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Adjuvant immunochemotherapy with oral Tegafur/Uracil plus PSK in patients with stage II or III colorectal cancer: a randomised controlled study
Intravenous fluorouracil and leucovorin is the standard adjuvant treatment for stage III colon cancer. However, oral adjuvant chemotherapy is attractive because it has low toxicity and greater convenience. We investigated the benefits of oral protein-bound polysaccharide K (PSK) with tegafur/uracil...
Autores principales: | , , , , , , , , , , , , |
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Formato: | Texto |
Lenguaje: | English |
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Nature Publishing Group
2004
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2409633/ https://www.ncbi.nlm.nih.gov/pubmed/14997197 http://dx.doi.org/10.1038/sj.bjc.6601619 |
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author | Ohwada, S Ikeya, T Yokomori, T Kusaba, T Roppongi, T Takahashi, T Nakamura, S Kakinuma, S Iwazaki, S Ishikawa, H Kawate, S Nakajima, T Morishita, Y |
author_facet | Ohwada, S Ikeya, T Yokomori, T Kusaba, T Roppongi, T Takahashi, T Nakamura, S Kakinuma, S Iwazaki, S Ishikawa, H Kawate, S Nakajima, T Morishita, Y |
author_sort | Ohwada, S |
collection | PubMed |
description | Intravenous fluorouracil and leucovorin is the standard adjuvant treatment for stage III colon cancer. However, oral adjuvant chemotherapy is attractive because it has low toxicity and greater convenience. We investigated the benefits of oral protein-bound polysaccharide K (PSK) with tegafur/uracil (UFT) as an adjuvant in stage II and III colorectal cancer. Patients were assigned to groups that received either 3 g PSK plus 300 mg UFT, or 300 mg UFT alone orally each day for a 2-year period following intravenous mitomycin C. Of 207 registered patients, 205 with stage II (n=123) or III (n=82) were analysed. The 5-year disease-free survival was 73.0% (95% CI 65.6–80.4%) with PSK (n=137) and 58.8% (95% CI 47.1–70.5%) in the controls (n=68) (P=0.016). Polysaccharide K reduced the recurrence by 43.6% (95% CI 4.5–66.7%) and mortality by 40.2% (95% CI −12.5 to 68.3%). The 5-year survival was 81.8% (95% CI 75.3–88.2%) in the PSK group and 72.1% (95% CI 61.4–82.7%) in the control group (P=0.056). In stage III patients, disease-free and overall survivals in patients receiving PSK were increased significantly: 60.0% (95% CI 47.1–72.9%) and 74.6% (95% CI 63.0–86.1%) in the PSK group as compared with 32.1% (95% CI 14.8–49.4%) and 46.4% (95% CI 28.0–64.9%) in the controls (P=0.002 and 0.003, respectively). Polysaccharide K prevented recurrence, particularly lung metastases (P=0.02; odds ratio 0.27; 95% CI 0.09–0.77). In the models, the presence of regional metastases (relative risk, 2.973; 95% CI 1.712–5.165; P<0.001), omission of PSK (relative risk, 2.106; 95% CI 1.221–3.633; P=0.007), and higher primary tumour (relative risk, 4.398; 95% CI 1.017–19.014; P=0.047) were each significant indicators of recurrence. Adverse effects were mild and compliance was good. Oral PSK with UFT reduced recurrence in stage II and III colorectal cancer, and increased survival in stage III. |
format | Text |
id | pubmed-2409633 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2004 |
publisher | Nature Publishing Group |
record_format | MEDLINE/PubMed |
