Table 3 Treatment regimens and safety outcomes of neoadjuvant chemotherapy plus pembrolizumab according to AC (doxorubicin and cyclophosphamide) regimen (N = 311)
Every 3-week AC (n = 130) | Dose-dense AC (n = 181) | P-value | |
---|---|---|---|
G-CSF, N (%) | 53 (40.7%) | 177 (98.8%) | <0.001 |
Number of neoadjuvant pembrolizumab cycles | 0.020 | ||
< 6 | 17 (13.1%) | 43 (23.9%) | |
6 or more | 113 (86.9%) | 137 (76.1%) | |
Reasons for less than 6 cycles of pembrolizumab | 0.001 | ||
Regulatory/ insurance | 7 (5.3%) | 31 (17.1%) | |
Toxicity | 13 (10%) | 27 (14.9%) | |
Other | 11 (8.3%) | 19 (10.5%) | |
Sequence between AC and carboplatin-paclitaxel | 0.002 | ||
Carboplatin-paclitaxel first | 103 (90.3%) | 124 (75.6%) | |
AC first | 11 (9.6%) | 40 (24.4%) | |
Carboplatin schedule | 0.366 | ||
Weekly | 103 (94.5%) | 152 (96.8%) | |
Every 3-week | 6 (5.5%) | 5 (3.2%) | |
Drug discontinuation during NACT | 26 (20.1%) | 45 (25.1%) | 0.339 |
Type of drug discontinued | |||
Pembrolizumab | 11 (8.4%) | 22 (12.1%) | 0.353 |
Carboplatin | 11 (8.4%) | 23 (12.7%) | 0.272 |
Paclitaxel | 4 (3%) | 8 (4.4%) | 0.767 |
Doxorubicin | 6 (4.6%) | 10 (5.6%) | 0.799 |
Cyclophosphamide | 6 (4.6%) | 10 (5.6%) | 0.799 |
Dose reduction | 19 (14.8%) | 23 (12.8%) | 0.618 |
Type of drug reduced | |||
Carboplatin | 8 (6.1%) | 3 (1.6%) | 0.057 |
Paclitaxel | 8 (6.1%) | 8 (4.4%) | 0.605 |
Doxorubicin | 8 (6.1%) | 13 (7.1%) | 0.821 |
Cyclophosphamide | 7 (5.3%) | 10 (5.5%) | 1.000 |
Delay > 7 days for treatment conclusion | 28 (21.8%) | 50 (28%) | 0.234 |
Use of antibiotics | 31 (24.4%) | 57 (31.8%) | 0.162 |
Grade 3-4 toxicity | 39 (30.7%) | 73 (40.5%) | 0.092 |
Type of G3-4 toxicity | |||
Anemia | 3 (2.3%) | 7 (3.8%) | 0.529 |
Neutropenia | 27 (20.7%) | 46 (25.4%) | 0.416 |
Febrile neutropenia | 12 (9.2%) | 29 (16%) | 0.091 |
Thrombocytopenia | 0 (0%) | 2 (1.1%) | 0.512 |
Nausea | 0 (0%) | 5 (2.7%) | 0.077 |
Vomiting | 0 (0%) | 5 (2.7%) | 0.077 |
Diarrhea | 4 (3%) | 4 (2.1%) | 0.724 |
ASL/ALT elevation | 1 (0.7%) | 8 (4.4%) | 0.085 |
Immune-related toxicity | 9 (6.9%) | 15 (8.2%) | 0.830 |