Summary of efficacy results in the RAS‐wt and RAS‐unselected populations in the EPIC study
| . | RAS‐wt population . | RAS‐unselected population [2] . | ||
|---|---|---|---|---|
| . | Irinotecan (n = 221) . | Cetuximab plus irinotecan (n = 231) . | Irinotecan (n = 650) . | Cetuximab plus irinotecan (n = 648) . |
| Median duration of therapy (range), weeks | ||||
| Cetuximab | NA | 19.0 (0.7–97.9) | NA | 14.0 (0.7–97.9) |
| Irinotecan | 10.0 (1.1–71.0) | 18.0 (0.7–89.1) | 9.9 (0.4–71.0) | 13.1 (0.7–89.1) |
| OS | ||||
| Number of events, n (%) | 126 (57.0) | 133 (57.6) | 429 (66.0) | 445 (68.8) |
| Median (95% CI), months | 12.0 (9.36–14.92) | 12.3 (11.37–14.09) | 9.99 (9.13–11.33) | 10.71 (9.59–11.30) |
| HR (95% CI) | 0.91 (0.71–1.17) | 0.975 (0.854–1.114) | ||
| Log‐rank p value | .4645 | .7114 | ||
| PFS | ||||
| Number of events, n (%) | 201 (91.0) | 212 (91.8) | 598 (92.0) | 610 (94.1) |
| Median (95% CI), months | 2.6 (2.30–2.83) | 5.4 (4.24–5.75) | 2.56 (2.1–2.69) | 3.98 (3.15–4.14) |
| HR (95% CI) | 0.57 (0.46–0.69) | 0.692 (0.617–0.776) | ||
| Log‐rank p value | <.0001 | <.0001 | ||
| Response | ||||
| Primary definition, n (%) | ||||
| Complete response | 0 | 4 (1.7) | 1 (0.2) | 9 (1.4) |
| Partial response | 11 (5.0) | 64 (27.7) | 26 (4.0) | 97 (15.0) |
| Stable disease | 100 (45.2) | 90 (39.0) | 271 (41.7) | 292 (45.1) |
| Progressive disease | 71 (32.1) | 46 (19.9) | 243 (37.4) | 174 (26.9) |
| Not assessable | 39 (17.6) | 27 (11.7) | 109 (16.8) | 76 (11.7) |
| ORR (CR + PR), n (%) [95% CI] | 11 (5.0) [2.51–8.73] | 68 (29.4) [23.63–35.77] | 27 (4.2) [2.75–5.99] | 106 (16.4) [13.59–19.44] |
| . | RAS‐wt population . | RAS‐unselected population [2] . | ||
|---|---|---|---|---|
| . | Irinotecan (n = 221) . | Cetuximab plus irinotecan (n = 231) . | Irinotecan (n = 650) . | Cetuximab plus irinotecan (n = 648) . |
| Median duration of therapy (range), weeks | ||||
| Cetuximab | NA | 19.0 (0.7–97.9) | NA | 14.0 (0.7–97.9) |
| Irinotecan | 10.0 (1.1–71.0) | 18.0 (0.7–89.1) | 9.9 (0.4–71.0) | 13.1 (0.7–89.1) |
| OS | ||||
| Number of events, n (%) | 126 (57.0) | 133 (57.6) | 429 (66.0) | 445 (68.8) |
| Median (95% CI), months | 12.0 (9.36–14.92) | 12.3 (11.37–14.09) | 9.99 (9.13–11.33) | 10.71 (9.59–11.30) |
| HR (95% CI) | 0.91 (0.71–1.17) | 0.975 (0.854–1.114) | ||
| Log‐rank p value | .4645 | .7114 | ||
| PFS | ||||
| Number of events, n (%) | 201 (91.0) | 212 (91.8) | 598 (92.0) | 610 (94.1) |
| Median (95% CI), months | 2.6 (2.30–2.83) | 5.4 (4.24–5.75) | 2.56 (2.1–2.69) | 3.98 (3.15–4.14) |
| HR (95% CI) | 0.57 (0.46–0.69) | 0.692 (0.617–0.776) | ||
| Log‐rank p value | <.0001 | <.0001 | ||
| Response | ||||
| Primary definition, n (%) | ||||
| Complete response | 0 | 4 (1.7) | 1 (0.2) | 9 (1.4) |
| Partial response | 11 (5.0) | 64 (27.7) | 26 (4.0) | 97 (15.0) |
| Stable disease | 100 (45.2) | 90 (39.0) | 271 (41.7) | 292 (45.1) |
| Progressive disease | 71 (32.1) | 46 (19.9) | 243 (37.4) | 174 (26.9) |
| Not assessable | 39 (17.6) | 27 (11.7) | 109 (16.8) | 76 (11.7) |
| ORR (CR + PR), n (%) [95% CI] | 11 (5.0) [2.51–8.73] | 68 (29.4) [23.63–35.77] | 27 (4.2) [2.75–5.99] | 106 (16.4) [13.59–19.44] |
Abbreviations: CI, confidence interval; CR, complete response; HR, hazard ratio; NA, not applicable; ORR, overall response rate; OS, overall survival; PFS, progression‐free survival; PR, partial response; wt, wild type.
