Potential Regional Differences for the Tolerability Profiles of Fluoropyrimidines

Daniel G Haller; Jim Cassidy; Stephen J Clarke; David Cunningham; Eric Van Cutsem; Paulo M Hoff; Mace L Rothenberg; Leonard B Saltz; Hans-Joachim Schmoll; Carmen Allegra; Joseph R Bertino; Jean-Yves Douillard; Bengt G Gustavsson; Gerard Milano; Michael O'Connell; Youcef Rustum; Josep Tabernero; Frank Gilberg; Florin Sirzén; Chris Twelves; Sahlgrenska akademin

doi:10.1200/JCO.2007.15.2090

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Potential Regional Differences for the Tolerability Profiles of Fluoropyrimidines

Journal article

Peer reviewed

Potential Regional Differences for the Tolerability Profiles of Fluoropyrimidines

Daniel G Haller, Jim Cassidy, Stephen J Clarke, David Cunningham, Eric Van Cutsem, Paulo M Hoff, Mace L Rothenberg, Leonard B Saltz, Hans-Joachim Schmoll, Carmen Allegra, …

Journal of clinical oncology, Vol.26(13), pp.2118-2123

05/01/2008

DOI: https://doi.org/10.1200/JCO.2007.15.2090

PMID: 18445840

Abstract

PurposeWe 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.MethodsTreatment-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).ResultsIn 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.ConclusionRegional 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.

