PMID- 38102538
OWN - NLM
STAT- MEDLINE
DCOM- 20231218
LR  - 20231218
IS  - 1471-2407 (Electronic)
IS  - 1471-2407 (Linking)
VI  - 23
IP  - 1
DP  - 2023 Dec 15
TI  - Immune checkpoint inhibitors enhanced the antitumor efficacy of disitamab vedotin 
      for patients with HER2-positive or HER2-low advanced or metastatic gastric 
      cancer: a multicenter real-world study.
PG  - 1239
LID - 10.1186/s12885-023-11735-z [doi]
LID - 1239
AB  - BACKGROUND: Novel ADC drugs provide a new therapeutic strategy for gastric 
      cancer.The present study aimed to analyze the clinical efficacy and drug 
      toxicities of disitamab vedotin (RC48) plus immune checkpoint inhibitors(ICIs) 
      and RC48 as third-line therapies and beyond for advanced and metastatic gastric 
      cancer patients. METHODS: This was an observational multicenter real-world 
      study.From August 2021 to January 2022,patients with HER2-positive or HER2-low 
      advanced and metastatic gastric cancer and failed from two or more lines of prior 
      therapy were enrolled and treated with RC48 plus ICIs or RC48. In this study, 
      progression free survival(PFS) was the primary end point. Other evaluation 
      indicators were objective response rate(ORR),disease control rate(DCR),overall 
      survival(OS) and drug toxicities. RESULTS: 45 patients were enrolled,of which 25 
      patients received RC48 plus ICIs,20 patients received RC48.Patients who received 
      RC48 plus ICIs obtained better ORR (36.0% vs. 10.0%, P = 0.044) and DCR (80.0% 
      vs. 50.0%, P = 0.034) compared with RC48,and simultaneously,the median PFS in 
      RC48 plus ICIs group were superior to RC48 group(6.2 m vs. 3.9 m).The median OS 
      was not reached.No statistically differences were found between HER2-positive and 
      HER2-low group with respect to ORR (27.3% vs. 16.7%, P = 0.464),DCR (66.7% vs. 
      66.7%, P = 1.000),median PFS(5.7 m vs. 4.3 m, P = 0.299).The most common adverse 
      events (AEs) were decreased white blood count,decreased neutrophil 
      count,fatigue,hypoaesthesia and alopecia.Grade 3-4 AEs occurred in 7(35.0%) 
      patients of RC48 group and 10(40.0%) patients of RC48 plus ICIs 
      group,respectively. CONCLUSION: Compared with RC48 monotherapy, ICIs plus RC48 
      demonstrated superior third-line and beyond therapeutic efficacy for 
      HER2-positive or HER2-low advanced and metastatic gastric cancer patients with 
      manageable safety.
CI  - (c) 2023. The Author(s).
FAU - Nie, Caiyun
AU  - Nie C
AD  - Department of Medical Oncology, Affiliated Cancer Hospital of Zhengzhou 
      University, Henan Cancer Hospital, No. 127 Dongming Road, Jinshui District, 
      Zhengzhou City, 450008, Henan Province, China.
AD  - State Key Laboratory of Esophageal Cancer Prevention & Treatment, Zhengzhou 
      University, Zhengzhou, 450052, Henan Province, China.
AD  - Henan Engineering Research Center of Precision Therapy of Gastrointestinal 
      Cancer, Zhengzhou, 450008, Henan Province, China.
AD  - Zhengzhou Key Laboratory for Precision Therapy of Gastrointestinal Cancer, 
      Zhengzhou, 450008, Henan Province, China.
FAU - Xu, Weifeng
AU  - Xu W
AD  - Department of Medical Oncology, Affiliated Cancer Hospital of Zhengzhou 
      University, Henan Cancer Hospital, No. 127 Dongming Road, Jinshui District, 
      Zhengzhou City, 450008, Henan Province, China.
AD  - State Key Laboratory of Esophageal Cancer Prevention & Treatment, Zhengzhou 
      University, Zhengzhou, 450052, Henan Province, China.
AD  - Henan Engineering Research Center of Precision Therapy of Gastrointestinal 
      Cancer, Zhengzhou, 450008, Henan Province, China.
AD  - Zhengzhou Key Laboratory for Precision Therapy of Gastrointestinal Cancer, 
      Zhengzhou, 450008, Henan Province, China.
