A phase II study of oxaliplatin with 5-FU/folinic acid and concomitant radiotherapy as a preoperative treatment in patients with locally advanced rectal cancer

Objective: To evaluate the activity and safety of adding oxaliplatin to a standard chemoradiotherapy schema, including 5-fluorouracil (5-FU)/folinic acid (FA), in locally-advanced rectal cancer (LARC). Methods: Two cycles of oxaliplatin 130 mg/m2 plus FA 20 mg/m2 bolus for 5 days and 5-FU 350 mg/m2...

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Main Authors: Chitapanarux I., Chitapanarux T., Tharavichitkul E., Mayurasakorn S., Siriwittayakorn P., Yamada S., Lorvidhaya V.
Format: Article
Language:English
Published: 2014
Online Access:http://www.scopus.com/inward/record.url?eid=2-s2.0-83455220049&partnerID=40&md5=538b3076f330acc5e7fc1d8cd7c8f095
http://www.ncbi.nlm.nih.gov/pubmed/22279502
http://cmuir.cmu.ac.th/handle/6653943832/2957
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spelling th-cmuir.6653943832-29572014-08-30T02:25:36Z A phase II study of oxaliplatin with 5-FU/folinic acid and concomitant radiotherapy as a preoperative treatment in patients with locally advanced rectal cancer Chitapanarux I. Chitapanarux T. Tharavichitkul E. Mayurasakorn S. Siriwittayakorn P. Yamada S. Lorvidhaya V. Objective: To evaluate the activity and safety of adding oxaliplatin to a standard chemoradiotherapy schema, including 5-fluorouracil (5-FU)/folinic acid (FA), in locally-advanced rectal cancer (LARC). Methods: Two cycles of oxaliplatin 130 mg/m2 plus FA 20 mg/m2 bolus for 5 days and 5-FU 350 mg/m2 continuous infusion for 5 days were given during week 1 and 4 of pelvic radiotherapy 46 Gy. Patients with a T3/4 and/or node-positive rectal tumour were eligible. Surgery was performed 4-6 weeks after radiotherapy. The primary endpoint was to determine the rate of pathological response. Secondary endpoints were to assess the rate of clinical response and the safety profile. Results: Between March 2005 and January 2009, a total of 35 patients were enrolled. The pathological downstaging rate was 79% with a pathological complete response rate of 17%. The overall clinical response rate (assessed by computed tomography or transrectal ultrasound) was 77%. Grade 3 diarrhoea and Grade 3 neutropaenia were reported in 14% and 11% of the patients, respectively. Eleven patients did not undergo surgery: four of them refused the operation, and seven patients were inoperable due to disease progression. In 24 patients who had surgery, a sphincter-preserving procedure could be performed in 29%. At the median follow-up time of 28.1 months, 25 patients (71%) survived with no evidence of disease. Conclusion: The promising results in terms of pathological response, and the associated good safety profile of a regimen of oxaliplatin plus 5-FU/FA with concomitant radiotherapy, suggest that the regimen could be used in LARC. © 2011 Biomedical Imaging and Intervention Journal. All rights reserved. 2014-08-30T02:25:36Z 2014-08-30T02:25:36Z 2011 Article 18235530 10.2349/biij.7.4.e25 http://www.scopus.com/inward/record.url?eid=2-s2.0-83455220049&partnerID=40&md5=538b3076f330acc5e7fc1d8cd7c8f095 http://www.ncbi.nlm.nih.gov/pubmed/22279502 http://cmuir.cmu.ac.th/handle/6653943832/2957 English
institution Chiang Mai University
building Chiang Mai University Library
country Thailand
collection CMU Intellectual Repository
language English
description Objective: To evaluate the activity and safety of adding oxaliplatin to a standard chemoradiotherapy schema, including 5-fluorouracil (5-FU)/folinic acid (FA), in locally-advanced rectal cancer (LARC). Methods: Two cycles of oxaliplatin 130 mg/m2 plus FA 20 mg/m2 bolus for 5 days and 5-FU 350 mg/m2 continuous infusion for 5 days were given during week 1 and 4 of pelvic radiotherapy 46 Gy. Patients with a T3/4 and/or node-positive rectal tumour were eligible. Surgery was performed 4-6 weeks after radiotherapy. The primary endpoint was to determine the rate of pathological response. Secondary endpoints were to assess the rate of clinical response and the safety profile. Results: Between March 2005 and January 2009, a total of 35 patients were enrolled. The pathological downstaging rate was 79% with a pathological complete response rate of 17%. The overall clinical response rate (assessed by computed tomography or transrectal ultrasound) was 77%. Grade 3 diarrhoea and Grade 3 neutropaenia were reported in 14% and 11% of the patients, respectively. Eleven patients did not undergo surgery: four of them refused the operation, and seven patients were inoperable due to disease progression. In 24 patients who had surgery, a sphincter-preserving procedure could be performed in 29%. At the median follow-up time of 28.1 months, 25 patients (71%) survived with no evidence of disease. Conclusion: The promising results in terms of pathological response, and the associated good safety profile of a regimen of oxaliplatin plus 5-FU/FA with concomitant radiotherapy, suggest that the regimen could be used in LARC. © 2011 Biomedical Imaging and Intervention Journal. All rights reserved.
format Article
author Chitapanarux I.
Chitapanarux T.
Tharavichitkul E.
Mayurasakorn S.
Siriwittayakorn P.
Yamada S.
Lorvidhaya V.
spellingShingle Chitapanarux I.
Chitapanarux T.
Tharavichitkul E.
Mayurasakorn S.
Siriwittayakorn P.
Yamada S.
Lorvidhaya V.
A phase II study of oxaliplatin with 5-FU/folinic acid and concomitant radiotherapy as a preoperative treatment in patients with locally advanced rectal cancer
author_facet Chitapanarux I.
Chitapanarux T.
Tharavichitkul E.
Mayurasakorn S.
Siriwittayakorn P.
Yamada S.
Lorvidhaya V.
author_sort Chitapanarux I.
title A phase II study of oxaliplatin with 5-FU/folinic acid and concomitant radiotherapy as a preoperative treatment in patients with locally advanced rectal cancer
title_short A phase II study of oxaliplatin with 5-FU/folinic acid and concomitant radiotherapy as a preoperative treatment in patients with locally advanced rectal cancer
title_full A phase II study of oxaliplatin with 5-FU/folinic acid and concomitant radiotherapy as a preoperative treatment in patients with locally advanced rectal cancer
title_fullStr A phase II study of oxaliplatin with 5-FU/folinic acid and concomitant radiotherapy as a preoperative treatment in patients with locally advanced rectal cancer
title_full_unstemmed A phase II study of oxaliplatin with 5-FU/folinic acid and concomitant radiotherapy as a preoperative treatment in patients with locally advanced rectal cancer
title_sort phase ii study of oxaliplatin with 5-fu/folinic acid and concomitant radiotherapy as a preoperative treatment in patients with locally advanced rectal cancer
publishDate 2014
url http://www.scopus.com/inward/record.url?eid=2-s2.0-83455220049&partnerID=40&md5=538b3076f330acc5e7fc1d8cd7c8f095
http://www.ncbi.nlm.nih.gov/pubmed/22279502
http://cmuir.cmu.ac.th/handle/6653943832/2957
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