Initial report of KSCC0803: feasibility study of capecitabine as adjuvant chemotherapy for stage III colon cancer in 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. Capeci...
Ausführliche Beschreibung
Autor*in: |
Emi, Yasunori [verfasserIn] Kakeji, Yoshihiro [verfasserIn] Oki, Eiji [verfasserIn] Saeki, Hiroshi [verfasserIn] Ando, Koji [verfasserIn] Kitazono, Masaki [verfasserIn] Sakaguchi, Yoshihisa [verfasserIn] Morita, Masaru [verfasserIn] Samura, Hironori [verfasserIn] Ogata, Yutaka [verfasserIn] Akagi, Yoshito [verfasserIn] Natsugoe, Shoji [verfasserIn] Shirouzu, Kazuo [verfasserIn] Tokunaga, Shoji [verfasserIn] Sirzen, Florin [verfasserIn] Maehara, Yoshihiko [verfasserIn] |
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E-Artikel |
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Sprache: |
Englisch |
Erschienen: |
2012 |
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Übergeordnetes Werk: |
Enthalten in: International journal of clinical oncology - Tokyo : Springer, 1996, 18(2012), 2 vom: 13. Jan., Seite 254-259 |
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Übergeordnetes Werk: |
volume:18 ; year:2012 ; number:2 ; day:13 ; month:01 ; pages:254-259 |
Links: |
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DOI / URN: |
10.1007/s10147-011-0371-7 |
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Katalog-ID: |
SPR008904146 |
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245 | 1 | 0 | |a Initial report of KSCC0803: feasibility study of capecitabine as adjuvant chemotherapy for stage III colon cancer in Japanese patients |
264 | 1 | |c 2012 | |
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520 | |a 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. | ||
650 | 4 | |a Capecitabine |7 (dpeaa)DE-He213 | |
650 | 4 | |a Adjuvant chemotherapy |7 (dpeaa)DE-He213 | |
650 | 4 | |a Colon cancer |7 (dpeaa)DE-He213 | |
650 | 4 | |a Japanese |7 (dpeaa)DE-He213 | |
650 | 4 | |a Feasibility study |7 (dpeaa)DE-He213 | |
650 | 4 | |a X-ACT trial |7 (dpeaa)DE-He213 | |
700 | 1 | |a Kakeji, Yoshihiro |e verfasserin |4 aut | |
700 | 1 | |a Oki, Eiji |e verfasserin |4 aut | |
700 | 1 | |a Saeki, Hiroshi |e verfasserin |4 aut | |
700 | 1 | |a Ando, Koji |e verfasserin |4 aut | |
700 | 1 | |a Kitazono, Masaki |e verfasserin |4 aut | |
700 | 1 | |a Sakaguchi, Yoshihisa |e verfasserin |4 aut | |
700 | 1 | |a Morita, Masaru |e verfasserin |4 aut | |
700 | 1 | |a Samura, Hironori |e verfasserin |4 aut | |
700 | 1 | |a Ogata, Yutaka |e verfasserin |4 aut | |
700 | 1 | |a Akagi, Yoshito |e verfasserin |4 aut | |
700 | 1 | |a Natsugoe, Shoji |e verfasserin |4 aut | |
700 | 1 | |a Shirouzu, Kazuo |e verfasserin |4 aut | |
700 | 1 | |a Tokunaga, Shoji |e verfasserin |4 aut | |
700 | 1 | |a Sirzen, Florin |e verfasserin |4 aut | |
700 | 1 | |a Maehara, Yoshihiko |e verfasserin |4 aut | |
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10.1007/s10147-011-0371-7 doi (DE-627)SPR008904146 (SPR)s10147-011-0371-7-e DE-627 ger DE-627 rakwb eng 610 ASE 610 ASE 44.81 bkl Emi, Yasunori verfasserin aut Initial report of KSCC0803: feasibility study of capecitabine as adjuvant chemotherapy for stage III colon cancer in Japanese patients 2012 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier 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. Capecitabine (dpeaa)DE-He213 Adjuvant chemotherapy (dpeaa)DE-He213 Colon cancer (dpeaa)DE-He213 Japanese (dpeaa)DE-He213 Feasibility study (dpeaa)DE-He213 X-ACT trial (dpeaa)DE-He213 Kakeji, Yoshihiro verfasserin aut Oki, Eiji verfasserin aut Saeki, Hiroshi verfasserin aut Ando, Koji verfasserin aut Kitazono, Masaki verfasserin aut Sakaguchi, Yoshihisa verfasserin aut Morita, Masaru verfasserin aut Samura, Hironori verfasserin aut Ogata, Yutaka verfasserin aut Akagi, Yoshito verfasserin aut Natsugoe, Shoji verfasserin aut Shirouzu, Kazuo verfasserin aut Tokunaga, Shoji verfasserin aut Sirzen, Florin verfasserin aut Maehara, Yoshihiko verfasserin aut Enthalten in International journal of clinical oncology Tokyo : Springer, 1996 18(2012), 2 vom: 13. Jan., Seite 254-259 (DE-627)300187033 (DE-600)1481773-1 1437-7772 nnns volume:18 year:2012 number:2 day:13 month:01 pages:254-259 https://dx.doi.org/10.1007/s10147-011-0371-7 lizenzpflichtig Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_32 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_74 GBV_ILN_90 GBV_ILN_95 GBV_ILN_100 GBV_ILN_101 GBV_ILN_105 GBV_ILN_110 GBV_ILN_120 GBV_ILN_138 GBV_ILN_150 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_171 GBV_ILN_187 GBV_ILN_213 GBV_ILN_224 GBV_ILN_230 GBV_ILN_250 GBV_ILN_267 GBV_ILN_281 GBV_ILN_285 GBV_ILN_293 GBV_ILN_370 GBV_ILN_602 GBV_ILN_636 GBV_ILN_702 GBV_ILN_711 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2004 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2007 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2026 GBV_ILN_2027 GBV_ILN_2031 GBV_ILN_2034 GBV_ILN_2037 GBV_ILN_2038 GBV_ILN_2039 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2057 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2064 GBV_ILN_2065 GBV_ILN_2068 GBV_ILN_2070 GBV_ILN_2086 GBV_ILN_2088 GBV_ILN_2093 GBV_ILN_2106 GBV_ILN_2107 GBV_ILN_2108 GBV_ILN_2110 GBV_ILN_2111 GBV_ILN_2112 GBV_ILN_2113 GBV_ILN_2116 GBV_ILN_2118 GBV_ILN_2119 GBV_ILN_2122 GBV_ILN_2129 GBV_ILN_2143 GBV_ILN_2144 GBV_ILN_2147 GBV_ILN_2148 GBV_ILN_2152 GBV_ILN_2153 GBV_ILN_2188 GBV_ILN_2190 GBV_ILN_2232 GBV_ILN_2336 GBV_ILN_2446 GBV_ILN_2470 GBV_ILN_2472 GBV_ILN_2507 GBV_ILN_2522 GBV_ILN_2548 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4046 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4242 GBV_ILN_4246 GBV_ILN_4249 GBV_ILN_4251 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4326 GBV_ILN_4333 GBV_ILN_4334 GBV_ILN_4335 GBV_ILN_4336 GBV_ILN_4338 GBV_ILN_4393 GBV_ILN_4700 44.81 ASE AR 18 2012 2 13 01 254-259 |
spelling |
10.1007/s10147-011-0371-7 doi (DE-627)SPR008904146 (SPR)s10147-011-0371-7-e DE-627 ger DE-627 rakwb eng 610 ASE 610 ASE 44.81 bkl Emi, Yasunori verfasserin aut Initial report of KSCC0803: feasibility study of capecitabine as adjuvant chemotherapy for stage III colon cancer in Japanese patients 2012 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier 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. Capecitabine (dpeaa)DE-He213 Adjuvant chemotherapy (dpeaa)DE-He213 Colon cancer (dpeaa)DE-He213 Japanese (dpeaa)DE-He213 Feasibility study (dpeaa)DE-He213 X-ACT trial (dpeaa)DE-He213 Kakeji, Yoshihiro verfasserin aut Oki, Eiji verfasserin aut Saeki, Hiroshi verfasserin aut Ando, Koji verfasserin aut Kitazono, Masaki verfasserin aut Sakaguchi, Yoshihisa verfasserin aut Morita, Masaru verfasserin aut Samura, Hironori verfasserin aut Ogata, Yutaka verfasserin aut Akagi, Yoshito verfasserin aut Natsugoe, Shoji verfasserin aut Shirouzu, Kazuo verfasserin aut Tokunaga, Shoji verfasserin aut Sirzen, Florin verfasserin aut Maehara, Yoshihiko