PMID- 33042628
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20201013
IS  - 2156-6976 (Print)
IS  - 2156-6976 (Electronic)
IS  - 2156-6976 (Linking)
VI  - 10
IP  - 9
DP  - 2020
TI  - Anti-PD-1 antibody SHR-1210 plus apatinib for metastatic colorectal cancer: a 
      prospective, single-arm, open-label, phase II trial.
PG  - 2946-2954
AB  - In the REGONIVO study, regorafenib combined with nivolumab was effective in the 
      treatment of microsatellite stable (MSS) metastatic colorectal cancer (mCRC), 
      which indicated anti-angiogenic drugs may enhance the efficacy of immune 
      checkpoint inhibitors. Therefore, we designed a single-arm, single-center, 
      open-label, phase II trial to determine the toxicity and efficacy of SHR-1210 (an 
      anti-PD-1 antibody) plus apatinib in MSS mCRC. The sample size was estimated 
      using a Simon Optimum two-stage design. 10 patients were included at the first 
      stage and if one effective patient observed, an additional 19 patients would be 
      added. Patients with MSS mCRC who refractory to second-line treatment or 
      intolerant to standard treatment were given SHR-1210 200 mg every 2 weeks and 
      apatinib 250-375 mg once daily until unacceptable toxicity or disease progression 
      occurred. In our study, the objective response rate was 0% and the disease 
      control rate was 22.2%. The median progression-free survival was 1.83 months (95% 
      confidence interval (CI) 1.80-1.86 months), and the median overall survival was 
      7.80 months (95% CI 0-17.07). Treatment-related adverse events (AEs) occurred in 
      all patients (100%). The most common treatment-related AEs were hypertension and 
      proteinuria (70% each). Grade 3 AEs were observed in nine patients (9/10, 90%), 
      and the commonest was hypertension (30%). In conclusion, SHR-1210 combined with 
      apatinib has failed to improve the efficacy of treatment of MSS mCRC, and the 
      intolerable toxicity may be the leading cause.
CI  - AJCR Copyright (c) 2020.
FAU - Ren, Chao
AU  - Ren C
AD  - Department of Medical Oncology, State Key Laboratory of Oncology in South China, 
      Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University 
      Cancer Center Guangzhou 510060, China.
FAU - Mai, Zong-Jiong
AU  - Mai ZJ
AD  - Department of Medical Oncology, State Key Laboratory of Oncology in South China, 
      Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University 
      Cancer Center Guangzhou 510060, China.
FAU - Jin, Ying
AU  - Jin Y
AD  - Department of Medical Oncology, State Key Laboratory of Oncology in South China, 
      Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University 
      Cancer Center Guangzhou 510060, China.
FAU - He, Ming-Ming
AU  - He MM
AD  - Department of Medical Oncology, State Key Laboratory of Oncology in South China, 
      Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University 
      Cancer Center Guangzhou 510060, China.
FAU - Wang, Zhi-Qiang
AU  - Wang ZQ
AD  - Department of Medical Oncology, State Key Laboratory of Oncology in South China, 
      Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University 
      Cancer Center Guangzhou 510060, China.
FAU - Luo, Hui-Yan
AU  - Luo HY
AD  - Department of Medical Oncology, State Key Laboratory of Oncology in South China, 
      Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University 
      Cancer Center Guangzhou 510060, China.
FAU - Zhang, Dong-Sheng
AU  - Zhang DS
AD  - Department of Medical Oncology, State Key Laboratory of Oncology in South China, 
      Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University 
      Cancer Center Guangzhou 510060, China.
FAU - Wu, Chen-Yi
AU  - Wu CY
AD  - Department of Medical Oncology, State Key Laboratory of Oncology in South China, 
      Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University 
      Cancer Center Guangzhou 510060, China.
FAU - Wang, Feng
AU  - Wang F
AD  - Department of Medical Oncology, State Key Laboratory of Oncology in South China, 
      Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University 
      Cancer Center Guangzhou 510060, China.
FAU - Xu, Rui-Hua
AU  - Xu RH
AD  - Department of Medical Oncology, State Key Laboratory of Oncology in South China, 
      Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University 
      Cancer Center Guangzhou 510060, China.
LA  - eng
PT  - Journal Article
DEP - 20200901
PL  - United States
TA  - Am J Cancer Res
JT  - American journal of cancer research
JID - 101549944
PMC - PMC7539766
OTO - NOTNLM
OT  - Apatinib
OT  - SHR-1210
OT  - immunotherapy
OT  - metastatic colorectal cancer
OT  - microsatellite stable
COIS- None.
EDAT- 2020/10/13 06:00
MHDA- 2020/10/13 06:01
PMCR- 2020/09/01
CRDT- 2020/10/12 05:31
PHST- 2020/06/08 00:00 [received]
PHST- 2020/06/27 00:00 [accepted]
PHST- 2020/10/12 05:31 [entrez]
PHST- 2020/10/13 06:00 [pubmed]
PHST- 2020/10/13 06:01 [medline]
PHST- 2020/09/01 00:00 [pmc-release]
PST - epublish
SO  - Am J Cancer Res. 2020 Sep 1;10(9):2946-2954. eCollection 2020.