Baseline characteristics of the RAS‐wt and RAS‐unselected populations in the EPIC study
| Characteristic . | RAS‐wt . | RAS‐unselected [2]Total (n = 1,298), n (%) . | ||
|---|---|---|---|---|
| Irinotecan (n = 221), n (%) . | Cetuximab plus irinotecan (n = 231), n (%) . | Total (n = 452), n (%) . | ||
| Sex | ||||
| Female | 74 (33.5) | 86 (37.2) | 160 (35.4) | 482 (37.1) |
| Male | 147 (66.5) | 145 (62.8) | 292 (64.6) | 816 (62.9) |
| Median age (range), years | 60.0 (23–82) | 61.0 (33–85) | 61.0 (23–85) | 62 (21–90) |
| ECOG PS | ||||
| 0 | 112 (50.7) | 126 (54.5) | 238 (52.7) | 664 (51.2) |
| 1 | 101 (45.7) | 90 (39.0) | 191 (42.3) | 555 (42.8) |
| 2 | 7 (3.2) | 15 (6.5) | 22 (4.9) | 70 (5.4) |
| Not reported | 1 (0.5) | 0 | 1 (0.2) | 9 (0.7) |
| Prior therapy | ||||
| Radiotherapy | 44 (19.9) | 46 (19.9) | 90 (19.9) | 249 (19.2) |
| Adjuvant | 19 (8.6) | 15 (6.5) | 34 (7.5) | 102 (7.9) |
| Metastatic | 8 (3.6) | 17 (7.4) | 25 (5.5) | 70 (5.4) |
| Neoadjuvant | 18 (8.1) | 17 (7.4) | 35 (7.7) | 90 (69.3) |
| Chemotherapy | 221 (100) | 231 (100) | 452 (100) | 1,298 (100) |
| Adjuvant | 55 (24.9) | 54 (23.4) | 109 (24.1) | 646 (49.8) |
| Metastatic | 219 (99.1) | 231 (100) | 450 (99.6) | 1,289 (99.3) |
| Neoadjuvant | 14 (6.3) | 17 (7.4) | 31 (6.9) | 80 (6.2) |
| First‐line therapy | ||||
| Fluoropyrimidine | 216 (97.7) | 225 (97.4) | 441 (97.6) | 1,266 (97.5) |
| Oxaliplatin | 219 (99.1) | 229 (99.1) | 448 (99.1) | 1,280 (98.6) |
| Reason for discontinuation | ||||
| Disease progression | 143 (64.7) | 144 (62.3) | 287 (63.5) | 843 (64.9) |
| Toxicity | 29 (13.1) | 36 (15.6) | 65 (14.4) | 207 (15.9) |
| Other | 44 (19.9) | 45 (19.5) | 89 (19.7) | 225 (17.3) |
| Unknown | 3 (1.4) | 5 (2.2) | 8 (1.8) | 11 (0.8) |
| Tumor type | ||||
| Colon | 160 (72.4) | 149 (64.5) | 309 (68.4) | 902 (69.5) |
| Rectum | 61 (27.6) | 82 (35.5) | 143 (31.6) | 395 (30.4) |
| Unknown | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (0.1) |
| Number of disease sites | ||||
| 1 | 69 (31.2) | 81 (35.1) | 150 (33.2) | 415 (32.0) |
| ≥ 2 | 150 (67.9) | 149 (64.5) | 299 (66.2) | 871 (67.1) |
| Missing | 2 (0.9) | 1 (0.4) | 3 (0.7) | 12 (0.9) |
| EGFR‐positive CRC | ||||
| Yes | 221 (100) | 230 (99.6) | 451 (99.8) | 1,275 (98.2) |
| No | 0 (0.0) | 1 (0.4) | 1 (0.2) | 2 (0.2) |
| Liver metastases | ||||
| Yes | 170 (76.9) | 176 (76.2) | 346 (76.5) | 989 (76.2) |
| No | 49 (22.2) | 54 (23.4) | 103 (22.8) | 297 (22.9) |
