Table 1. Baseline Characteristics of Patients and Corresponding ORRs and DCRs.
Characteristic | Patient groupa | ORR, %b | P valuec | DCR, %d | P valuec | ||||
---|---|---|---|---|---|---|---|---|---|
All (Nā=ā95) | Best overall response | ||||||||
Complete (n = 1) | Partial (n = 7) | Stable disease (n = 17) | Progressive disease (n = 70) | ||||||
Age, median (IQR), y | 55 (49-64) | 47 (47-47) | 62 (50-63) | 55 (47-57) | 55 (49-66) | NA | .86 | NA | .27 |
Sex | |||||||||
Female | 41 (43.2) | 0 | 6 (85.7) | 6 (35.3) | 29 (41.4) | 14.6 | .07 | 29.3 | .64 |
Male | 54 (56.8) | 1 (100) | 1 (14.3) | 11 (64.7) | 41 (58.6) | 3.7 | 24.1 | ||
Primary tumor | |||||||||
Left-sided | 69 (72.6) | 1 (100) | 3 (42.9) | 16 (94.1) | 49 (70.0) | 5.8 | .21 | 29.0 | .44 |
Right-sided | 26 (27.4) | 0 | 4 (57.1) | 1 (5.9) | 21 (30.0) | 15.4 | 19.2 | ||
ECOG status | |||||||||
0 | 42 (44.2) | 1 (100) | 6 (85.7) | 10 (58.8) | 25 (35.7) | 16.7 | .02 | 40.5 | .01 |
1 | 53 (55.8) | 0 | 1 (14.3) | 7 (41.2) | 45 (64.3) | 1.9 | 15.1 | ||
Metastasis sitee | |||||||||
Peritoneal | |||||||||
Involved | 29 (30.5) | 0 | 1 (14.3) | 5 (29.4) | 23 (32.9) | 3.4 | .43 | 20.7 | .46 |
Noninvolved | 66 (69.5) | 1 (100) | 6 (85.7) | 12 (70.6) | 47 (67.1) | 0.6 | 28.8 | ||
Bone | |||||||||
Involved | 10 (10.5) | 0 | 0 | 2 (11.8) | 8 (11.4) | 0 | .59 | 20.0 | >.99 |
Noninvolved | 85 (89.5) | 1 (100) | 7 (100) | 15 (88.2) | 62 (88.6) | 9.4 | 27.1 | ||
Brain | |||||||||
Involved | 3 (3.2) | 0 | 0 | 1 (5.9) | 2 (2.9) | 0 | >.99 | 33.3 | >.99 |
Noninvolved | 92 (96.8) | 1 (100) | 7 (100) | 16 (94.1) | 68 (97.1) | 8.7 | 26.1 | ||
Liver | |||||||||
Involved | 54 (56.8) | 0 | 0 | 1 (5.9) | 53 (75.7) | 0 | <.001 | 1.9 | <.001 |
Noninvolved | 41 (43.2) | 1 (100) | 7 (100) | 16 (94.1) | 17 (24.3) | 19.5 | 58.5 | ||
Lung | |||||||||
Involved | 66 (69.5) | 0 | 3 (42.9) | 13 (76.5) | 50 (71.4) | 4.5 | .054 | 24.2 | .61 |
Noninvolved | 29 (30.5) | 1 (100) | 4 (57.1) | 4 (23.5) | 20 (28.6) | 17.2 | 31.0 | ||
Lymph node | |||||||||
Involved | 50 (52.6) | 1 (100) | 5 (71.4) | 7 (41.2) | 37 (52.9) | 12.0 | .27 | 26.0 | >.99 |
Noninvolved | 45 (47.4) | 0 | 2 (28.6) | 10 (58.8) | 33 (47.1) | 4.4 | 26.7 | ||
Variant status | |||||||||
APC f | |||||||||
Altered | 50 (71.4) | 1 (100) | 3 (60.0) | 13 (81.3) | 33 (68.8) | 8.0 | >.99 | 34.0 | .57 |
Nonaltered | 20 (28.6) | 0 | 2 (40.0) | 3 (18.7) | 15 (31.3) | 10.0 | 25.0 | ||
BRAF V600E | |||||||||
Altered | 4 (4.2) | 0 | 2 (28.6) | 0 | 2 (2.9) | 50.0 | .03 | 50.0 | .28 |
Nonaltered | 91 (95.8) | 1 (100) | 5 (71.4) | 17 (100) | 68 (97.1) | 6.5 | 25.3 | ||
RAS g | |||||||||
Altered | 58 (61.1) | 0 | 2 (28.6) | 10 (58.8) | 46 (65.7) | 3.4 | .053 | 20.7 | .15 |
Nonaltered | 37 (38.9) | 1 (100) | 5 (71.4) | 7 (41.2) | 24 (34.3) | 16.2 | 35.1 | ||
TP53 h | |||||||||
Altered | 56 (78.9) | 1 (100) | 5 (100) | 12 (75.0) | 38 (77.6) | 10.7 | .33 | 32.1 | .76 |
Nonaltered | 15 (21.1) | 0 | 0 | 4 (25.0) | 11 (22.4) | 0 | 26.7 | ||
TMB, median (IQR)i | 5.0 (3-7) | 3 (3-3) | 4 (2-10) | 5 (4-7) | 4 (3-7) | NA | .65 | NA | .61 |
Abbreviations: DCR, disease control rate; ECOG, Eastern Cooperative Oncology Group; IQR, interquartile range; NA, not applicable; ORR, objective response rate; TMB, tumor mutation burden.
Unless otherwise indicated, data are expressed as number (%) of patients. Percentages have been rounded and may not total 100. All percentages are based on weighted analysis.
Calculated as complete plus partial responses vs stable plus progressive disease.
Calculated using the Fisher exact test except for age and TMB (Wilcoxon rank sum test).
Calculated as complete plus partial responses plus stable disease vs progressive disease.
Indicates at treatment.
Data were missing for 25 cases.
Including KRAS and NRAS.
Data were missing for 24 cases.
Data were missing for 32 cases.