FAU - Guo, Yanwei
AU  - Guo Y
AD  - Department of Oncology, Fifth Affiliated Hospital of Zhengzhou University, 
      Zhengzhou, 450052, Henan Province, China.
FAU - Gao, Xiaohui
AU  - Gao X
AD  - Department of Oncology, First Affiliated Hospital of Henan University of Science 
      and Technology, Luoyang, 471003, Henan Province, China.
FAU - Lv, Huifang
AU  - Lv H
AD  - Department of Medical Oncology, Affiliated Cancer Hospital of Zhengzhou 
      University, Henan Cancer Hospital, No. 127 Dongming Road, Jinshui District, 
      Zhengzhou City, 450008, Henan Province, China.
AD  - State Key Laboratory of Esophageal Cancer Prevention & Treatment, Zhengzhou 
      University, Zhengzhou, 450052, Henan Province, China.
AD  - Henan Engineering Research Center of Precision Therapy of Gastrointestinal 
      Cancer, Zhengzhou, 450008, Henan Province, China.
AD  - Zhengzhou Key Laboratory for Precision Therapy of Gastrointestinal Cancer, 
      Zhengzhou, 450008, Henan Province, China.
FAU - Chen, Beibei
AU  - Chen B
AD  - Department of Medical Oncology, Affiliated Cancer Hospital of Zhengzhou 
      University, Henan Cancer Hospital, No. 127 Dongming Road, Jinshui District, 
      Zhengzhou City, 450008, Henan Province, China.
AD  - State Key Laboratory of Esophageal Cancer Prevention & Treatment, Zhengzhou 
      University, Zhengzhou, 450052, Henan Province, China.
AD  - Henan Engineering Research Center of Precision Therapy of Gastrointestinal 
      Cancer, Zhengzhou, 450008, Henan Province, China.
AD  - Zhengzhou Key Laboratory for Precision Therapy of Gastrointestinal Cancer, 
      Zhengzhou, 450008, Henan Province, China.
FAU - Wang, Jianzheng
AU  - Wang J
AD  - Department of Medical Oncology, Affiliated Cancer Hospital of Zhengzhou 
      University, Henan Cancer Hospital, No. 127 Dongming Road, Jinshui District, 
      Zhengzhou City, 450008, Henan Province, China.
AD  - State Key Laboratory of Esophageal Cancer Prevention & Treatment, Zhengzhou 
      University, Zhengzhou, 450052, Henan Province, China.
AD  - Henan Engineering Research Center of Precision Therapy of Gastrointestinal 
      Cancer, Zhengzhou, 450008, Henan Province, China.
AD  - Zhengzhou Key Laboratory for Precision Therapy of Gastrointestinal Cancer, 
      Zhengzhou, 450008, Henan Province, China.
FAU - Liu, Yingjun
AU  - Liu Y
AD  - Department of General Surgery, Affiliated Cancer Hospital of Zhengzhou 
      University, Henan Cancer Hospital, Zhengzhou, 450008, Henan Province, China.
FAU - Zhao, Jing
AU  - Zhao J
AD  - Department of Medical Oncology, Affiliated Cancer Hospital of Zhengzhou 
      University, Henan Cancer Hospital, No. 127 Dongming Road, Jinshui District, 
      Zhengzhou City, 450008, Henan Province, China.
AD  - State Key Laboratory of Esophageal Cancer Prevention & Treatment, Zhengzhou 
      University, Zhengzhou, 450052, Henan Province, China.
AD  - Henan Engineering Research Center of Precision Therapy of Gastrointestinal 
      Cancer, Zhengzhou, 450008, Henan Province, China.
AD  - Zhengzhou Key Laboratory for Precision Therapy of Gastrointestinal Cancer, 
      Zhengzhou, 450008, Henan Province, China.
FAU - Wang, Saiqi
AU  - Wang S
AD  - Department of Medical Oncology, Affiliated Cancer Hospital of Zhengzhou 
      University, Henan Cancer Hospital, No. 127 Dongming Road, Jinshui District, 
      Zhengzhou City, 450008, Henan Province, China.
AD  - State Key Laboratory of Esophageal Cancer Prevention & Treatment, Zhengzhou 
      University, Zhengzhou, 450052, Henan Province, China.
