Cargando…
A phase II study of 5-fluorouracil/L-leucovorin/oxaliplatin (mFOLFOX6) in Japanese patients with metastatic or unresectable small bowel adenocarcinoma
BACKGROUND: Several studies have suggested that chemotherapy prolonged survival in patients with metastatic or recurrent small bowel adenocarcinoma (SBA); however, there is still no standard chemotherapy regimen. Here, we evaluated the efficacy and safety of a 5-fluorouracil (5-FU)/L-leucovorin (l-L...
Autores principales: | , , , , , , , , , , , , , |
---|---|
Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Springer Japan
2017
|
Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5608770/ https://www.ncbi.nlm.nih.gov/pubmed/28536826 http://dx.doi.org/10.1007/s10147-017-1138-6 |
_version_ | 1783265491031162880 |
---|---|
author | Horimatsu, Takahiro Nakayama, Norisuke Moriwaki, Toshikazu Hirashima, Yoshinori Fujita, Mikio Asayama, Masako Moriyama, Ichiro Nakashima, Koji Baba, Eishi Kitamura, Hiroshi Tamura, Takao Hosokawa, Ayumu Yoshimura, Kenichi Muto, Manabu |
author_facet | Horimatsu, Takahiro Nakayama, Norisuke Moriwaki, Toshikazu Hirashima, Yoshinori Fujita, Mikio Asayama, Masako Moriyama, Ichiro Nakashima, Koji Baba, Eishi Kitamura, Hiroshi Tamura, Takao Hosokawa, Ayumu Yoshimura, Kenichi Muto, Manabu |
author_sort | Horimatsu, Takahiro |
collection | PubMed |
description | BACKGROUND: Several studies have suggested that chemotherapy prolonged survival in patients with metastatic or recurrent small bowel adenocarcinoma (SBA); however, there is still no standard chemotherapy regimen. Here, we evaluated the efficacy and safety of a 5-fluorouracil (5-FU)/L-leucovorin (l-LV)/oxaliplatin (mFOLFOX6) protocol as a first-line therapy for patients with SBA. PATIENTS AND METHODS: This was a multicenter, single-arm, open-label phase II study. Eligibility criteria included histologically confirmed adenocarcinoma, age 20–80 years, and an Eastern Cooperative Oncology Group performance status (PS) of 0–2. The primary endpoint was 1-year progression-free survival (PFS). The secondary endpoints included overall response rate (ORR), overall survival (OS), overall PFS, and safety. RESULTS: Between April 2010 and November 2012, 24 patients were enrolled from 12 institutions. The median age of the patients was 63 years (range 31–79) and there was a male/female ratio of 18/6. The number of PS 0/1 patients was 17/7 and locally advanced/metastatic disease was seen in 2/22 patients, respectively. The primary tumor site was the duodenum in 14 patients (58%) and jejunum in 10 patients (42%). The median follow-up time was 14.7 months (3.7–40.3). The 1-year PFS was 23.3%. The ORR was 9/20 (45%). The median PFS and OS times were 5.9 months (95% confidence interval [CI] 3.0–10.2) and 17.3 months (95% CI 11.7–19.0), respectively. Major grade 3/4 toxicities were neutropenia (38%), anemia/peripheral neuropathy (25%), and stenosis (17%). There were no treatment-related deaths. CONCLUSIONS: Although the primary endpoint was not met, mFOLFOX6 showed effective and good tolerance as a first-line treatment for SBA. |
format | Online Article Text |
id | pubmed-5608770 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2017 |
publisher | Springer Japan |
record_format | MEDLINE/PubMed |
