Definitive S-1/mitomycin-C chemoradiotherapy for stage II/III anal canal squamous cell carcinoma: a phase I/II dose-finding and single-arm confirmatory study (JCOG0903)
Background Definitive chemoradiotherapy (CRT) with 5-fluorouracil plus mitomycin-C is a standard treatment for stage II/III squamous cell carcinoma of the anal canal (SCCA). We performed this dose-finding and single-arm confirmatory trial of CRT with S-1 plus mitomycin-C to determine the recommended...
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| Veröffentlicht in: | International journal of clinical oncology 2023-08, Vol.28 (8), p.1063-1072 |
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| creator | Ito, Yoshinori Hamaguchi, Tetsuya Takashima, Atsuo Mizusawa, Junki Shimada, Yasuhiro Shiozawa, Manabu Mizoguchi, Nobutaka Kodaira, Takeshi Komori, Koji Ohue, Masayuki Konishi, Koji Teraishi, Fuminori Kinouchi, Makoto Murata, Kohei Fujita, Fumihiko Watanabe, Masahiko Iinuma, Gen Ishida, Fumio Saida, Yoshihisa Matsuda, Takahisa Katayama, Hiroshi Fukuda, Haruhiko Kanemitsu, Yukihide |
| description | Background
Definitive chemoradiotherapy (CRT) with 5-fluorouracil plus mitomycin-C is a standard treatment for stage II/III squamous cell carcinoma of the anal canal (SCCA). We performed this dose-finding and single-arm confirmatory trial of CRT with S-1 plus mitomycin-C to determine the recommended dose (RD) of S-1 and evaluate its efficacy and safety for locally advanced SCCA.
Methods
Patients with clinical stage II/III SCCA (UICC 6th) received CRT comprising mitomycin-C (10 mg/m
2
on days 1 and 29) and S-1 (60 mg/m
2
/day at level 0 and 80 mg/m
2
/day at level 1 on days 1–14 and 29–42) with concurrent radiotherapy (59.4 Gy). Dose-finding used a 3 + 3 cohort design. The primary endpoint of the confirmatory trial was 3-year event-free survival. The sample size was 65, with one-sided alpha of 5%, power of 80%, and expected and threshold values of 75% and 60%, respectively.
Results
Sixty-nine patients (dose-finding, n = 10; confirmatory, n = 59) were enrolled. The RD of S-1 was determined as 80 mg/m
2
/day. Three-year event-free survival in 63 eligible patients who received the RD was 65.0% (90% confidence interval 54.1–73.9). Three-year overall, progression-free, and colostomy-free survival rates were 87.3%, 85.7%, and 76.2%, respectively; the complete response rate was 81% on central review. Common grade 3/4 acute toxicities were leukopenia (63.1%), neutropenia (40.0%), diarrhea (20.0%), radiation dermatitis (15.4%), and febrile neutropenia (3.1%). No treatment-related deaths occurred.
Conclusions
Although the primary endpoint was not met, S-1/mitomycin-C chemoradiotherapy had an acceptable toxicity profile and favorable 3-year survival and could be a treatment option for locally advanced SCCA.
