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- W2230895416 abstract "4165 Background: Rubitecan (Orathecin) is a novel oral inhibitor of topoisomerase I in the camptothecin class. Methods: A Phase III randomized multinational open-label study of rubitecan versus 5-FU in pancreatic cancer patients who had progressive disease following gemcitabine treatment was undertaken. The primary endpoint was overall survival. Key patient eligibility criteria included pathologic diagnosis of pancreatic cancer, progressive disease on gemcitabine, Karnofsky Performance Status of ≥50 and life expectancy of ≥2 months. Rubitecan was administered at 1.5 mg/m2 orally 5 days/week. 5-FU was administered at 600 mg/m2 intravenously once weekly. Patients who progressed or experienced intolerable toxicity could crossover to the alternate treatment arm. Results: 93 of 224 (41%) 5-FU patients crossed over to rubitecan rescue. Only 1 of 224 rubitecan patients crossed over to 5-FU. Main reasons for rescue with rubitecan were radiologic (75%) and symptomatic (12%) progression on 5-FU. Median survival from randomized baseline was longer for patients who crossed over from 5-FU to rubitecan rescue compared to patients who did not crossover from 5-FU (184 versus 66 days). 35 of 93 (38%) patients had follow-up scans after the initiation of rubitecan rescue and were evaluable for tumor response assessment. 14 of 35 (40%) patients achieved tumor growth control (4 had objective tumor responses and 10 had disease stabilization). The most common Grade 3/4 adverse events with rubitecan were myelotoxicity (34%) and gastrointestinal (14%). All deaths on study were primarily related to disease progression. Conclusions: These results support that patients with refractory/resistant pancreatic cancer, who have progressed on gemcitabine and 5-FU, can derive benefit from rubitecan, an oral medication that can be taken at home with manageable toxicity. Author Disclosure Employment or Leadership Consultant or Advisory Role Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration SuperGen SuperGen SuperGen SuperGen" @default.
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- W2230895416 date "2005-06-01" @default.
- W2230895416 modified "2023-10-18" @default.
- W2230895416 title "Patients rescued by crossover to rubitecan in phase III study of rubitecan capsules versus 5-FU in pancreatic cancer" @default.
- W2230895416 doi "https://doi.org/10.1200/jco.2005.23.16_suppl.4165" @default.
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