verfasserin aut Enthalten in International journal of clinical oncology Tokyo : Springer, 1996 18(2012), 2 vom: 13. Jan., Seite 254-259 (DE-627)300187033 (DE-600)1481773-1 1437-7772 nnns volume:18 year:2012 number:2 day:13 month:01 pages:254-259 https://dx.doi.org/10.1007/s10147-011-0371-7 lizenzpflichtig Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_32 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_74 GBV_ILN_90 GBV_ILN_95 GBV_ILN_100 GBV_ILN_101 GBV_ILN_105 GBV_ILN_110 GBV_ILN_120 GBV_ILN_138 GBV_ILN_150 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_171 GBV_ILN_187 GBV_ILN_213 GBV_ILN_224 GBV_ILN_230 GBV_ILN_250 GBV_ILN_267 GBV_ILN_281 GBV_ILN_285 GBV_ILN_293 GBV_ILN_370 GBV_ILN_602 GBV_ILN_636 GBV_ILN_702 GBV_ILN_711 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2004 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2007 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2026 GBV_ILN_2027 GBV_ILN_2031 GBV_ILN_2034 GBV_ILN_2037 GBV_ILN_2038 GBV_ILN_2039 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2057 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2064 GBV_ILN_2065 GBV_ILN_2068 GBV_ILN_2070 GBV_ILN_2086 GBV_ILN_2088 GBV_ILN_2093 GBV_ILN_2106 GBV_ILN_2107 GBV_ILN_2108 GBV_ILN_2110 GBV_ILN_2111 GBV_ILN_2112 GBV_ILN_2113 GBV_ILN_2116 GBV_ILN_2118 GBV_ILN_2119 GBV_ILN_2122 GBV_ILN_2129 GBV_ILN_2143 GBV_ILN_2144 GBV_ILN_2147 GBV_ILN_2148 GBV_ILN_2152 GBV_ILN_2153 GBV_ILN_2188 GBV_ILN_2190 GBV_ILN_2232 GBV_ILN_2336 GBV_ILN_2446 GBV_ILN_2470 GBV_ILN_2472 GBV_ILN_2507 GBV_ILN_2522 GBV_ILN_2548 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4046 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4242 GBV_ILN_4246 GBV_ILN_4249 GBV_ILN_4251 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4326 GBV_ILN_4333 GBV_ILN_4334 GBV_ILN_4335 GBV_ILN_4336 GBV_ILN_4338 GBV_ILN_4393 GBV_ILN_4700 44.81 ASE AR 18 2012 2 13 01 254-259 |
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10.1007/s10147-011-0371-7 doi (DE-627)SPR008904146 (SPR)s10147-011-0371-7-e DE-627 ger DE-627 rakwb eng 610 ASE 610 ASE 44.81 bkl Emi, Yasunori verfasserin aut Initial report of KSCC0803: feasibility study of capecitabine as adjuvant chemotherapy for stage III colon cancer in Japanese patients 2012 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier 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. Capecitabine (dpeaa)DE-He213 Adjuvant chemotherapy (dpeaa)DE-He213 Colon cancer (dpeaa)DE-He213 Japanese (dpeaa)DE-He213 Feasibility study (dpeaa)DE-He213 X-ACT trial (dpeaa)DE-He213 Kakeji, Yoshihiro verfasserin aut Oki, Eiji verfasserin aut Saeki, Hiroshi verfasserin aut Ando, Koji verfasserin aut Kitazono, Masaki verfasserin aut Sakaguchi, Yoshihisa verfasserin aut Morita, Masaru verfasserin aut Samura, Hironori verfasserin aut Ogata, Yutaka verfasserin aut Akagi, Yoshito verfasserin aut Natsugoe, Shoji verfasserin aut Shirouzu, Kazuo verfasserin aut Tokunaga, Shoji verfasserin aut Sirzen, Florin verfasserin aut Maehara, Yoshihiko verfasserin aut Enthalten in International journal of clinical oncology Tokyo : Springer, 1996 18(2012), 2 vom: 13. Jan., Seite 254-259 (DE-627)300187033 (DE-600)1481773-1 1437-7772 nnns volume:18 year:2012 number:2 day:13 month:01 pages:254-259 https://dx.doi.org/10.1007/s10147-011-0371-7 lizenzpflichtig Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_32 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_74 GBV_ILN_90 GBV_ILN_95 GBV_ILN_100 