (35) | 3 (19) | 19 (31) |
Rectum | 8 (17) | 1 (6) | 9 (15) |
Oesophageal/gastroesophageal junction | 3 (7) | 3 (19) | 6 (10) |
Pancreas | 2 (4) | 2 (13) | 4 (7) |
Cervix | 1 (2) | 1 (6) | 2 (3) |
Other | 16 (35) | 6 (38) | 22 (35) |
Prior therapies | |||
Prior systemic therapy, median [range] | 3 [0, 6] | 3 [1, 11] | 3 [0, 11] |
Prior fluoropyrimidine therapy a, n (%) | 37 (80) | 9 (56) | 46 (74) |
Prior 5-FU | 27 (59) | 5 (31) | 32 (52) |
Prior capecitabine | 26 (57) | 6 (38) | 32 (52) |
Prior tipiracil / trifluridine | 7 (15) | 2 (13) | 9 (15) |
Median BSA, m2 [range] | 1.84 [1.4, 2.6] | 1.88 [1.5, 2.4] | 1.86 [1.4, 2.6] |