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Title: Potential Regional Differences for the Tolerability Profiles of Fluoropyrimidines
Creators: Daniel G Haller - From the Abramson Cancer Center at the University of Pennsylvania, Philadelphia; NSABP Foundation, Pittsburgh, PA; University of Texas, M.D. Anderson Cancer Center, Houston, TX; Vanderbilt-Ingram Cancer Center, Nashville, TN; Memorial Sloan-Kettering Cancer Center, New York; Roswell Park Cancer Institute, Buffalo, NY; NCI-Navy Medical Oncology Branch, National Cancer Institute, Bethesda, MD; The Cancer Institute of New Jersey, New Brunswick, NJ; Glasgow University, Glasgow; Royal Marsden Hospital
Jim Cassidy - From the Abramson Cancer Center at the University of Pennsylvania, Philadelphia; NSABP Foundation, Pittsburgh, PA; University of Texas, M.D. Anderson Cancer Center, Houston, TX; Vanderbilt-Ingram Cancer Center, Nashville, TN; Memorial Sloan-Kettering Cancer Center, New York; Roswell Park Cancer Institute, Buffalo, NY; NCI-Navy Medical Oncology Branch, National Cancer Institute, Bethesda, MD; The Cancer Institute of New Jersey, New Brunswick, NJ; Glasgow University, Glasgow; Royal Marsden Hospital
Stephen J Clarke - From the Abramson Cancer Center at the University of Pennsylvania, Philadelphia; NSABP Foundation, Pittsburgh, PA; University of Texas, M.D. Anderson Cancer Center, Houston, TX; Vanderbilt-Ingram Cancer Center, Nashville, TN; Memorial Sloan-Kettering Cancer Center, New York; Roswell Park Cancer Institute, Buffalo, NY; NCI-Navy Medical Oncology Branch, National Cancer Institute, Bethesda, MD; The Cancer Institute of New Jersey, New Brunswick, NJ; Glasgow University, Glasgow; Royal Marsden Hospital
David Cunningham - From the Abramson Cancer Center at the University of Pennsylvania, Philadelphia; NSABP Foundation, Pittsburgh, PA; University of Texas, M.D. Anderson Cancer Center, Houston, TX; Vanderbilt-Ingram Cancer Center, Nashville, TN; Memorial Sloan-Kettering Cancer Center, New York; Roswell Park Cancer Institute, Buffalo, NY; NCI-Navy Medical Oncology Branch, National Cancer Institute, Bethesda, MD; The Cancer Institute of New Jersey, New Brunswick, NJ; Glasgow University, Glasgow; Royal Marsden Hospital
Eric Van Cutsem - From the Abramson Cancer Center at the University of Pennsylvania, Philadelphia; NSABP Foundation, Pittsburgh, PA; University of Texas, M.D. Anderson Cancer Center, Houston, TX; Vanderbilt-Ingram Cancer Center, Nashville, TN; Memorial Sloan-Kettering Cancer Center, New York; Roswell Park Cancer Institute, Buffalo, NY; NCI-Navy Medical Oncology Branch, National Cancer Institute, Bethesda, MD; The Cancer Institute of New Jersey, New Brunswick, NJ; Glasgow University, Glasgow; Royal Marsden Hospital
Paulo M Hoff - From the Abramson Cancer Center at the University of Pennsylvania, Philadelphia; NSABP Foundation, Pittsburgh, PA; University of Texas, M.D. Anderson Cancer Center, Houston, TX; Vanderbilt-Ingram Cancer Center, Nashville, TN; Memorial Sloan-Kettering Cancer Center, New York; Roswell Park Cancer Institute, Buffalo, NY; NCI-Navy Medical Oncology Branch, National Cancer Institute, Bethesda, MD; The Cancer Institute of New Jersey, New Brunswick, NJ; Glasgow University, Glasgow; Royal Marsden Hospital
Mace L Rothenberg - From the Abramson Cancer Center at the University of Pennsylvania, Philadelphia; NSABP Foundation, Pittsburgh, PA; University of Texas, M.D. Anderson Cancer Center, Houston, TX; Vanderbilt-Ingram Cancer Center, Nashville, TN; Memorial Sloan-Kettering Cancer Center, New York; Roswell Park Cancer Institute, Buffalo, NY; NCI-Navy Medical Oncology Branch, National Cancer Institute, Bethesda, MD; The Cancer Institute of New Jersey, New Brunswick, NJ; Glasgow University, Glasgow; Royal Marsden Hospital
Leonard B Saltz - From the Abramson Cancer Center at the University of Pennsylvania, Philadelphia; NSABP Foundation, Pittsburgh, PA; University of Texas, M.D. Anderson Cancer Center, Houston, TX; Vanderbilt-Ingram Cancer Center, Nashville, TN; Memorial Sloan-Kettering Cancer Center, New York; Roswell Park Cancer Institute, Buffalo, NY; NCI-Navy Medical Oncology Branch, National Cancer Institute, Bethesda, MD; The Cancer Institute of New Jersey, New Brunswick, NJ; Glasgow University, Glasgow; Royal Marsden Hospital
Hans-Joachim Schmoll - From the Abramson Cancer Center at the University of Pennsylvania, Philadelphia; NSABP Foundation, Pittsburgh, PA; University of Texas, M.D. Anderson Cancer Center, Houston, TX; Vanderbilt-Ingram Cancer Center, Nashville, TN; Memorial Sloan-Kettering Cancer Center, New York; Roswell Park Cancer Institute, Buffalo, NY; NCI-Navy Medical Oncology Branch, National Cancer Institute, Bethesda, MD; The Cancer Institute of New Jersey, New Brunswick, NJ; Glasgow University, Glasgow; Royal Marsden Hospital
Carmen Allegra - From the Abramson Cancer Center at the University of Pennsylvania, Philadelphia; NSABP Foundation, Pittsburgh, PA; University of Texas, M.D. Anderson Cancer Center, Houston, TX; Vanderbilt-Ingram Cancer Center, Nashville, TN; Memorial Sloan-Kettering Cancer Center, New York; Roswell Park Cancer Institute, Buffalo, NY; NCI-Navy Medical Oncology Branch, National Cancer Institute, Bethesda, MD; The Cancer Institute of New Jersey, New Brunswick, NJ; Glasgow University, Glasgow; Royal Marsden Hospital
