Table 2.
Incidence and management of diarrheal episodes during neoadjuvant treatment in patients with HER2-positive early-stage breast cancer
|
NeoSpherea |
TRYPHAENAa |
||||||
|---|---|---|---|---|---|---|---|
| H + D x4 | P + H + D x4 | P + H x4 | P + D x4 | FEC + P + H x3 → P + H + D x3 | FEC x3 → P + H + D x3 | TCH + P x6 | |
| (Arm A) | (Arm B) | (Arm C) | (Arm D) | (Arm A) | (Arm B) | (Arm C) | |
| n = 107 | n = 107 | n = 108 | n = 94 | n = 72 | n = 75 | n = 76 | |
| Patients with ≥1 episode of any-grade diarrhea, n (%) | 36 (34) | 49 (46) | 30 (28) | 51 (54) | 44 (61) | 46 (61) | 55 (72) |
| Severityb | |||||||
| Grade 1 | 27 (25) | 39 (36) | 23 (21) | 36 (38) | 31 (43) | 29 (39) | 34 (45) |
| Grade 2 | 10 (9) | 17 (16) | 9 (8) | 22 (23) | 20 (28) | 17 (23) | 28 (37) |
| Grade 3 | 4 (4) | 6 (6) | 0 | 4 (4) | 3 (4) | 4 (5) | 9 (12) |
| Median number of diarrheal episodes per patient (range) | 1 | 1 | 1 | 1 | 1 | 1 | 1 |
| (1 –3) | (1 –6) | (1 –4) | (1 –4) | (1 –6) | (1 –4) | (1 –6) | |
| Median time to first diarrheal episode, days (IQR) | 6 | 7 | 5 | 6 | 7 | 69c | 6 |
| (3 –15) | (3 –22) | (2 –15) | (3 –16) | (4 –27) | (64 –81) | (3 –21) | |
| Patients with diarrhea leading to discontinuation of any study drug, n | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Patients with diarrhea leading to dose interruption/ modification (i.e. dose delay, not reduction), n (%) | 1 (1) | 8 (7) | 0 | 4 (4) | 0 | 4 (5) | 3 (4) |
| Patients treated with ≥1 antidiarrheal medication, n (%)d | 13 (36) | 23 (47) | 20 (67) | 28 (55) | 23 (52) | 22 (48) | 31 (56) |
| Patients treated with loperamide, n (%)d | 11 (31) | 19 (39) | 18 (60) | 26 (51) | 23 (52) | 22 (48) | 31 (56) |
a
Safety populations (as described in the Methods section).
b
No patient in NeoSphere or TRYPHAENA experienced grade 4 or 5 diarrhea.
c
Cycle 4 was the first pertuzumab-containing cycle.
D, docetaxel; FEC, 5-fluorouracil, epirubicin, cyclophosphamide; H, trastuzumab; IQR, interquartile range; P, pertuzumab; TCH, docetaxel (T), carboplatin (C), trastuzumab (H).
d
Percentages were calculated using the number of patients with ≥1 episode of diarrhea as the denominator.