BACKGROUND: A prospective feasibility study was planned to clarify the proportion of compliance and adverse events in the administration of capecitabine as adjuvant chemotherapy for colon cancer in Japanese patients. METHODS: We aimed initially to register 92 cases of R0 stage III colon cancer. Capecitabine (2,500 mg/m(2)/day) was given orally on days 1-14 every 3 weeks for 8 cycles. The proportion of treatments completed as planned was selected as the primary endpoint. RESULTS: Ninety-seven cases were registered and treated between September 2008 and August 2009. The proportion of treatments completed in the full analysis set was 64/97 [66.0%; 95% confidence interval (CI), 55.7-75.3%] and in the per protocol set was 64/91 (70.3%; 95% CI, 59.8-79.5%). Adverse events which led to treatment discontinuation included hand-foot syndrome (HFS) (7), haematotoxicity (5) and increased hepatic damage (4). The proportions of patients with major grade 3/4 adverse events were HFS 22.7%, neutropenia 7.2%, diarrhoea 2.1%, and increased bilirubin 0.0%. CONCLUSIONS: This collaborative multi-facility study, the first of its kind in Japan, presented results of a safety confirmation experiment on capecitabine as adjuvant chemotherapy for stage III colon cancer. The results suggest that capecitabine may be administered safely to Japanese patients.
BACKGROUND: A prospective feasibility study was planned to clarify the proportion of compliance and adverse events in the administration of capecitabine as adjuvant chemotherapy for colon cancer in Japanese patients. METHODS: We aimed initially to register 92 cases of R0 stage III colon cancer. Capecitabine (2,500 mg/m(2)/day) was given orally on days 1-14 every 3 weeks for 8 cycles. The proportion of treatments completed as planned was selected as the primary endpoint. RESULTS: Ninety-seven cases were registered and treated between September 2008 and August 2009. The proportion of treatments completed in the full analysis set was 64/97 [66.0%; 95% confidence interval (CI), 55.7-75.3%] and in the per protocol set was 64/91 (70.3%; 95% CI, 59.8-79.5%). Adverse events which led to treatment discontinuation included hand-foot syndrome (HFS) (7), haematotoxicity (5) and increased hepatic damage (4). The proportions of patients with major grade 3/4 adverse events were HFS 22.7%, neutropenia 7.2%, diarrhoea 2.1%, and increased bilirubin 0.0%. CONCLUSIONS: This collaborative multi-facility study, the first of its kind in Japan, presented results of a safety confirmation experiment on capecitabine as adjuvant chemotherapy for stage III colon cancer. The results suggest that capecitabine may be administered safely to Japanese patients.
Authors: P M Hoff; R Ansari; G Batist; J Cox; W Kocha; M Kuperminc; J Maroun; D Walde; C Weaver; E Harrison; H U Burger; B Osterwalder; A O Wong; R Wong Journal: J Clin Oncol Date: 2001-04-15 Impact factor: 44.544
Authors: E Van Cutsem; C Twelves; J Cassidy; D Allman; E Bajetta; M Boyer; R Bugat; M Findlay; S Frings; M Jahn; J McKendrick; B Osterwalder; G Perez-Manga; R Rosso; P Rougier; W H Schmiegel; J F Seitz; P Thompson; J M Vieitez; C Weitzel; P Harper Journal: J Clin Oncol Date: 2001-11-01 Impact factor: 44.544
Authors: M M Borner; P Schoffski; R de Wit; F Caponigro; G Comella; A Sulkes; G Greim; G J Peters; K van der Born; J Wanders; R F de Boer; C Martin; P Fumoleau Journal: Eur J Cancer Date: 2002-02 Impact factor: 9.162
Authors: Chris Twelves; Alfred Wong; Marek P Nowacki; Markus Abt; Howard Burris; Alfredo Carrato; Jim Cassidy; Andrés Cervantes; Jan Fagerberg; Vassilis Georgoulias; Fares Husseini; Duncan Jodrell; Piotr Koralewski; Hendrik Kröning; Jean Maroun; Norbert Marschner; Joseph McKendrick; Marek Pawlicki; Riccardo Rosso; Johannes Schüller; Jean-François Seitz; Borut Stabuc; Jerzy Tujakowski; Guy Van Hazel; Jerzy Zaluski; Werner Scheithauer Journal: N Engl J Med Date: 2005-06-30 Impact factor: 91.245
Authors: K Shirao; P M Hoff; A Ohtsu; P J Loehrer; I Hyodo; S Wadler; R G Wadleigh; P J O'Dwyer; K Muro; Y Yamada; N Boku; F Nagashima; J L Abbruzzese Journal: J Clin Oncol Date: 2004-07-26 Impact factor: 44.544
Authors: M Miwa; M Ura; M Nishida; N Sawada; T Ishikawa; K Mori; N Shimma; I Umeda; H Ishitsuka Journal: Eur J Cancer Date: 1998-07 Impact factor: 9.162
Authors: Xianglin L Du; Charles R Key; Cynthia Osborne; Jonathan D Mahnken; James S Goodwin Journal: Ann Intern Med Date: 2003-01-21 Impact factor: 25.391