Table 1.
Characteristics of the Study Patients (Modified Intention-to-Treat Population).*
| Characteristic | TOSCA (N = 2402) | SCOT (N =3983) | IDEA France (N =2010) | CALGB/SWOG 80702 (N = 2440) | HORG (N = 708) |
ACHIEVE (N = 1291) | All Patients (N = 12,834) |
|---|---|---|---|---|---|---|---|
| Countries | Italy | U.K., Denmark, Spain, Australia, Sweden, New Zealand | France | U.S., Canada | Greece | Japan | |
| Median age (range) — yr | 64 (20–83) | 65 (20–84) | 64 (18–85) | 61 (19–88) | 67 (20–75) | 66 (28–85) | 64 (18–88) |
| Male sex — no. (%) | 1348 (56.1) | 2356 (59.2) | 1144 (56.9) | 1348 (55.3) | 398 (56.2) | 649 (50.3) | 7,243 (56.4) |
| ECOG performance status — no. (%) | |||||||
| 0 | 2268 (94.4) | 2827 (71.0) | 1479 (73.6) | 1734 (71.1) | 579 (81.8) | 1245 (96.4) | 10,132 (79.0) |
| 1 | 130 (5.4) | 1156 (29.0) | 502 (25.0) | 680 (27.9) | 128 (18.1) | 46 (3.6) | 2,642 (20.6) |
| 2 | 1 (<0.1) | 0 | 29 (1.4) | 26 (1.1) | 1 (0.1) | 0 | 57 (0.4) |
| Missing data | 3 (0.1) | 0 | 0 | 0 | 0 | 0 | 3 (<0.1) |
| Tumor stage — no. (%) | |||||||
| T1 | 76 (3.2) | 128 (3.2) | 78 (3.9) | 135 (5.5) | 1 (0.1) | 75 (5.8) | 493 (3.8) |
| T2 | 236 (9.8) | 333 (8.4) | 161 (8.0) | 288 (11.8) | 60 (8.5) | 119 (9.2) | 1,197 (9.3) |
| T3 | 1773 (73.8) | 2347 (58.9) | 1399 (69.6) | 1598 (65.5) | 549 (77.5) | 734 (56.9) | 8,400 (65.5) |
| T4 | 291 (12.1) | 1174 (29.5) | 372 (18.5) | 359 (14.7) | 96 (13.6) | 363 (28.1) | 2,655 (20.7) |
| Missing data | 26 (1.1) | 1 (<0.1) | 0 | 60 (2.5) | 2 (0.3) | 0 | 89 (0.7) |
| Nodal stage — no. (%) | |||||||
| N1 | 1748 (72.8) | 2749 (69.0) | 1501 (74.7) | 1739 (71.3) | 472 (66.7) | 959 (74.3) | 9,168 (71.4) |
| N2 | 636 (26.5) | 1233 (31.0) | 506 (25.2) | 630 (25.8) | 230 (32.5) | 332 (25.7) | 3,567 (27.8) |
| Missing data | 18 (0.7) | 1 (<0.1) | 3 (0.1) | 71 (2.9) | 6 (0.8) | 0 | 99 (0.8) |
| Risk group — no. (%) | |||||||
| T1,T2, or T3 N1 | 1553 (65.5) | 2032 (51.0) | 1245 (62.0) | 1507 (63.6) | 416 (59.1) | 718 (55.6) | 7,471 (58.7) |
| T4, N2, or both | 817 (34.5) | 1950 (49.0) | 764 (38.0) | 864 (36.4) | 288 (40.9) | 573 (44.4) | 5,256 (41.3) |
| Median no. of lymph nodes examined (range) | 18 (0–85) | Not recorded | 20 (1–99) | 20 (1–132) | 18 (10–85) | 21 (1–123) | 19 (0–132) |
| Chemotherapy regimen — no. (%) | |||||||
| CAPOX | 840 (35.0) | 2649 (66.5) | 201 (10.0) | 0 | 412 (58.2) | 969 (75.1) | 5,071 (39.5) |
| FOLFOX | 1562 (65.0)† | 1334 (33.5) | 1809 (90.0) | 2440 (100) | 296 (41.8)† | 322 (24.9) | 7,763 (60.5) |
| Median follow-up time — mo | 61.7 | 36.8 | 51.3 | 34.9 | 47.5 | 36.7 | 41.8 |
*
Percentages may not total 100 because of rounding. ACHIEVE denotes Adjuvant Chemotherapy for Colon Cancer with High Evidence, CALGB/SWOG Cancer and Leukemia Group B/Southwest Oncology Group, HORG Hellenic Oncology Research Group, IDEA International Duration Evaluation of Adjuvant Therapy, SCOT Short Course Oncology Treatment, and TOSCA Three or Six Colon Adjuvant.
†
Patients in this trial received FOLFOX4; those in the other trials received modified FOLFOX6.