Table 2.
n (%) | Median OS, mo (95% CI) | HR (95% CI)b | p valueb | |
---|---|---|---|---|
Week 4 | ||||
All patients | 440 | 11.4 (10.5–12.4) | ||
Response | 283 (64.3) | 14.4 (12.8–15.9) | 0.45 (0.36–0.56) | <0.001 |
Non-response | 157 (35.7) | 7.9 (6.9–8.9) | ||
IMMC-38 | 113 | 11.2 (9.7–12.6) | ||
Response | 75 (66.4) | 12.3 (8.2–16.3) | 0.46 (0.29–0.74) | 0.001 |
Non-response | 38 (33.6) | 6.8 (4.4–9.2) | ||
COU-AA-301 | 327 | 11.7 (10.3–13.1) | ||
Response | 208 (63.6) | 14.4 (13.2–15.5) | 0.44 (0.34–0.57) | <0.001 |
Non-response | 119 (36.4) | 7.9 (6.9–9) | ||
Week 8 | ||||
All patients | 380 | 12.5 (11.1–13.9) | ||
Response | 248 (65.3) | 15.4 (13.9–16.8) | 0.41 (0.33–0.53) | <0.001 |
Non-response | 132 (34.7) | 7.9 (15.4–12.5) | ||
IMMC-38 | 84 | 12.3 (9.4–15.1) | ||
Response | 56 (66.7) | 17.2 (9.7–24.6) | 0.42 (0.24–0.74) | 0.003 |
Non-response | 28 (33.3) | 10.2 (5.5–14.9) | ||
COU-AA-301 | 296 | 12.6 (11.1–14.2) | ||
Response | 192 (64.9) | 15.4 (14.1–16.7) | 0.4 (0.31–0.53) | <0.001 |
Non-response | 104 (35.1) | 7.7 (6.7–8.5) | ||
Week 12 | ||||
All patients | 351 | 13.8 (12.3–15.3) | ||
Response | 226 (64.4) | 16.1 (14.6–17.7) | 0.39 (0.3–0.5) | <0.001 |
Non-response | 125 (35.6) | 9.7 (8.3–11.1) | ||
IMMC-38 | 79 | 13.6 (10.6–16.6) | ||
Response | 55 (69.6) | 18.2 (11.7–24.7) | 0.35 (0.19–0.63) | <0.001 |
Non-response | 24 (30.4) | 13.6 (10.6–16.6) | ||
COU-AA-301 | 272 | 13.9 (12.2–15.6) | ||
Response | 171 (62.9) | 15.9 (14.5–17.4) | 0.41 (0.3–0.54) | <0.001 |
Non-response | 101 (37.1) | 9.7 (7.7–11.7) |
CTC = circulating tumor cell; OS = overall survival; HR = hazard ratio; CI = confidence interval.
Response was defined as a 30% decline in CTC count relative to baseline at each of the landmark time points.
Univariable Cox regression.