PMID- 37675621
OWN - NLM
STAT- MEDLINE
DCOM- 20231027
LR  - 20231028
IS  - 1759-7714 (Electronic)
IS  - 1759-7706 (Print)
IS  - 1759-7706 (Linking)
VI  - 14
IP  - 30
DP  - 2023 Oct
TI  - Effectiveness and safety of human type 5 recombinant adenovirus (H101) in 
      malignant tumor with malignant pleural effusion and ascites: A multicenter, 
      observational, real-world study.
PG  - 3051-3057
LID - 10.1111/1759-7714.15101 [doi]
AB  - BACKGROUND: The aim of this study was to analyze the effectiveness and safety of 
      H101 in Chinese patients with malignant pleural effusion and ascites (MPE/MA) in 
      the real world. METHODS: This multicenter, observational, real-world study 
      recruited patients with MPE/MA caused by malignant tumor receiving 
      H101-containing treatment between January 2020 and June 2022. Effectiveness was 
      evaluated by overall remission rate (ORR), and safety was evaluated based on 
      adverse events (AEs). Subgroup analysis was performed on patients grouped 
      according to tumor type, the volume of MPE and MA, and dosage of H101. RESULTS: A 
      total of 643 eligible patients were enrolled, and 467 received H101 monotherapy 
      and 176 received H101 combined with chemotherapy. The ORR of total patients 
      was60.3% with 388 case of PR. In the H101 monotherapy group, the decrease of MPE 
      or MA was achieved in 282 (60.4%, PR) patients, 176 (37.7%, NC) patients showed 
      no change in volume of MPE or MA, and nine (1.9%, PD) patients showed an 
      increase, yielding an ORR of 60.4% (282/467). The ORR for the combination therapy 
      group was 60.2% (106/176), with 106 cases of PR, 69 cases of NC and one case of 
      PD. Subgroup analyses based on tumor type, volume of MPE and MA, and dosage of 
      H101 all showed high ORR, approximately 60%. The main AEs associated with 
      H101-containing regimens were fever, nausea and vomiting. No serious AEs occurred 
      in both groups. CONCLUSION: Encouraging clinical benefits and manageable toxicity 
      of H101 against MPE/MA were preliminarily observed in the real-world clinical 
      setting, indicating that the H101-containing regimen is reliable, safe, and 
      feasible, providing a novel and effective option for the treatment of this 
      disease.
CI  - (c) 2023 The Authors. Thoracic Cancer published by China Lung Oncology Group and 
      John Wiley & Sons Australia, Ltd.
FAU - Wang, Baocheng
AU  - Wang B
AUID- ORCID: 0009-0000-5635-5837
AD  - Department of Oncology, No. 960 Hospital of PLA, Jinan, People's Republic of 
      China.
FAU - Zhong, Chen
AU  - Zhong C
AD  - Department of Oncology, No. 960 Hospital of PLA, Jinan, People's Republic of 
      China.
FAU - Liao, Zijun
AU  - Liao Z
AD  - Department of Medical Oncology, Shaanxi Provincial Cancer Hospital, Taiyuan, 
      People's Republic of China.
FAU - Wang, Haitao
AU  - Wang H
AD  - Department of Oncology, The Second Hospital of Tianjin Medical University, 
      Tianjin, People's Republic of China.
FAU - Cai, Xiuyu
AU  - Cai X
AD  - Department of General Internal Medicine, Sun Yat-sen University Cancer Center, 
      Guangzhou, People's Republic of China.
FAU - Zhang, Yanbing
AU  - Zhang Y
AD  - Department of Medical Oncology, Shaanxi Provincial Cancer Hospital, Taiyuan, 
      People's Republic of China.
FAU - Wang, Jun
AU  - Wang J
AUID- ORCID: 0000-0003-3941-2507
AD  - Department of Oncology, The First Affiliated Hospital of Shandong First Medical 
      University and Shandong Provincial Qianfoshan Hospital, Jinan, People's Republic 
      of China.
FAU - Wang, Tianxiao
AU  - Wang T
AD  - Hepatobiliary Pancreatic Center, Beijing Tsinghua Changgung Hospital, School of 
      Clinical Medicine, Beijing, People's Republic of China.
FAU - Yao, Hongtao
AU  - Yao H
AD  - Department of Medical Affairs, Guangdong Techpool Bio-pharma Co., Ltd., 
      Guangzhou, People's Republic of China.
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Observational Study
DEP - 20230907
PL  - Singapore
TA  - Thorac Cancer
JT  - Thoracic cancer
JID - 101531441
SB  - IM
MH  - Humans
MH  - *Pleural Effusion, Malignant/pathology
MH  - *Adenoviruses, Human
MH  - Ascites/drug therapy/etiology
MH  - Combined Modality Therapy
MH  - *Pleural Effusion
PMC - PMC10599969
OTO - NOTNLM
OT  - human type 5 recombinant adenovirus
OT  - malignant ascites
OT  - malignant pleural effusion
OT  - malignant serous effusion
OT  - real-world
COIS- The authors declare that they have no conflict of interest.
EDAT- 2023/09/07 06:42
MHDA- 2023/10/27 06:43
PMCR- 2023/09/07
CRDT- 2023/09/07 05:35
PHST- 2023/08/24 00:00 [revised]
PHST- 2023/07/07 00:00 [received]
PHST- 2023/08/25 00:00 [accepted]
PHST- 2023/10/27 06:43 [medline]
PHST- 2023/09/07 06:42 [pubmed]
PHST- 2023/09/07 05:35 [entrez]
PHST- 2023/09/07 00:00 [pmc-release]
AID - TCA15101 [pii]
AID - 10.1111/1759-7714.15101 [doi]
PST - ppublish
SO  - Thorac Cancer. 2023 Oct;14(30):3051-3057. doi: 10.1111/1759-7714.15101. Epub 2023 
      Sep 7.