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Title: Raltitrexed plus gemcitabine (TOMGEM) in advanced pancreatic cancer. Results of a Belgian multicentre phase II study
Authors: Van Laethem, J-L
Van Maele, Ph
Verslype, Chris
Polus, Marian
Demols, A
Houbiers, Gh
Caenepeel, P
Leleux, A
Vermaut, R R
Van Cutsem, Eric
Peeters, M #
Issue Date: 2004
Publisher: Karger
Series Title: Oncology vol:67 issue:5-6 pages:338-43
Abstract: OBJECTIVES: This multicenter phase II study was designed to determine the activity and tolerance of gemcitabine and raltitrexed in advanced pancreatic adenocarcinoma. PATIENTS AND METHODS: Thirty-three chemonaive patients with measurable disease received the TOMGEM regimen consisting of Raltitrexed 3 mg/m(2) in 15 min followed by Gemcitabine 1,000 mg/m(2) in 30 min on day 1, Gemcitabine alone 1,000 mg/m(2) 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: 14-46%); 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 III-IV) 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.
ISSN: 0030-2414
Publication status: published
KU Leuven publication type: IT
Appears in Collections:Hepatology
ESAT - STADIUS, Stadius Centre for Dynamical Systems, Signal Processing and Data Analytics
Translational Research in GastroIntestinal Disorders
Animal Research Center
Clinical Digestive Oncology (+)
# (joint) last author

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