Clinical trial information
jRCTs031180002. |
| doi_str_mv | 10.1007/s10147-023-02361-7 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_cross</sourceid><recordid>TN_cdi_proquest_miscellaneous_2823991951</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>2823991951</sourcerecordid><originalsourceid>FETCH-LOGICAL-c399t-6174728992ddd36cb7d095bc8a7b245974b0a64f54c980d408863b63e3afa1453</originalsourceid><addsrcrecordid>eNp9Uctu1DAUjRCIlsIPsECW2JSFGb9ix-zQACWoUhfAOnJsZ8bVOJ7aCVL-iM_kplNAYsHC9pV9Hvf6VNVLSt5SQtSmUEKFwoTxdUmK1aPqnAqusFKKPYaaC4q1ZPVZ9ayUW0KokjV7Wp1xxRrZqOa8-vnBD2EMU_jh0VdMNzFMKS42jHiL7N7HlI0Ladr7bI4LGlJGZTI7j9p207YtMqM5IHu_l7vZxDQXZP1hvcsgkqJ5hww67k0BCjCQS8VjcHRh3AHboQLFwWOTI7JpHEKOZkp5AZvZLejyy_bmimjC3zyvngzmUPyLh_Oi-v7p47ftZ3x9c9Vu319jy7WesKRKwHBaM-ccl7ZXjui6t41RPRO1VqInRoqhFlY3xAnSNJL3kntuBkNFzS-qy5PuMae72Zepi6GsI5nRw3QdaxgYUV1TgL7-B3qb5gx_saKgZwbNSECxE8rmVEr2Q3fMIZq8dJR0a47dKccOMuzuc-wUkF49SM999O4P5XdwAOAnQIGncefzX-__yP4CHz2nIg</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>2890326176</pqid></control><display><type>article</type><title>Definitive S-1/mitomycin-C chemoradiotherapy for stage II/III anal canal squamous cell carcinoma: a phase I/II dose-finding and single-arm confirmatory study (JCOG0903)</title><source>SpringerLink Journals</source><creator>Ito, Yoshinori ; Hamaguchi, Tetsuya ; Takashima, Atsuo ; Mizusawa, Junki ; Shimada, Yasuhiro ; Shiozawa, Manabu ; Mizoguchi, Nobutaka ; Kodaira, Takeshi ; Komori, Koji ; Ohue, Masayuki ; Konishi, Koji ; Teraishi, Fuminori ; Kinouchi, Makoto ; Murata, Kohei ; Fujita, Fumihiko ; Watanabe, Masahiko ; Iinuma, Gen ; Ishida, Fumio ; Saida, Yoshihisa ; Matsuda, Takahisa ; Katayama, Hiroshi ; Fukuda, Haruhiko ; Kanemitsu, Yukihide</creator><creatorcontrib>Ito, Yoshinori ; Hamaguchi, Tetsuya ; Takashima, Atsuo ; Mizusawa, Junki ; Shimada, Yasuhiro ; Shiozawa, Manabu ; Mizoguchi, Nobutaka ; Kodaira, Takeshi ; Komori, Koji ; Ohue, Masayuki ; Konishi, Koji ; Teraishi, Fuminori ; Kinouchi, Makoto ; Murata, Kohei ; Fujita, Fumihiko ; Watanabe, Masahiko ; Iinuma, Gen ; Ishida, Fumio ; Saida, Yoshihisa ; Matsuda, Takahisa ; Katayama, Hiroshi ; Fukuda, Haruhiko ; Kanemitsu, Yukihide ; Colorectal Cancer Study Group of the Japan Clinical Oncology Group ; The Colorectal Cancer Study Group of the Japan Clinical Oncology Group</creatorcontrib><description>Background
Definitive chemoradiotherapy (CRT) with 5-fluorouracil plus mitomycin-C is a standard treatment for stage II/III squamous cell carcinoma of the anal canal (SCCA). We performed this dose-finding and single-arm confirmatory trial of CRT with S-1 plus mitomycin-C to determine the recommended dose (RD) of S-1 and evaluate its efficacy and safety for locally advanced SCCA.
Methods
Patients with clinical stage II/III SCCA (UICC 6th) received CRT comprising mitomycin-C (10 mg/m
2
on days 1 and 29) and S-1 (60 mg/m
2
/day at level 0 and 80 mg/m
2
/day at level 1 on days 1–14 and 29–42) with concurrent radiotherapy (59.4 Gy). Dose-finding used a 3 + 3 cohort design. The primary endpoint of the confirmatory trial was 3-year event-free survival. The sample size was 65, with one-sided alpha of 5%, power of 80%, and expected and threshold values of 75% and 60%, respectively.
