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Potential regional ...
Potential regional differences for the tolerability profiles of fluoropyrimidines.
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Haller, Daniel G (author)
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Cassidy, Jim (author)
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Clarke, Stephen J (author)
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Cunningham, David (author)
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Van Cutsem, Eric (author)
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Hoff, Paulo M (author)
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Rothenberg, Mace L (author)
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Saltz, Leonard B (author)
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Schmoll, Hans-Joachim (author)
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Allegra, Carmen (author)
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Bertino, Joseph R (author)
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Douillard, Jean-Yves (author)
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- Gustavsson, Bengt, 1947 (author)
- Gothenburg University,Göteborgs universitet,Institutionen för kliniska vetenskaper,Institute of Clinical Sciences
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Milano, Gerard (author)
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O'Connell, Michael (author)
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Rustum, Youcef (author)
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Tabernero, Josep (author)
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Gilberg, Frank (author)
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Sirzén, Florin (author)
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Twelves, Chris (author)
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(creator_code:org_t)
- 2008
- 2008
- English.
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In: Journal of clinical oncology : official journal of the American Society of Clinical Oncology. - 1527-7755. ; 26:13, s. 2118-23
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https://gup.ub.gu.se...
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https://doi.org/10.1...
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Abstract
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- PURPOSE: We conducted a retrospective analysis of safety data from randomized, single-agent fluoropyrimidine clinical trials (bolus fluorouracil/leucovorin [FU/LV] and capecitabine) to test the hypothesis that there are regional differences in fluoropyrimidine tolerability. METHODS: Treatment-related safety data from three phase III clinical studies were analyzed by multivariate analysis: two comparing capecitabine with bolus FU/LV in metastatic colorectal cancer (MCRC) and one comparing capecitabine plus oxaliplatin (XELOX) with bolus FU/LV as adjuvant treatment for colon cancer. The United States (US) was compared with non-US countries (all three studies) and with the rest of the world and East Asia (adjuvant study). RESULTS: In the MCRC studies (n = 1,189), more grade 3/4 adverse events (AEs; relative risk [RR], 1.77), dose reductions (RR, 1.72), and discontinuations (RR, 1.83) were reported in US versus non-US patients. Likewise, in the adjuvant colon cancer study (n = 1,864), more grade 3/4 AEs (RR, 1.47) and discontinuations (RR, 2.09) were reported in US versus non-US patients. After further dividing non-US patients into those in East Asia and the rest of the world, differential RRs for related grade 3/4 AEs, grade 4 AEs, and serious AEs were again observed, with East Asian patients having the lowest and US patients the highest RR. CONCLUSION: Regional differences exist in the tolerability profiles of fluoropyrimidines. More treatment-related toxicity was reported in the US compared with the rest of the world for bolus FU/LV and capecitabine in first-line MCRC and adjuvant colon cancer. In the adjuvant setting, a range of fluoropyrimidine tolerability was observed, with East Asian patients having the lowest, and US patients the highest, RR.
Subject headings
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Kirurgi (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Surgery (hsv//eng)
Keyword
- Antimetabolites
- Antineoplastic
- administration & dosage
- adverse effects
- Antineoplastic Combined Chemotherapy Protocols
- adverse effects
- Chemotherapy
- Adjuvant
- Colorectal Neoplasms
- drug therapy
- ethnology
- pathology
- Deoxycytidine
- administration & dosage
- adverse effects
- analogs & derivatives
- Europe
- Far East
- Fluorouracil
- administration & dosage
- adverse effects
- analogs & derivatives
- Gastrointestinal Diseases
- chemically induced
- ethnology
- Humans
- Leucovorin
- administration & dosage
- Neoplasm Metastasis
- Neutropenia
- chemically induced
- ethnology
- Organoplatinum Compounds
- administration & dosage
- Prodrugs
- administration & dosage
- adverse effects
- Residence Characteristics
- Retrospective Studies
- Risk Assessment
- Severity of Illness Index
- Treatment Outcome
- United States
- Vitamin B Complex
- administration & dosage
- Withholding Treatment
Publication and Content Type
- ref (subject category)
- art (subject category)
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- By the author/editor
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Haller, Daniel G
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Cassidy, Jim
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Clarke, Stephen ...
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Cunningham, Davi ...
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Van Cutsem, Eric
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Hoff, Paulo M
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show more...
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Rothenberg, Mace ...
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Saltz, Leonard B
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Schmoll, Hans-Jo ...
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Allegra, Carmen
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Bertino, Joseph ...
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Douillard, Jean- ...
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Gustavsson, Beng ...
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Milano, Gerard
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O'Connell, Micha ...
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Rustum, Youcef
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Tabernero, Josep
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Gilberg, Frank
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Sirzén, Florin
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Twelves, Chris
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show less...
- About the subject
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- MEDICAL AND HEALTH SCIENCES
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MEDICAL AND HEAL ...
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and Clinical Medicin ...
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and Surgery
- Articles in the publication
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Journal of clini ...
- By the university
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University of Gothenburg