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Phase 2 randomized controlled trial of intravenous or intraperitoneal paclitaxel plus mFOLFOX6 vs. mFOLFOX6 as first-line treatment of advanced gastric cancer
OBJECTIVE: We conducted a phase 2 trial to compare the safety and efficacy of intravenous paclitaxel or intraperitoneal paclitaxel plus mFOLFOX6 vs. mFOLFOX6 in untreated advanced gastric cancer. METHODS: Participants with untreated advanced gastric cancer were randomly assigned (1:1:1) to: intraven...
Autores principales: | , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Frontiers Media S.A.
2022
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9491235/ https://www.ncbi.nlm.nih.gov/pubmed/36158665 http://dx.doi.org/10.3389/fonc.2022.850242 |
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author | Zhao, Shen Su, Liyu Chen, Yigui Li, Xiaofeng Lin, Peicheng Chen, Wujin Fang, Wenzheng Zhu, Jinfeng Li, Hui Ren, Liping Liu, Jie Hong, Yanni Lin, Shaowei Fan, Nanfeng Lin, Rongbo |
author_facet | Zhao, Shen Su, Liyu Chen, Yigui Li, Xiaofeng Lin, Peicheng Chen, Wujin Fang, Wenzheng Zhu, Jinfeng Li, Hui Ren, Liping Liu, Jie Hong, Yanni Lin, Shaowei Fan, Nanfeng Lin, Rongbo |
author_sort | Zhao, Shen |
collection | PubMed |
description | OBJECTIVE: We conducted a phase 2 trial to compare the safety and efficacy of intravenous paclitaxel or intraperitoneal paclitaxel plus mFOLFOX6 vs. mFOLFOX6 in untreated advanced gastric cancer. METHODS: Participants with untreated advanced gastric cancer were randomly assigned (1:1:1) to: intravenous paclitaxel 135 mg/m(2) or intraperitoneal paclitaxel 80 mg/m(2) plus mFOLFOX6 omitting bolus fluorouracil; or mFOLFOX6 (oxaliplatin 85 mg/m(2), leucovorin 400 mg/m(2), fluorouracil 400 mg/m(2) bolus, fluorouracil 2,400 mg/m(2) 46-h continuous infusion). Treatment was every 14 days for up to 9 cycles followed by S-1 maintenance. The primary outcome was progression-free survival. RESULTS: Of 90 enrolled participants, 30 in the intravenous paclitaxel group, 29 in the intraperitoneal paclitaxel group, and 30 in the mFOLFOX6 group were included in the analyses. The median progression-free survival was 6.52, 5.83, and 4.55 months, respectively, for the intravenous paclitaxel group, intraperitoneal paclitaxel group, and mFOLFOX6 group. The hazard ratios were 0.56 (95% CI: 0.33–0.94; p = 0.026) and 0.56 (95% CI: 0.33–0.96; p = 0.037), respectively, for the intravenous paclitaxel group and the intraperitoneal paclitaxel group vs. the mFOLFOX6 group. The most common grade 3/4 adverse events for the intravenous paclitaxel group, intraperitoneal paclitaxel group, and mFOLFOX6 group, respectively, were neutropenia (30.0%, 34.5%, 33.3%), diarrhea (13.3%, 20.7%, 13.3%), and leukopenia (10.0%, 13.8%, 10.0%). No treatment-related death occurred. CONCLUSION: The findings of this phase 2 trial suggest that adding intravenous paclitaxel or intraperitoneal paclitaxel to mFOLFOX6 for untreated advanced gastric cancer improved progression-free survival with manageable adverse events. |
format | Online Article Text |
id | pubmed-9491235 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | Frontiers Media S.A. |
record_format | MEDLINE/PubMed |