Results
Sixty-nine patients (dose-finding, n = 10; confirmatory, n = 59) were enrolled. The RD of S-1 was determined as 80 mg/m
2
/day. Three-year event-free survival in 63 eligible patients who received the RD was 65.0% (90% confidence interval 54.1–73.9). Three-year overall, progression-free, and colostomy-free survival rates were 87.3%, 85.7%, and 76.2%, respectively; the complete response rate was 81% on central review. Common grade 3/4 acute toxicities were leukopenia (63.1%), neutropenia (40.0%), diarrhea (20.0%), radiation dermatitis (15.4%), and febrile neutropenia (3.1%). No treatment-related deaths occurred.
Conclusions
Although the primary endpoint was not met, S-1/mitomycin-C chemoradiotherapy had an acceptable toxicity profile and favorable 3-year survival and could be a treatment option for locally advanced SCCA.
Clinical trial information
jRCTs031180002.</description><identifier>ISSN: 1341-9625</identifier><identifier>EISSN: 1437-7772</identifier><identifier>DOI: 10.1007/s10147-023-02361-7</identifier><identifier>PMID: 37286878</identifier><language>eng</language><publisher>Singapore: Springer Nature Singapore</publisher><subject>5-Fluorouracil ; Anus ; Canals (anatomy) ; Cancer Research ; Chemoradiotherapy ; Chemotherapy ; Dermatitis ; Diarrhea ; jRCTs ; jRCTs031180002 ; Leukopenia ; Medicine ; Medicine & Public Health ; Mitomycin C ; Neutropenia ; Oncology ; Original Article ; Patients ; Radiation therapy ; Squamous cell carcinoma ; Surgical Oncology ; Toxicity</subject><ispartof>International journal of clinical oncology, 2023-08, Vol.28 (8), p.1063-1072</ispartof><rights>The Author(s) under exclusive licence to Japan Society of Clinical Oncology 2023. Springer Nature or its licensor (e.g. a society or other partner) holds exclusive rights to this article under a publishing agreement with the author(s) or other rightsholder(s); author self-archiving of the accepted manuscript version of this article is solely governed by the terms of such publishing agreement and applicable law.</rights><rights>2023. The Author(s) under exclusive licence to Japan Society of Clinical Oncology.</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c399t-6174728992ddd36cb7d095bc8a7b245974b0a64f54c980d408863b63e3afa1453</citedby><cites>FETCH-LOGICAL-c399t-6174728992ddd36cb7d095bc8a7b245974b0a64f54c980d408863b63e3afa1453</cites><orcidid>0000-0002-0135-5589</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://link.springer.com/content/pdf/10.1007/s10147-023-02361-7$$EPDF$$P50$$Gspringer$$H</linktopdf><linktohtml>$$Uhttps://link.springer.com/10.1007/s10147-023-02361-7$$EHTML$$P50$$Gspringer$$H</linktohtml><link.rule.ids>314,776,780,27903,27904,41466,42535,51296</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/37286878$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Ito, Yoshinori</creatorcontrib><creatorcontrib>Hamaguchi, Tetsuya</creatorcontrib><creatorcontrib>Takashima, Atsuo</creatorcontrib><creatorcontrib>Mizusawa, Junki</creatorcontrib><creatorcontrib>Shimada, Yasuhiro</creatorcontrib><creatorcontrib>Shiozawa, Manabu</creatorcontrib><creatorcontrib>Mizoguchi, Nobutaka</creatorcontrib><creatorcontrib>Kodaira, Takeshi</creatorcontrib><creatorcontrib>Komori, Koji</creatorcontrib><creatorcontrib>Ohue, Masayuki</creatorcontrib><creatorcontrib>Konishi, Koji</creatorcontrib><creatorcontrib>Teraishi, Fuminori</creatorcontrib><creatorcontrib>Kinouchi, Makoto</creatorcontrib><creatorcontrib>Murata, Kohei</creatorcontrib><creatorcontrib>Fujita, Fumihiko</creatorcontrib><creatorcontrib>Watanabe, Masahiko</creatorcontrib><creatorcontrib>Iinuma, Gen</creatorcontrib><creatorcontrib>Ishida, Fumio</creatorcontrib><creatorcontrib>Saida, Yoshihisa</creatorcontrib><creatorcontrib>Matsuda, Takahisa</creatorcontrib><creatorcontrib>Katayama, Hiroshi</creatorcontrib><creatorcontrib>Fukuda, Haruhiko</creatorcontrib><creatorcontrib>Kanemitsu, Yukihide</creatorcontrib><creatorcontrib>Colorectal Cancer Study Group of the Japan Clinical Oncology Group</creatorcontrib><creatorcontrib>The Colorectal Cancer Study Group of the Japan Clinical Oncology Group</creatorcontrib><title>Definitive S-1/mitomycin-C chemoradiotherapy for stage II/III anal canal squamous cell carcinoma: a phase I/II dose-finding and single-arm confirmatory study (JCOG0903)</title><title>International journal of clinical oncology</title><addtitle>Int J Clin Oncol</addtitle><addtitle>Int J Clin Oncol</addtitle><description>Background
Definitive chemoradiotherapy (CRT) with 5-fluorouracil plus mitomycin-C is a standard treatment for stage II/III squamous cell carcinoma of the anal canal (SCCA). We performed this dose-finding and single-arm confirmatory trial of CRT with S-1 plus mitomycin-C to determine the recommended dose (RD) of S-1 and evaluate its efficacy and safety for locally advanced SCCA.
Methods
Patients with clinical stage II/III SCCA (UICC 6th) received CRT comprising mitomycin-C (10 mg/m
2
on days 1 and 29) and S-1 (60 mg/m
2
/day at level 0 and 80 mg/m
2
/day at level 1 on days 1–14 and 29–42) with concurrent radiotherapy (59.4 Gy). Dose-finding used a 3 + 3 cohort design. The primary endpoint of the confirmatory trial was 3-year event-free survival. The sample size was 65, with one-sided alpha of 5%, power of 80%, and expected and threshold values of 75% and 60%, respectively.
Results
Sixty-nine patients (dose-finding, n = 10; confirmatory, n = 59) were enrolled. The RD of S-1 was determined as 80 mg/m
2
/day. Three-year event-free survival in 63 eligible patients who received the RD was 65.0% (90% confidence interval 54.1–73.9). Three-year overall, progression-free, and colostomy-free survival rates were 87.3%, 85.7%, and 76.2%, respectively; the complete response rate was 81% on central review. Common grade 3/4 acute toxicities were leukopenia (63.1%), neutropenia (40.0%), diarrhea (20.0%), radiation dermatitis (15.4%), and febrile neutropenia (3.1%). No treatment-related deaths occurred.
Conclusions
Although the primary endpoint was not met, S-1/mitomycin-C chemoradiotherapy had an acceptable toxicity profile and favorable 3-year survival and could be a treatment option for locally advanced SCCA.