spelling | pubmed-24096332009-09-10 Adjuvant immunochemotherapy with oral Tegafur/Uracil plus PSK in patients with stage II or III colorectal cancer: a randomised controlled study Ohwada, S Ikeya, T Yokomori, T Kusaba, T Roppongi, T Takahashi, T Nakamura, S Kakinuma, S Iwazaki, S Ishikawa, H Kawate, S Nakajima, T Morishita, Y Br J Cancer Clinical Intravenous fluorouracil and leucovorin is the standard adjuvant treatment for stage III colon cancer. However, oral adjuvant chemotherapy is attractive because it has low toxicity and greater convenience. We investigated the benefits of oral protein-bound polysaccharide K (PSK) with tegafur/uracil (UFT) as an adjuvant in stage II and III colorectal cancer. Patients were assigned to groups that received either 3 g PSK plus 300 mg UFT, or 300 mg UFT alone orally each day for a 2-year period following intravenous mitomycin C. Of 207 registered patients, 205 with stage II (n=123) or III (n=82) were analysed. The 5-year disease-free survival was 73.0% (95% CI 65.6–80.4%) with PSK (n=137) and 58.8% (95% CI 47.1–70.5%) in the controls (n=68) (P=0.016). Polysaccharide K reduced the recurrence by 43.6% (95% CI 4.5–66.7%) and mortality by 40.2% (95% CI −12.5 to 68.3%). The 5-year survival was 81.8% (95% CI 75.3–88.2%) in the PSK group and 72.1% (95% CI 61.4–82.7%) in the control group (P=0.056). In stage III patients, disease-free and overall survivals in patients receiving PSK were increased significantly: 60.0% (95% CI 47.1–72.9%) and 74.6% (95% CI 63.0–86.1%) in the PSK group as compared with 32.1% (95% CI 14.8–49.4%) and 46.4% (95% CI 28.0–64.9%) in the controls (P=0.002 and 0.003, respectively). Polysaccharide K prevented recurrence, particularly lung metastases (P=0.02; odds ratio 0.27; 95% CI 0.09–0.77). In the models, the presence of regional metastases (relative risk, 2.973; 95% CI 1.712–5.165; P<0.001), omission of PSK (relative risk, 2.106; 95% CI 1.221–3.633; P=0.007), and higher primary tumour (relative risk, 4.398; 95% CI 1.017–19.014; P=0.047) were each significant indicators of recurrence. Adverse effects were mild and compliance was good. Oral PSK with UFT reduced recurrence in stage II and III colorectal cancer, and increased survival in stage III. Nature Publishing Group 2004-03-08 2004-03-02 /pmc/articles/PMC2409633/ /pubmed/14997197 http://dx.doi.org/10.1038/sj.bjc.6601619 Text en Copyright © 2004 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 Ohwada, S Ikeya, T Yokomori, T Kusaba, T Roppongi, T Takahashi, T Nakamura, S Kakinuma, S Iwazaki, S Ishikawa, H Kawate, S Nakajima, T Morishita, Y Adjuvant immunochemotherapy with oral Tegafur/Uracil plus PSK in patients with stage II or III colorectal cancer: a randomised controlled study |
title | Adjuvant immunochemotherapy with oral Tegafur/Uracil plus PSK in patients with stage II or III colorectal cancer: a randomised controlled study |
title_full | Adjuvant immunochemotherapy with oral Tegafur/Uracil plus PSK in patients with stage II or III colorectal cancer: a randomised controlled study |
title_fullStr | Adjuvant immunochemotherapy with oral Tegafur/Uracil plus PSK in patients with stage II or III colorectal cancer: a randomised controlled study |
title_full_unstemmed | Adjuvant immunochemotherapy with oral Tegafur/Uracil plus PSK in patients with stage II or III colorectal cancer: a randomised controlled study |
title_short | Adjuvant immunochemotherapy with oral Tegafur/Uracil plus PSK in patients with stage II or III colorectal cancer: a randomised controlled study |
title_sort | adjuvant immunochemotherapy with oral tegafur/uracil plus psk in patients with stage ii or iii colorectal cancer: a randomised controlled study |
topic | Clinical |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2409633/ https://www.ncbi.nlm.nih.gov/pubmed/14997197 http://dx.doi.org/10.1038/sj.bjc.6601619 |
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