{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,10,26]],"date-time":"2025-10-26T21:04:43Z","timestamp":1761512683544},"reference-count":36,"publisher":"American Society of Clinical Oncology (ASCO)","issue":"19","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JCO"],"published-print":{"date-parts":[[2009,7,1]]},"abstract":"<jats:sec><jats:title>Purpose<\/jats:title><jats:p> To evaluate the safety, maximum tolerated dose (MTD), and pharmacokinetics of patupilone administered once every 3 weeks with proactive standardized diarrhea management in patients with resistant or refractory ovarian, fallopian, or peritoneal cancer. <\/jats:p><\/jats:sec><jats:sec><jats:title>Patients and Methods<\/jats:title><jats:p> Patients received patupilone (6.5 to 11.0 mg\/m<jats:sup>2<\/jats:sup>) every 3 weeks via 20-minute infusion. Adverse events, dose-limiting toxicities (DLT), MTD, and tumor response were determined. The tumor response was measured by Response Evaluation Criteria in Solid Tumors (RECIST) and cancer antigen 125 levels. <\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p> Forty-five patients were enrolled. Adverse events were mild to moderate in intensity, and grade 3 diarrhea (13%) was the most commonly reported serious adverse event. Grade 3 peripheral neuropathy was noted in two patients (4%). Diarrhea, peripheral neuropathy, and fatigue were the most common DLTs; however, these were uncommon in the first cycle and the MTD was therefore not reached in this study. Overall response (OR; complete and partial responses; median cycles, 8) per RECIST in patients with measurable disease (n = 36) was 19.5%. Median duration of disease stabilization (complete and partial responses and stable disease) was 15.8 months. These results appear improved from a previous study in a similar patient population using a weekly schedule (2.5 mg\/m<jats:sup>2<\/jats:sup>\/week; N = 53; OR, 5.7%). <\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p> Patupilone once every 3 weeks was well-tolerated at doses up to 11.0 mg\/m<jats:sup>2<\/jats:sup>. Patupilone demonstrated promising antitumor activity in patients with drug-resistant\/refractory disease. An ongoing phase III study in this patient population is testing the 10.0 mg\/m<jats:sup>2<\/jats:sup> dose. <\/jats:p><\/jats:sec>","DOI":"10.1200\/jco.2008.20.4826","type":"journal-article","created":{"date-parts":[[2009,5,19]],"date-time":"2009-05-19T01:47:03Z","timestamp":1242697623000},"page":"3097-3103","source":"Crossref","is-referenced-by-count":39,"title":["Safety and Efficacy of Patupilone in Patients With Advanced Ovarian, Primary Fallopian, or Primary Peritoneal Cancer: A Phase I, Open-Label, Dose-Escalation Study"],"prefix":"10.1200","volume":"27","author":[{"given":"Wim W.","family":"ten Bokkel Huinink","sequence":"first","affiliation":[{"name":"From the Netherlands Cancer Institute, Amsterdam; Medisch Spectrum Twente, Enschede, the Netherlands; Narodny Onkologicky Ustav; Onkologicky Ustave sv. Alzbety, s.r.o., Bratislava; East Slovak Oncology Institute, a.s., Ko\u0161ice, Slovakia; The Juravinski Cancer Centre, Hamilton; Princess Margaret Hospital, Toronto, Ontario, Canada; The Royal Marsden Hospital, Sutton, Surrey, United Kingdom; and Novartis Pharmaceuticals Corporation, East Hanover, NJ."}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jozef","family":"Sufliarsky","sequence":"additional","affiliation":[{"name":"From the Netherlands Cancer Institute, Amsterdam; Medisch Spectrum Twente, Enschede, the Netherlands; Narodny Onkologicky Ustav; Onkologicky Ustave sv. Alzbety, s.r.o., Bratislava; East Slovak Oncology Institute, a.s., Ko\u0161ice, Slovakia; The Juravinski Cancer Centre, Hamilton; Princess Margaret Hospital, Toronto, Ontario, Canada; The Royal Marsden Hospital, Sutton, Surrey, United Kingdom; and Novartis Pharmaceuticals Corporation, East Hanover, NJ."