Table 2.
Baseline characteristics of included studies comparing nivolumab to other drugs
| Study | Year | Country | Study type | Treatment arms | Indication | Fatiguea | Headachea | Dysgeusiaa | Vertigoa | Paresthesiaa | Anxiety malaisea | Peripheral neuropathya |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Robert et al12 | 2015 | France | Phase III | Arm A: nivolumab 3 mg/kg of body weight every 2 weeks (206 pts) Arm B: dacarbazine (205 pts) |
Stage III or IV unresectable melanoma without a BRAF mutation | 41 (20%) versus 30 (14.6%) | 9 (4.4%) versus 14 (6.8%) | 6 (2.9%) versus 2 (1%) | 2 (1%) versus 5 (2.4%) | 2 (1%) versus 7 (3.4%) | 1 (0.5%) versus 4 (2%) | – |
| Weber et al13 | 2015 | USA | Phase III | Arm A: nivolumab 3 mg/kg of body weight every 2 weeks (268 pts) Arm B: investigator choice chemotherapy (102 pts) |
Patients with advanced melanoma who progressed after anti-CTLA-4 treatment | 67 (25%) versus 35 (34%) | – | – | – | – | – | – |
| Larkin et al10 | 2015 | USA | Phase III | 945 patients were randomized in a 1:1:1 fashion into: 1) nivolumab 3 mg/kg combined with placebo (316 pts) 2) ipilimumab (3 mg/kg) combined with nivolumab (1 mg/kg) (314 pts) 3) ipilimumab (3 mg/kg) combined with placebo (315 pts) |
Advanced melanoma | 107 (34.2%) versus 87 (28%) | 23 (7.3%) versus 24 (7.7%) | – | – | – | – | – |
| Borghaei et al8 | 2015 | USA | Phase III | Arm A: nivolumab 3 mg/kg of body weight every 2 weeks (292 pts) Arm B: docetaxel (290 pts) |
Advanced non-squamous cell NSCLC | 91 (32%) versus 102 (38%) | 29 (10%) versus 32 (12%) | 7 (2%) versus 27 (10%) | 25 (9%) versus 24 (9%) | 12 (4%) versus 23 (9%) | 16 (6%) versus 5 (2%) | 9 (3%) versus 25 (9%) |
| Brahmer et al9 | 2015 | USA | Phase III | Arm A: nivolumab 3 mg/kg of body weight every 2 weeks (131 pts) Arm B: docetaxel (129 pts) |
Advanced squamous cell NSCLC | 21 (16%) versus 42 (33%) | – | – | 2 (2%) versus 7 (5%) | 2 (2%) versus 7 (5%) | – | 1 (1%) versus 15 (12%) |
| Motzer et al11 | 2015 | USA | Phase III | 821 patients were randomly assigned (in a 1:1 ratio) to receive 3 mg of nivolumab per kilogram of body weight intravenously every 2 weeks or a 10 mg everolimus tablet orally once daily | Advanced clear-cell renal cell carcinoma for which they had received previous treatment with 1 or 2 regimens of antiangiogenic therapy | 134 (33%) versus 134 (34%) | – | 11 (3%) versus 51 (13%) | – | – | – | – |
Notes:
a
Data presented as number of patients with versus number of patients without.
Abbreviations: pts, patients; BRAF, B-Raf; CTLA-4, cytotoxic T lymphocyte antigen-4; NSCLC, non-small-cell lung cancer.