Table 3. Capecitabine-specific skin toxicity – survival data.
| Grade 0, n=101 (78.5%) | Grade 1, n=16 (10.7%) | Grade 2, n=22 (14.8%) | Grade 3, n=10 (6.7%) | P-value logrank a | Hazard ratio (95% CI) | |
|---|---|---|---|---|---|---|
| (A) Capecitabine-related skin toxicities | ||||||
| Progression-free survival (PFS) (in months) 95% CI | 5.6 (4.8–6.3) | 8.5 (5.0–11.9) | 8.9 (7.1–10.6) | 13.6 (10.4–16.9) | 0.002 | 0.72 (0.60–0.86) |
| Overall survival (OS) (in months) 95% CI | 22.4 (17.6–27.2) | 30.5 (27.0–33.9) | 33.1 (20.8–45.5) | 37.5 (24.4–46.0)b | 0.053 | 0.74 (0.60–0.92) |
|
Grade 0, n=101 (67.8%)
c
|
Grade 1–3, n=48 (33.2%) c |
P-value logrank
|
Hazard ratio (95% CI) | |||
| (B) Capecitabine-related skin toxicities, n=149 | ||||||
| Progression-free survival (PFS) (in months) 95% CI | 5.6 (4.8–6.3) | 9.9 (8.2–11.6) | <0.001 | 0.51 (0.36–0.72) | ||
| Overall survival (OS) in months 95% CI | 22.4 (17.6–27.2) | 32.8 (22.9–42.3) | 0.008 | 0.56 (0.36–0.86) | ||
|
Grade 0, n=58 (74.4%)
c
|
Grade 1-3, n=20 (25.6%) c |
P-value logrank
|
Hazard ratio (95% CI) | |||
| (C) Capecitabine-related skin toxicities, Arm A (CAIPIRI), n=78 | ||||||
| Progression-free survival (PFS) in months, 95% CI | 5.2 (4.5–5.9) | 8.5 (5.3–11.7) | 0.011 | 0.52 (0.31–0.87) | ||
| Overall survival (OS) in months, 95% CI | 19.7 (11.9–27.5) | 32.0 (25.5–38.5) | 0.125 | 0.63 (0.35–1.14) | ||
|
Grade 0, n=43 (60.6%)
c
|
Grade 1-3, n=28 (39.4%) c |
P-value logrank
|
Hazard ratio (95% CI) | |||
| (D) Capecitabine-related skin toxicities, Arm B (CAPOX), n=71 | ||||||
| Progression-free survival (PFS) (in months) 95% CI | 6.5 (4.7–8.4) | 9.9 (8.3–11.5) | 0.004 | 0.48 (0.29–0.80) | ||
| Overall survival (OS) (in months) 95% CI | 24.0 (11.9–36.1) | 37.5 (30.8–46.4)b | 0.056 | 0.54 (0.29–1.03) | ||
Abbreviation: CI=confidence interval.
a
Logrank for differences of all grades.
b
95% CI of mean as 50% of patients are censored for s.d. of median.
c
According to the National Cancer Institute Common Toxicity Criteria of Adverse Events, version 3.0. The bold value in (A) indicates statistically significant (0.002; P<0.05); in (B) indicates statistically highly significant (<0.001) and statistically significant (0.008; P<0.05); in (C) and (D) indicate statistically significant (0.011 in (C) and 0.004 in (D); P<0.05).