Safety and efficacy of nivolumab in the treatment of cancers: A meta-analysis of 27 prospective clinical trials.
Immune checkpoint inhibition therapy has benefited people and shown powerful anti-tumor activity during the past several years. Nivolumab, a fully human IgG4 monoclonal antibody against PD-1, is a widely studied immune checkpoint inhibitor for the treatment of cancers. To assess the safety and efficacy of nivolumab, 27 clinical trials on nivolumab were analyzed. Results showed that the summary risks of all grade adverse effects (AEs) and grade ≥3 AEs were 0.65 and 0.12. The rate of nivolumab-related death was 0.25%. The most common any grade AEs were fatigue (25.1%), rush (13.0%), pruritus (12.5%), diarrhea (12.1%), nausea (11.8%) and asthenia (10.4%). The most common grade ≥3 AEs were hypophosphatemia (only 2.3%) and lymphopenia (only 2.1%). The pooled objective response rate (ORR), 6-month progression-free survival (PFS) rate and 1-year overall survival (OS) rate were 0.26, 0.40 and 0.52, respectively. The odds ratio of ORR between PD-L1 positive and negative was 2.34 (95% CI 1.77-3.10, p < 0.0001). The odds ratios of ORR, 6-month PFS rate and 1-year OS rate between nivolumab and chemotherapeutics were 2.77 (95% CI 1.69-4.56, p < 0.0001), 1.97 (95% CI 1.02-3.81, p = 0.04) and 1.87 (95% CI 1.46-2.40, p <0.0001), respectively. In conclusion, nivolumab has durable outcomes with tolerable AEs and drug-related deaths in cancer patients. Nivolumab monotherapy has better treatment response compared with chemotherapy, whereas chemotherapeutics have significantly higher risk of adverse effects than nivolumab.
State Key Laboratory of Biotherapy and Cancer Center, West China Hospital, West China Medical School Sichuan University, Chengdu, China.|Collaborative Innovation Center of Biotherapy, West China Hospital, West China Medical School Sichuan University, Chengdu, China.
Yan
Y
Tie
State Key Laboratory of Biotherapy and Cancer Center, West China Hospital, West China Medical School Sichuan University, Chengdu, China.|Collaborative Innovation Center of Biotherapy, West China Hospital, West China Medical School Sichuan University, Chengdu, China.
Xuelei
X
Ma
West China Medical School, West China Hospital, Sichuan University, Chengdu, China.
Chenjing
C
Zhu
State Key Laboratory of Biotherapy and Cancer Center, West China Hospital, West China Medical School Sichuan University, Chengdu, China.|Collaborative Innovation Center of Biotherapy, West China Hospital, West China Medical School Sichuan University, Chengdu, China.
Ye
Y
Mao
West China Medical School, West China Hospital, Sichuan University, Chengdu, China.
Kai
K
Shen
Department of Gerontology, West China Hospital, Sichuan University, Chengdu, China.
Xiawei
X
Wei
Department of Gerontology, West China Hospital, Sichuan University, Chengdu, China.
Yan
Y
Chen
Department of Gynaecology, West China Second Hospital, Sichuan University, Chengdu, China.
Heng
H
Zheng
D000911:Antibodies, Monoclonal / Q000009:adverse effects / Q000627:therapeutic use*; D000970:Antineoplastic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use; D002986:Clinical Trials as Topic / Q000706:statistics & numerical data*; D018572:Disease-Free Survival; D003875:Drug Eruptions / Q000209:etiology; D005260:Female; D005767:Gastrointestinal Diseases / Q000139:chemically induced; D006402:Hematologic Diseases / Q000139:chemically induced; D006801:Humans; D017674:Hypophosphatemia / Q000139:chemically induced; D058990:Molecular Targeted Therapy / Q000009:adverse effects; D009363:Neoplasm Proteins / Q000037:antagonists & inhibitors; D009369:Neoplasms / Q000188:drug therapy*; D000077594:Nivolumab; D061026:Programmed Cell Death 1 Receptor / Q000037:antagonists & inhibitors; D011446:Prospective Studies
D000911:Antibodies, Monoclonal; D000970:Antineoplastic Agents; D009363:Neoplasm Proteins; C105992:PDCD1 protein, human; D061026:Programmed Cell Death 1 Receptor; D000077594:Nivolumab
efficacy; meta-analysis; nivolumab; safety