spelling | pubmed-56087702017-10-05 A phase II study of 5-fluorouracil/L-leucovorin/oxaliplatin (mFOLFOX6) in Japanese patients with metastatic or unresectable small bowel adenocarcinoma Horimatsu, Takahiro Nakayama, Norisuke Moriwaki, Toshikazu Hirashima, Yoshinori Fujita, Mikio Asayama, Masako Moriyama, Ichiro Nakashima, Koji Baba, Eishi Kitamura, Hiroshi Tamura, Takao Hosokawa, Ayumu Yoshimura, Kenichi Muto, Manabu Int J Clin Oncol Original Article BACKGROUND: Several studies have suggested that chemotherapy prolonged survival in patients with metastatic or recurrent small bowel adenocarcinoma (SBA); however, there is still no standard chemotherapy regimen. Here, we evaluated the efficacy and safety of a 5-fluorouracil (5-FU)/L-leucovorin (l-LV)/oxaliplatin (mFOLFOX6) protocol as a first-line therapy for patients with SBA. PATIENTS AND METHODS: This was a multicenter, single-arm, open-label phase II study. Eligibility criteria included histologically confirmed adenocarcinoma, age 20–80 years, and an Eastern Cooperative Oncology Group performance status (PS) of 0–2. The primary endpoint was 1-year progression-free survival (PFS). The secondary endpoints included overall response rate (ORR), overall survival (OS), overall PFS, and safety. RESULTS: Between April 2010 and November 2012, 24 patients were enrolled from 12 institutions. The median age of the patients was 63 years (range 31–79) and there was a male/female ratio of 18/6. The number of PS 0/1 patients was 17/7 and locally advanced/metastatic disease was seen in 2/22 patients, respectively. The primary tumor site was the duodenum in 14 patients (58%) and jejunum in 10 patients (42%). The median follow-up time was 14.7 months (3.7–40.3). The 1-year PFS was 23.3%. The ORR was 9/20 (45%). The median PFS and OS times were 5.9 months (95% confidence interval [CI] 3.0–10.2) and 17.3 months (95% CI 11.7–19.0), respectively. Major grade 3/4 toxicities were neutropenia (38%), anemia/peripheral neuropathy (25%), and stenosis (17%). There were no treatment-related deaths. CONCLUSIONS: Although the primary endpoint was not met, mFOLFOX6 showed effective and good tolerance as a first-line treatment for SBA. Springer Japan 2017-05-23 2017 /pmc/articles/PMC5608770/ /pubmed/28536826 http://dx.doi.org/10.1007/s10147-017-1138-6 Text en © The Author(s) 2017 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. |
spellingShingle | Original Article Horimatsu, Takahiro Nakayama, Norisuke Moriwaki, Toshikazu Hirashima, Yoshinori Fujita, Mikio Asayama, Masako Moriyama, Ichiro Nakashima, Koji Baba, Eishi Kitamura, Hiroshi Tamura, Takao Hosokawa, Ayumu Yoshimura, Kenichi Muto, Manabu A phase II study of 5-fluorouracil/L-leucovorin/oxaliplatin (mFOLFOX6) in Japanese patients with metastatic or unresectable small bowel adenocarcinoma |
title | A phase II study of 5-fluorouracil/L-leucovorin/oxaliplatin (mFOLFOX6) in Japanese patients with metastatic or unresectable small bowel adenocarcinoma
|
title_full | A phase II study of 5-fluorouracil/L-leucovorin/oxaliplatin (mFOLFOX6) in Japanese patients with metastatic or unresectable small bowel adenocarcinoma
|
title_fullStr | A phase II study of 5-fluorouracil/L-leucovorin/oxaliplatin (mFOLFOX6) in Japanese patients with metastatic or unresectable small bowel adenocarcinoma
|
title_full_unstemmed | A phase II study of 5-fluorouracil/L-leucovorin/oxaliplatin (mFOLFOX6) in Japanese patients with metastatic or unresectable small bowel adenocarcinoma
|
title_short | A phase II study of 5-fluorouracil/L-leucovorin/oxaliplatin (mFOLFOX6) in Japanese patients with metastatic or unresectable small bowel adenocarcinoma
|
title_sort | phase ii study of 5-fluorouracil/l-leucovorin/oxaliplatin (mfolfox6) in japanese patients with metastatic or unresectable small bowel adenocarcinoma |
topic | Original Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5608770/ https://www.ncbi.nlm.nih.gov/pubmed/28536826 http://dx.doi.org/10.1007/s10147-017-1138-6 |
