Cargando…
Phase II Study of Adjuvant Chemoradiotherapy Using Docetaxel/Cisplatin/5-Fluorouracil Before and After Intensity-modulated Radiotherapy With Concurrent Docetaxel in Patients With Completely (R0) Resected Gastric Carcinoma
OBJECTIVES: The Intergroup 0116 study has demonstrated a significant survival benefit for completely resected (R0) gastric cancer patients treated with a fluorouracil/leucovorin chemoradiotherapy regimen. However, this regimen is also toxic and less effective in terms of distant disease control. The...
Autores principales: | , , , , , , , , , , , , , , , |
---|---|
Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Lippincott Williams & Wilkins
2018
|
Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6023597/ https://www.ncbi.nlm.nih.gov/pubmed/28263232 http://dx.doi.org/10.1097/COC.0000000000000373 |
_version_ | 1783335899852963840 |
---|---|
author | Liu, Yong Zhao, Guoqi Xu, Yi Zhang, Tiening Chen, Zhixiao Yan, Ge Tu, Wenzhi Hu, Ye Chen, Ying He, Xia Li, Xiaodong Chen, Hui Yao, Shengyu Hu, Zhekai Chen, Xuming Chen, Tingfeng |
author_facet | Liu, Yong Zhao, Guoqi Xu, Yi Zhang, Tiening Chen, Zhixiao Yan, Ge Tu, Wenzhi Hu, Ye Chen, Ying He, Xia Li, Xiaodong Chen, Hui Yao, Shengyu Hu, Zhekai Chen, Xuming Chen, Tingfeng |
author_sort | Liu, Yong |
collection | PubMed |
description | OBJECTIVES: The Intergroup 0116 study has demonstrated a significant survival benefit for completely resected (R0) gastric cancer patients treated with a fluorouracil/leucovorin chemoradiotherapy regimen. However, this regimen is also toxic and less effective in terms of distant disease control. Therefore, a more efficacious and safer regimen is urgently needed. METHODS: Patients with R0 resected gastric carcinoma received up to two 21-day cycles of postoperative adjuvant preradiation and postradiation DCF chemotherapy (docetaxel 37.5 mg/m(2) on days 1 and 8, cisplatin 25 mg/m(2) on days 1 to 3, and a continuous infusion of fluorouracil 750 mg/m(2) on days 1 to 5), respectively. Chemoradiotherapy between preradiation and postradiation chemotherapy was initiated on day 43 and consisted of intensity-modulated radiotherapy (45 Gy) plus concurrent docetaxel 20 mg/m(2) weekly for 5 weeks. RESULTS: A total of 55 patients were evaluated and 76% (42) of patients completed the prescribed therapy. With a median follow-up of 61 months, the 3- and 5-year progression-free survival rates were 67% (95% confidence interval [CI], 54%-80%) and 59% (95% CI, 46%-72%), respectively; and the 3- and 5-year overall survival rates were 72% (95% CI, 60%-84%) and 61% (95% CI, 48%-74%), respectively. The most common grade 3 or greater toxicity, during the chemotherapy phase, was neutropenia (24%). Common grade 3/4 toxicities during concurrent chemoradiotherapy were nausea (32%), vomiting (26%), fatigue (15%), and anorexia (19%). CONCLUSIONS: These results demonstrate that this adjuvant regimen is active with an acceptable toxicity profile. A randomized phase 3 trial comparing the Intergroup 0116 chemoradiotherapy regimen with this regimen is underway. |
format | Online Article Text |
id | pubmed-6023597 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2018 |
publisher | Lippincott Williams & Wilkins |
record_format | MEDLINE/PubMed |
