Cargando…
Randomized phase II study of TX followed by XELOX versus the reverse sequence for chemo-naive patients with metastatic gastric cancer
This research found that the clinical outcomes (PFS, ORR, OS) of the non-platinum-based doublet regimen (docetaxel capecitabine combination) were similar to those of the platinum-based (oxaliplatin capecitabine combination) when used as first line therapy for MGC patients. BACKGROUND: Docetaxel, pla...
Autores principales: | , , , , , , , , , , |
---|---|
Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Frontiers Media S.A.
2022
|
Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9643736/ https://www.ncbi.nlm.nih.gov/pubmed/36387112 http://dx.doi.org/10.3389/fonc.2022.911160 |
_version_ | 1784826582775365632 |
---|---|
author | Zhao, Xiao-Yin Liu, Xin Li, Wen-Hua Qiu, Li-Xin Huang, Ming-Zhu Wang, Chen-Chen Chen, Zhi-Yu Zhang, Wen Feng, Wan-Jing Guo, Wei-Jian Zhu, Xiaodong |
author_facet | Zhao, Xiao-Yin Liu, Xin Li, Wen-Hua Qiu, Li-Xin Huang, Ming-Zhu Wang, Chen-Chen Chen, Zhi-Yu Zhang, Wen Feng, Wan-Jing Guo, Wei-Jian Zhu, Xiaodong |
author_sort | Zhao, Xiao-Yin |
collection | PubMed |
description | This research found that the clinical outcomes (PFS, ORR, OS) of the non-platinum-based doublet regimen (docetaxel capecitabine combination) were similar to those of the platinum-based (oxaliplatin capecitabine combination) when used as first line therapy for MGC patients. BACKGROUND: Docetaxel, platinum and fluorouracil are the three most important drugs in the treatment of MGC. This study was to compare clinical outcomes of the docetaxel capecitabine combination and the oxaliplatin capecitabine combination as first-line therapy in MGC patients. METHODS: In this phase II trial, MGC patients were randomly assigned and treated with either TX (capecitabine 1000 mg/m(2)/twice daily/1-14 days and docetaxel 60/75 mg/m(2) on the 1st day) (because of toxicity, the dose of docetaxel was reduced to 60 mg/m(2)) or XELOX (capecitabine the same dose with TX and oxaliplatin 130 mg/m(2) on the 1st day) as first-line therapy. After progression, patients were crossover to the other group as second-line treatment. RESULTS: Total 134 MGC patients were randomized (69 in TX, 65 in XELOX). There was no significant difference between the PFS of the two groups (TX vs XELOX, 4.6 months vs 5.1 months, p=0.359), and the SFS (9.3 months vs 7.5 months, p=0.705), OS (13.1 months vs 9.6 months, p=0.261), and ORR (46.4% vs 46.2%) were also similar. Among patients with ascites, the TX group had significantly longer PFS and OS than the XELOX group. A total of 85 patients (48 in TX, 37 in XELOX) received second-line treatment, with overall survival of second-line chemotherapy (OS2) of 8.0 m and 5.3 m (p=0.046), respectively. Grade 3 to 4 treatment-related adverse events of first line treatment occurred more in TX group than that in XELOX group(60.6% vs 55.4%). CONCLUSION: TX regimen is an alternative choice of first-line treatment for MGC patients. We still need to explore the large number of cohort to confirm this results. |
format | Online Article Text |
id | pubmed-9643736 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | Frontiers Media S.A. |
record_format | MEDLINE/PubMed |
spelling | pubmed-96437362022-11-15 Randomized phase II study of TX followed by XELOX versus the reverse sequence for chemo-naive patients with metastatic gastric cancer Zhao, Xiao-Yin Liu, Xin Li, Wen-Hua Qiu, Li-Xin Huang, Ming-Zhu Wang, Chen-Chen Chen, Zhi-Yu Zhang, Wen Feng, Wan-Jing Guo, Wei-Jian Zhu, Xiaodong Front Oncol Oncology This research found that the clinical outcomes (PFS, ORR, OS) of the non-platinum-based doublet regimen (docetaxel capecitabine combination) were similar to those of the platinum-based (oxaliplatin capecitabine combination) when used as first line therapy for MGC patients. BACKGROUND: Docetaxel, platinum and fluorouracil are the three most important drugs in the treatment of MGC. This study was to compare clinical outcomes of the docetaxel capecitabine combination and the oxaliplatin capecitabine combination as first-line therapy in MGC patients. METHODS: In this phase II trial, MGC patients were randomly assigned and treated with either TX (capecitabine 1000 mg/m(2)/twice daily/1-14 days and docetaxel 60/75 mg/m(2) on