Joseph R Bertino - From the Abramson Cancer Center at the University of Pennsylvania, Philadelphia; NSABP Foundation, Pittsburgh, PA; University of Texas, M.D. Anderson Cancer Center, Houston, TX; Vanderbilt-Ingram Cancer Center, Nashville, TN; Memorial Sloan-Kettering Cancer Center, New York; Roswell Park Cancer Institute, Buffalo, NY; NCI-Navy Medical Oncology Branch, National Cancer Institute, Bethesda, MD; The Cancer Institute of New Jersey, New Brunswick, NJ; Glasgow University, Glasgow; Royal Marsden Hospital
Jean-Yves Douillard - From the Abramson Cancer Center at the University of Pennsylvania, Philadelphia; NSABP Foundation, Pittsburgh, PA; University of Texas, M.D. Anderson Cancer Center, Houston, TX; Vanderbilt-Ingram Cancer Center, Nashville, TN; Memorial Sloan-Kettering Cancer Center, New York; Roswell Park Cancer Institute, Buffalo, NY; NCI-Navy Medical Oncology Branch, National Cancer Institute, Bethesda, MD; The Cancer Institute of New Jersey, New Brunswick, NJ; Glasgow University, Glasgow; Royal Marsden Hospital
Bengt G Gustavsson - From the Abramson Cancer Center at the University of Pennsylvania, Philadelphia; NSABP Foundation, Pittsburgh, PA; University of Texas, M.D. Anderson Cancer Center, Houston, TX; Vanderbilt-Ingram Cancer Center, Nashville, TN; Memorial Sloan-Kettering Cancer Center, New York; Roswell Park Cancer Institute, Buffalo, NY; NCI-Navy Medical Oncology Branch, National Cancer Institute, Bethesda, MD; The Cancer Institute of New Jersey, New Brunswick, NJ; Glasgow University, Glasgow; Royal Marsden Hospital
Gerard Milano - From the Abramson Cancer Center at the University of Pennsylvania, Philadelphia; NSABP Foundation, Pittsburgh, PA; University of Texas, M.D. Anderson Cancer Center, Houston, TX; Vanderbilt-Ingram Cancer Center, Nashville, TN; Memorial Sloan-Kettering Cancer Center, New York; Roswell Park Cancer Institute, Buffalo, NY; NCI-Navy Medical Oncology Branch, National Cancer Institute, Bethesda, MD; The Cancer Institute of New Jersey, New Brunswick, NJ; Glasgow University, Glasgow; Royal Marsden Hospital
Michael O'Connell - From the Abramson Cancer Center at the University of Pennsylvania, Philadelphia; NSABP Foundation, Pittsburgh, PA; University of Texas, M.D. Anderson Cancer Center, Houston, TX; Vanderbilt-Ingram Cancer Center, Nashville, TN; Memorial Sloan-Kettering Cancer Center, New York; Roswell Park Cancer Institute, Buffalo, NY; NCI-Navy Medical Oncology Branch, National Cancer Institute, Bethesda, MD; The Cancer Institute of New Jersey, New Brunswick, NJ; Glasgow University, Glasgow; Royal Marsden Hospital
Youcef Rustum - From the Abramson Cancer Center at the University of Pennsylvania, Philadelphia; NSABP Foundation, Pittsburgh, PA; University of Texas, M.D. Anderson Cancer Center, Houston, TX; Vanderbilt-Ingram Cancer Center, Nashville, TN; Memorial Sloan-Kettering Cancer Center, New York; Roswell Park Cancer Institute, Buffalo, NY; NCI-Navy Medical Oncology Branch, National Cancer Institute, Bethesda, MD; The Cancer Institute of New Jersey, New Brunswick, NJ; Glasgow University, Glasgow; Royal Marsden Hospital
Josep Tabernero - From the Abramson Cancer Center at the University of Pennsylvania, Philadelphia; NSABP Foundation, Pittsburgh, PA; University of Texas, M.D. Anderson Cancer Center, Houston, TX; Vanderbilt-Ingram Cancer Center, Nashville, TN; Memorial Sloan-Kettering Cancer Center, New York; Roswell Park Cancer Institute, Buffalo, NY; NCI-Navy Medical Oncology Branch, National Cancer Institute, Bethesda, MD; The Cancer Institute of New Jersey, New Brunswick, NJ; Glasgow University, Glasgow; Royal Marsden Hospital
Frank Gilberg - From the Abramson Cancer Center at the University of Pennsylvania, Philadelphia; NSABP Foundation, Pittsburgh, PA; University of Texas, M.D. Anderson Cancer Center, Houston, TX; Vanderbilt-Ingram Cancer Center, Nashville, TN; Memorial Sloan-Kettering Cancer Center, New York; Roswell Park Cancer Institute, Buffalo, NY; NCI-Navy Medical Oncology Branch, National Cancer Institute, Bethesda, MD; The Cancer Institute of New Jersey, New Brunswick, NJ; Glasgow University, Glasgow; Royal Marsden Hospital
Florin Sirzén - From the Abramson Cancer Center at the University of Pennsylvania, Philadelphia; NSABP Foundation, Pittsburgh, PA; University of Texas, M.D. Anderson Cancer Center, Houston, TX; Vanderbilt-Ingram Cancer Center, Nashville, TN; Memorial Sloan-Kettering Cancer Center, New York; Roswell Park Cancer Institute, Buffalo, NY; NCI-Navy Medical Oncology Branch, National Cancer Institute, Bethesda, MD; The Cancer Institute of New Jersey, New Brunswick, NJ; Glasgow University, Glasgow; Royal Marsden Hospital
Chris Twelves - From the Abramson Cancer Center at the University of Pennsylvania, Philadelphia; NSABP Foundation, Pittsburgh, PA; University of Texas, M.D. Anderson Cancer Center, Houston, TX; Vanderbilt-Ingram Cancer Center, Nashville, TN; Memorial Sloan-Kettering Cancer Center, New York; Roswell Park Cancer Institute, Buffalo, NY; NCI-Navy Medical Oncology Branch, National Cancer Institute, Bethesda, MD; The Cancer Institute of New Jersey, New Brunswick, NJ; Glasgow University, Glasgow; Royal Marsden Hospital
Sahlgrenska akademin
Publication Details: Journal of clinical oncology, Vol.26(13), pp.2118-2123
Date published: 05/01/2008
Academic Unit: Bertino Office
Language: English
Resource Type: Journal article
Identifiers: 991031665631004646