spelling | pubmed-94912352022-09-22 Phase 2 randomized controlled trial of intravenous or intraperitoneal paclitaxel plus mFOLFOX6 vs. mFOLFOX6 as first-line treatment of advanced gastric cancer Zhao, Shen Su, Liyu Chen, Yigui Li, Xiaofeng Lin, Peicheng Chen, Wujin Fang, Wenzheng Zhu, Jinfeng Li, Hui Ren, Liping Liu, Jie Hong, Yanni Lin, Shaowei Fan, Nanfeng Lin, Rongbo Front Oncol Oncology OBJECTIVE: We conducted a phase 2 trial to compare the safety and efficacy of intravenous paclitaxel or intraperitoneal paclitaxel plus mFOLFOX6 vs. mFOLFOX6 in untreated advanced gastric cancer. METHODS: Participants with untreated advanced gastric cancer were randomly assigned (1:1:1) to: intravenous paclitaxel 135 mg/m(2) or intraperitoneal paclitaxel 80 mg/m(2) plus mFOLFOX6 omitting bolus fluorouracil; or mFOLFOX6 (oxaliplatin 85 mg/m(2), leucovorin 400 mg/m(2), fluorouracil 400 mg/m(2) bolus, fluorouracil 2,400 mg/m(2) 46-h continuous infusion). Treatment was every 14 days for up to 9 cycles followed by S-1 maintenance. The primary outcome was progression-free survival. RESULTS: Of 90 enrolled participants, 30 in the intravenous paclitaxel group, 29 in the intraperitoneal paclitaxel group, and 30 in the mFOLFOX6 group were included in the analyses. The median progression-free survival was 6.52, 5.83, and 4.55 months, respectively, for the intravenous paclitaxel group, intraperitoneal paclitaxel group, and mFOLFOX6 group. The hazard ratios were 0.56 (95% CI: 0.33–0.94; p = 0.026) and 0.56 (95% CI: 0.33–0.96; p = 0.037), respectively, for the intravenous paclitaxel group and the intraperitoneal paclitaxel group vs. the mFOLFOX6 group. The most common grade 3/4 adverse events for the intravenous paclitaxel group, intraperitoneal paclitaxel group, and mFOLFOX6 group, respectively, were neutropenia (30.0%, 34.5%, 33.3%), diarrhea (13.3%, 20.7%, 13.3%), and leukopenia (10.0%, 13.8%, 10.0%). No treatment-related death occurred. CONCLUSION: The findings of this phase 2 trial suggest that adding intravenous paclitaxel or intraperitoneal paclitaxel to mFOLFOX6 for untreated advanced gastric cancer improved progression-free survival with manageable adverse events. Frontiers Media S.A. 2022-09-07 /pmc/articles/PMC9491235/ /pubmed/36158665 http://dx.doi.org/10.3389/fonc.2022.850242 Text en Copyright © 2022 Zhao, Su, Chen, Li, Lin, Chen, Fang, Zhu, Li, Ren, Liu, Hong, Lin, Fan and Lin 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, Shen Su, Liyu Chen, Yigui Li, Xiaofeng Lin, Peicheng Chen, Wujin Fang, Wenzheng Zhu, Jinfeng Li, Hui Ren, Liping Liu, Jie Hong, Yanni Lin, Shaowei Fan, Nanfeng Lin, Rongbo Phase 2 randomized controlled trial of intravenous or intraperitoneal paclitaxel plus mFOLFOX6 vs. mFOLFOX6 as first-line treatment of advanced gastric cancer |
title | Phase 2 randomized controlled trial of intravenous or intraperitoneal paclitaxel plus mFOLFOX6 vs. mFOLFOX6 as first-line treatment of advanced gastric cancer |
title_full | Phase 2 randomized controlled trial of intravenous or intraperitoneal paclitaxel plus mFOLFOX6 vs. mFOLFOX6 as first-line treatment of advanced gastric cancer |
title_fullStr | Phase 2 randomized controlled trial of intravenous or intraperitoneal paclitaxel plus mFOLFOX6 vs. mFOLFOX6 as first-line treatment of advanced gastric cancer |
title_full_unstemmed | Phase 2 randomized controlled trial of intravenous or intraperitoneal paclitaxel plus mFOLFOX6 vs. mFOLFOX6 as first-line treatment of advanced gastric cancer |
title_short | Phase 2 randomized controlled trial of intravenous or intraperitoneal paclitaxel plus mFOLFOX6 vs. mFOLFOX6 as first-line treatment of advanced gastric cancer |
title_sort | phase 2 randomized controlled trial of intravenous or intraperitoneal paclitaxel plus mfolfox6 vs. mfolfox6 as first-line treatment of advanced gastric cancer |
topic | Oncology |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9491235/ https://www.ncbi.nlm.nih.gov/pubmed/36158665 http://dx.doi.org/10.3389/fonc.2022.850242 |
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