Parameters | Nivolumab + chemotherapy | Chemotherapy alone | Reference | Distribution |
---|---|---|---|---|
Survival data | Â | |||
OS (HR), PD-L1 CPS > = 5 | 0.71 (95% CI:0.59–0.86) | - | [10] | - |
PFS (HR), PD-L1 CPS > = 5 | 0.68 (95% CI: 0.56–0.81) | - | [10] | - |
Median OS (months), PD-L1 CPS > = 5 | 14.4 (95% CI: 13.1–16.2) | 11.1 (95% CI: 10.0-12.1) | [10] | - |
Median PFS (months), PD-L1 CPS > = 5 | 7.7 (95% CI: 7.0-9.2) | 6.0 (95% CI: 5.6–6.9) | [10] | - |
OS (HR), All randomized | 0.80 (95% CI:0.68–0.94) | - | [10] | - |
PFS (HR), All randomized | 0.77 (95% CI: 0.68–0.87) | - | [10] | - |
Median OS (months), All randomized | 13.8 (95% CI: 12.6–14.6) | 11.6 (95% CI: 10.9–12.5) | [10] | - |
Median PFS (months), All randomized | 7.7 (95% CI: 7.1–8.5) | 6.9 (95% CI: 6.6–7.1) | [10] | - |
Grade 3 or 4 AEs, n (%) | Â | |||
Nausea | 20 (3%) | 19 (2%) | [10] | Beta |
Diarrhea | 35 (4%) | 24 (3%) | [10] | Beta |
Peripheral neuropathy | 31 (4%) | 22 (3%) | [10] | Beta |
Vomiting | 17 (2%) | 24 (3%) | [10] | Beta |
Fatigue | 30 (4%) | 16 (2%) | [10] | Beta |
Anemia | 47 (6%) | 21 (3%) | [10] | Beta |
Decreased appetite | 14 (2%) | 13 (2%) | [10] | Beta |
Thrombocytopenia | 19 (2%) | 13 (2%) | [10] | Beta |
Platelet count decreased | 20 (3%) | 19 (2%) | [10] | Beta |
Peripheral sensory neuropathy | 16 (2%) | 14 (2%) | [10] | Beta |
Aspartate aminotransferase increased | 12 (2%) | 5 (1%) | [10] | Beta |
White blood cell count decreased | 23 (3%) | 13 (2%) | [10] | Beta |
Alanine aminotransferase increased | 6 (1%) | 5 (1%) | [10] | Beta |
Palmar-plantar erythrodysesthesia syndrome | 11 (1%) | 6 (1%) | [10] | Beta |
Neutrophil count decreased | 83 (11%) | 67 (8%) | [10] | Beta |
Neutropenia | 118 (15%) | 93 (12%) | [10] | Beta |
Asthenia | 7 (1%) | 10 (1%) | [10] | Beta |
Lipase increased | 45 (6%) | 16 (2%) | [10] | Beta |
Utility (Range) | Â | |||
PFS | 0.797 (0.638–0.956) | 0.797 (0.638–0.956) | [14] | Beta |
PD | 0.577 (0.462–0.692) | 0.577 (0.462–0.692) | [14] | Beta |
Death | 0 | 0 | [14] | Beta |