Table 2.
Characteristics of analysed studies
| Author Patients |
Saiura 180 |
ENG 129 |
FFCD 173 |
|||
| Arm | ADJ UFT/LV | Surgery alone | ADJ 5-FU/FA | Surgery alone | ADJ 5-FU/FA | Surgery alone |
| Randomised (analysed) |
90 (88) |
90 (89) |
62 (52) |
67 (55) |
87 (86) |
86 (85) |
| Male | 57 (64.8%) | 63 (70.8%) | 34 (65.4%) | 36 (65.4%) | 46 (53.5%) | 53 (62.4%) |
| Female | 31 (35.2%) | 26 (29.2%) | 28 (34.6%) | 31 (34.6%) | 40 (46.5%) | 32 (37.6%) |
| Median age | 62.3* (8.5 SD) |
64.4* (9.2 SD) |
63.5 (35-76) |
60 (20-82) |
63 (35-77) |
63 (36-76) |
| Primary tumour | ||||||
| Rectum | 36 (40.9%) | 31 (34.8%) | 14 (26.9%) | 17 (30.9%) | 35 (40.7%) | 34 (40.0%) |
| Colon | 52 (59.1%) | 58 (65.2%) | 32 (61.5%) | 35 (60.0%) | 50 (58.1%) | 51 (60.0%) |
| Unknown | – | – | 6 (11.5%) | 5 (9.1%) | 1 (1.2%) | – |
| Nodal status | ||||||
| Negative | 41 (48.2%) | 29 (33.0%) | 24 (46.1%) | 26 (47.3%) | 46 (53.5%) | 39 (45.8%) |
| Positive | 44 (51.8%) | 59 (67.0%) | 26 (50.0%) | 25 (45.4) | 39 (44.3%) | 43 (50.6%) |
| Unknown | – | – | 2 (3.9.%) | 4 (7.3%) | 1 (1.2%) | 3 (3.5%) |
| Disease-free interval, years† | ||||||
| <1 | NA | NA | 18 (34.6%) | 21 (38.2%) | 42 (48.8%) | 39 (45.9%) |
| >1 | NA | NA | 34 (65.3%) | 34 (61.8%) | 44 (51.2%) | 46 (54.1%) |
| Metastases | ||||||
| Single | 37 (42.0%) | 44 (49.4%) | 33 (63.5%) | 37 (67.3%) | 59 (68.6%) | 59 (69.4%) |
| Multiple | 51 (58.0%) | 45 (50.6%) | 19 (36.5%) | 18 (32.7%) | 27 (31.4%) | 26 (30.1%) |
| Synchronous | 39 (43.3%) | 40 (44.9%) | NA | NA | NA | NA |
| Metachronous | 49 (55.7%) | 49 (55.1%) | NA | NA | NA | NA |
| Maximum size, cm | ||||||
| >5 | 21 (23.3%) | 18 (20.0%) | NA | NA | 22 (25.6%) | 26 (30.6%) |
| <5 | 57 (76.7%) | 71 (80.0%) | NA | NA | 64 (74.4%) | 59 (69.4%) |
| Metastatic site | ||||||
| Liver | 88 (100%) | 89 (100%) | 44 (84.6%) | 46 (83.6%) | 86 (100%) | 85 (100%) |
| Lung | – | – | 7 (13.5%) | 6 (10.9%) | – | – |
| Unknown | – | – | 1 (1.9%) | 3 (5.4%) | – | – |
*mean, †DFS in ENG study was calculate as <vs > 6 months (and not 12 months as in FFCD study.
ADJ, adjuvant; DFS, disease-free survival; ENG, European Organization for Research and Treatment of Cancer, National Cancer Institute of Canada, Gruppo Italiano di Valutazione Interventi in Oncologia; FFCD, Federation Francophone de Cancerologie Digestive; 5-FU, fluorouracil; LV, leucovorin; UFT, uracil tegafur.