Phase III trial of capecitabine plus oxaliplatin as adjuvant therapy for stage III colon cancer: A planned safety analysis in 1,864 patients

Hans Joachim Schmoll, Thomas Cartwright, Josep Tabernero, Marek P. Nowacki, Arie Figer, Jean Maroun, Timothy Price, Robert Lim, Eric Van Cutsem, Young Suk Park, Joseph McKendrick, Claire Topham, Gemma Soler-Gonzalez, Filipo De Braud, Mark Hill, Florin Sirzén, Daniel G. Haller

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Abstract

Purpose: To report the results of a planned safety analysis from a phase III trial comparing capecitabine plus oxaliplatin (XELOX) with bolus fluorouracil/leucovorin (FU/LV) as adjuvant therapy for stage III colon cancer. Patients and Methods: Patients with stage III colon carcinoma were randomly assigned to receive either XELOX (intravenous oxaliplatin plus oral capecitabine; 3-week cycle for eight cycles) or standard intravenous bolus FU/LV administered as the Mayo Clinic (Mayo; Rochester, MN) or Roswell Park (RP; Buffalo, NY) regimen for a similar length of time. A total of 1,886 patients were randomly assigned. Results: The safety population comprised 1,864 patients, of whom 938 received XELOX and 926 received FU/LV. Most treatment-related adverse events (AEs) occurred at similar rates in both treatment arms. However, patients receiving XELOX experienced less all-grade diarrhea, alopecia, and more neurosensory toxicity, vomiting, and hand-foot syndrome than those patients receiving FU/LV. Compared with Mayo, XELOX showed fewer grade 3/4 hematologic AE and more grade 3/4 gastrointestinal AE. Compared with RP, XELOX showed less grade 3/4 gastrointestinal AE and more grade 3/4 hematologic AE. As expected grade 3/4 neurosensory toxicity and grade 3 hand-foot syndrome were higher with XELOX. Treatment-related mortality within 28 days from the last study dose was 0.6% in the XELOX group and 0.6% in the FU/LV group. Conclusion: XELOX has a manageable tolerability profile in the adjuvant setting. Efficacy data will be available within the next 24 months.

Original languageEnglish
Pages (from-to)102-109
Number of pages8
JournalJournal of Clinical Oncology
Volume25
Issue number1
DOIs
Publication statusPublished - Jan 1 2007

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oxaliplatin
Colonic Neoplasms
Safety
Leucovorin
Fluorouracil
Hand-Foot Syndrome
Therapeutics
XELOX
Capecitabine
Buffaloes
Alopecia

ASJC Scopus subject areas

  • Cancer Research
  • Oncology
  • Medicine(all)

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Phase III trial of capecitabine plus oxaliplatin as adjuvant therapy for stage III colon cancer : A planned safety analysis in 1,864 patients. / Schmoll, Hans Joachim; Cartwright, Thomas; Tabernero, Josep; Nowacki, Marek P.; Figer, Arie; Maroun, Jean; Price, Timothy; Lim, Robert; Van Cutsem, Eric; Park, Young Suk; McKendrick, Joseph; Topham, Claire; Soler-Gonzalez, Gemma; De Braud, Filipo; Hill, Mark; Sirzén, Florin; Haller, Daniel G.

In: Journal of Clinical Oncology, Vol. 25, No. 1, 01.01.2007, p. 102-109.

