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A comprehensive evaluation of clinical efficacy and safety of celecoxib in combination with chemotherapy in metastatic or postoperative recurrent gastric cancer patients: A preliminary, three-center, clinical trial study

AIM: To evaluate the efficacy and safety of celecoxib combined with chemotherapy in the treatment of metastatic or postoperative recurrent gastric cancer. METHODS: This preliminary, three-center, clinical trial study was conducted between September 2010 and December 2016. In the experimental group (...

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Autores principales: Guo, Qinghong, Li, Qiang, Wang, Jiong, Liu, Min, Wang, Yuping, Chen, Zhaofeng, Ye, Yuwei, Guan, Quanlin, Zhou, Yongning
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Wolters Kluwer Health 2019
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6635161/
https://www.ncbi.nlm.nih.gov/pubmed/31277138
http://dx.doi.org/10.1097/MD.0000000000016234
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author Guo, Qinghong
Li, Qiang
Wang, Jiong
Liu, Min
Wang, Yuping
Chen, Zhaofeng
Ye, Yuwei
Guan, Quanlin
Zhou, Yongning
author_facet Guo, Qinghong
Li, Qiang
Wang, Jiong
Liu, Min
Wang, Yuping
Chen, Zhaofeng
Ye, Yuwei
Guan, Quanlin
Zhou, Yongning
author_sort Guo, Qinghong
collection PubMed
description AIM: To evaluate the efficacy and safety of celecoxib combined with chemotherapy in the treatment of metastatic or postoperative recurrent gastric cancer. METHODS: This preliminary, three-center, clinical trial study was conducted between September 2010 and December 2016. In the experimental group (n = 100), patients were treated with celecoxib combined with chemotherapy, and chemotherapy alone was used in the control group. Progression-free survival (PFS) was considered as the primary efficacy parameter. Overall survival (OS), remission rate (RR), quality of life (QOL) and drug safety were considered as the secondary efficacy parameters. RESULTS: The PFS of the experimental group was 6 months, which was not significantly longer than that of the control group (5 months, P = .73). The average OS was not significantly different between the experimental group (12 months) and the control group (10 months, P = .59). The average OS of the COX-2 positive patients in the experimental group was 14 months and it was significantly longer than the 10-month OS in the control group (P = .01). The PFS of the COX-2 positive patients in the experimental group was 7.5 months, significantly longer than the 5-month PFS of patients in the control group (P < .001). No statistical significance was identified in the incidence of nausea, neutropenia, anorexia, peripheral neurotoxicity, diarrhea, vomiting, asthenia and thrombocytopenia. The EORTC QLQ-C30 questionnaire revealed that the overall QOL of the experimental group was significantly higher than that of the control group (P < .05). No statistical significance was found in the scores of functioning scale between the 2 groups. However, the scores of the symptom scale, especially for pain and fatigue in the experimental group was remarkably higher than that in the control group (P < .05). The overall score of EORTC QLQ-STO22 for the experimental group was considerably higher compared to that for the control group (P < .05). No statistical significance was identified in term of the domains of restrictions on feeding, dysphagia, anxiety, reflux, sense of taste, dry mouth, hair loss and body shape between the 2 groups (P > .05 for all mentioned outcomes). CONCLUSION: Celecoxib combined with chemotherapy offers more clinical benefits for COX-2 positive advanced gastric cancer patients.
