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Adjuvant sequential methotrexate → 5-fluorouracil vs 5-fluorouracil plus leucovorin in radically resected stage III and high-risk stage II colon cancer
The aim of the study was to determine whether modulation of 5-fluorouracil (FU) by methotrexate (MTX) improves survival compared to FU+6-s-leucovorin (LV) following potentially curative resection of stage II and III colon cancer. Within 8 weeks from surgery, 1945 patients with stage III (44%) or hig...
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Formato: | Texto |
Lenguaje: | English |
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Nature Publishing Group
2005
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Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2361725/ https://www.ncbi.nlm.nih.gov/pubmed/15611795 http://dx.doi.org/10.1038/sj.bjc.6602276 |
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author | Sobrero, A Frassineti, G Falcone, A Dogliotti, L Rosso, R Costanzo, F D Bruzzi, P |
author_facet | Sobrero, A Frassineti, G Falcone, A Dogliotti, L Rosso, R Costanzo, F D Bruzzi, P |
author_sort | Sobrero, A |
collection | PubMed |
description | The aim of the study was to determine whether modulation of 5-fluorouracil (FU) by methotrexate (MTX) improves survival compared to FU+6-s-leucovorin (LV) following potentially curative resection of stage II and III colon cancer. Within 8 weeks from surgery, 1945 patients with stage III (44%) or high-risk stage II (55%) colon cancer were randomly assigned to receive either 6 monthly cycles of FU 370 mg m(−2) i.v. bolus preceded by LV 100 mg m(−2) i.v. bolus on days 1–5, or 6 monthly cycles of sequential MTX 200 mg m(−2) i.v. days 1 and 15 and FU 600 mg m(−2) i.v. on days 2 and 16 followed by LV rescue (15 mg given p.o. q 6 h × 6 doses). Levamisole 50 mg p.o. t.i.d. on days 1–3, every 14 days for 6 months, was planned to be given in both arms. After a median follow-up of 4.2 years, 568 patients have relapsed and 403 have died. Survival was similar with MTX → FU and FU+LV (77 vs 77% at 5 years; P=0.90), as were 5-year disease-free survivals (67 vs 63%; P=0.44). Efficacy results were similar for both stage III and II patients. There were two toxic deaths, two in the MTX → FU arm (0.2%) and zero in the control arm. We conclude that biochemical modulation of FU with LV or with MTX produces similar results in the adjuvant setting of colon cancer. |
format | Text |
id | pubmed-2361725 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2005 |
publisher | Nature Publishing Group |
record_format | MEDLINE/PubMed |
spelling | pubmed-23617252009-09-10 Adjuvant sequential methotrexate → 5-fluorouracil vs 5-fluorouracil plus leucovorin in radically resected stage III and high-risk stage II colon cancer Sobrero, A Frassineti, G Falcone, A Dogliotti, L Rosso, R Costanzo, F D Bruzzi, P Br J Cancer Clinical Study The aim of the study was to determine whether modulation of 5-fluorouracil (FU) by methotrexate (MTX) improves survival compared to FU+6-s-leucovorin (LV) following potentially curative resection of stage II and III colon cancer. Within 8 weeks from surgery, 1945 patients with stage III (44%) or high-risk stage II (55%) colon cancer were randomly assigned to receive either 6 monthly cycles of FU 370 mg m(−2) i.v. bolus preceded by LV 100 mg m(−2) i.v. bolus on days 1–5, or 6 monthly cycles of sequential MTX 200 mg m(−2) i.v. days 1 and 15 and FU 600 mg m(−2) i.v. on days 2 and 16 followed by LV rescue (15 mg given p.o. q 6 h × 6 doses). Levamisole 50 mg p.o. t.i.d. on days 1–3, every 14 days for 6 months, was planned to be given in both arms. After a median follow-up of 4.2 years, 568 patients have relapsed and 403 have died. Survival was similar with MTX → FU and FU+LV (77 vs 77% at 5 years; P=0.90), as were 5-year disease-free survivals (67 vs 63%; P=0.44). Efficacy results were similar for both stage III and II patients. There were two toxic deaths, two in the MTX → FU arm (0.2%) and zero in the control arm. We conclude that biochemical modulation of FU with LV or with MTX produces similar results in the adjuvant setting of colon cancer. Nature Publishing Group 2005-01-17 2004-12-21 /pmc/articles/PMC2361725/ /pubmed/15611795 http://dx.doi.org/10.1038/sj.bjc.6602276 Text en Copyright © 2005 Cancer Research UK https://creativecommons.org/licenses/by/4.0/This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as 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 images or other third party material in this article are included in the article’s Creative Commons license, unless indicated otherwise in a credit line to the material.If material is not included in the article’s Creative Commons license and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this license, visit https://creativecommons.org/licenses/by/4.0/. |
spellingShingle | Clinical Study Sobrero, A Frassineti, G Falcone, A Dogliotti, L Rosso, R Costanzo, F D Bruzzi, P Adjuvant sequential methotrexate → 5-fluorouracil vs 5-fluorouracil plus leucovorin in radically resected stage III and high-risk stage II colon cancer |
title | Adjuvant sequential methotrexate → 5-fluorouracil vs 5-fluorouracil plus leucovorin in radically resected stage III and high-risk stage II colon cancer |
title_full | Adjuvant sequential methotrexate → 5-fluorouracil vs 5-fluorouracil plus leucovorin in radically resected stage III and high-risk stage II colon cancer |
title_fullStr | Adjuvant sequential methotrexate → 5-fluorouracil vs 5-fluorouracil plus leucovorin in radically resected stage III and high-risk stage II colon cancer |
title_full_unstemmed | Adjuvant sequential methotrexate → 5-fluorouracil vs 5-fluorouracil plus leucovorin in radically resected stage III and high-risk stage II colon cancer |
title_short | Adjuvant sequential methotrexate → 5-fluorouracil vs 5-fluorouracil plus leucovorin in radically resected stage III and high-risk stage II colon cancer |
title_sort | adjuvant sequential methotrexate → 5-fluorouracil vs 5-fluorouracil plus leucovorin in radically resected stage iii and high-risk stage ii colon cancer |
topic | Clinical Study |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2361725/ https://www.ncbi.nlm.nih.gov/pubmed/15611795 http://dx.doi.org/10.1038/sj.bjc.6602276 |
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