Table 1.
Incidence and management of diarrheal episodes in patients with HER2-positive metastatic breast cancer
| CLEOPATRAa | ||
|---|---|---|
| P + H + D | Placebo + H + D | |
| n = 408 | n = 396 | |
| Median number of pertuzumab or placebo cycles (range) | 24 (1–96) | 15 (1–92) |
| Median number of docetaxel cycles (range) | 8 (1–52) | 8 (1–42) |
| Patients with ≥1 episode of any-grade diarrhea, n (%) | 279 (68) | 193 (49) |
| Severityb | ||
| Grade 1 | 220 (54) | 150 (38) |
| Grade 2 | 143 (35) | 87 (22) |
| Grade 3 | 38 (9) | 19 (5) |
| Median number of diarrheal episodes per patient (range) | 2 (1–46) | 2 (1–20) |
| Median time to first diarrheal episode, days (IQR) | 8 (4–44) | 23 (6–68) |
| Patients with diarrhea leading to discontinuation of any study drug, n (%) | 8 (2) | 2 (0.5) |
| Patients with diarrhea leading to dose interruption/modification (ie, dose delay, not reduction), n (%) | 25 (6) | 7 (2) |
| Patients treated with ≥1 antidiarrheal medication, n (%)c | 164 (59) | 79 (41) |
| Patients treated with loperamide, n (%)c | 158 (57) | 77 (40) |
a
Safety population (as described in the Methods section).
b
One patient in the control arm experienced grade 4 diarrhea.
c
Percentages were calculated using the number of patients with ≥1 episode of diarrhea as the denominator.
IQR, interquartile range; P + H + D, pertuzumab + trastuzumab + docetaxel; placebo + H + D, placebo + trastuzumab + docetaxel.