spelling | pubmed-60235972018-07-11 Phase II Study of Adjuvant Chemoradiotherapy Using Docetaxel/Cisplatin/5-Fluorouracil Before and After Intensity-modulated Radiotherapy With Concurrent Docetaxel in Patients With Completely (R0) Resected Gastric Carcinoma Liu, Yong Zhao, Guoqi Xu, Yi Zhang, Tiening Chen, Zhixiao Yan, Ge Tu, Wenzhi Hu, Ye Chen, Ying He, Xia Li, Xiaodong Chen, Hui Yao, Shengyu Hu, Zhekai Chen, Xuming Chen, Tingfeng Am J Clin Oncol Original Articles: Gastrointestinal OBJECTIVES: The Intergroup 0116 study has demonstrated a significant survival benefit for completely resected (R0) gastric cancer patients treated with a fluorouracil/leucovorin chemoradiotherapy regimen. However, this regimen is also toxic and less effective in terms of distant disease control. Therefore, a more efficacious and safer regimen is urgently needed. METHODS: Patients with R0 resected gastric carcinoma received up to two 21-day cycles of postoperative adjuvant preradiation and postradiation DCF chemotherapy (docetaxel 37.5 mg/m(2) on days 1 and 8, cisplatin 25 mg/m(2) on days 1 to 3, and a continuous infusion of fluorouracil 750 mg/m(2) on days 1 to 5), respectively. Chemoradiotherapy between preradiation and postradiation chemotherapy was initiated on day 43 and consisted of intensity-modulated radiotherapy (45 Gy) plus concurrent docetaxel 20 mg/m(2) weekly for 5 weeks. RESULTS: A total of 55 patients were evaluated and 76% (42) of patients completed the prescribed therapy. With a median follow-up of 61 months, the 3- and 5-year progression-free survival rates were 67% (95% confidence interval [CI], 54%-80%) and 59% (95% CI, 46%-72%), respectively; and the 3- and 5-year overall survival rates were 72% (95% CI, 60%-84%) and 61% (95% CI, 48%-74%), respectively. The most common grade 3 or greater toxicity, during the chemotherapy phase, was neutropenia (24%). Common grade 3/4 toxicities during concurrent chemoradiotherapy were nausea (32%), vomiting (26%), fatigue (15%), and anorexia (19%). CONCLUSIONS: These results demonstrate that this adjuvant regimen is active with an acceptable toxicity profile. A randomized phase 3 trial comparing the Intergroup 0116 chemoradiotherapy regimen with this regimen is underway. Lippincott Williams & Wilkins 2018-07 2017-03-03 /pmc/articles/PMC6023597/ /pubmed/28263232 http://dx.doi.org/10.1097/COC.0000000000000373 Text en Copyright © 2017 The Author(s). Published by Wolters Kluwer Health, Inc. This is an open-access article distributed under the terms of the Creative Commons Attribution-Non Commercial-No Derivatives License 4.0 (http://creativecommons.org/licenses/by-nc-nd/4.0/) (CCBY-NC-ND), where it is permissible to download and share the work provided it is properly cited. The work cannot be changed in any way or used commercially without permission from the journal. http://creativecommons.org/licenses/by-nc-nd/4.0/ |
spellingShingle | Original Articles: Gastrointestinal Liu, Yong Zhao, Guoqi Xu, Yi Zhang, Tiening Chen, Zhixiao Yan, Ge Tu, Wenzhi Hu, Ye Chen, Ying He, Xia Li, Xiaodong Chen, Hui Yao, Shengyu Hu, Zhekai Chen, Xuming Chen, Tingfeng Phase II Study of Adjuvant Chemoradiotherapy Using Docetaxel/Cisplatin/5-Fluorouracil Before and After Intensity-modulated Radiotherapy With Concurrent Docetaxel in Patients With Completely (R0) Resected Gastric Carcinoma |
title | Phase II Study of Adjuvant Chemoradiotherapy Using Docetaxel/Cisplatin/5-Fluorouracil Before and After Intensity-modulated Radiotherapy With Concurrent Docetaxel in Patients With Completely (R0) Resected Gastric Carcinoma |
title_full | Phase II Study of Adjuvant Chemoradiotherapy Using Docetaxel/Cisplatin/5-Fluorouracil Before and After Intensity-modulated Radiotherapy With Concurrent Docetaxel in Patients With Completely (R0) Resected Gastric Carcinoma |
title_fullStr | Phase II Study of Adjuvant Chemoradiotherapy Using Docetaxel/Cisplatin/5-Fluorouracil Before and After Intensity-modulated Radiotherapy With Concurrent Docetaxel in Patients With Completely (R0) Resected Gastric Carcinoma |
title_full_unstemmed | Phase II Study of Adjuvant Chemoradiotherapy Using Docetaxel/Cisplatin/5-Fluorouracil Before and After Intensity-modulated Radiotherapy With Concurrent Docetaxel in Patients With Completely (R0) Resected Gastric Carcinoma |
title_short | Phase II Study of Adjuvant Chemoradiotherapy Using Docetaxel/Cisplatin/5-Fluorouracil Before and After Intensity-modulated Radiotherapy With Concurrent Docetaxel in Patients With Completely (R0) Resected Gastric Carcinoma |
