Table 1.
Baseline characteristics of all clinical trial participants and the corresponding data when patients were grouped according to the development of grade 3/4 toxicities (diarrhea and neutropenia) and response to treatment
| Toxicity groups | Response groups | ||||
|---|---|---|---|---|---|
| All patients | ≤ Grade 2 toxicities | Grade 3–4 toxicities | Clinical benefit (PR/SD) | Progressive disease | |
| Number of assessable patients | 42 (100) | 31 (74) | 11 (26) | 292 | 72 |
| Sex | |||||
| Male | 27 (64) | 20 (65) | 7 (64) | 19 (66) | 4 (57) |
| Female | 15 (36) | 11 (35) | 4 (36) | 10 (34) | 3 (43) |
| Median age (range) | 64 (34–77) | 62 (34–77) | 67 (61–74) | 62 (44–76) | 68 (34–77) |
| Race | |||||
| Caucasian | 39 (93) | 28 (91) | 11 (100) | 26 (90) | 7 (100) |
| Asian | 2 (5) | 2 (6) | 0 | 2 (7) | 0 |
| Afro-Caribbean | 1 (2) | 1 (3) | 0 | 1 (3) | 0 |
| ECOG PS at baseline | |||||
| 0 | 17 (40) | 16 (52) | 1 (9)1 | 15 (52) | 1 (14) |
| 1 | 23 (55) | 14 (45) | 9 (82) | 13 (45) | 6 (86) |
| 2 | 2 (5) | 1 (3) | 1 (9) | 1 (3) | 0 |
| Status of primary | |||||
| Resected | 17 (40) | 10 (32) | 7 (64) | 11 (38) | 2 (29) |
| Unresected | 22 (52) | 19 (61) | 3 (27) | 16 (55) | 5 (71) |
| Local recurrence | 3 (7) | 2 (6) | 1 (9) | 2 (7) | 0 |
| Site of metastasis | |||||
| Locally advanced | 3 (7) | 3 (10) | 0 | 3 (10) | 0 |
| Liver | 5 (12) | 4 (13) | 1 (9) | 2 (7) | 2 (29) |
| Liver + others | 23 (55) | 19 (61) | 4 (36) | 17 (59) | 4 (57) |
| None liver | 11 (26) | 5 (16) | 6 (5) | 7 (24) | 1 (14) |
| Metastatectomy peri-irinotecan | |||||
| Yes | 3 (7) | 2 (6) | 1 (9) | 2 (7) | 0 |
| No | 39 (93) | 29 (94) | 10 (91) | 27 (93) | 7 (100) |
| UGT1A1*1*1 | 21 (50)3 | 14 (45) | 7 (64) | 13 (45) | 4 (57) |
| UGT1A1*1*28 | 15 (36) | 12 (39) | 3 (27) | 11 (38) | 3 (43) |
| UGT1A1*28*28 | 6 (14) | 5 (16) | 1 (9) | 5 (17) | 0 |
Values within parenthesis are expressed in percentage.
1
Statistically significant with P < 0.05 calculated using the chi-squared test for trend.
2
Six patients did not have response assessed due to either the absence of measurable disease or the premature cessation of treatment as a result of toxicities or death.
3
These gene frequencies were in Hardy–Weinberg equilibrium (P = 0.50 calculated using the chi-squared test).