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Title
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Raltitrexed plus gemcitabine (TOMGEM) in advanced pancreatic cancer
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Author
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Abstract
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| Objectives: This multicenter phase II study was designed to determine the activity and tolerance of gemcitabine and raltitrexed in advanced pancreatic adenocarcinoma. Patients andMethods: Thirty-three chemonaive patients with measurable disease received the TOMGEM regimen consisting of Raltitrexed 3 mg/m2 in 15 min followed by Gemcitabine 1,000 mg/m2 in 30 min on day 1, Gemcitabine alone 1,000 mg/m2 on day 8 and repeated on day 21. Results: Thirty-three patients (median age: 62; locally advanced/metastatic disease: 5/28) were enrolled; the total number of cycles administered was 173 (median: 4). There were 10 partial response (confirmed), 2 stable disease (SD) ≧24 weeks, 7 SD <24 weeks, and 14 progressive disease for a response rate of 30.3% (95% CI: 1446%); a clinical benefit was observed in 8/30 patients assessed (30%); median duration of response was 9.1 months. National Cancer Institute Common Toxicity Criteria grade III or IV neutropenia/thrombocytopenia were observed in 42 and 12% of the patients, respectively. Relevant nonhematological toxicities (grade IIIIV) were rare although one toxic death was observed. Median time to progression was 2.8 months; one-year survival was 21%; median survival was 4.7 months. Conclusion: Our data suggest that the combination of raltitrexed/gemcitabine is a very convenient regimen with an acceptable toxicity, and is active in advanced pancreatic cancer. |
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Language
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English
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Source (journal)
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Oncology. - Basel
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Publication
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Basel
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2004
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ISSN
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0030-2414
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DOI
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10.1159/000082916
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Volume/pages
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67
:5-6
(2004)
, p. 338-343
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ISI
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000227007100002
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Full text (Publisher's DOI)
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