Table 2.
Univariate and multivariate analyzes of ORR
| Variable (Comparator) |
ORR | ||
| Univariarte analysis | Multivariate analysis | ||
| Response/ratio—ORR (%) (95% CI) | OR (95% CI); p value | aOR (95% CI); p value | |
| Baseline steroids | |||
| (No) | 293/715–41.0 (36.4 to 45.9) | ||
| Non-cancer indications | 20/50–40.0 (24.4 to 61.7) | 0.96 (0.53 to 1.72); p=0.8917 | 1.18 (0.65 to 2.17); p=0.5836 |
| Cancer indications | 48/195–24.6 (18.1 to 32.6) | 0.47 (0.32 to 0.67); p<0.0001 | 0.55 (0.38 to 0.81); p=0.0020 |
| Systemic antibiotics | |||
| (No) | 340/883–38.5 (34.5 to 42.8) | ||
| Prophylaxis | 5/29–17.2 (5.6 to 40.2) | 0.33 (0.12 to 0.88); p=0.0266 | 0.39 (0.14 to 1.05); p=0.0631 |
| Infection | 16/48–33.3 (19.1 to 54.1) | 0.79 (0.43 to 1.48); p=0.4735 | 0.89 (0.47 to 1.69); p=0.7314 |
| Gastric acid suppressant | |||
| (No) | 185/446–41.5 (35.7 to 47.9) | ||
| Prophylaxis | 146/422–34.6 (29.2 to 40.7) | 0.74 (0.56 to 0.97); p=0.0342 | 0.85 (0.64 to 1.14); p=0.3057 |
| Gastritis/GERD | 30/92–32.6 (22.0 to 46.5) | 0.68 (0.42 to 1.09); p=0.1135 | 0.75 (0.46 to 1.24); p=0.2750 |
| Gastric acid suppressant | |||
| (No) | 185/446–41.5 (35.7 to 47.9) | ||
| H2 antagonists | 19/51–37.3 (22.4 to 58.1) | 0.84 (0.46 to 1.53); p=0.5700 | 1.03 (0.55 to 1.93); p=0.9196 |
| Proton pump inhibitors | 157/463–33.9 (28.8 to 39.6) | 0.72 (0.55 to 0.95); p=0.0214 | 0.82 (0.62 to 1.09); p=0.1725 |
| Statins | |||
| (No) | 275/774–35.5 (31.4 to 39.9) | 1.56 (1.13 to 2.15); p=0.0070 | 1.60 (1.14 to 2.25); p=0.0064 |
| Yes | 86/186–46.2 (36.9 to 57.1) | ||
| Other lipid lowerings | |||
| (No) | 345/915–37.7 (33.9 to 41.9) | 1.22 (0.66–2.24); p=0.5130 | 1.11 (0.59 to 2.09); 0.7271 |
| Yes | 19/45–42.2 (25.4 to 65.9) | ||
| Aspirin | |||
| (No) | 281/780–36.0 (31.9 to 40.5) | 1.42 (1.02 to 1.97); p=0.0361 | 1.47 (1.04 to 2.08); 0.0267 |
| Yes | 80/180–44.4 (35.2 to 55.3) | ||
| Anticoagulants | |||
| (No) | 319/826–38.6 (34.5 to 43.1) | 0.72 (0.49 to 1.07); p=0.1078 | 0.79 (0.53 to 1.19); 0.2774 |
| Yes | 42/134–31.3 (22.6 to 42.3) | ||
| NSAIDs | |||
| (No) | 346/905–38.2 (34.3 to 42.4) | 0.61 (0.32 to 1.11); p=0.1064 | 0.64 (0.34 to 1.20); 0.1667 |
| Yes | 15/55–27.3 (15.2 to 44.9) | ||
| ACE inhibitors/ARBs | |||
| (No) | 235/666–35.3 (30.9 to 40.1) | 1.37 (1.04 to 1.82); p=0.0258 | 1.26 (0.93 to 1.71); p=0.1241 |
| Yes | 126/294–42.9 (35.7 to 51.0) | ||
| Calcium antagonist | |||