GBV_ILN_101 GBV_ILN_105 GBV_ILN_110 GBV_ILN_120 GBV_ILN_138 GBV_ILN_150 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_171 GBV_ILN_187 GBV_ILN_213 GBV_ILN_224 GBV_ILN_230 GBV_ILN_250 GBV_ILN_267 GBV_ILN_281 GBV_ILN_285 GBV_ILN_293 GBV_ILN_370 GBV_ILN_602 GBV_ILN_636 GBV_ILN_702 GBV_ILN_711 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2004 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2007 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2026 GBV_ILN_2027 GBV_ILN_2031 GBV_ILN_2034 GBV_ILN_2037 GBV_ILN_2038 GBV_ILN_2039 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2057 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2064 GBV_ILN_2065 GBV_ILN_2068 GBV_ILN_2070 GBV_ILN_2086 GBV_ILN_2088 GBV_ILN_2093 GBV_ILN_2106 GBV_ILN_2107 GBV_ILN_2108 GBV_ILN_2110 GBV_ILN_2111 GBV_ILN_2112 GBV_ILN_2113 GBV_ILN_2116 GBV_ILN_2118 GBV_ILN_2119 GBV_ILN_2122 GBV_ILN_2129 GBV_ILN_2143 GBV_ILN_2144 GBV_ILN_2147 GBV_ILN_2148 GBV_ILN_2152 GBV_ILN_2153 GBV_ILN_2188 GBV_ILN_2190 GBV_ILN_2232 GBV_ILN_2336 GBV_ILN_2446 GBV_ILN_2470 GBV_ILN_2472 GBV_ILN_2507 GBV_ILN_2522 GBV_ILN_2548 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4046 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4242 GBV_ILN_4246 GBV_ILN_4249 GBV_ILN_4251 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4326 GBV_ILN_4333 GBV_ILN_4334 GBV_ILN_4335 GBV_ILN_4336 GBV_ILN_4338 GBV_ILN_4393 GBV_ILN_4700 44.81 ASE AR 18 2012 2 13 01 254-259 |
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10.1007/s10147-011-0371-7 doi (DE-627)SPR008904146 (SPR)s10147-011-0371-7-e DE-627 ger DE-627 rakwb eng 610 ASE 610 ASE 44.81 bkl Emi, Yasunori verfasserin aut Initial report of KSCC0803: feasibility study of capecitabine as adjuvant chemotherapy for stage III colon cancer in Japanese patients 2012 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier 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. Capecitabine (dpeaa)DE-He213 Adjuvant chemotherapy (dpeaa)DE-He213 Colon cancer (dpeaa)DE-He213 Japanese (dpeaa)DE-He213 Feasibility study (dpeaa)DE-He213 X-ACT trial (dpeaa)DE-He213 Kakeji, Yoshihiro verfasserin aut Oki, Eiji verfasserin aut Saeki, Hiroshi verfasserin aut Ando, Koji verfasserin aut Kitazono, Masaki verfasserin aut Sakaguchi, Yoshihisa verfasserin aut Morita, Masaru verfasserin aut Samura, Hironori verfasserin aut Ogata, Yutaka verfasserin aut Akagi, Yoshito verfasserin aut Natsugoe, Shoji verfasserin aut Shirouzu, Kazuo verfasserin aut Tokunaga, Shoji verfasserin aut Sirzen, Florin verfasserin aut Maehara, Yoshihiko verfasserin aut Enthalten in International journal of clinical oncology Tokyo : Springer, 1996 18(2012), 2 vom: 13. Jan., Seite 254-259 (DE-627)300187033 (DE-600)1481773-1 1437-7772 nnns volume:18 year:2012 number:2 day:13 month:01 pages:254-259 https://dx.doi.org/10.1007/s10147-011-0371-7 lizenzpflichtig Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_32 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_74 GBV_ILN_90 GBV_ILN_95 GBV_ILN_100 GBV_ILN_101 GBV_ILN_105 GBV_ILN_110 GBV_ILN_120 GBV_ILN_138 GBV_ILN_150 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_171 GBV_ILN_187 GBV_ILN_213 GBV_ILN_224 GBV_ILN_230 GBV_ILN_250 GBV_ILN_267 GBV_ILN_281 GBV_ILN_285 GBV_ILN_293 GBV_ILN_370 GBV_ILN_602 GBV_ILN_636 GBV_ILN_702 GBV_ILN_711 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2004 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2007 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2026 