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A randomized phase II trial of hepatic arterial infusion of oxaliplatin plus raltitrexed versus oxaliplatin plus 5-fluorouracil for unresectable colorectal cancer liver metastases
BACKGROUND: The purpose was to compare the efficacy and safety of hepatic arterial infusion (HAI) of oxaliplatin plus raltitrexed (TOMOX) to those of oxaliplatin plus 5-fluorouracil (FOLFOX) for unresectable colorectal cancer liver metastases (CRCLM). METHODS: Patients with unresectable CRCLM were r...
Autores principales: | , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Frontiers Media S.A.
2022
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Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9532863/ https://www.ncbi.nlm.nih.gov/pubmed/36212504 http://dx.doi.org/10.3389/fonc.2022.913017 |
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author | Feng, Ai-Wei Guo, Jian-Hai Gao, Song Kou, Fu-Xin Liu, Shao-Xing Liu, Peng Chen, Hui Wang, Xiao-Dong Xu, Hai-Feng Cao, Guang Zhu, Xu |
author_facet | Feng, Ai-Wei Guo, Jian-Hai Gao, Song Kou, Fu-Xin Liu, Shao-Xing Liu, Peng Chen, Hui Wang, Xiao-Dong Xu, Hai-Feng Cao, Guang Zhu, Xu |
author_sort | Feng, Ai-Wei |
collection | PubMed |
description | BACKGROUND: The purpose was to compare the efficacy and safety of hepatic arterial infusion (HAI) of oxaliplatin plus raltitrexed (TOMOX) to those of oxaliplatin plus 5-fluorouracil (FOLFOX) for unresectable colorectal cancer liver metastases (CRCLM). METHODS: Patients with unresectable CRCLM were randomly assigned to receive HAI of TOMOX or FOLFOX. The primary end points were progression-free survival (PFS) measured from the date of randomisation until the date of disease progression and objective response rate (ORR). The secondary end points were overall survival (OS) measured from the date of randomisation until the date of death from any cause, disease control rate (DCR), and adverse events. RESULTS: 113 patients were randomly assigned. With a median follow-up of 39.5 months, the PFS was 5.8 months [95% CI, 4.838–6.762]) and 4.6 months [95% CI, 3.419–5.781; P = 0.840], and the median OS was 17.6 months [95% CI, 13.828–21.372] and 13.1 months [95% CI, 11.215–14.985; P = 0.178] for the FOLFOX and TOMOX arm, respectively. The ORR were 26.1% vs 22.4% and DCR were 80.4% vs 71.4% in the FOLFOX and TOMOX arms. The most common severe adverse event was elevation of liver enzymes and pain, which did not differ in the two arms. CONCLUSION: HAI chemotherapy was effective for unresectable CRCLM. HAI of FOLFOX has similar efficacy to TOMOX, and HAI of TOMOX had shorter arterial infusion time. CLINICAL TRIAL REGISTRATION: https://clinicaltrials.gov/, identifier NCT02557490. |
format | Online Article Text |
id | pubmed-9532863 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | Frontiers Media S.A. |
record_format | MEDLINE/PubMed |
spelling | pubmed-95328632022-10-06 A randomized phase II trial of hepatic arterial infusion of oxaliplatin plus raltitrexed versus oxaliplatin plus 5-fluorouracil for unresectable colorectal cancer liver metastases Feng, Ai-Wei Guo, Jian-Hai Gao, Song Kou, Fu-Xin Liu, Shao-Xing Liu, Peng Chen, Hui Wang, Xiao-Dong Xu, Hai-Feng Cao, Guang Zhu, Xu Front Oncol Oncology BACKGROUND: The purpose was to compare the efficacy and safety of hepatic arterial infusion (HAI) of oxaliplatin plus raltitrexed (TOMOX) to those of oxaliplatin plus 5-fluorouracil (FOLFOX) for unresectable colorectal cancer liver metastases (CRCLM). METHODS: Patients with unresectable CRCLM were randomly assigned to receive HAI of TOMOX or FOLFOX. The primary end points were progression-free survival (PFS) measured from the date of randomisation until the date of disease progression and objective response rate (ORR). The secondary end points were overall survival (OS) measured from the date of randomisation until the date of death from any cause, disease control rate (DCR), and adverse events. RESULTS: 113 patients were randomly assigned. With a median follow-up of 39.5 months, the PFS was 5.8 months [95% CI, 4.838–6.762]) and 4.6 months [95% CI, 3.419–5.781; P = 0.840], and the median OS was 17.6 months [95% CI, 13.828–21.372] and 13.1 months [95% CI, 11.215–14.985; P = 0.178] for the FOLFOX and TOMOX arm, respectively. The ORR were 26.1% vs 22.4% and DCR were 80.4% vs 71.4% in the FOLFOX and TOMOX arms. The most common severe adverse event was elevation of liver enzymes and pain, which did not differ in the two arms. CONCLUSION: HAI chemotherapy was effective for unresectable CRCLM. HAI of FOLFOX has similar efficacy to TOMOX, and HAI of TOMOX had shorter arterial infusion time. CLINICAL TRIAL REGISTRATION: https://clinicaltrials.gov/, identifier NCT02557490. Frontiers Media S.A. 2022-09-21 /pmc/articles/PMC9532863/ /pubmed/36212504 http://dx.doi.org/10.3389/fonc.2022.913017 Text en Copyright © 2022 Feng, Guo, Gao, Kou, Liu, Liu, Chen, Wang, Xu, Cao 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 Feng, Ai-Wei Guo, Jian-Hai Gao, Song Kou, Fu-Xin Liu, Shao-Xing Liu, Peng Chen, Hui Wang, Xiao-Dong Xu, Hai-Feng Cao, Guang Zhu, Xu A randomized phase II trial of hepatic arterial infusion of oxaliplatin plus raltitrexed versus oxaliplatin plus 5-fluorouracil for unresectable colorectal cancer liver metastases |
title | A randomized phase II trial of hepatic arterial infusion of oxaliplatin plus raltitrexed versus oxaliplatin plus 5-fluorouracil for unresectable colorectal cancer liver metastases |
title_full | A randomized phase II trial of hepatic arterial infusion of oxaliplatin plus raltitrexed versus oxaliplatin plus 5-fluorouracil for unresectable colorectal cancer liver metastases |
title_fullStr | A randomized phase II trial of hepatic arterial infusion of oxaliplatin plus raltitrexed versus oxaliplatin plus 5-fluorouracil for unresectable colorectal cancer liver metastases |
title_full_unstemmed | A randomized phase II trial of hepatic arterial infusion of oxaliplatin plus raltitrexed versus oxaliplatin plus 5-fluorouracil for unresectable colorectal cancer liver metastases |
title_short | A randomized phase II trial of hepatic arterial infusion of oxaliplatin plus raltitrexed versus oxaliplatin plus 5-fluorouracil for unresectable colorectal cancer liver metastases |
title_sort | randomized phase ii trial of hepatic arterial infusion of oxaliplatin plus raltitrexed versus oxaliplatin plus 5-fluorouracil for unresectable colorectal cancer liver metastases |
topic | Oncology |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9532863/ https://www.ncbi.nlm.nih.gov/pubmed/36212504 http://dx.doi.org/10.3389/fonc.2022.913017 |
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