Hideki Ishikawa1, Michihiro Mutoh2, Sadao Suzuki3, Shinkan Tokudome4, Yoshihisa Saida5, Takashi Abe6, Shozo Okamura7, Masahiro Tajika8, Takashi Joh9, Shinji Tanaka10, Shin-Ei Kudo11, Takahisa Matsuda12, Masaki Iimuro13, Tomomi Yukawa14, Tetsuji Takayama15, Yasushi Sato16, Kyowon Lee17, Shinji Kitamura18, Motowo Mizuno19, Yasushi Sano20, Nobuhisa Gondo21, Kenji Sugimoto22, Masato Kusunoki23, Chiho Goto24, Nariaki Matsuura25, Toshiyuki Sakai1, Keiji Wakabayashi26. 1. Department of Molecular-Targeting Cancer Prevention, Kyoto Prefectural University of Medicine, Kyoto, Japan. 2. Division of Cancer Prevention Research, National Cancer Center Research Institute, Tokyo, Japan. 3. Department of Public Health, Nagoya City University Graduate School of Medical Sciences, Aichi, Japan. 4. Department of Public Health, Nagoya City University Graduate School of Medical Sciences, Aichi, Japan National Institute of Health and Nutrition, Tokyo, Japan. 5. Toho University Ohashi Medical Center, Tokyo, Japan. 6. Department of Gastroenterology, Takarazuka Municipal Hospital, Hyogo, Japan. 7. Department of Internal Medicine, Toyohashi Municipal Hospital, Aichi, Japan. 8. Department of Endoscopy, Aichi Cancer Center Hospital, Aichi, Japan. 9. Department of Gastroenterology and Metabolism, Nagoya City University Graduate School of Medical Sciences, Aichi, Japan. 10. Department of Endoscopy, Hiroshima University Hospital, Hiroshima, Japan. 11. Digestive Disease Center Northern Yokohama Hospital Showa University, School of Medicine, Kanagawa, Japan. 12. Endoscopy Division, National Cancer Center Hospital, Tokyo, Japan. 13. Higashisumiyoshi Morimoto Hospital, Osaka, Japan Department of Lower Gastroenterology, Hyogo College of Medicine, Hyogo, Japan. 14. Higashisumiyoshi Morimoto Hospital, Osaka, Japan. 15. Department of Gastroenterology and Oncology, Institute of Health Biosciences, The University of Tokushima Graduate School, Tokushima, Japan. 16. 4th Department of Internal Medicine, Sapporo Medical University, School of Medicine, Hokkaido, Japan. 17. Moriguchi Keijinkai Hospital, Osaka, Japan. 18. Department of Gastroenterology, Sakai City Hospital, Osaka, Japan. 19. Department of Internal Medicine, Hiroshima City Hospital, Hiroshima, Japan. 20. Division of Digestive Endoscopy and Gastrointestinal Oncology, National Cancer Center Hospital East, Chiba, Japan. 21. Kimura Hospital, Hyogo, Japan. 22. Sugimoto Kenji Clinic, Osaka, Japan. 23. Department of Gastrointestinal and Pediatric Surgery Division of Reparative Medicine, Institute of Life Sciences, Mie University Graduate School of Medicine, Mie, Japan. 24. Department of Health and Nutrition, Nagoya-Bunri University, Aichi, Japan. 25. Department of Functional Diagnostic Science, Osaka University Graduate School of Medicine, Osaka, Japan. 26. Graduate Division of Nutritional and Environmental Sciences, University of Shizuoka, Shizuoka, Japan.
Abstract
OBJECTIVE: To evaluate the influence of low-dose, enteric-coated aspirin tablets (100 mg/day for 2 years) on colorectal tumour recurrence in Asian patients with single/multiple colorectal tumours excised by endoscopy. DESIGN: A double-blinded, randomised, placebo-controlled multicentre clinical trial was conducted. PARTICIPANTS: 311 subjects with single/multiple colorectal adenomas and adenocarcinomas excised by endoscopy were enrolled in the study (152 patients in the aspirin group and 159 patients in the placebo group). Enrolment began at the hospitals (n=19) in 2007 and was completed in 2009. RESULTS: The subjects treated with aspirin displayed reduced colorectal tumourigenesis and primary endpoints with an adjusted OR of 0.60 (95% CI 0.36 to 0.98) compared with the subjects in the placebo group. Subgroup analysis revealed that subjects who were non-smokers, defined as those who had smoked in the past or who had never smoked, had a marked reduction in the number of recurrent tumours in the aspirin-treated group. The adjusted OR for aspirin treatment in non-smokers was 0.37 (CI 0.21 to 0.68, p<0.05). Interestingly, the use of aspirin in smokers resulted in an increased risk, with an OR of 3.44. In addition, no severe adverse effects were observed in either group. CONCLUSIONS: Low-dose, enteric-coated aspirin tablets reduced colorectal tumour recurrence in an Asian population. The results are consistent with those obtained from other randomised controlled trials in Western countries. THE CLINICAL TRIAL REGISTRY WEBSITE AND THE CLINICAL TRIAL NUMBER: http://www.umin.ac.jp (number UMIN000000697). Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.
RCT Entities:
OBJECTIVE: To evaluate the influence of low-dose, enteric-coated aspirin tablets (100 mg/day for 2 years) on colorectal tumour recurrence in Asian patients with single/multiple colorectal tumours excised by endoscopy. DESIGN: A double-blinded, randomised, placebo-controlled multicentre clinical trial was conducted. PARTICIPANTS: 311 subjects with single/multiple colorectal adenomas and adenocarcinomas excised by endoscopy were enrolled in the study (152 patients in the aspirin group and 159 patients in the placebo group). Enrolment began at the hospitals (n=19) in 2007 and was completed in 2009. RESULTS: The subjects treated with aspirin displayed reduced colorectal tumourigenesis and primary endpoints with an adjusted OR of 0.60 (95% CI 0.36 to 0.98) compared with the subjects in the placebo group. Subgroup analysis revealed that subjects who were non-smokers, defined as those who had smoked in the past or who had never smoked, had a marked reduction in the number of recurrent tumours in the aspirin-treated group. The adjusted OR for aspirin treatment in non-smokers was 0.37 (CI 0.21 to 0.68, p<0.05). Interestingly, the use of aspirin in smokers resulted in an increased risk, with an OR of 3.44. In addition, no severe adverse effects were observed in either group. CONCLUSIONS: Low-dose, enteric-coated aspirin tablets reduced colorectal tumour recurrence in an Asian population. The results are consistent with those obtained from other randomised controlled trials in Western countries. THE CLINICAL TRIAL REGISTRY WEBSITE AND THE CLINICAL TRIAL NUMBER: http://www.umin.ac.jp (number UMIN000000697). Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.
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