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Phase II study of neo-adjuvant chemotherapy for locally advanced gastric cancer
BACKGROUND: Neoadjuvant chemotherapy improves survival of locally advanced gastric cancer patients. However, benefit is limited and the best regimen remains controversial. OBJECTIVES: Our primary objective of this prospective, multicenter phase 2 study was to evaluate the pathological complete respo...
Autores principales: | , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BMJ Publishing Group
2016
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5013330/ https://www.ncbi.nlm.nih.gov/pubmed/27648294 http://dx.doi.org/10.1136/bmjgast-2016-000095 |
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author | Chang, Alex Yuang-Chi Foo, Kian Fong Koo, Wen-Hsin Ong, Simon So, Jimmy Tan, Daniel Lim, Khong Hee |
author_facet | Chang, Alex Yuang-Chi Foo, Kian Fong Koo, Wen-Hsin Ong, Simon So, Jimmy Tan, Daniel Lim, Khong Hee |
author_sort | Chang, Alex Yuang-Chi |
collection | PubMed |
description | BACKGROUND: Neoadjuvant chemotherapy improves survival of locally advanced gastric cancer patients. However, benefit is limited and the best regimen remains controversial. OBJECTIVES: Our primary objective of this prospective, multicenter phase 2 study was to evaluate the pathological complete response rate (PCR) with 2 cycles of docetaxel and capecitabine. METHODS: To be eligible, patients had to have histologically documented gastric cancer, a ECOG performance status 0 or 1, T(3or4) N(any) M(0) staging after oesophagogastroduodenoscopy (OGD), endoscopic ultrasound (EUS), CT scan of thorax and abdomen, and negative laparoscopic examination and peritoneal washing. Eligible patients received two cycles of intravenous docetaxel 60 mg/m(2) on day 1 and oral capecitabine 900 mg/m(2) two times per day from day 1 to day 14 every 3 weeks. We evaluated the response by CT scan and EUS. The patients underwent curative resection with D2 lymphadenectomy subsequently. RESULTS: 18 patients were enrolled in the study: 66% were male and the median age was 60 years. 17 patients had T3 disease at diagnosis. There was no pCR noted. 4 patients had a partial response of 22% (95% CI: 7–42%), 8 patients had stable disease and 3 patients had disease progression. The median survival was 17.1 months with 3 long-term survivors after at least 3 years of follow-up. The treatment was well tolerated with neutropenia being the most common toxicity. We observed 22% grade III and 33% grade IV neutropenia, but no neutropenic fever or death was observed from chemotherapy. CONCLUSION: Neo-adjuvant chemotherapy with docetaxel and capecitabine has limited activity against GC. More effective treatment regimens are needed urgently. TRIAL REGISTRATION NUMBER: NCT00414271. |
format | Online Article Text |
id | pubmed-5013330 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2016 |
publisher | BMJ Publishing Group |
record_format | MEDLINE/PubMed |
spelling | pubmed-50133302016-09-19 Phase II study of neo-adjuvant chemotherapy for locally advanced gastric cancer Chang, Alex Yuang-Chi Foo, Kian Fong Koo, Wen-Hsin Ong, Simon So, Jimmy Tan, Daniel Lim, Khong Hee BMJ Open Gastroenterol Gastric Cancer BACKGROUND: Neoadjuvant chemotherapy improves survival of locally advanced gastric cancer patients. However, benefit is limited and the best regimen remains controversial. OBJECTIVES: Our primary objective of this prospective, multicenter phase 2 study was to evaluate the pathological complete response rate (PCR) with 2 cycles of docetaxel and capecitabine. METHODS: To be eligible, patients had to have histologically documented gastric cancer, a ECOG performance status 0 or 1, T(3or4) N(any) M(0) staging after oesophagogastroduodenoscopy (OGD), endoscopic ultrasound (EUS), CT scan of thorax and abdomen, and negative laparoscopic examination and peritoneal washing. Eligible patients received two cycles of intravenous docetaxel 60 mg/m(2) on day 1 and oral capecitabine 900 mg/m(2) two times per day from day 1 to day 14 every 3 weeks. We evaluated the response by CT scan and EUS. The patients underwent curative resection with D2 lymphadenectomy subsequently. RESULTS: 18 patients were enrolled in the study: 66% were male and the median age was 60 years. 17 patients had T3 disease at diagnosis. There was no pCR noted. 4 patients had a partial response of 22% (95% CI: 7–42%), 8 patients had stable disease and 3 patients had disease progression. The median survival was 17.1 months with 3 long-term survivors after at least 3 years of follow-up. The treatment was well tolerated with neutropenia being the most common toxicity. We observed 22% grade III and 33% grade IV neutropenia, but no neutropenic fever or death was observed from chemotherapy. CONCLUSION: Neo-adjuvant chemotherapy with docetaxel and capecitabine has limited activity against GC. More effective treatment regimens are needed urgently. TRIAL REGISTRATION NUMBER: NCT00414271. BMJ Publishing Group 2016-08-23 /pmc/articles/PMC5013330/ /pubmed/27648294 http://dx.doi.org/10.1136/bmjgast-2016-000095 Text en Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/ This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/ |
spellingShingle | Gastric Cancer Chang, Alex Yuang-Chi Foo, Kian Fong Koo, Wen-Hsin Ong, Simon So, Jimmy Tan, Daniel Lim, Khong Hee Phase II study of neo-adjuvant chemotherapy for locally advanced gastric cancer |
title | Phase II study of neo-adjuvant chemotherapy for locally advanced gastric cancer |
title_full | Phase II study of neo-adjuvant chemotherapy for locally advanced gastric cancer |
title_fullStr | Phase II study of neo-adjuvant chemotherapy for locally advanced gastric cancer |
title_full_unstemmed | Phase II study of neo-adjuvant chemotherapy for locally advanced gastric cancer |
title_short | Phase II study of neo-adjuvant chemotherapy for locally advanced gastric cancer |
title_sort | phase ii study of neo-adjuvant chemotherapy for locally advanced gastric cancer |
topic | Gastric Cancer |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5013330/ https://www.ncbi.nlm.nih.gov/pubmed/27648294 http://dx.doi.org/10.1136/bmjgast-2016-000095 |
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