Table 4.
RR of all-grade AEs associated with regorafenib based on the subgroup analysis
| AEs | Prior MKI exposure (95% CI) | Tumor type (95% CI) | ||||
|---|---|---|---|---|---|---|
| Yes (2 trials) | No (3 trials) | P-value | CRC (2 trials) | Non-CRC (4 trials) | P-value | |
| Any AE | 1.61 (1.30–2.00)a | 1.76 (1.27–2.45)a | 0.65 | 1.76 (1.27–2.45)a | 1.61 (1.30–2.00)a | 0.65 |
| Clinical AE | ||||||
| Hand–foot skin reaction | 5.78 (3.07–10.87)a | 11.77 (4.27–32.47)a | 0.24 | 8.92 (3.43–23.18)a | 7.25 (3.25–16.16)a | 0.74 |
| Fatigue | 1.50 (1.15–1.95) | 1.73 (1.40–2.14) | 0.40 | 1.73 (1.40–2.14) | 1.50 (1.15–1.95) | 0.40 |
| Diarrhea | 4.34 (2.83–6.66) | 4.64 (3.23–6.68) | 0.81 | 4.24 (2.82–6.39) | 4.76 (3.26–6.93) | 0.69 |
| Hypertension | 3.84 (2.49–5.93) | 4.34 (2.96–6.37) | 0.68 | 4.77 (2.99–7.61) | 3.70 (2.57–5.31) | 0.40 |
| Voice changes | 3.50 (0.82–14.95) | 5.31 (3.14–9.00) | 0.60 | 5.31 (3.14–9.00) | 3.50 (0.82–14.95) | 0.60 |
| Anorexia | 3.46 (2.13–5.63) | 1.90 (1.47–2.46) | 0.03 | 1.95 (1.43–2.65) | 2.67 (1.89–3.77) | 0.18 |
| Oral mucositis | 4.67 (2.49–8.76) | 6.30 (3.90–10.17) | 0.46 | 7.65 (3.96–14.76) | 4.59 (2.89–7.29) | 0.21 |
| Rash or desquamation | 6.00 (1.46–24.62) | 6.53 (3.59–11.86) | 0.91 | 6.53 (3.59–11.86) | 6.00 (1.46–24.62) | 0.91 |
| Myalgia | 1.50 (0.63–3.60) | 1.57 (1.00–2.47) | 0.93 | 7.55 (0.44–130.35) | 1.42 (0.95–2.13) | 0.26 |
| Hoarseness | 9.20 (3.20–26.46) | 13.50 (1.87–97.25) | 0.74 | 13.50 (1.87–97.25) | 9.20 (3.20–26.46) | 0.74 |
| Nausea | 1.64 (1.00–2.68) | 1.30 (0.86–1.96) | 0.48 | 1.30 (0.86–1.96) | 1.64 (1.00–2.68) | 0.48 |
| Weight loss | 4.64 (1.43–15.12) | 5.82 (2.56–13.22) | 0.76 | 5.82 (2.56–13.22) | 4.64 (1.43–15.12) | 0.76 |
| Alopecia | 15.50 (2.16–111.07) | 18.22 (2.51–132.10) | 0.91 | 18.22 (2.51–132.10) | 15.50 (2.16–111.07) | 0.91 |
| Laboratory abnormalities | ||||||
| Hyperbilirubinemia | 5.16 (2.42–11.00) | 5.31 (2.74–10.28) | 0.96 | 5.31 (2.74–10.28) | 5.16 (2.42–11.00) | 0.96 |
| Increased AST | 1.65 (0.95–2.87) | 2.67 (1.17–6.07) | 0.34 | 2.67 (1.17–6.07) | 1.65 (0.95–2.87) | 0.34 |
| Increased ALT | 1.87 (0.87–4.01) | 3.20 (1.31–7.84) | 0.37 | 3.20 (1.31–7.84) | 1.87 (0.87–4.01) | 0.37 |
Note:
a
The RR of AEs and 95% CI were calculated with a random effects model.
Abbreviations: AE/s, adverse event/s; ALT, alanine aminotransferase; AST, aspartate aminotransferase; CRC, colorectal cancer; MKI, multikinase inhibitor; RR, relative risk.