Research output: Contribution to journalArticle

Schmoll, HJ, Cartwright, T, Tabernero, J, Nowacki, MP, Figer, A, Maroun, J, Price, T, Lim, R, Van Cutsem, E, Park, YS, McKendrick, J, Topham, C, Soler-Gonzalez, G, De Braud, F, Hill, M, Sirzén, F & Haller, DG 2007, 'Phase III trial of capecitabine plus oxaliplatin as adjuvant therapy for stage III colon cancer: A planned safety analysis in 1,864 patients', Journal of Clinical Oncology, vol. 25, no. 1, pp. 102-109. https://doi.org/10.1200/JCO.2006.08.1075
Schmoll, Hans Joachim ; Cartwright, Thomas ; Tabernero, Josep ; Nowacki, Marek P. ; Figer, Arie ; Maroun, Jean ; Price, Timothy ; Lim, Robert ; Van Cutsem, Eric ; Park, Young Suk ; McKendrick, Joseph ; Topham, Claire ; Soler-Gonzalez, Gemma ; De Braud, Filipo ; Hill, Mark ; Sirzén, Florin ; Haller, Daniel G. / Phase III trial of capecitabine plus oxaliplatin as adjuvant therapy for stage III colon cancer : A planned safety analysis in 1,864 patients. In: Journal of Clinical Oncology. 2007 ; Vol. 25, No. 1. pp. 102-109.
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abstract = "Purpose: To report the results of a planned safety analysis from a phase III trial comparing capecitabine plus oxaliplatin (XELOX) with bolus fluorouracil/leucovorin (FU/LV) as adjuvant therapy for stage III colon cancer. Patients and Methods: Patients with stage III colon carcinoma were randomly assigned to receive either XELOX (intravenous oxaliplatin plus oral capecitabine; 3-week cycle for eight cycles) or standard intravenous bolus FU/LV administered as the Mayo Clinic (Mayo; Rochester, MN) or Roswell Park (RP; Buffalo, NY) regimen for a similar length of time. A total of 1,886 patients were randomly assigned. Results: The safety population comprised 1,864 patients, of whom 938 received XELOX and 926 received FU/LV. Most treatment-related adverse events (AEs) occurred at similar rates in both treatment arms. However, patients receiving XELOX experienced less all-grade diarrhea, alopecia, and more neurosensory toxicity, vomiting, and hand-foot syndrome than those patients receiving FU/LV. Compared with Mayo, XELOX showed fewer grade 3/4 hematologic AE and more grade 3/4 gastrointestinal AE. Compared with RP, XELOX showed less grade 3/4 gastrointestinal AE and more grade 3/4 hematologic AE. As expected grade 3/4 neurosensory toxicity and grade 3 hand-foot syndrome were higher with XELOX. Treatment-related mortality within 28 days from the last study dose was 0.6{\%} in the XELOX group and 0.6{\%} in the FU/LV group. Conclusion: XELOX has a manageable tolerability profile in the adjuvant setting. Efficacy data will be available within the next 24 months.",
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AU - Schmoll, Hans Joachim

AU - Cartwright, Thomas

AU - Tabernero, Josep

AU - Nowacki, Marek P.

AU - Figer, Arie

AU - Maroun, Jean

AU - Price, Timothy

AU - Lim, Robert

AU - Van Cutsem, Eric

AU - Park, Young Suk

AU - McKendrick, Joseph

AU - Topham, Claire

AU - Soler-Gonzalez, Gemma

AU - De Braud, Filipo

AU - Hill, Mark

AU - Sirzén, Florin

AU - Haller, Daniel G.

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N2 - Purpose: To report the results of a planned safety analysis from a phase III trial comparing capecitabine plus oxaliplatin (XELOX) with bolus fluorouracil/leucovorin (FU/LV) as adjuvant therapy for stage III colon cancer. Patients and Methods: Patients with stage III colon carcinoma were randomly assigned to receive either XELOX (intravenous oxaliplatin plus oral capecitabine; 3-week cycle for eight cycles) or standard intravenous bolus FU/LV administered as the Mayo Clinic (Mayo; Rochester, MN) or Roswell Park (RP; Buffalo, NY) regimen for a similar length of time. A total of 1,886 patients were randomly assigned. Results: The safety population comprised 1,864 patients, of whom 938 received XELOX and 926 received FU/LV. Most treatment-related adverse events (AEs) occurred at similar rates in both treatment arms. However, patients receiving XELOX experienced less all-grade diarrhea, alopecia, and more neurosensory toxicity, vomiting, and hand-foot syndrome than those patients receiving FU/LV. Compared with Mayo, XELOX showed fewer grade 3/4 hematologic AE and more grade 3/4 gastrointestinal AE. Compared with RP, XELOX showed less grade 3/4 gastrointestinal AE and more grade 3/4 hematologic AE. As expected grade 3/4 neurosensory toxicity and grade 3 hand-foot syndrome were higher with XELOX. Treatment-related mortality within 28 days from the last study dose was 0.6% in the XELOX group and 0.6% in the FU/LV group. Conclusion: XELOX has a manageable tolerability profile in the adjuvant setting. Efficacy data will be available within the next 24 months.

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