title_sort | phase ii study of adjuvant chemoradiotherapy using docetaxel/cisplatin/5-fluorouracil before and after intensity-modulated radiotherapy with concurrent docetaxel in patients with completely (r0) resected gastric carcinoma |
topic | Original Articles: Gastrointestinal |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6023597/ https://www.ncbi.nlm.nih.gov/pubmed/28263232 http://dx.doi.org/10.1097/COC.0000000000000373 |
work_keys_str_mv | AT liuyong phaseiistudyofadjuvantchemoradiotherapyusingdocetaxelcisplatin5fluorouracilbeforeandafterintensitymodulatedradiotherapywithconcurrentdocetaxelinpatientswithcompletelyr0resectedgastriccarcinoma AT zhaoguoqi phaseiistudyofadjuvantchemoradiotherapyusingdocetaxelcisplatin5fluorouracilbeforeandafterintensitymodulatedradiotherapywithconcurrentdocetaxelinpatientswithcompletelyr0resectedgastriccarcinoma AT xuyi phaseiistudyofadjuvantchemoradiotherapyusingdocetaxelcisplatin5fluorouracilbeforeandafterintensitymodulatedradiotherapywithconcurrentdocetaxelinpatientswithcompletelyr0resectedgastriccarcinoma AT zhangtiening phaseiistudyofadjuvantchemoradiotherapyusingdocetaxelcisplatin5fluorouracilbeforeandafterintensitymodulatedradiotherapywithconcurrentdocetaxelinpatientswithcompletelyr0resectedgastriccarcinoma AT chenzhixiao phaseiistudyofadjuvantchemoradiotherapyusingdocetaxelcisplatin5fluorouracilbeforeandafterintensitymodulatedradiotherapywithconcurrentdocetaxelinpatientswithcompletelyr0resectedgastriccarcinoma AT yange phaseiistudyofadjuvantchemoradiotherapyusingdocetaxelcisplatin5fluorouracilbeforeandafterintensitymodulatedradiotherapywithconcurrentdocetaxelinpatientswithcompletelyr0resectedgastriccarcinoma AT tuwenzhi phaseiistudyofadjuvantchemoradiotherapyusingdocetaxelcisplatin5fluorouracilbeforeandafterintensitymodulatedradiotherapywithconcurrentdocetaxelinpatientswithcompletelyr0resectedgastriccarcinoma AT huye phaseiistudyofadjuvantchemoradiotherapyusingdocetaxelcisplatin5fluorouracilbeforeandafterintensitymodulatedradiotherapywithconcurrentdocetaxelinpatientswithcompletelyr0resectedgastriccarcinoma AT chenying phaseiistudyofadjuvantchemoradiotherapyusingdocetaxelcisplatin5fluorouracilbeforeandafterintensitymodulatedradiotherapywithconcurrentdocetaxelinpatientswithcompletelyr0resectedgastriccarcinoma AT hexia phaseiistudyofadjuvantchemoradiotherapyusingdocetaxelcisplatin5fluorouracilbeforeandafterintensitymodulatedradiotherapywithconcurrentdocetaxelinpatientswithcompletelyr0resectedgastriccarcinoma AT lixiaodong phaseiistudyofadjuvantchemoradiotherapyusingdocetaxelcisplatin5fluorouracilbeforeandafterintensitymodulatedradiotherapywithconcurrentdocetaxelinpatientswithcompletelyr0resectedgastriccarcinoma AT chenhui phaseiistudyofadjuvantchemoradiotherapyusingdocetaxelcisplatin5fluorouracilbeforeandafterintensitymodulatedradiotherapywithconcurrentdocetaxelinpatientswithcompletelyr0resectedgastriccarcinoma AT yaoshengyu phaseiistudyofadjuvantchemoradiotherapyusingdocetaxelcisplatin5fluorouracilbeforeandafterintensitymodulatedradiotherapywithconcurrentdocetaxelinpatientswithcompletelyr0resectedgastriccarcinoma AT huzhekai phaseiistudyofadjuvantchemoradiotherapyusingdocetaxelcisplatin5fluorouracilbeforeandafterintensitymodulatedradiotherapywithconcurrentdocetaxelinpatientswithcompletelyr0resectedgastriccarcinoma AT chenxuming phaseiistudyofadjuvantchemoradiotherapyusingdocetaxelcisplatin5fluorouracilbeforeandafterintensitymodulatedradiotherapywithconcurrentdocetaxelinpatientswithcompletelyr0resectedgastriccarcinoma AT chentingfeng phaseiistudyofadjuvantchemoradiotherapyusingdocetaxelcisplatin5fluorouracilbeforeandafterintensitymodulatedradiotherapywithconcurrentdocetaxelinpatientswithcompletelyr0resectedgastriccarcinoma |