GBV_ILN_2027 GBV_ILN_2031 GBV_ILN_2034 GBV_ILN_2037 GBV_ILN_2038 GBV_ILN_2039 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2057 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2064 GBV_ILN_2065 GBV_ILN_2068 GBV_ILN_2070 GBV_ILN_2086 GBV_ILN_2088 GBV_ILN_2093 GBV_ILN_2106 GBV_ILN_2107 GBV_ILN_2108 GBV_ILN_2110 GBV_ILN_2111 GBV_ILN_2112 GBV_ILN_2113 GBV_ILN_2116 GBV_ILN_2118 GBV_ILN_2119 GBV_ILN_2122 GBV_ILN_2129 GBV_ILN_2143 GBV_ILN_2144 GBV_ILN_2147 GBV_ILN_2148 GBV_ILN_2152 GBV_ILN_2153 GBV_ILN_2188 GBV_ILN_2190 GBV_ILN_2232 GBV_ILN_2336 GBV_ILN_2446 GBV_ILN_2470 GBV_ILN_2472 GBV_ILN_2507 GBV_ILN_2522 GBV_ILN_2548 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4046 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4242 GBV_ILN_4246 GBV_ILN_4249 GBV_ILN_4251 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4326 GBV_ILN_4333 GBV_ILN_4334 GBV_ILN_4335 GBV_ILN_4336 GBV_ILN_4338 GBV_ILN_4393 GBV_ILN_4700 44.81 ASE AR 18 2012 2 13 01 254-259 |
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10.1007/s10147-011-0371-7 doi (DE-627)SPR008904146 (SPR)s10147-011-0371-7-e DE-627 ger DE-627 rakwb eng 610 ASE 610 ASE 44.81 bkl Emi, Yasunori verfasserin aut Initial report of KSCC0803: feasibility study of capecitabine as adjuvant chemotherapy for stage III colon cancer in Japanese patients 2012 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier 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. Capecitabine (dpeaa)DE-He213 Adjuvant chemotherapy (dpeaa)DE-He213 Colon cancer (dpeaa)DE-He213 Japanese (dpeaa)DE-He213 Feasibility study (dpeaa)DE-He213 X-ACT trial (dpeaa)DE-He213 Kakeji, Yoshihiro verfasserin aut Oki, Eiji verfasserin aut Saeki, Hiroshi verfasserin aut Ando, Koji verfasserin aut Kitazono, Masaki verfasserin aut Sakaguchi, Yoshihisa verfasserin aut Morita, Masaru verfasserin aut Samura, Hironori verfasserin aut Ogata, Yutaka verfasserin aut Akagi, Yoshito verfasserin aut Natsugoe, Shoji verfasserin aut Shirouzu, Kazuo verfasserin aut Tokunaga, Shoji verfasserin aut Sirzen, Florin verfasserin aut Maehara, Yoshihiko verfasserin aut Enthalten in International journal of clinical oncology Tokyo : Springer, 1996 18(2012), 2 vom: 13. Jan., Seite 254-259 (DE-627)300187033 (DE-600)1481773-1 1437-7772 nnns volume:18 year:2012 number:2 day:13 month:01 pages:254-259 https://dx.doi.org/10.1007/s10147-011-0371-7 lizenzpflichtig Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_32 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_74 GBV_ILN_90 GBV_ILN_95 GBV_ILN_100 GBV_ILN_101 GBV_ILN_105 GBV_ILN_110 GBV_ILN_120 GBV_ILN_138 GBV_ILN_150 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_171 GBV_ILN_187 GBV_ILN_213 GBV_ILN_224 GBV_ILN_230 GBV_ILN_250 GBV_ILN_267 GBV_ILN_281 GBV_ILN_285 GBV_ILN_293 GBV_ILN_370 GBV_ILN_602 GBV_ILN_636 GBV_ILN_702 GBV_ILN_711 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2004 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2007 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2026 GBV_ILN_2027 GBV_ILN_2031 GBV_ILN_2034 GBV_ILN_2037 GBV_ILN_2038 GBV_ILN_2039 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2057 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2064 GBV_ILN_2065 GBV_ILN_2068 GBV_ILN_2070 GBV_ILN_2086 GBV_ILN_2088 GBV_ILN_2093 GBV_ILN_2106 GBV_ILN_2107 GBV_ILN_2108 GBV_ILN_2110 GBV_ILN_2111 GBV_ILN_2112 GBV_ILN_2113 GBV_ILN_2116 GBV_ILN_2118 GBV_ILN_2119 GBV_ILN_2122 GBV_ILN_2129 GBV_ILN_2143 GBV_ILN_2144 