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. 2018 Mar 23;7(5):1642–1659. doi: 10.1002/cam4.1387

Table 7.

Subgroup analysis of modified objective response rate (ORR) and grade 3–4 adverse effects rate (grade 3–4 AEs%) of nivolumab in non‐small‐cell lung cancer (NSCLC) patients

Group ORR Grade 3–4 AEs%
No. of studies ES (95% CI) P heterogeneity I 2 (%) No. of studies ES (95% CI) P heterogeneity I 2 (%)
Total 13 18% (15–20%) 0.235 20.6 13 12% (9–16%) <0.001 89.1
Study design
Randomized open‐label study 2 19% (16–23%) 0.374 0.0 3 12% (6–18%) 0.002 84.0
Noncomparative open‐label cohort study 11 17% (15–20%) 0.192 26.4 10 13% (8–17%) <0.001 88.7
Medication type
Nivolumab 10 17% (15–19%) 0.352 9.9 12 12% (8–16%) <0.001 89.4
Nivolumab with other drugsa 3 22% (13–31%) 0.183 41.4 1 25% (10–40%) NR NR
Program subgroup
Subgroupb therapy 5 19% (15–24%) 0.356 8.9 2 17% (7–27%) 0.176 45.3
No subgroup therapy 8 17% (15–19%) 0.195 29.2 11 12% (8–16%) <0.001 89.8
Region
North America 12 18% (15–20%) 0.185 26.4 11 14% (9–19%) <0.001 90.7
Europe 1 18% (14–22%) NR NR 2 5% (3–8%) 0.949 0.0
Study phase
I 7 18% (14–22%) 0.199 30.1 4 14% (3–24%) <0.001 84.6
II 3 16% (10–21%) 0.145 48.3 4 17% (13–21%) 0.638 0.0
III 3 19% (16–22%) 0.872 0.0 5 9% (5–13%) <0.001 84.6
Histology
Squamous 4 16% (13–20%) 0.231 30.2 4 10% (5–16%) 0.001 81.3
Nonsquamous 1 19% (15–24%) NR NR 2 16% (4–27%) 0.018 82.2
Mixed histologyc 8 19% (15–22%) 0.203 28.3 7 13% (6–20%) <0.001 92.1

ES, Effect size (main outcome such as ORR or Grade 3–4 AEs% with corrected standard deviation); NR, no relevant statistic data.

a

Ipilimumab, bevacizumab, platinum‐based doublet chemotherapy (gemcitabine, cisplatin, pemetrexed, carboplatin, paclitaxel).

b

The study contained different nivolumab therapy strategy of various dosage and duration et al.

c

Squamous, nonsquamous, adenocarcinoma, unknown types etc.