PMID- 37488083
OWN - NLM
STAT- MEDLINE
DCOM- 20230730
LR  - 20230730
IS  - 1999-6187 (Electronic)
IS  - 1009-3419 (Print)
IS  - 1009-3419 (Linking)
VI  - 26
IP  - 6
DP  - 2023 Jun 20
TI  - [Role of Adverse Events Supervision in Clinical Trials in Neoadjuvant Treatment 
      of 
Operable Stage III NSCLC].
PG  - 461-466
LID - 10.3779/j.issn.1009-3419.2023.102.23 [doi]
AB  - BACKGROUND: Programmed cell death protein 1 (PD-1) combined with platinum 
      containing dual drug chemotherapy is a new adjuvant treatment option for operable 
      stage III non-small cell lung cancer (NSCLC), and the quality assurance of 
      clinical trials of related drugs plays a crucial role in the results of the 
      clinical trials. This study aims to explore the impact of adverse events (AEs) 
      supervision on reducing treatment-related AEs in patients. METHODS: 66 NSCLC 
      patients admitted to Shanghai Chest Hospital from July 2020 to October 2021 were 
      prospectively collected. All the patients received 3 cycles of neoadjuvant 
      treatment of Camrelizumab in combination with Docetaxel and Cisplatin. 4 weeks-6 
      weeks after neoadjuvant therapy, the patients accepted surgical treatment. One 
      cycle of postoperative adjuvant treatment was given within 30 days after surgery, 
      and 3 weeks after the completion of postoperative adjuvant treatment, 
      Camrelizumab consolidation treatment was intiated, with a total of 13 cycles. The 
      quality of life-C30 (QoL-C30) was used to measure patients' quality of life and 
      the occurrence of AEs was monitored. RESULTS: The overall safety is good, with a 
      total of 300 AEs occurring in 66 patients, including 282 cases of grade 1-2 AEs 
      and 18 cases of grades 3-4 AEs. The most common grades 3-4 AEs associated with 
      PD-1 antibodies occurred in 6 cases (9.1%). Neoadjuvant therapy supervision can 
      lead to a decrease in patients' QOL-C30 scores (P<0.05) and an improvement in 
      their quality of life. CONCLUSIONS: Camrelizumab combined with Docetaxel and 
      Cisplatin can be used as a new adjuvant treatment for operable stage III NSCLC. 
      Through the observation and control of AEs, treatment measures can be taken in 
      time to reduce further complications, ensure patient' safety, and ensure the 
      authenticity, scientificity and reliability of clinical trial data.
FAU - Zhang, Yun
AU  - Zhang Y
AD  - Shanghai Chest Hospital, Clinical Research Center, Chest Hospital Affiliated to 
      Shanghai Jiaotong University, Shanghai 200030, China.
FAU - Zhou, Shuang
AU  - Zhou S
AD  - Shanghai Chest Hospital, Clinical Research Center, Chest Hospital Affiliated to 
      Shanghai Jiaotong University, Shanghai 200030, China.
FAU - Tao, Wentao
AU  - Tao W
AD  - Shanghai Chest Hospital, Clinical Research Center, Chest Hospital Affiliated to 
      Shanghai Jiaotong University, Shanghai 200030, China.
FAU - Li, Rong
AU  - Li R
AD  - Shanghai Chest Hospital, Clinical Research Center, Chest Hospital Affiliated to 
      Shanghai Jiaotong University, Shanghai 200030, China.
AD  - Research Institute of China Hospital Development Research Institute, Shanghai 
      Jiao Tong University, Shanghai 200020, China.
LA  - chi
PT  - English Abstract
PT  - Journal Article
PL  - China
TA  - Zhongguo Fei Ai Za Zhi
JT  - Zhongguo fei ai za zhi = Chinese journal of lung cancer
JID - 101126433
RN  - Q20Q21Q62J (Cisplatin)
RN  - 15H5577CQD (Docetaxel)
RN  - 0 (Programmed Cell Death 1 Receptor)
SB  - IM
MH  - Humans
MH  - *Carcinoma, Non-Small-Cell Lung
MH  - China
MH  - Cisplatin
MH  - Docetaxel
MH  - *Lung Neoplasms
MH  - Neoadjuvant Therapy
MH  - Programmed Cell Death 1 Receptor
MH  - Quality of Life
MH  - Reproducibility of Results
MH  - Prospective Studies
PMC - PMC10365963
OTO - NOTNLM
OT  - Adverse events
OT  - Lung neoplasms
OT  - Neoadjuvant therapy
OT  - Supervision
EDAT- 2023/07/25 01:09
MHDA- 2023/07/26 06:43
PMCR- 2023/06/20
CRDT- 2023/07/24 22:33
PHST- 2023/07/26 06:43 [medline]
PHST- 2023/07/25 01:09 [pubmed]
PHST- 2023/07/24 22:33 [entrez]
PHST- 2023/06/20 00:00 [pmc-release]
AID - 10.3779/j.issn.1009-3419.2023.102.23 [doi]
PST - ppublish
SO  - Zhongguo Fei Ai Za Zhi. 2023 Jun 20;26(6):461-466. doi: 
      10.3779/j.issn.1009-3419.2023.102.23.