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spelling pubmed-66351612019-08-01 A comprehensive evaluation of clinical efficacy and safety of celecoxib in combination with chemotherapy in metastatic or postoperative recurrent gastric cancer patients: A preliminary, three-center, clinical trial study Guo, Qinghong Li, Qiang Wang, Jiong Liu, Min Wang, Yuping Chen, Zhaofeng Ye, Yuwei Guan, Quanlin Zhou, Yongning Medicine (Baltimore) Research Article AIM: To evaluate the efficacy and safety of celecoxib combined with chemotherapy in the treatment of metastatic or postoperative recurrent gastric cancer. METHODS: This preliminary, three-center, clinical trial study was conducted between September 2010 and December 2016. In the experimental group (n = 100), patients were treated with celecoxib combined with chemotherapy, and chemotherapy alone was used in the control group. Progression-free survival (PFS) was considered as the primary efficacy parameter. Overall survival (OS), remission rate (RR), quality of life (QOL) and drug safety were considered as the secondary efficacy parameters. RESULTS: The PFS of the experimental group was 6 months, which was not significantly longer than that of the control group (5 months, P = .73). The average OS was not significantly different between the experimental group (12 months) and the control group (10 months, P = .59). The average OS of the COX-2 positive patients in the experimental group was 14 months and it was significantly longer than the 10-month OS in the control group (P = .01). The PFS of the COX-2 positive patients in the experimental group was 7.5 months, significantly longer than the 5-month PFS of patients in the control group (P < .001). No statistical significance was identified in the incidence of nausea, neutropenia, anorexia, peripheral neurotoxicity, diarrhea, vomiting, asthenia and thrombocytopenia. The EORTC QLQ-C30 questionnaire revealed that the overall QOL of the experimental group was significantly higher than that of the control group (P < .05). No statistical significance was found in the scores of functioning scale between the 2 groups. However, the scores of the symptom scale, especially for pain and fatigue in the experimental group was remarkably higher than that in the control group (P < .05). The overall score of EORTC QLQ-STO22 for the experimental group was considerably higher compared to that for the control group (P < .05). No statistical significance was identified in term of the domains of restrictions on feeding, dysphagia, anxiety, reflux, sense of taste, dry mouth, hair loss and body shape between the 2 groups (P > .05 for all mentioned outcomes). CONCLUSION: Celecoxib combined with chemotherapy offers more clinical benefits for COX-2 positive advanced gastric cancer patients. Wolters Kluwer Health 2019-07-05 /pmc/articles/PMC6635161/ /pubmed/31277138 http://dx.doi.org/10.1097/MD.0000000000016234 Text en Copyright © 2019 the Author(s). Published by Wolters Kluwer Health, Inc. http://creativecommons.org/licenses/by-nc/4.0 This is an open access article distributed under the terms of the Creative Commons Attribution-Non Commercial License 4.0 (CCBY-NC), where it is permissible to download, share, remix, transform, and buildup the work provided it is properly cited. The work cannot be used commercially without permission from the journal. http://creativecommons.org/licenses/by-nc/4.0
spellingShingle Research Article
Guo, Qinghong
Li, Qiang
Wang, Jiong
Liu, Min
Wang, Yuping
Chen, Zhaofeng
Ye, Yuwei
Guan, Quanlin
Zhou, Yongning
A comprehensive evaluation of clinical efficacy and safety of celecoxib in combination with chemotherapy in metastatic or postoperative recurrent gastric cancer patients: A preliminary, three-center, clinical trial study
title A comprehensive evaluation of clinical efficacy and safety of celecoxib in combination with chemotherapy in metastatic or postoperative recurrent gastric cancer patients: A preliminary, three-center, clinical trial study
title_full A comprehensive evaluation of clinical efficacy and safety of celecoxib in combination with chemotherapy in metastatic or postoperative recurrent gastric cancer patients: A preliminary, three-center, clinical trial study
title_fullStr A comprehensive evaluation of clinical efficacy and safety of celecoxib in combination with chemotherapy in metastatic or postoperative recurrent gastric cancer patients: A preliminary, three-center, clinical trial study
title_full_unstemmed A comprehensive evaluation of clinical efficacy and safety of celecoxib in combination with chemotherapy in metastatic or postoperative recurrent gastric cancer patients: A preliminary, three-center, clinical trial study
title_short A comprehensive evaluation of clinical efficacy and safety of celecoxib in combination with chemotherapy in metastatic or postoperative recurrent gastric cancer patients: A preliminary, three-center, clinical trial study
title_sort comprehensive evaluation of clinical efficacy and safety of celecoxib in combination with chemotherapy in metastatic or postoperative recurrent gastric cancer patients: a preliminary, three-center, clinical trial study
topic Research Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6635161/
https://www.ncbi.nlm.nih.gov/pubmed/31277138
http://dx.doi.org/10.1097/MD.0000000000016234
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