GBV_ILN_2147 GBV_ILN_2148 GBV_ILN_2152 GBV_ILN_2153 GBV_ILN_2188 GBV_ILN_2190 GBV_ILN_2232 GBV_ILN_2336 GBV_ILN_2446 GBV_ILN_2470 GBV_ILN_2472 GBV_ILN_2507 GBV_ILN_2522 GBV_ILN_2548 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4046 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4242 GBV_ILN_4246 GBV_ILN_4249 GBV_ILN_4251 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4326 GBV_ILN_4333 GBV_ILN_4334 GBV_ILN_4335 GBV_ILN_4336 GBV_ILN_4338 GBV_ILN_4393 GBV_ILN_4700 44.81 ASE AR 18 2012 2 13 01 254-259 |
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Enthalten in International journal of clinical oncology 18(2012), 2 vom: 13. Jan., Seite 254-259 volume:18 year:2012 number:2 day:13 month:01 pages:254-259 |
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Enthalten in International journal of clinical oncology 18(2012), 2 vom: 13. Jan., Seite 254-259 volume:18 year:2012 number:2 day:13 month:01 pages:254-259 |
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Capecitabine Adjuvant chemotherapy Colon cancer Japanese Feasibility study X-ACT trial |
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International journal of clinical oncology |
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Emi, Yasunori @@aut@@ Kakeji, Yoshihiro @@aut@@ Oki, Eiji @@aut@@ Saeki, Hiroshi @@aut@@ Ando, Koji @@aut@@ Kitazono, Masaki @@aut@@ Sakaguchi, Yoshihisa @@aut@@ Morita, Masaru @@aut@@ Samura, Hironori @@aut@@ Ogata, Yutaka @@aut@@ Akagi, Yoshito @@aut@@ Natsugoe, Shoji @@aut@@ Shirouzu, Kazuo @@aut@@ Tokunaga, Shoji @@aut@@ Sirzen, Florin @@aut@@ Maehara, Yoshihiko @@aut@@ |
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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. 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|
author |
Emi, Yasunori |
spellingShingle |
Emi, Yasunori ddc 610 bkl 44.81 misc Capecitabine misc Adjuvant chemotherapy misc Colon cancer misc Japanese misc Feasibility study misc X-ACT trial Initial report of KSCC0803: feasibility study of capecitabine as adjuvant chemotherapy for stage III colon cancer in Japanese patients |
authorStr |
Emi, Yasunori |
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@@773@@(DE-627)300187033 |
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electronic Article |
dewey-ones |
610 - Medicine & health |
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keep |
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springer |
remote_str |
true |
illustrated |
Not Illustrated |
issn |
1437-7772 |
topic_title |
610 ASE 44.81 bkl Initial report of KSCC0803: feasibility study of capecitabine as adjuvant chemotherapy for stage III colon cancer in Japanese patients Capecitabine (dpeaa)DE-He213 Adjuvant chemotherapy (dpeaa)DE-He213 Colon cancer (dpeaa)DE-He213 Japanese (dpeaa)DE-He213 Feasibility study (dpeaa)DE-He213 X-ACT trial (dpeaa)DE-He213 |
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Initial report of KSCC0803: feasibility study of capecitabine as adjuvant chemotherapy for stage III colon cancer in Japanese patients |
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Initial report of KSCC0803: feasibility study of capecitabine as adjuvant chemotherapy for stage III colon cancer in Japanese patients |
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Emi, Yasunori |