Clinical trial information
jRCTs031180002.</description><subject>5-Fluorouracil</subject><subject>Anus</subject><subject>Canals (anatomy)</subject><subject>Cancer Research</subject><subject>Chemoradiotherapy</subject><subject>Chemotherapy</subject><subject>Dermatitis</subject><subject>Diarrhea</subject><subject>jRCTs</subject><subject>jRCTs031180002</subject><subject>Leukopenia</subject><subject>Medicine</subject><subject>Medicine & Public Health</subject><subject>Mitomycin C</subject><subject>Neutropenia</subject><subject>Oncology</subject><subject>Original Article</subject><subject>Patients</subject><subject>Radiation therapy</subject><subject>Squamous cell carcinoma</subject><subject>Surgical Oncology</subject><subject>Toxicity</subject><issn>1341-9625</issn><issn>1437-7772</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2023</creationdate><recordtype>article</recordtype><sourceid>8G5</sourceid><sourceid>BENPR</sourceid><sourceid>GUQSH</sourceid><sourceid>M2O</sourceid><recordid>eNp9Uctu1DAUjRCIlsIPsECW2JSFGb9ix-zQACWoUhfAOnJsZ8bVOJ7aCVL-iM_kplNAYsHC9pV9Hvf6VNVLSt5SQtSmUEKFwoTxdUmK1aPqnAqusFKKPYaaC4q1ZPVZ9ayUW0KokjV7Wp1xxRrZqOa8-vnBD2EMU_jh0VdMNzFMKS42jHiL7N7HlI0Ladr7bI4LGlJGZTI7j9p207YtMqM5IHu_l7vZxDQXZP1hvcsgkqJ5hww67k0BCjCQS8VjcHRh3AHboQLFwWOTI7JpHEKOZkp5AZvZLejyy_bmimjC3zyvngzmUPyLh_Oi-v7p47ftZ3x9c9Vu319jy7WesKRKwHBaM-ccl7ZXjui6t41RPRO1VqInRoqhFlY3xAnSNJL3kntuBkNFzS-qy5PuMae72Zepi6GsI5nRw3QdaxgYUV1TgL7-B3qb5gx_saKgZwbNSECxE8rmVEr2Q3fMIZq8dJR0a47dKccOMuzuc-wUkF49SM999O4P5XdwAOAnQIGncefzX-__yP4CHz2nIg</recordid><startdate>20230801</startdate><enddate>20230801</enddate><creator>Ito, Yoshinori</creator><creator>Hamaguchi, Tetsuya</creator><creator>Takashima, Atsuo</creator><creator>Mizusawa, Junki</creator><creator>Shimada, Yasuhiro</creator><creator>Shiozawa, Manabu</creator><creator>Mizoguchi, Nobutaka</creator><creator>Kodaira, Takeshi</creator><creator>Komori, Koji</creator><creator>Ohue, Masayuki</creator><creator>Konishi, Koji</creator><creator>Teraishi, Fuminori</creator><creator>Kinouchi, Makoto</creator><creator>Murata, Kohei</creator><creator>Fujita, Fumihiko</creator><creator>Watanabe, Masahiko</creator><creator>Iinuma, Gen</creator><creator>Ishida, Fumio</creator><creator>Saida, Yoshihisa</creator><creator>Matsuda, Takahisa</creator><creator>Katayama, Hiroshi</creator><creator>Fukuda, Haruhiko</creator><creator>Kanemitsu, Yukihide</creator><general>Springer Nature Singapore</general><general>Springer Nature B.V</general><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>3V.</scope><scope>7TO</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>8AO</scope><scope>8C1</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>8G5</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>AZQEC</scope><scope>BENPR</scope><scope>CCPQU</scope><scope>DWQXO</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>GNUQQ</scope><scope>GUQSH</scope><scope>H94</scope><scope>K9.</scope><scope>M0S</scope><scope>M1P</scope><scope>M2O</scope><scope>MBDVC</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>Q9U</scope><scope>7X8</scope><orcidid>https://orcid.org/0000-0002-0135-5589</orcidid></search><sort><creationdate>20230801</creationdate><title>Definitive S-1/mitomycin-C chemoradiotherapy for stage II/III anal canal squamous cell carcinoma: a phase I/II dose-finding and single-arm confirmatory study (JCOG0903)</title><author>Ito, Yoshinori ; Hamaguchi, Tetsuya ; Takashima, Atsuo ; Mizusawa, Junki ; Shimada, Yasuhiro ; Shiozawa, Manabu ; Mizoguchi, Nobutaka ; Kodaira, Takeshi ; Komori, Koji ; Ohue, Masayuki ; Konishi, Koji ; Teraishi, Fuminori ; Kinouchi, Makoto ; Murata, Kohei ; Fujita, Fumihiko ; Watanabe, Masahiko ; Iinuma, Gen ; Ishida, Fumio ; Saida, Yoshihisa ; Matsuda, Takahisa ; Katayama, Hiroshi ; Fukuda, Haruhiko ; Kanemitsu, Yukihide</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c399t-6174728992ddd36cb7d095bc8a7b245974b0a64f54c980d408863b63e3afa1453</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2023</creationdate><topic>5-Fluorouracil</topic><topic>Anus</topic><topic>Canals (anatomy)</topic><topic>Cancer Research</topic><topic>Chemoradiotherapy</topic><topic>Chemotherapy</topic><topic>Dermatitis</topic><topic>Diarrhea</topic><topic>jRCTs</topic><topic>jRCTs031180002</topic><topic>Leukopenia</topic><topic>Medicine</topic><topic>Medicine & Public Health</topic><topic>Mitomycin C</topic><topic>Neutropenia</topic><topic>Oncology</topic><topic>Original Article</topic><topic>Patients</topic><topic>Radiation therapy</topic><topic>Squamous cell carcinoma</topic><topic>Surgical Oncology</topic><topic>Toxicity</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Ito, Yoshinori</creatorcontrib><creatorcontrib>Hamaguchi, Tetsuya</creatorcontrib><creatorcontrib>Takashima, Atsuo</creatorcontrib><creatorcontrib>Mizusawa, Junki</creatorcontrib><creatorcontrib>Shimada, Yasuhiro</creatorcontrib><creatorcontrib>Shiozawa, Manabu</creatorcontrib><creatorcontrib>Mizoguchi, Nobutaka</creatorcontrib><creatorcontrib>Kodaira, Takeshi</creatorcontrib><creatorcontrib>Komori, Koji</creatorcontrib><creatorcontrib>Ohue, Masayuki</creatorcontrib><creatorcontrib>Konishi, Koji</creatorcontrib><creatorcontrib>Teraishi, Fuminori</creatorcontrib><creatorcontrib>Kinouchi, Makoto</creatorcontrib><creatorcontrib>Murata, Kohei</creatorcontrib><creatorcontrib>Fujita, Fumihiko</creatorcontrib><creatorcontrib>Watanabe, Masahiko</creatorcontrib><creatorcontrib>Iinuma, Gen</creatorcontrib><creatorcontrib>Ishida, Fumio</creatorcontrib><creatorcontrib>Saida, Yoshihisa</creatorcontrib><creatorcontrib>Matsuda, Takahisa</creatorcontrib><creatorcontrib>Katayama, Hiroshi</creatorcontrib><creatorcontrib>Fukuda, Haruhiko</creatorcontrib><creatorcontrib>Kanemitsu, Yukihide</creatorcontrib><creatorcontrib>Colorectal Cancer Study Group of the Japan Clinical Oncology Group</creatorcontrib><creatorcontrib>The Colorectal Cancer Study Group of the Japan Clinical Oncology Group</creatorcontrib><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Oncogenes and Growth Factors Abstracts</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Medical Database (Alumni Edition)</collection><collection>ProQuest Pharma Collection</collection><collection>Public Health Database</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>Research Library (Alumni Edition)</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest Central UK/Ireland</collection><collection>ProQuest Central Essentials</collection><collection>ProQuest Central</collection><collection>ProQuest One Community 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Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Ito, Yoshinori</au><au>Hamaguchi, Tetsuya</au><au>Takashima, Atsuo</au><au>Mizusawa, Junki</au><au>Shimada, Yasuhiro</au><au>Shiozawa, Manabu</au><au>Mizoguchi, Nobutaka</au><au>Kodaira, Takeshi</au><au>Komori, Koji</au><au>Ohue, Masayuki</au><au>Konishi, Koji</au><au>Teraishi, Fuminori</au><au>Kinouchi, Makoto</au><au>Murata, Kohei</au><au>Fujita, Fumihiko</au><au>Watanabe, Masahiko</au><au>Iinuma, Gen</au><au>Ishida, Fumio</au><au>Saida, Yoshihisa</au><au>Matsuda, Takahisa</au><au>Katayama, Hiroshi</au><au>Fukuda, Haruhiko</au><au>Kanemitsu, Yukihide</au><aucorp>Colorectal