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. 2016 Mar 4;10(3):183–193. doi: 10.1177/1753465816636557

Table 1.

Baseline characteristics of included studies comparing immune checkpoint inhibitors to non immune checkpoint inhibitors.

Study Study type Treatment arms Indication All-grade (grades 1–4) pneumonitis High-grade (grades 3–4) pneumonitis
1. Ipilimumab studies
Kwon et al. [2014] Phase III Arm A: ipilimumab 10 mg/kg (393 pts)
Arm B: placebo (396 pts)
Metastatic castration-resistant prostate cancer 5 (1.3%) versus 0 1 (0.3%) versus 0
2. Nivolumab studies
Robert et al. [2015a] 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. 3 (1.5%) versus 0 0 versus 0
Weber et al. [2015] 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 5 (1.9%) versus 0 0 versus 0
Brahmer et al. [2015] 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 6 (5%) versus 0 0 versus 0
Borghaei et al. [2015] 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 8 (3%) versus 1 (<1%) 3 (1%) versus 1 (<1%)
Motzer et al. [2015] 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 one or two regimens of antiangiogenic therapy 16 (4%) versus 58 (15%) 6 (1%) versus 11 (3%)
3. Pembrolizumab studies
Ribas et al. [2015] Randomized phase II Arm A: pembrolizumab (low dose 2 mg/kg): 179 pts
Arm B: pembrolizumab (high dose 10 mg/kg):178 pts
Arm C: chemotherapy control: 171 pts
Ipilimumab-refractory advanced melanoma 3 (2%) versus 3(2%) versus 0 0 versus 2(1%) versus 0
Herbst et al. [2015] Randomized phase II/III study Arm A: pembrolizumab (low dose 2 mg/kg): 344 pts
Arm B: pembrolizumab (high dose3 mg/kg ):346 pts
Arm C: Docetaxel: 343 pts
Previously treated NSCLC with PD-L1>1% 16 (5%) versus 15 (4%) versus 6 (2%) 7 (2%) versus 7 (2%) versus 2 (1%)

CTLA-4, cytotoxic T lymphocyte antigen-4; NSCLC, non-small cell lung cancer; PD-L1, programmed death ligand 1; pts, patients.