{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,29]],"date-time":"2026-04-29T22:36:05Z","timestamp":1777502165443,"version":"3.51.4"},"reference-count":16,"publisher":"SAGE Publications","issue":"7","license":[{"start":{"date-parts":[[2014,9,1]],"date-time":"2014-09-01T00:00:00Z","timestamp":1409529600000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Acta Radiol"],"published-print":{"date-parts":[[2014,9]]},"abstract":"\n Background<\/jats:title>\n Drug leakage and lack of a drug-removal system have prevented clinical application of isolated pelvic perfusion (IPP). These barriers were overcome with negative-balance IPP (NIPP) in experimental pig models. Here, a phase 1 clinical study of NIPP was performed in patients with incurable symptomatic rectal cancer.<\/jats:p>\n <\/jats:sec>\n \n Purpose<\/jats:title>\n To establish a safe regimen of high-dose regional chemotherapy with NIPP using cisplatin in patients with incurable rectal cancer.<\/jats:p>\n <\/jats:sec>\n \n Material and Methods<\/jats:title>\n \n Between June 2004 and January 2007, NIPP therapy was performed for 23 patients (11 women, 12 men; mean age, 58 years). NIPP was routinely performed twice over a 4-week interval. Dose-limiting toxicities (DLTs) were defined using a 5\u2009+\u20093 design, and cisplatin doses were escalated from 170\u2009mg\/m\n 2<\/jats:sup>\n , with a fixed 5-fluorouracil dose of 1000\u2009mg\/m\n 2<\/jats:sup>\n . The grade of adverse events (AEs) at the first and second sessions of NIPP therapy, pharmacokinetics, and antitumor response were evaluated.\n <\/jats:p>\n <\/jats:sec>\n \n Results<\/jats:title>\n \n No DLTs were observed during the first session of NIPP. However, at the second session, two patients experienced the DLT of neuropathy after administration of 200\u2009mg\/m\n 2<\/jats:sup>\n cisplatin. Therefore, 190\u2009mg\/m\n 2<\/jats:sup>\n cisplatin was indicated as the maximum tolerated dose (MTD). The plasma pelvic-to-systemic exposure ratio was 18.4 based on the maximum concentration and 19.0 based on the concentration-time curve. Solid tumor responses included complete response in two patients, partial response in five patients, stable disease in 15 patients, and progressive disease in one patient.\n <\/jats:p>\n <\/jats:sec>\n \n Conclusion<\/jats:title>\n \n NIPP may offer the safe delivery of high-dose regional chemotherapy (MTD of 190\u2009mg\/m\n 2<\/jats:sup>\n cisplatin) with negligible AEs and effective control of tumor growth in patients with incurable rectal cancer.\n <\/jats:p>\n <\/jats:sec>","DOI":"10.1177\/0284185113507253","type":"journal-article","created":{"date-parts":[[2013,10,5]],"date-time":"2013-10-05T20:34:48Z","timestamp":1381005288000},"page":"793-801","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":9,"title":["Negative-balance isolated pelvic perfusion in patients with incurable symptomatic rectal cancer: results and drug dose correlation to adverse events"],"prefix":"10.1177","volume":"55","author":[{"given":"Satoru","family":"Murata","sequence":"first","affiliation":[{"name":"Department of Radiology\/Center for Advanced Medical Technology, Nippon Medical School, Tokyo, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Shiro","family":"Onozawa","sequence":"additional","affiliation":[{"name":"Department of Radiology\/Center for Advanced Medical Technology, Nippon Medical School, Tokyo, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Chol","family":"Kim","sequence":"additional","affiliation":[{"name":"Department of Anesthesiology, Nippon Medical School, Tokyo, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hiroyuki","family":"Tajima","sequence":"additional","affiliation":[{"name":"Department of Radiology\/Center for Advanced Medical Technology, Nippon Medical School, Tokyo, 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