}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Willem M.","family":"Smit","sequence":"additional","affiliation":[{"name":"From the Netherlands Cancer Institute, Amsterdam; Medisch Spectrum Twente, Enschede, the Netherlands; Narodny Onkologicky Ustav; Onkologicky Ustave sv. Alzbety, s.r.o., Bratislava; East Slovak Oncology Institute, a.s., Ko\u0161ice, Slovakia; The Juravinski Cancer Centre, Hamilton; Princess Margaret Hospital, Toronto, Ontario, Canada; The Royal Marsden Hospital, Sutton, Surrey, United Kingdom; and Novartis Pharmaceuticals Corporation, East Hanover, NJ."}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Stanislav","family":"Spanik","sequence":"additional","affiliation":[{"name":"From the Netherlands Cancer Institute, Amsterdam; Medisch Spectrum Twente, Enschede, the Netherlands; Narodny Onkologicky Ustav; Onkologicky Ustave sv. Alzbety, s.r.o., Bratislava; East Slovak Oncology Institute, a.s., Ko\u0161ice, Slovakia; The Juravinski Cancer Centre, Hamilton; Princess Margaret Hospital, Toronto, Ontario, Canada; The Royal Marsden Hospital, Sutton, Surrey, United Kingdom; and Novartis Pharmaceuticals Corporation, East Hanover, NJ."}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Maria","family":"Wagnerova","sequence":"additional","affiliation":[{"name":"From the Netherlands Cancer Institute, Amsterdam; Medisch Spectrum Twente, Enschede, the Netherlands; Narodny Onkologicky Ustav; Onkologicky Ustave sv. Alzbety, s.r.o., Bratislava; East Slovak Oncology Institute, a.s., Ko\u0161ice, Slovakia; The Juravinski Cancer Centre, Hamilton; Princess Margaret Hospital, Toronto, Ontario, Canada; The Royal Marsden Hospital, Sutton, Surrey, United Kingdom; and Novartis Pharmaceuticals Corporation, East Hanover, NJ."}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hal W.","family":"Hirte","sequence":"additional","affiliation":[{"name":"From the Netherlands Cancer Institute, Amsterdam; Medisch Spectrum Twente, Enschede, the Netherlands; Narodny Onkologicky Ustav; Onkologicky Ustave sv. Alzbety, s.r.o., Bratislava; East Slovak Oncology Institute, a.s., Ko\u0161ice, Slovakia; The Juravinski Cancer Centre, Hamilton; Princess Margaret Hospital, Toronto, Ontario, Canada; The Royal Marsden Hospital, Sutton, Surrey, United Kingdom; and Novartis Pharmaceuticals Corporation, East Hanover, NJ."}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Stan","family":"Kaye","sequence":"additional","affiliation":[{"name":"From the Netherlands Cancer Institute, Amsterdam; Medisch Spectrum Twente, Enschede, the Netherlands; Narodny Onkologicky Ustav; Onkologicky Ustave sv. Alzbety, s.r.o., Bratislava; East Slovak Oncology Institute, a.s., Ko\u0161ice, Slovakia; The Juravinski Cancer Centre, Hamilton; Princess Margaret Hospital, Toronto, Ontario, Canada; The Royal Marsden Hospital, Sutton, Surrey, United Kingdom; and Novartis Pharmaceuticals Corporation, East Hanover, NJ."}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Anandhi R.","family":"Johri","sequence":"additional","affiliation":[{"name":"From the Netherlands Cancer Institute, Amsterdam; Medisch Spectrum Twente, Enschede, the Netherlands; Narodny Onkologicky Ustav; Onkologicky Ustave sv. Alzbety, s.r.o., Bratislava; East Slovak Oncology Institute, a.s., Ko\u0161ice, Slovakia; The Juravinski Cancer Centre, Hamilton; Princess Margaret Hospital, Toronto, Ontario, Canada; The Royal Marsden Hospital, Sutton, Surrey, United Kingdom; and Novartis Pharmaceuticals Corporation, East Hanover, NJ."}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Amit M.","family":"Oza","sequence":"additional","affiliation":[{"name":"From the Netherlands Cancer Institute, Amsterdam; Medisch Spectrum Twente, Enschede, the Netherlands; Narodny Onkologicky Ustav; Onkologicky Ustave sv. 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