Table 2.
Logistic regression analysis * of association between pre-treatment characteristics and grade ≥3 diarrhea with afatinib.
| Baseline Characteristics | Univariate Analysis * | Multivariable Analysis * | |||||
|---|---|---|---|---|---|---|---|
| Events/N (%) | OR | 95% CI | p | OR | 95% CI | p | |
| Sex | <0.001 | <0.001 | |||||
| Male | 44/443 (10%) | 1.00 | 1.00 | ||||
| Female | 140/708 (20%) | 2.22 | 1.53–3.21 | 2.04 | 1.36–3.07 | ||
| Age (years) | <0.001 | 0.008 | |||||
| 27–49 | 21/237 (9%) | 1.00 | 1.00 | ||||
| 50–59 | 40/319 (13%) | 1.44 | 0.82–2.53 | 1.38 | 0.78–2.47 | ||
| 60–69 | 78/373 (21%) | 2.57 | 1.52–4.33 | 2.32 | 1.35–4.00 | ||
| 70–86 | 45/222 (20%) | 2.24 | 1.27–3.96 | 1.97 | 1.08–3.61 | ||
| Race † | 0.080 | 0.079 | |||||
| Asian | 121/839 (14%) | 1.00 | 1.00 | ||||
| Non-Asian | 63/312 (20%) | 1.45 | 0.96–2.20 | 1.49 | 0.96–2.32 | ||
| Weight (kg) | <0.001 | 0.003 | |||||
| ≥50 | 138/977 (14%) | 1.00 | 1.00 | ||||
| 45–49 | 22/102 (22%) | 1.60 | 0.94–2.71 | 1.51 | 0.85–2.65 | ||
| 40–44 | 16/56 (29%) | 2.11 | 1.12–3.99 | 1.98 | 1.00–3.93 | ||
| <40 | 8/13 (62%) | 8.81 | 2.72–28.5 | 7.93 | 2.32–27.1 | ||
| BMI (kg/m2) | 0.002 | ||||||
| ≥18.5 | 157/1063 (15%) | 1.00 | |||||
| 17.0–18.4 | 13/58 (22%) | 1.50 | 0.77–2.93 | ||||
| 16.0–16.9 | 7/14 (50%) | 5.11 | 1.68–15.5 | ||||
| <16.0 | 4/6 (67%) | 10.2 | 1.66–62.5 | ||||
| BSA (m2) | <0.001 | ||||||
| ≥1.50 | 121/898 (13%) | 1.00 | |||||
| 1.40–1.49 | 32/155 (21%) | 1.65 | 1.05–2.60 | ||||
| 1.30–1.39 | 18/70 (26%) | 2.13 | 1.17–3.86 | ||||
| <1.30 | 9/17 (53%) | 5.46 | 1.95–15.3 | ||||
| eGFR (mL/min/1.73 m2) | 0.066 | 0.248 | |||||
| ≥90 | 74/591 (13%) | 1.00 | 1.00 | ||||
| 60–89 | 92/478 (19%) | 1.54 | 1.09–2.19 | 1.46 | 1.00–2.12 | ||
| 45–59 | 14/64 (22%) | 1.60 | 0.82–3.12 | 1.27 | 0.63–2.57 | ||
| <45 | 4/13 (31%) | 2.17 | 0.63–7.46 | 1.72 | 0.48–6.16 | ||
| ECOG PS | 0.460 | 0.306 | |||||
| 0 | 71/385 (18%) | 1.00 | 1.00 | ||||
| 1–2 | 113/766 (15%) | 0.88 | 0.62–1.24 | 0.82 | 0.57–1.19 | ||
| Hemoglobin (g/L) | 0.061 | 0.600 | |||||
| 75–117 | 56/294 (19%) | 1.00 | 1.00 | ||||
| 118–128 | 55/288 (19%) | 1.07 | 0.70–1.64 | 1.03 | 0.66–1.61 | ||
| 129–138 | 38/281 (14%) | 0.69 | 0.43–1.09 | 0.76 | 0.47–1.23 | ||
| 139–185 | 34/283 (12%) | 0.63 | 0.39–1.02 | 0.91 | 0.54–1.53 | ||
BMI: body mass index; BSA: body surface area; CI: confidence interval; ECOG PS: Eastern Cooperative Oncology Group performance status; eGFR: estimated glomerular filtration rate; N: number of patients; OR: odds ratio; * All logistic regression models were adjusted for any between-study differences in diarrhea incidence. † Limited to subset of studies (LUX-Lung 1, 2, and 3) that have within-study race differences.