| Characteristic . | RAS‐wt . | RAS‐unselected [2]Total (n = 1,298), n (%) . | ||
|---|---|---|---|---|
| Irinotecan (n = 221), n (%) . | Cetuximab plus irinotecan (n = 231), n (%) . | Total (n = 452), n (%) . | ||
| Sex | ||||
| Female | 74 (33.5) | 86 (37.2) | 160 (35.4) | 482 (37.1) |
| Male | 147 (66.5) | 145 (62.8) | 292 (64.6) | 816 (62.9) |
| Median age (range), years | 60.0 (23–82) | 61.0 (33–85) | 61.0 (23–85) | 62 (21–90) |
| ECOG PS | ||||
| 0 | 112 (50.7) | 126 (54.5) | 238 (52.7) | 664 (51.2) |
| 1 | 101 (45.7) | 90 (39.0) | 191 (42.3) | 555 (42.8) |
| 2 | 7 (3.2) | 15 (6.5) | 22 (4.9) | 70 (5.4) |
| Not reported | 1 (0.5) | 0 | 1 (0.2) | 9 (0.7) |
| Prior therapy | ||||
| Radiotherapy | 44 (19.9) | 46 (19.9) | 90 (19.9) | 249 (19.2) |
| Adjuvant | 19 (8.6) | 15 (6.5) | 34 (7.5) | 102 (7.9) |
| Metastatic | 8 (3.6) | 17 (7.4) | 25 (5.5) | 70 (5.4) |
| Neoadjuvant | 18 (8.1) | 17 (7.4) | 35 (7.7) | 90 (69.3) |
| Chemotherapy | 221 (100) | 231 (100) | 452 (100) | 1,298 (100) |
| Adjuvant | 55 (24.9) | 54 (23.4) | 109 (24.1) | 646 (49.8) |
| Metastatic | 219 (99.1) | 231 (100) | 450 (99.6) | 1,289 (99.3) |
| Neoadjuvant | 14 (6.3) | 17 (7.4) | 31 (6.9) | 80 (6.2) |
| First‐line therapy | ||||
| Fluoropyrimidine | 216 (97.7) | 225 (97.4) | 441 (97.6) | 1,266 (97.5) |
| Oxaliplatin | 219 (99.1) | 229 (99.1) | 448 (99.1) | 1,280 (98.6) |
| Reason for discontinuation | ||||
| Disease progression | 143 (64.7) | 144 (62.3) | 287 (63.5) | 843 (64.9) |
| Toxicity | 29 (13.1) | 36 (15.6) | 65 (14.4) | 207 (15.9) |
| Other | 44 (19.9) | 45 (19.5) | 89 (19.7) | 225 (17.3) |
| Unknown | 3 (1.4) | 5 (2.2) | 8 (1.8) | 11 (0.8) |
| Tumor type | ||||
| Colon | 160 (72.4) | 149 (64.5) | 309 (68.4) | 902 (69.5) |
| Rectum | 61 (27.6) | 82 (35.5) | 143 (31.6) | 395 (30.4) |
| Unknown | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (0.1) |
| Number of disease sites | ||||
| 1 | 69 (31.2) | 81 (35.1) | 150 (33.2) | 415 (32.0) |
| ≥ 2 | 150 (67.9) | 149 (64.5) | 299 (66.2) | 871 (67.1) |
| Missing | 2 (0.9) | 1 (0.4) | 3 (0.7) | 12 (0.9) |
| EGFR‐positive CRC | ||||
| Yes | 221 (100) | 230 (99.6) | 451 (99.8) | 1,275 (98.2) |
| No | 0 (0.0) | 1 (0.4) | 1 (0.2) | 2 (0.2) |
| Liver metastases | ||||
| Yes | 170 (76.9) | 176 (76.2) | 346 (76.5) | 989 (76.2) |
| No | 49 (22.2) | 54 (23.4) | 103 (22.8) | 297 (22.9) |
Abbreviations: CRC, colorectal cancer; ECOG PS, Eastern Cooperative Oncology Group performance status; EGFR, epidermal growth factor receptor; wt, wild type.