the 1st day) (because of toxicity, the dose of docetaxel was reduced to 60 mg/m(2)) or XELOX (capecitabine the same dose with TX and oxaliplatin 130 mg/m(2) on the 1st day) as first-line therapy. After progression, patients were crossover to the other group as second-line treatment. RESULTS: Total 134 MGC patients were randomized (69 in TX, 65 in XELOX). There was no significant difference between the PFS of the two groups (TX vs XELOX, 4.6 months vs 5.1 months, p=0.359), and the SFS (9.3 months vs 7.5 months, p=0.705), OS (13.1 months vs 9.6 months, p=0.261), and ORR (46.4% vs 46.2%) were also similar. Among patients with ascites, the TX group had significantly longer PFS and OS than the XELOX group. A total of 85 patients (48 in TX, 37 in XELOX) received second-line treatment, with overall survival of second-line chemotherapy (OS2) of 8.0 m and 5.3 m (p=0.046), respectively. Grade 3 to 4 treatment-related adverse events of first line treatment occurred more in TX group than that in XELOX group(60.6% vs 55.4%). CONCLUSION: TX regimen is an alternative choice of first-line treatment for MGC patients. We still need to explore the large number of cohort to confirm this results. Frontiers Media S.A. 2022-10-26 /pmc/articles/PMC9643736/ /pubmed/36387112 http://dx.doi.org/10.3389/fonc.2022.911160 Text en Copyright © 2022 Zhao, Liu, Li, Qiu, Huang, Wang, Chen, Zhang, Feng, Guo and Zhu https://creativecommons.org/licenses/by/4.0/This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms. |
spellingShingle | Oncology Zhao, Xiao-Yin Liu, Xin Li, Wen-Hua Qiu, Li-Xin Huang, Ming-Zhu Wang, Chen-Chen Chen, Zhi-Yu Zhang, Wen Feng, Wan-Jing Guo, Wei-Jian Zhu, Xiaodong Randomized phase II study of TX followed by XELOX versus the reverse sequence for chemo-naive patients with metastatic gastric cancer |
title | Randomized phase II study of TX followed by XELOX versus the reverse sequence for chemo-naive patients with metastatic gastric cancer |
title_full | Randomized phase II study of TX followed by XELOX versus the reverse sequence for chemo-naive patients with metastatic gastric cancer |
title_fullStr | Randomized phase II study of TX followed by XELOX versus the reverse sequence for chemo-naive patients with metastatic gastric cancer |
title_full_unstemmed | Randomized phase II study of TX followed by XELOX versus the reverse sequence for chemo-naive patients with metastatic gastric cancer |
title_short | Randomized phase II study of TX followed by XELOX versus the reverse sequence for chemo-naive patients with metastatic gastric cancer |
title_sort | randomized phase ii study of tx followed by xelox versus the reverse sequence for chemo-naive patients with metastatic gastric cancer |
topic | Oncology |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9643736/ https://www.ncbi.nlm.nih.gov/pubmed/36387112 http://dx.doi.org/10.3389/fonc.2022.911160 |
work_keys_str_mv | AT zhaoxiaoyin randomizedphaseiistudyoftxfollowedbyxeloxversusthereversesequenceforchemonaivepatientswithmetastaticgastriccancer AT liuxin randomizedphaseiistudyoftxfollowedbyxeloxversusthereversesequenceforchemonaivepatientswithmetastaticgastriccancer AT liwenhua randomizedphaseiistudyoftxfollowedbyxeloxversusthereversesequenceforchemonaivepatientswithmetastaticgastriccancer AT qiulixin randomizedphaseiistudyoftxfollowedbyxeloxversusthereversesequenceforchemonaivepatientswithmetastaticgastriccancer AT huangmingzhu randomizedphaseiistudyoftxfollowedbyxeloxversusthereversesequenceforchemonaivepatientswithmetastaticgastriccancer AT wangchenchen randomizedphaseiistudyoftxfollowedbyxeloxversusthereversesequenceforchemonaivepatientswithmetastaticgastriccancer AT chenzhiyu randomizedphaseiistudyoftxfollowedbyxeloxversusthereversesequenceforchemonaivepatientswithmetastaticgastriccancer AT zhangwen randomizedphaseiistudyoftxfollowedbyxeloxversusthereversesequenceforchemonaivepatientswithmetastaticgastriccancer AT fengwanjing randomizedphaseiistudyoftxfollowedbyxeloxversusthereversesequenceforchemonaivepatientswithmetastaticgastriccancer AT guoweijian randomizedphaseiistudyoftxfollowedbyxeloxversusthereversesequenceforchemonaivepatientswithmetastaticgastriccancer AT zhuxiaodong randomizedphaseiistudyoftxfollowedbyxeloxversusthereversesequenceforchemonaivepatientswithmetastaticgastriccancer |