PMID- 30774373
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20220331
IS  - 1178-6930 (Print)
IS  - 1178-6930 (Electronic)
IS  - 1178-6930 (Linking)
VI  - 12
DP  - 2019
TI  - Efficacy and safety of nivolumab for metastatic biliary tract cancer.
PG  - 861-867
LID - 10.2147/OTT.S195537 [doi]
AB  - OBJECTIVE: PD-1 inhibitors have improved efficacy in many cancers. There are 
      currently no reports of the use of PD-1 inhibitors, such as nivolumab, for 
      metastatic biliary tract cancer (mBTC). This study reviewed the efficacy and 
      safety of nivolumab for mBTC with the aim of exploring ways to improve efficacy 
      and survival. METHODS: Thirty patients with mBTC were voluntarily treated with 
      nivolumab at the PLA General Hospital. Nivolumab 3 mg/kg was administered. 
      Progression-free survival (PFS) and overall survival were evaluated by 
      Kaplan-Meier and univariate and multivariate analyses were carried out for 
      clinical characteristics. Objective response rate (ORR), disease control rate 
      (DCR), and treatment-related adverse events (AEs) were also evaluated. RESULTS: 
      The median treatment cycle is four cycles. One case was complete response, 5 
      cases partial response, 12 cases stable, and 12 cases progression. ORR was 20%, 
      DCR was 60%, and PFS was 3.1 months (95% CI: 2.13-4.06). The AEs of nivolumab 
      monotherapy were fatigue (three cases), fever (two cases), hypothyroidism (one 
      case), skin reaction (one case), and liver injury (one case). Nivolumab combined 
      with chemotherapy related grade 1-2 hematologic toxicity were leukopenia (five 
      cases) and thrombocytopenia (two cases), and grade 3-4 were leukopenia (three 
      cases). Non-hematologic toxicity grade 1-2 were nausea and vomiting (four cases), 
      fatigue (four cases), fever (three cases), peripheral neurotoxicity (three 
      cases), and hypothyroidism (one case). Univariate analysis showed that PFS of 
      nivolumab combined with chemotherapy was statistically significant compared with 
      that of nivolumab monotherapy (4.1 vs 2.3 months, P=0.031). Programmed 
      death-ligand 1 (PD-L1) expression positively has no relationship with better PFS 
      in contrast with PD-L1 negatively (3.6 vs 3.0 months P>0.05). Multivariate 
      analysis show nivolumab combined with chemotherapy was only the independent 
      factor for longer PFS (HR: 0.432, P<0.05). CONCLUSION: The safety of nivolumab in 
      mBTC is controllable. Further selection of superior populations is needed to 
      improve the efficacy of nivolumab in mBTC.
FAU - Gou, Miaomiao
AU  - Gou M
AD  - Department of Medical Oncology, Chinese People's Liberation Army General 
      Hospital, Beijing 100853, People's Republic of China, daigh60@sohu.com.
FAU - Zhang, Yong
AU  - Zhang Y
AD  - Department of Medical Oncology, Chinese People's Liberation Army General 
      Hospital, Beijing 100853, People's Republic of China, daigh60@sohu.com.
FAU - Si, Haiyan
AU  - Si H
AD  - Department of Medical Oncology, Chinese People's Liberation Army General 
      Hospital, Beijing 100853, People's Republic of China, daigh60@sohu.com.
FAU - Dai, Guanghai
AU  - Dai G
AD  - Department of Medical Oncology, Chinese People's Liberation Army General 
      Hospital, Beijing 100853, People's Republic of China, daigh60@sohu.com.
LA  - eng
PT  - Journal Article
DEP - 20190125
PL  - New Zealand
TA  - Onco Targets Ther
JT  - OncoTargets and therapy
JID - 101514322
PMC - PMC6355165
OTO - NOTNLM
OT  - PD-1
OT  - PD-L1
OT  - metastatic biliary tract cancer
OT  - nivolumab
COIS- Disclosure The authors report no conflicts of interest in this work.
EDAT- 2019/02/19 06:00
MHDA- 2019/02/19 06:01
PMCR- 2019/01/25
CRDT- 2019/02/19 06:00
PHST- 2019/02/19 06:00 [entrez]
PHST- 2019/02/19 06:00 [pubmed]
PHST- 2019/02/19 06:01 [medline]
PHST- 2019/01/25 00:00 [pmc-release]
AID - ott-12-861 [pii]
AID - 10.2147/OTT.S195537 [doi]
PST - epublish
SO  - Onco Targets Ther. 2019 Jan 25;12:861-867. doi: 10.2147/OTT.S195537. eCollection 
      2019.