Baseline characteristics of the RAS‐wt and RAS‐unselected populations in the EPIC study
| Characteristic . | RAS‐wt . | RAS‐unselected [2]Total (n = 1,298), n (%) . | ||
|---|---|---|---|---|
| Irinotecan (n = 221), n (%) . | Cetuximab plus irinotecan (n = 231), n (%) . | Total (n = 452), n (%) . | ||
| Sex | ||||
| Female | 74 (33.5) | 86 (37.2) | 160 (35.4) | 482 (37.1) |
| Male | 147 (66.5) | 145 (62.8) | 292 (64.6) | 816 (62.9) |
| Median age (range), years | 60.0 (23–82) | 61.0 (33–85) | 61.0 (23–85) | 62 (21–90) |
| ECOG PS | ||||
| 0 | 112 (50.7) | 126 (54.5) | 238 (52.7) | 664 (51.2) |
| 1 | 101 (45.7) | 90 (39.0) | 191 (42.3) | 555 (42.8) |
| 2 | 7 (3.2) | 15 (6.5) | 22 (4.9) | 70 (5.4) |
| Not reported | 1 (0.5) | 0 | 1 (0.2) | 9 (0.7) |
| Prior therapy | ||||
| Radiotherapy | 44 (19.9) | 46 (19.9) | 90 (19.9) | 249 (19.2) |
| Adjuvant | 19 (8.6) | 15 (6.5) | 34 (7.5) | 102 (7.9) |
| Metastatic | 8 (3.6) | 17 (7.4) | 25 (5.5) | 70 (5.4) |
| Neoadjuvant | 18 (8.1) | 17 (7.4) | 35 (7.7) | 90 (69.3) |
| Chemotherapy | 221 (100) | 231 (100) | 452 (100) | 1,298 (100) |
| Adjuvant | 55 (24.9) | 54 (23.4) | 109 (24.1) | 646 (49.8) |
| Metastatic | 219 (99.1) | 231 (100) | 450 (99.6) | 1,289 (99.3) |
| Neoadjuvant | 14 (6.3) | 17 (7.4) | 31 (6.9) | 80 (6.2) |
| First‐line therapy | ||||
| Fluoropyrimidine | 216 (97.7) | 225 (97.4) | 441 (97.6) | 1,266 (97.5) |
| Oxaliplatin | 219 (99.1) | 229 (99.1) | 448 (99.1) | 1,280 (98.6) |
| Reason for discontinuation | ||||
| Disease progression | 143 (64.7) | 144 (62.3) | 287 (63.5) | 843 (64.9) |
| Toxicity | 29 (13.1) | 36 (15.6) | 65 (14.4) | 207 (15.9) |
| Other | 44 (19.9) | 45 (19.5) | 89 (19.7) | 225 (17.3) |
| Unknown | 3 (1.4) | 5 (2.2) | 8 (1.8) | 11 (0.8) |
| Tumor type | ||||
| Colon | 160 (72.4) | 149 (64.5) | 309 (68.4) | 902 (69.5) |
| Rectum | 61 (27.6) | 82 (35.5) | 143 (31.6) | 395 (30.4) |
| Unknown | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (0.1) |
| Number of disease sites | ||||
| 1 | 69 (31.2) | 81 (35.1) | 150 (33.2) | 415 (32.0) |
| ≥ 2 | 150 (67.9) | 149 (64.5) | 299 (66.2) | 871 (67.1) |
| Missing | 2 (0.9) | 1 (0.4) | 3 (0.7) | 12 (0.9) |
| EGFR‐positive CRC | ||||
| Yes | 221 (100) | 230 (99.6) | 451 (99.8) | 1,275 (98.2) |
| No | 0 (0.0) | 1 (0.4) | 1 (0.2) | 2 (0.2) |
| Liver metastases | ||||
| Yes | 170 (76.9) | 176 (76.2) | 346 (76.5) | 989 (76.2) |
| No | 49 (22.2) | 54 (23.4) | 103 (22.8) | 297 (22.9) |
| Characteristic . | RAS‐wt . | RAS‐unselected [2]Total (n = 1,298), n (%) . | ||
