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Treatment cycles were repeated for up to 12 cycles or until disease progression, unacceptable toxicity, patient refusal or treatment delay for &gt;2 weeks. The primary efficacy endpoint was objective response rate according to RECIST. Secondary endpoints were the rate of SD lasting \u22656 months and time-to-event variables. Toxicity was assessed using NCI-CTC v. 3.0. Twenty-one patients received 57 treatment cycles. No objective tumor responses occurred. SD lasting <\/jats:p>","DOI":"10.3390\/md7030451","type":"journal-article","created":{"date-parts":[[2009,9,16]],"date-time":"2009-09-16T12:07:21Z","timestamp":1253102841000},"page":"451-463","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":23,"title":["Phase II Study of Biweekly Plitidepsin as Second-Line Therapy for Advanced or Metastatic Transitional Cell Carcinoma of the Urothelium"],"prefix":"10.3390","volume":"7","author":[{"given":"Herlinde","family":"Dumez","sequence":"first","affiliation":[{"name":"University Hospitals Gasthuisberg, Catholic University Leuven, Herestraat 49, 3000 Leuven, Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Enrique","family":"Gallardo","sequence":"additional","affiliation":[{"name":"Corporaci\u00f3 Parc Taul\u00ed, C\/Parc Taul\u00ed, s\/n, 08208 Sabadell (Barcelona), Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stephane","family":"Culine","sequence":"additional","affiliation":[{"name":"Parc Euromedicine, 323 rue des Apothicaires, 34298 Montpellier, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Joan  Carles","family":"Galceran","sequence":"additional","affiliation":[{"name":"Hospital Universitari del Mar, Passeig Mar\u00edtim, 25-29, 08003 Barcelona, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Patrick","family":"Sch\u00f6ffski","sequence":"additional","affiliation":[{"name":"University Hospitals Gasthuisberg, Catholic University Leuven, Herestraat 49, 3000 Leuven, Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jean  P.","family":"Droz","sequence":"additional","affiliation":[{"name":"Centre L\u00e9on B\u00e9rard, 28 Rue Laennec, F-69008, Lyon, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sonia","family":"Extremera","sequence":"additional","affiliation":[{"name":"Pharma Mar S.A., Av. de los Reyes, 1, PI La Mina-Norte, 28770 Colmenar Viejo, Madrid, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sergio","family":"Szyldergemajn","sequence":"additional","affiliation":[{"name":"Pharma Mar S.A., Av. de los Reyes, 1, PI La Mina-Norte, 28770 Colmenar Viejo, Madrid, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Aude","family":"Fl\u00e9chon","sequence":"additional","affiliation":[{"name":"Centre L\u00e9on B\u00e9rard, 28 Rue Laennec, F-69008, Lyon, France"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2009,9,16]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","first-page":"74","DOI":"10.3322\/canjclin.55.2.74","article-title":"Global cancer statistics, 2002","volume":"55","author":"Parkin","year":"2005","journal-title":"CA Cancer J Clin"},{"key":"ref_2","doi-asserted-by":"crossref","first-page":"2448","DOI":"10.1002\/1097-0142(19891215)64:12<2448::AID-CNCR2820641209>3.0.CO;2-7","article-title":"Methotrexate, vinblastine, doxorubicin, and cisplatin for advanced transitional cell carcinoma of the urothelium. 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