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Emi, Yasunori Kakeji, Yoshihiro Oki, Eiji Saeki, Hiroshi Ando, Koji Kitazono, Masaki Sakaguchi, Yoshihisa Morita, Masaru Samura, Hironori Ogata, Yutaka Akagi, Yoshito Natsugoe, Shoji Shirouzu, Kazuo Tokunaga, Shoji Sirzen, Florin Maehara, Yoshihiko |
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initial report of kscc0803: feasibility study of capecitabine as adjuvant chemotherapy for stage iii colon cancer in japanese patients |
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Initial report of KSCC0803: feasibility study of capecitabine as adjuvant chemotherapy for stage III colon cancer in Japanese patients |
abstract |
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} $/day) was given orally on days 1–14 every 3 weeks for 8 cycles. The proportion of treatments completed as planned was selected as the primary endpoint. Results Ninety-seven cases were registered and treated between September 2008 and August 2009. The proportion of treatments completed in the full analysis set was 64/97 [66.0%; 95% confidence interval (CI), 55.7–75.3%] and in the per protocol set was 64/91 (70.3%; 95% CI, 59.8–79.5%). Adverse events which led to treatment discontinuation included hand–foot syndrome (HFS) (7), haematotoxicity (5) and increased hepatic damage (4). The proportions of patients with major grade 3/4 adverse events were HFS 22.7%, neutropenia 7.2%, diarrhoea 2.1%, and increased bilirubin 0.0%. Conclusions This collaborative multi-facility study, the first of its kind in Japan, presented results of a safety confirmation experiment on capecitabine as adjuvant chemotherapy for stage III colon cancer. The results suggest that capecitabine may be administered safely to Japanese patients. |
abstractGer |
Background A prospective feasibility study was planned to clarify the proportion of compliance and adverse events in the administration of capecitabine as adjuvant chemotherapy for colon cancer in Japanese patients. Methods We aimed initially to register 92 cases of R0 stage III colon cancer. Capecitabine (2,500 mg/$ m^{2} $/day) was given orally on days 1–14 every 3 weeks for 8 cycles. The proportion of treatments completed as planned was selected as the primary endpoint. Results Ninety-seven cases were registered and treated between September 2008 and August 2009. The proportion of treatments completed in the full analysis set was 64/97 [66.0%; 95% confidence interval (CI), 55.7–75.3%] and in the per protocol set was 64/91 (70.3%; 95% CI, 59.8–79.5%). Adverse events which led to treatment discontinuation included hand–foot syndrome (HFS) (7), haematotoxicity (5) and increased hepatic damage (4). The proportions of patients with major grade 3/4 adverse events were HFS 22.7%, neutropenia 7.2%, diarrhoea 2.1%, and increased bilirubin 0.0%. Conclusions This collaborative multi-facility study, the first of its kind in Japan, presented results of a safety confirmation experiment on capecitabine as adjuvant chemotherapy for stage III colon cancer. The results suggest that capecitabine may be administered safely to Japanese patients. |
abstract_unstemmed |
Background A prospective feasibility study was planned to clarify the proportion of compliance and adverse events in the administration of capecitabine as adjuvant chemotherapy for colon cancer in Japanese patients. Methods We aimed initially to register 92 cases of R0 stage III colon cancer. Capecitabine (2,500 mg/$ 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. |
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score |
7.398162 |