Table 4.
Treatment-related select adverse events for chemotherapy
| Event | CAP cohort (n=243) |
Control cohort (n=1196) |
P value* | ||||
| Any grade | Grade 1–2 | Grade 3–5 | Any grade | Grade 1–2 | Grade 3–5 | ||
| Rash | 27 (11.0) | 25 (10.2) | 2 (0.8) | 110 (9.2) | 103 (8.6) | 7 (0.6) | 0.34 |
| Pruritus | 10 (4.1) | 10 (4.1) | 0 (0.0) | 40 (3.4) | 37 (3.1) | 3 (0.3) | 0.56 |
| Stomatitis | 35 (14.4) | 29 (11.9) | 6 (2.5) | 105 (8.8) | 87 (7.3) | 18 (1.5) | 0.009 |
| Diarrhea | 30 (12.3) | 26 (10.7) | 4 (1.6) | 104 (8.7) | 90 (7.5) | 14 (1.2) | 0.09 |
| Colitis | 3 (1.2) | 1 (0.4) | 2 (0.8) | 6 (0.6) | 3 (0.3) | 3 (0.3) | 0.18 |
| Hypothyroidism | 3 (1.2) | 3 (1.2) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0.005 |
| Hyperthyroidism | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | |
| Hypophysitis | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | |
| Hyperglycemia | 6 (2.4) | 4 (1.6) | 2 (0.8) | 21 (1.8) | 20 (1.7) | 1 (0.1) | 0.44 |
| AST increase | 41 (16.9) | 37 (15.3) | 4 (1.6) | 165 (13.8) | 159 (13.3) | 6 (0.5) | 0.23 |
| ALT increase | 37 (15.2) | 30 (12.3) | 7 (2.9) | 136 (11.4) | 129 (10.8) | 7 (0.6) | 0.10 |
| Total bilirubin increase | 9 (3.7) | 7 (2.9) | 2 (0.8) | 21 (1.8) | 20 (1.7) | 1 (0.1) | 0.08 |
| Creatinine increase | 14 (5.8) | 14 (5.8) | 0 (0.0) | 67 (5.6) | 65 (5.4) | 2 (0.2) | 0.88 |
| Pneumonitis | 17 (7.0) | 8 (3.3) | 9 (3.7)† | 88 (7.3) | 45 (3.7) | 43 (3.6)‡ | >0.99 |
Data are presented as n (%).
*P values were determined by Fisher’s exact test and are for between-cohort comparisons of rates of any-grade adverse events.
†Data include one patient with treatment-related pneumonitis of grade 5.
‡Data include seven patients with treatment-related pneumonitis of grade 5.
CAP, chemotherapy after PD-1 inhibitor treatment; AST, aspartate aminotransferase; ALT, alanine aminotransferase.