| (No) | 307/828–37.1 (33.0 to 41.5) | 1.17 (0.81 to 1.71); p=0.3990 | 1.07 (0.72 to 1.59); p=0.7188 |
| Yes | 54/132–40.9 (30.7 to 53.4) | ||
| β-blockers* | |||
| (No) | 293/794–36.9 (32.8 to 41.4) | 1.71 (1.14 to 2.56); p=0.0092 | 1.76 (1.16 to 2.69); p=0.0080 |
| Yes | 54/108–50.0 (37.5 to 65.2) | ||
| Metformin | |||
| (No) | 318/849–37.5 (33.4 to 41.8) | 1.06 (0.70 to 1.58); p=0.7930 | 1.02 (0.67 to 1.56); p=0.9081 |
| Yes | 43/111–38.7 (28.0 to 52.2) | ||
| Other oral antidiabetics | |||
| (No) | 342/919–37.2 (33.3 to 41.4) | 1.45 (0.77 to 2.73); p=0.2402 | 1.34 (0.69 to 2.8); p=0.3808 |
| Yes | 19/41–46.3 (27.9 to 72.3) | ||
| Opioids† | |||
| (No) | 317/822–38.6 (34.4 to 43.1) | 0.75 (0.43 to 1.33); p=0.3325 | 0.90 (0.49 to 1.63); p=0.7325 |
| Yes | 19/59–32.2 (19.4 to 50.3) | ||
| Primary tumor | – | ||
| (NSCLC) | 160/491–32.6 (27.8 to 38.1) | ||
| Melanoma | 114/254–44.9 (37.0 to 53.9) | 1.68 (1.23 to 2.29); 0.0010 | |
| Kidney | 74/180–41.1 (32.3 to 51.6) | 1.44 (1.02 to 2.05); 0.0406 | |
| Others | 13/35–37.1 (19.7 to 63.5) | 1.22 (0.60 to 2.49); 0.5799 | |
| BMI | – | ||
| (Normal weight) | 12/36–33.3 (17.2 to 58.2) | ||
| Underweight | 167/435–38.4 (32.8 to 44.7) | 0.83 (0.41 to 1.67); 0.6038 | |
| Overweight | 128/352–36.3 (30.3 to 43.2) | 0.91 (0.68 to 1.22); 0.5226 | |
| Obese | 54/136–39.7 (29.8 to 51.8) | 1.03 (0.69 to 1.53); 0.8709 | |
| Gender | – | ||
| (Female) | 128/348–36.8 (30.7 to 43.7) | 1.06 (0.81 to 1.39); p=0.6638 | |
| Male | 233/612–38.1 (33.3 to 43.3) | ||
| Age | – | ||
| (Non-elderly) | 190/535–35.5 (30.6 to 40.9) | 1.22 (0.94 to 1.59); p=0.1338 | |
| Elderly | 171/425–40.2 (34.5 to 46.7) | ||
| Treatment line | – | ||
| (First) | 181/373–48.5 (41.7 to 56.1) | 0.46 (0.39 to 0.61); p<0.0001 | |
| Non-first | 180/587–30.7 (26.3 to 35.5) | ||
| No of metastatic sites | – | ||
| (≤2) | 203/503–40.4 (35.0 to 46.3) | 0.78 (0.60 to 1.01); p=0.0648 | |
| >2 | 158/457–34.6 (29.4 to 40.4) | ||
| ECOG PS | – | ||
| (0–1) | 322/828–38.9 (34.8 to 43.4) | 0.66 (0.44 to 0.98); p=0.0406 | |
| ≥2 | 39/132–29.5 (21.0 to 40.4) | ||
At the multivariate analysis, each drug category was adjusted for the preplanned key covariates separately.
*Available for 902 patients.
†Available for 881 patients.
ARBs, AngiotensinII receptor blockers; BMI, body mass index; ECOG-PS, Eastern Cooperative Oncology Group-Performance Status; GERD, gastroesophageal reflux disease; NSCLC, non-small cell lung cancer; ORR, objective response rate.