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A phase II trial of S-1 and oxaliplatin in patients with advanced hepatocellular carcinoma
BACKGROUND: Oxaliplatin is a platinum derivative that has shown efficacy in advanced hepatocellular carcinoma. S-1 is an oral fluoropyrimidine that has substituted for 5-fluorouracil in many cancers. This was a multicenter, open-label, single-arm phase II trial that evaluated the efficacy of S-1 and...
Autores principales: | , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BioMed Central
2018
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5838934/ https://www.ncbi.nlm.nih.gov/pubmed/29506478 http://dx.doi.org/10.1186/s12885-018-4039-9 |
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author | Lee, Dae-Won Lee, Kyung-Hun Kim, Hee-Jun Kim, Tae-Yong Kim, Jin-Soo Han, Sae-Won Oh, Do-Youn Kim, Jee Hyun Im, Seock-Ah Kim, Tae-You |
author_facet | Lee, Dae-Won Lee, Kyung-Hun Kim, Hee-Jun Kim, Tae-Yong Kim, Jin-Soo Han, Sae-Won Oh, Do-Youn Kim, Jee Hyun Im, Seock-Ah Kim, Tae-You |
author_sort | Lee, Dae-Won |
collection | PubMed |
description | BACKGROUND: Oxaliplatin is a platinum derivative that has shown efficacy in advanced hepatocellular carcinoma. S-1 is an oral fluoropyrimidine that has substituted for 5-fluorouracil in many cancers. This was a multicenter, open-label, single-arm phase II trial that evaluated the efficacy of S-1 and oxaliplatin (SOX) in advanced hepatocellular carcinoma. All patients included in the present study were systemic treatment-naïve. Prior treatment with sorafenib was allowed, but other treatments were not. METHODS: Patients received S-1 (40 mg/m(2) twice daily from day 1–14) and oxaliplatin (130 mg/m(2) on day 1) every 3 weeks. The primary end point was time to progression (TTP). Secondary end points included progression-free survival, overall survival (OS), response rate, and safety profile. RESULTS: Thirty six patients with advanced hepatocellular carcinoma were included in this study. The median TTP was 3.0 months (95% confidence interval (CI), 0.75–5.25), and the median OS was 10.3 months (95% CI, 6.4–14.3). Bone metastasis was associated with poorer TTP and OS. The efficacy of SOX was unaffected by prior sorafenib or locoregional therapy. The objective response rate was 13.9%. No grade 4 toxicity or death from adverse events occurred. The most common grade 3 toxicities were neutropenia (13.9%), thrombocytopenia (13.9%), and diarrhea (8.3%). CONCLUSIONS: Although this trial did not meet its primary end point, the SOX regimen showed comparable efficacy and safety to the 5-fluorouracil, leucovorin, and oxaliplatin (FOLFOX) regimen. As the SOX regimen is easier for patients, SOX may be a reasonable substitute for FOLFOX in hepatocellular carcinoma. TRIAL REGISTRATION: Clinicaltrials.gov NCT01429961. Registered 7 September 2011. |
format | Online Article Text |
id | pubmed-5838934 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2018 |
publisher | BioMed Central |
record_format | MEDLINE/PubMed |
spelling | pubmed-58389342018-03-09 A phase II trial of S-1 and oxaliplatin in patients with advanced hepatocellular carcinoma Lee, Dae-Won Lee, Kyung-Hun Kim, Hee-Jun Kim, Tae-Yong Kim, Jin-Soo Han, Sae-Won Oh, Do-Youn Kim, Jee Hyun Im, Seock-Ah Kim, Tae-You BMC Cancer Research Article BACKGROUND: Oxaliplatin is a platinum derivative that has shown efficacy in advanced hepatocellular carcinoma. S-1 is an oral fluoropyrimidine that has substituted for 5-fluorouracil in many cancers. This was a multicenter, open-label, single-arm phase II trial that evaluated the efficacy of S-1 and oxaliplatin (SOX) in advanced hepatocellular carcinoma. All patients included in the present study were systemic treatment-naïve. Prior treatment with sorafenib was allowed, but other treatments were not. METHODS: Patients received S-1 (40 mg/m(2) twice daily from day 1–14) and oxaliplatin (130 mg/m(2) on day 1) every 3 weeks. The primary end point was time to progression (TTP). Secondary end points included progression-free survival, overall survival (OS), response rate, and safety profile. RESULTS: Thirty six patients with advanced hepatocellular carcinoma were included in this study. The median TTP was 3.0 months (95% confidence interval (CI), 0.75–5.25), and the median OS was 10.3 months (95% CI, 6.4–14.3). Bone metastasis was associated with poorer TTP and OS. The efficacy of SOX was unaffected by prior sorafenib or locoregional therapy. The objective response rate was 13.9%. No grade 4 toxicity or death from adverse events occurred. The most common grade 3 toxicities were neutropenia (13.9%), thrombocytopenia (13.9%), and diarrhea (8.3%). CONCLUSIONS: Although this trial did not meet its primary end point, the SOX regimen showed comparable efficacy and safety to the 5-fluorouracil, leucovorin, and oxaliplatin (FOLFOX) regimen. As the SOX regimen is easier for patients, SOX may be a reasonable substitute for FOLFOX in hepatocellular carcinoma. TRIAL REGISTRATION: Clinicaltrials.gov NCT01429961. Registered 7 September 2011. BioMed Central 2018-03-05 /pmc/articles/PMC5838934/ /pubmed/29506478 http://dx.doi.org/10.1186/s12885-018-4039-9 Text en © The Author(s). 2018 Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated. |
spellingShingle | Research Article Lee, Dae-Won Lee, Kyung-Hun Kim, Hee-Jun Kim, Tae-Yong Kim, Jin-Soo Han, Sae-Won Oh, Do-Youn Kim, Jee Hyun Im, Seock-Ah Kim, Tae-You A phase II trial of S-1 and oxaliplatin in patients with advanced hepatocellular carcinoma |
title | A phase II trial of S-1 and oxaliplatin in patients with advanced hepatocellular carcinoma |
title_full | A phase II trial of S-1 and oxaliplatin in patients with advanced hepatocellular carcinoma |
title_fullStr | A phase II trial of S-1 and oxaliplatin in patients with advanced hepatocellular carcinoma |
title_full_unstemmed | A phase II trial of S-1 and oxaliplatin in patients with advanced hepatocellular carcinoma |
title_short | A phase II trial of S-1 and oxaliplatin in patients with advanced hepatocellular carcinoma |
title_sort | phase ii trial of s-1 and oxaliplatin in patients with advanced hepatocellular carcinoma |
topic | Research Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5838934/ https://www.ncbi.nlm.nih.gov/pubmed/29506478 http://dx.doi.org/10.1186/s12885-018-4039-9 |
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