{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,11,4]],"date-time":"2025-11-04T10:50:07Z","timestamp":1762253407205,"version":"3.40.5"},"reference-count":16,"publisher":"S. Karger AG","issue":"9","license":[{"start":{"date-parts":[[2020,1,1]],"date-time":"2020-01-01T00:00:00Z","timestamp":1577836800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"},{"start":{"date-parts":[[2020,1,1]],"date-time":"2020-01-01T00:00:00Z","timestamp":1577836800000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Oncology"],"published-print":{"date-parts":[[2020]]},"abstract":"<b><i>Background:<\/i><\/b> FOLFIRI plus bevacizumab have been widely used as first-line treatment for metastatic colorectal cancer (mCRC). Pharmacokinetics and pharmacodynamics suggested a low dose of irinotecan given as a long-term infusion is expected to enhance antitumor activity. We conducted a randomized phase II study to compare oral S-1 with a 24-h infusion of irinotecan plus bevacizumab versus FOLFIRI plus bevacizumab. <b><i>Methods:<\/i><\/b> The subjects comprised 120 chemotherapy-na\u00efve patients with mCRC. The study group received a 24-h infusion of irinotecan at a dose of 125 mg\/m<sup>2<\/sup> on days 1 and 15, combined with oral S-1 80 mg\/m<sup>2<\/sup> on days 1\u201314 (24h-SIRI\/B). The FOLFIRI\/B group received irinotecan at a dose of 150 mg\/m<sup>2<\/sup>, 5-fluorouracil given at a dose of 400 mg\/m<sup>2<\/sup> as a bolus injection and at a dose of 2,400 mg\/m<sup>2<\/sup> as a 46-h infusion, and 200 mg\/m<sup>2<\/sup> leucovorin on days 1 and 15. Bevacizumab was given at a dose of 5.0 mg\/kg on days 1 and 15 in both groups. Treatment was repeated every 4 weeks. The primary endpoint was 1-year progression-free survival (PFS). Secondary endpoints were PFS, response rates (RR), overall survival (OS), and adverse events (AEs). <b><i>Results:<\/i><\/b> From December 2013 through January 2018, 120 patients were randomly assigned, 61 patients to the 24h-SIRI\/B and 59 patients to the FOLFIRI\/B. The median follow-up period was 22.8 months. The 1-year PFS rate was 43.14% in the 24h-SIRI\/B arm and 19.15% in the FOLFIRI\/B arm (HR = 0.312 [95%CI 0.13\u20130.78], <i>p<\/i> = 0.01). The median PFS was 10.2 months (95%CI 8.8\u201314.3) and 10.0 months (95%CI 7.4\u201311.0), and the median OS was 29.7 months (95%CI 22.9\u201343.9) and 28.8 months (95%CI 18.4-ND), respectively (<i>p<\/i> = 0.3758, <i>p<\/i> = 0.8234). The overall RR was 86.3 and 61.7%, respectively (<i>p<\/i> = 0.0053). AEs were similar. <b><i>Conclusions:<\/i><\/b> Our results show that the 24h-SIRI\/B regimen is an effective and reasonably well-tolerated regimen for the first-line treatment of mCRC. <\/jats:p>","DOI":"10.1159\/000507293","type":"journal-article","created":{"date-parts":[[2020,5,29]],"date-time":"2020-05-29T21:01:18Z","timestamp":1590786078000},"page":"637-642","source":"Crossref","is-referenced-by-count":7,"title":["Oral S-1 with 24-h Infusion of Irinotecan plus Bevacizumab versus FOLFIRI plus Bevacizumab as First-Line Chemotherapy for Metastatic Colorectal Cancer: An Open-Label Randomized Phase II Trial"],"prefix":"10.1159","volume":"98","author":[{"given":"Sotaro","family":"Sadahiro","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Toshiyuki","family":"Suzuki","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kazutake","family":"Okada","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Gota","family":"Saito","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hiroshi","family":"Miyakita","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9819-5149","authenticated-orcid":false,"given":"Takashi","family":"Ogimi","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Lin Fung","family":"Chan","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yutaro","family":"Kamei","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"127","published-online":{"date-parts":[[2020,5,29]]},"reference":[{"key":"ref1","doi-asserted-by":"publisher","DOI":"10.1093\/annonc\/mdu260"},{"key":"ref2","doi-asserted-by":"publisher","DOI":"10.1007\/s10147-017-1101-6"},{"key":"ref3","doi-asserted-by":"publisher","DOI":"10.1093\/annonc\/mdw206"},{"key":"ref4","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.2008.20.6771"},{"key":"ref5","doi-asserted-by":"publisher","DOI":"10.1007\/BF00686188"},{"key":"ref6","doi-asserted-by":"publisher","DOI":"10.1159\/000118666"},{"key":"ref7","doi-asserted-by":"publisher","DOI":"10.1159\/000209963"},{"key":"ref8","doi-asserted-by":"publisher","DOI":"10.1097\/00001813-199607000-00010"},{"key":"ref9","doi-asserted-by":"publisher","DOI":"10.1159\/000369976"},{"key":"ref10","doi-asserted-by":"publisher","DOI":"10.1159\/000367972"},{"key":"ref11","doi-asserted-by":"publisher","DOI":"10.1080\/03602530500316254"},{"key":"ref12","doi-asserted-by":"publisher","DOI":"10.1016\/S1470-2045(10)70181-9"},{"key":"ref13","doi-asserted-by":"publisher","DOI":"10.3109\/0284186X.2012.682629"},{"key":"ref14","doi-asserted-by":"publisher","DOI":"10.1007\/s10637-011-9743-0"},{"key":"ref15","doi-asserted-by":"publisher","DOI":"10.1159\/000356018"},{"key":"ref16","doi-asserted-by":"publisher","DOI":"10.1093\/annonc\/mdx816"}],"container-title":["Oncology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.karger.com\/Article\/Pdf\/507293","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/www.karger.com\/Article\/Pdf\/507293","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,4,23]],"date-time":"2025-04-23T15:59:01Z","timestamp":1745423941000},"score":1,"resource":{"primary":{"URL":"https:\/\/karger.com\/article\/doi\/10.1159\/000507293"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2020]]},"references-count":16,"journal-issue":{"issue":"9","published-online":{"date-parts":[[2020,9,2]]},"published-print":{"date-parts":[[2020,9,8]]}},"URL":"https:\/\/doi.org\/10.1159\/000507293","archive":["Portico"],"relation":{},"ISSN":["0030-2414","1423-0232"],"issn-type":[{"type":"print","value":"0030-2414"},{"type":"electronic","value":"1423-0232"}],"subject":[],"published":{"date-parts":[[2020]]}}}