Cancer Study Group of the Japan Clinical Oncology Group</aucorp><aucorp>The Colorectal Cancer Study Group of the Japan Clinical Oncology Group</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Definitive S-1/mitomycin-C chemoradiotherapy for stage II/III anal canal squamous cell carcinoma: a phase I/II dose-finding and single-arm confirmatory study (JCOG0903)</atitle><jtitle>International journal of clinical oncology</jtitle><stitle>Int J Clin Oncol</stitle><addtitle>Int J Clin Oncol</addtitle><date>2023-08-01</date><risdate>2023</risdate><volume>28</volume><issue>8</issue><spage>1063</spage><epage>1072</epage><pages>1063-1072</pages><issn>1341-9625</issn><eissn>1437-7772</eissn><abstract>Background
Definitive chemoradiotherapy (CRT) with 5-fluorouracil plus mitomycin-C is a standard treatment for stage II/III squamous cell carcinoma of the anal canal (SCCA). We performed this dose-finding and single-arm confirmatory trial of CRT with S-1 plus mitomycin-C to determine the recommended dose (RD) of S-1 and evaluate its efficacy and safety for locally advanced SCCA.
Methods
Patients with clinical stage II/III SCCA (UICC 6th) received CRT comprising mitomycin-C (10 mg/m
2
on days 1 and 29) and S-1 (60 mg/m
2
/day at level 0 and 80 mg/m
2
/day at level 1 on days 1–14 and 29–42) with concurrent radiotherapy (59.4 Gy). Dose-finding used a 3 + 3 cohort design. The primary endpoint of the confirmatory trial was 3-year event-free survival. The sample size was 65, with one-sided alpha of 5%, power of 80%, and expected and threshold values of 75% and 60%, respectively.
Results
Sixty-nine patients (dose-finding, n = 10; confirmatory, n = 59) were enrolled. The RD of S-1 was determined as 80 mg/m
2
/day. Three-year event-free survival in 63 eligible patients who received the RD was 65.0% (90% confidence interval 54.1–73.9). Three-year overall, progression-free, and colostomy-free survival rates were 87.3%, 85.7%, and 76.2%, respectively; the complete response rate was 81% on central review. Common grade 3/4 acute toxicities were leukopenia (63.1%), neutropenia (40.0%), diarrhea (20.0%), radiation dermatitis (15.4%), and febrile neutropenia (3.1%). No treatment-related deaths occurred.
Conclusions
Although the primary endpoint was not met, S-1/mitomycin-C chemoradiotherapy had an acceptable toxicity profile and favorable 3-year survival and could be a treatment option for locally advanced SCCA.
Clinical trial information
jRCTs031180002.</abstract><cop>Singapore</cop><pub>Springer Nature Singapore</pub><pmid>37286878</pmid><doi>10.1007/s10147-023-02361-7</doi><tpages>10</tpages><orcidid>https://orcid.org/0000-0002-0135-5589</orcidid></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 1341-9625 |
| ispartof | International journal of clinical oncology, 2023-08, Vol.28 (8), p.1063-1072 |
| issn | 1341-9625 1437-7772 |
| language | eng |
| recordid | cdi_proquest_miscellaneous_2823991951 |
| source | SpringerLink Journals |
| subjects | 5-Fluorouracil Anus Canals (anatomy) Cancer Research Chemoradiotherapy Chemotherapy Dermatitis Diarrhea jRCTs jRCTs031180002 Leukopenia Medicine Medicine & Public Health Mitomycin C Neutropenia Oncology Original Article Patients Radiation therapy Squamous cell carcinoma Surgical Oncology Toxicity |
| title | Definitive S-1/mitomycin-C chemoradiotherapy for stage II/III anal canal squamous cell carcinoma: a phase I/II dose-finding and single-arm confirmatory study (JCOG0903) |
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