|---|---|---|---|---|
| Irinotecan (n = 221), n (%) . | Cetuximab plus irinotecan (n = 231), n (%) . | Total (n = 452), n (%) . | ||
| Sex | ||||
| Female | 74 (33.5) | 86 (37.2) | 160 (35.4) | 482 (37.1) |
| Male | 147 (66.5) | 145 (62.8) | 292 (64.6) | 816 (62.9) |
| Median age (range), years | 60.0 (23–82) | 61.0 (33–85) | 61.0 (23–85) | 62 (21–90) |
| ECOG PS | ||||
| 0 | 112 (50.7) | 126 (54.5) | 238 (52.7) | 664 (51.2) |
| 1 | 101 (45.7) | 90 (39.0) | 191 (42.3) | 555 (42.8) |
| 2 | 7 (3.2) | 15 (6.5) | 22 (4.9) | 70 (5.4) |
| Not reported | 1 (0.5) | 0 | 1 (0.2) | 9 (0.7) |
| Prior therapy | ||||
| Radiotherapy | 44 (19.9) | 46 (19.9) | 90 (19.9) | 249 (19.2) |
| Adjuvant | 19 (8.6) | 15 (6.5) | 34 (7.5) | 102 (7.9) |
| Metastatic | 8 (3.6) | 17 (7.4) | 25 (5.5) | 70 (5.4) |
| Neoadjuvant | 18 (8.1) | 17 (7.4) | 35 (7.7) | 90 (69.3) |
| Chemotherapy | 221 (100) | 231 (100) | 452 (100) | 1,298 (100) |
| Adjuvant | 55 (24.9) | 54 (23.4) | 109 (24.1) | 646 (49.8) |
| Metastatic | 219 (99.1) | 231 (100) | 450 (99.6) | 1,289 (99.3) |
| Neoadjuvant | 14 (6.3) | 17 (7.4) | 31 (6.9) | 80 (6.2) |
| First‐line therapy | ||||
| Fluoropyrimidine | 216 (97.7) | 225 (97.4) | 441 (97.6) | 1,266 (97.5) |
| Oxaliplatin | 219 (99.1) | 229 (99.1) | 448 (99.1) | 1,280 (98.6) |
| Reason for discontinuation | ||||
| Disease progression | 143 (64.7) | 144 (62.3) | 287 (63.5) | 843 (64.9) |
| Toxicity | 29 (13.1) | 36 (15.6) | 65 (14.4) | 207 (15.9) |
| Other | 44 (19.9) | 45 (19.5) | 89 (19.7) | 225 (17.3) |
| Unknown | 3 (1.4) | 5 (2.2) | 8 (1.8) | 11 (0.8) |
| Tumor type | ||||
| Colon | 160 (72.4) | 149 (64.5) | 309 (68.4) | 902 (69.5) |
| Rectum | 61 (27.6) | 82 (35.5) | 143 (31.6) | 395 (30.4) |
| Unknown | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (0.1) |
| Number of disease sites | ||||
| 1 | 69 (31.2) | 81 (35.1) | 150 (33.2) | 415 (32.0) |
| ≥ 2 | 150 (67.9) | 149 (64.5) | 299 (66.2) | 871 (67.1) |
| Missing | 2 (0.9) | 1 (0.4) | 3 (0.7) | 12 (0.9) |
| EGFR‐positive CRC | ||||
| Yes | 221 (100) | 230 (99.6) | 451 (99.8) | 1,275 (98.2) |
| No | 0 (0.0) | 1 (0.4) | 1 (0.2) | 2 (0.2) |
| Liver metastases | ||||
| Yes | 170 (76.9) | 176 (76.2) | 346 (76.5) | 989 (76.2) |
| No | 49 (22.2) | 54 (23.4) | 103 (22.8) | 297 (22.9) |
Abbreviations: CRC, colorectal cancer; ECOG PS, Eastern Cooperative Oncology Group performance status; EGFR, epidermal growth factor receptor; wt, wild type.
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