Summary of efficacy results in the RAS‐wt and RAS‐unselected populations in the EPIC study
| . | RAS‐wt population . | RAS‐unselected population [2] . | ||
|---|---|---|---|---|
| . | Irinotecan (n = 221) . | Cetuximab plus irinotecan (n = 231) . | Irinotecan (n = 650) . | Cetuximab plus irinotecan (n = 648) . |
| Median duration of therapy (range), weeks | ||||
| Cetuximab | NA | 19.0 (0.7–97.9) | NA | 14.0 (0.7–97.9) |
| Irinotecan | 10.0 (1.1–71.0) | 18.0 (0.7–89.1) | 9.9 (0.4–71.0) | 13.1 (0.7–89.1) |
| OS | ||||
| Number of events, n (%) | 126 (57.0) | 133 (57.6) | 429 (66.0) | 445 (68.8) |
| Median (95% CI), months | 12.0 (9.36–14.92) | 12.3 (11.37–14.09) | 9.99 (9.13–11.33) | 10.71 (9.59–11.30) |
| HR (95% CI) | 0.91 (0.71–1.17) | 0.975 (0.854–1.114) | ||
| Log‐rank p value | .4645 | .7114 | ||
| PFS | ||||
| Number of events, n (%) | 201 (91.0) | 212 (91.8) | 598 (92.0) | 610 (94.1) |
| Median (95% CI), months | 2.6 (2.30–2.83) | 5.4 (4.24–5.75) | 2.56 (2.1–2.69) | 3.98 (3.15–4.14) |
| HR (95% CI) | 0.57 (0.46–0.69) | 0.692 (0.617–0.776) | ||
| Log‐rank p value | <.0001 | <.0001 | ||
| Response | ||||
| Primary definition, n (%) | ||||
| Complete response | 0 | 4 (1.7) | 1 (0.2) | 9 (1.4) |
| Partial response | 11 (5.0) | 64 (27.7) | 26 (4.0) | 97 (15.0) |
| Stable disease | 100 (45.2) | 90 (39.0) | 271 (41.7) | 292 (45.1) |
| Progressive disease | 71 (32.1) | 46 (19.9) | 243 (37.4) | 174 (26.9) |
| Not assessable | 39 (17.6) | 27 (11.7) | 109 (16.8) | 76 (11.7) |
| ORR (CR + PR), n (%) [95% CI] | 11 (5.0) [2.51–8.73] | 68 (29.4) [23.63–35.77] | 27 (4.2) [2.75–5.99] | 106 (16.4) [13.59–19.44] |
| . | RAS‐wt population . | RAS‐unselected population [2] . | ||
|---|---|---|---|---|
| . | Irinotecan (n = 221) . | Cetuximab plus irinotecan (n = 231) . | Irinotecan (n = 650) . | Cetuximab plus irinotecan (n = 648) . |
| Median duration of therapy (range), weeks | ||||
| Cetuximab | NA | 19.0 (0.7–97.9) | NA | 14.0 (0.7–97.9) |
| Irinotecan | 10.0 (1.1–71.0) | 18.0 (0.7–89.1) | 9.9 (0.4–71.0) | 13.1 (0.7–89.1) |
| OS | ||||
| Number of events, n (%) | 126 (57.0) | 133 (57.6) | 429 (66.0) | 445 (68.8) |
| Median (95% CI), months | 12.0 (9.36–14.92) | 12.3 (11.37–14.09) | 9.99 (9.13–11.33) | 10.71 (9.59–11.30) |
| HR (95% CI) | 0.91 (0.71–1.17) | 0.975 (0.854–1.114) | ||
| Log‐rank p value | .4645 | .7114 | ||
| PFS | ||||
| Number of events, n (%) | 201 (91.0) | 212 (91.8) | 598 (92.0) | 610 (94.1) |
| Median (95% CI), months | 2.6 (2.30–2.83) | 5.4 (4.24–5.75) | 2.56 (2.1–2.69) | 3.98 (3.15–4.14) |
| HR (95% CI) | 0.57 (0.46–0.69) | 0.692 (0.617–0.776) | ||
| Log‐rank p value | <.0001 | <.0001 | ||
| Response | ||||
| Primary definition, n (%) | ||||
| Complete response | 0 | 4 (1.7) | 1 (0.2) | 9 (1.4) |
| Partial response | 11 (5.0) | 64 (27.7) | 26 (4.0) | 97 (15.0) |
| Stable disease | 100 (45.2) | 90 (39.0) | 271 (41.7) | 292 (45.1) |
| Progressive disease | 71 (32.1) | 46 (19.9) | 243 (37.4) | 174 (26.9) |
| Not assessable | 39 (17.6) | 27 (11.7) | 109 (16.8) | 76 (11.7) |
| ORR (CR + PR), n (%) [95% CI] | 11 (5.0) [2.51–8.73] | 68 (29.4) [23.63–35.77] | 27 (4.2) [2.75–5.99] | 106 (16.4) [13.59–19.44] |
Abbreviations: CI, confidence interval; CR, complete response; HR, hazard ratio; NA, not applicable; ORR, overall response rate; OS, overall survival; PFS, progression‐free survival; PR, partial response; wt, wild type.
This PDF is available to Subscribers Only
View Article Abstract & Purchase OptionsFor full access to this pdf, sign in to an existing account, or purchase an annual subscription.