AD  - Henan Engineering Research Center of Precision Therapy of Gastrointestinal 
      Cancer, Zhengzhou, 450008, Henan Province, China.
AD  - Zhengzhou Key Laboratory for Precision Therapy of Gastrointestinal Cancer, 
      Zhengzhou, 450008, Henan Province, China.
FAU - He, Yunduan
AU  - He Y
AD  - Department of Medical Oncology, Affiliated Cancer Hospital of Zhengzhou 
      University, Henan Cancer Hospital, No. 127 Dongming Road, Jinshui District, 
      Zhengzhou City, 450008, Henan Province, China.
AD  - State Key Laboratory of Esophageal Cancer Prevention & Treatment, Zhengzhou 
      University, Zhengzhou, 450052, Henan Province, China.
AD  - Henan Engineering Research Center of Precision Therapy of Gastrointestinal 
      Cancer, Zhengzhou, 450008, Henan Province, China.
AD  - Zhengzhou Key Laboratory for Precision Therapy of Gastrointestinal Cancer, 
      Zhengzhou, 450008, Henan Province, China.
FAU - Chen, Xiaobing
AU  - Chen X
AD  - Department of Medical Oncology, Affiliated Cancer Hospital of Zhengzhou 
      University, Henan Cancer Hospital, No. 127 Dongming Road, Jinshui District, 
      Zhengzhou City, 450008, Henan Province, China. zlyychenxb0807@zzu.edu.cn.
AD  - State Key Laboratory of Esophageal Cancer Prevention & Treatment, Zhengzhou 
      University, Zhengzhou, 450052, Henan Province, China. zlyychenxb0807@zzu.edu.cn.
AD  - Henan Engineering Research Center of Precision Therapy of Gastrointestinal 
      Cancer, Zhengzhou, 450008, Henan Province, China. zlyychenxb0807@zzu.edu.cn.
AD  - Zhengzhou Key Laboratory for Precision Therapy of Gastrointestinal Cancer, 
      Zhengzhou, 450008, Henan Province, China. zlyychenxb0807@zzu.edu.cn.
LA  - eng
GR  - No. 212102310623. LHGJ20210172. 222102310424/Medical Science and Technique 
      Foundation of Henan Province/
GR  - No. 212102310623. LHGJ20210172. 222102310424/Medical Science and Technique 
      Foundation of Henan Province/
GR  - No. 204200510023/1000 Talents Program of Central plains/
GR  - No. YXKC2020008/Young and Middle-aged Health and Technology Innovation Leading 
      Talent Project of Henan Province/
GR  - No. YXKC2020008/Sate Key Laboratory of Esophageal Cancer Prevention & Treatment/
PT  - Journal Article
PT  - Multicenter Study
PT  - Observational Study
DEP - 20231215
PL  - England
TA  - BMC Cancer
JT  - BMC cancer
JID - 100967800
RN  - 0 (disitamab vedotin)
RN  - 0 (Immune Checkpoint Inhibitors)
SB  - IM
MH  - Humans
MH  - Immune Checkpoint Inhibitors
MH  - *Stomach Neoplasms/drug therapy
MH  - Alopecia
MH  - *Splenic Neoplasms
MH  - *Drug-Related Side Effects and Adverse Reactions
PMC - PMC10724908
OTO - NOTNLM
OT  - Antibody-drug conjugates drugs
OT  - Gastric cancer
OT  - HER2
OT  - Immunotherapy
OT  - RC48
COIS- The authors declare no competing interests.
EDAT- 2023/12/16 11:43
MHDA- 2023/12/18 06:42
PMCR- 2023/12/15
CRDT- 2023/12/15 23:49
PHST- 2023/09/27 00:00 [received]
PHST- 2023/12/09 00:00 [accepted]
PHST- 2023/12/18 06:42 [medline]
PHST- 2023/12/16 11:43 [pubmed]
PHST- 2023/12/15 23:49 [entrez]
PHST- 2023/12/15 00:00 [pmc-release]
AID - 10.1186/s12885-023-11735-z [pii]
AID - 11735 [pii]
AID - 10.1186/s12885-023-11735-z [doi]
PST - epublish
SO  - BMC Cancer. 2023 Dec 15;23(1):1239. doi: 10.1186/s12885-023-11735-z.