work_keys_str_mv | AT horimatsutakahiro aphaseiistudyof5fluorouracillleucovorinoxaliplatinmfolfox6injapanesepatientswithmetastaticorunresectablesmallboweladenocarcinoma AT nakayamanorisuke aphaseiistudyof5fluorouracillleucovorinoxaliplatinmfolfox6injapanesepatientswithmetastaticorunresectablesmallboweladenocarcinoma AT moriwakitoshikazu aphaseiistudyof5fluorouracillleucovorinoxaliplatinmfolfox6injapanesepatientswithmetastaticorunresectablesmallboweladenocarcinoma AT hirashimayoshinori aphaseiistudyof5fluorouracillleucovorinoxaliplatinmfolfox6injapanesepatientswithmetastaticorunresectablesmallboweladenocarcinoma AT fujitamikio aphaseiistudyof5fluorouracillleucovorinoxaliplatinmfolfox6injapanesepatientswithmetastaticorunresectablesmallboweladenocarcinoma AT asayamamasako aphaseiistudyof5fluorouracillleucovorinoxaliplatinmfolfox6injapanesepatientswithmetastaticorunresectablesmallboweladenocarcinoma AT moriyamaichiro aphaseiistudyof5fluorouracillleucovorinoxaliplatinmfolfox6injapanesepatientswithmetastaticorunresectablesmallboweladenocarcinoma AT nakashimakoji aphaseiistudyof5fluorouracillleucovorinoxaliplatinmfolfox6injapanesepatientswithmetastaticorunresectablesmallboweladenocarcinoma AT babaeishi aphaseiistudyof5fluorouracillleucovorinoxaliplatinmfolfox6injapanesepatientswithmetastaticorunresectablesmallboweladenocarcinoma AT kitamurahiroshi aphaseiistudyof5fluorouracillleucovorinoxaliplatinmfolfox6injapanesepatientswithmetastaticorunresectablesmallboweladenocarcinoma AT tamuratakao aphaseiistudyof5fluorouracillleucovorinoxaliplatinmfolfox6injapanesepatientswithmetastaticorunresectablesmallboweladenocarcinoma AT hosokawaayumu aphaseiistudyof5fluorouracillleucovorinoxaliplatinmfolfox6injapanesepatientswithmetastaticorunresectablesmallboweladenocarcinoma AT yoshimurakenichi aphaseiistudyof5fluorouracillleucovorinoxaliplatinmfolfox6injapanesepatientswithmetastaticorunresectablesmallboweladenocarcinoma AT mutomanabu aphaseiistudyof5fluorouracillleucovorinoxaliplatinmfolfox6injapanesepatientswithmetastaticorunresectablesmallboweladenocarcinoma AT horimatsutakahiro phaseiistudyof5fluorouracillleucovorinoxaliplatinmfolfox6injapanesepatientswithmetastaticorunresectablesmallboweladenocarcinoma AT nakayamanorisuke phaseiistudyof5fluorouracillleucovorinoxaliplatinmfolfox6injapanesepatientswithmetastaticorunresectablesmallboweladenocarcinoma AT moriwakitoshikazu phaseiistudyof5fluorouracillleucovorinoxaliplatinmfolfox6injapanesepatientswithmetastaticorunresectablesmallboweladenocarcinoma AT hirashimayoshinori phaseiistudyof5fluorouracillleucovorinoxaliplatinmfolfox6injapanesepatientswithmetastaticorunresectablesmallboweladenocarcinoma AT fujitamikio phaseiistudyof5fluorouracillleucovorinoxaliplatinmfolfox6injapanesepatientswithmetastaticorunresectablesmallboweladenocarcinoma AT asayamamasako phaseiistudyof5fluorouracillleucovorinoxaliplatinmfolfox6injapanesepatientswithmetastaticorunresectablesmallboweladenocarcinoma AT moriyamaichiro phaseiistudyof5fluorouracillleucovorinoxaliplatinmfolfox6injapanesepatientswithmetastaticorunresectablesmallboweladenocarcinoma AT nakashimakoji phaseiistudyof5fluorouracillleucovorinoxaliplatinmfolfox6injapanesepatientswithmetastaticorunresectablesmallboweladenocarcinoma AT babaeishi phaseiistudyof5fluorouracillleucovorinoxaliplatinmfolfox6injapanesepatientswithmetastaticorunresectablesmallboweladenocarcinoma AT kitamurahiroshi phaseiistudyof5fluorouracillleucovorinoxaliplatinmfolfox6injapanesepatientswithmetastaticorunresectablesmallboweladenocarcinoma AT tamuratakao phaseiistudyof5fluorouracillleucovorinoxaliplatinmfolfox6injapanesepatientswithmetastaticorunresectablesmallboweladenocarcinoma AT hosokawaayumu phaseiistudyof5fluorouracillleucovorinoxaliplatinmfolfox6injapanesepatientswithmetastaticorunresectablesmallboweladenocarcinoma AT yoshimurakenichi phaseiistudyof5fluorouracillleucovorinoxaliplatinmfolfox6injapanesepatientswithmetastaticorunresectablesmallboweladenocarcinoma AT mutomanabu phaseiistudyof5fluorouracillleucovorinoxaliplatinmfolfox6injapanesepatientswithmetastaticorunresectablesmallboweladenocarcinoma |