549P - Gender and chemotherapy-related toxicity in colon cancer: an analysis of the PETACC-3 trial conducted by the EORTC GI-group

Date 08 October 2016
Event ESMO 2016 Congress
Session Poster Display
Topics Colon and Rectal Cancer
Presenter Valérie Cristina
Citation Annals of Oncology (2016) 27 (6): 149-206. 10.1093/annonc/mdw370
Authors V. Cristina1, J. Mahachie2, M. Mauer2, C. Csajka3, D. Cunningham4, E. van Cutsem5, A. Roth6, A.D. Wagner1
  • 1Département D'oncologie, Centre Hospitalier Universitaire Vaudois - CHUV, 1011 - Lausanne/CH
  • 2Gi Group, EORTC, 1200 - Brussels/BE
  • 3Division De Pharmacologie Clinique, Centre Hospitalier Universitaire Vaudois - CHUV, 1005 - Lausanne/CH
  • 4Department Of Oncology, The Institute of Cancer Research/Royal Marsden NHS Foundation Trust, SM2 5PT - Sutton/GB
  • 5Gastro-enterology, University Hospitals Leuven - Campus Gasthuisberg, Leuven/BE
  • 6Group Cancer Gastro-intestinal, SAKK, 3008 - Bern/CH



Drug metabolism is genetically determined. Gender is one of the factors responsible for the large interpatient variability in the dose-effect relationship of cytotoxics. Comparative data on the effect of gender on chemotherapy (CT)-related toxicity are lacking in colon cancer.


This is a retrospective analysis of data from the PETACC-3 trial: 2974 pts (55.7% men (m) and 44.3% women (f)) with stage II and III colon cancer were treated with adjuvant 5-fluorouracil/leucovorin alone (5FU/LV) or with irinotecan (FOLFIRI). Primary aim was to compare CT-related toxicity (according to NCIC-CTCG) in m and f. Clinical and hematologic adverse events (AEs) rates and frequency of dose reductions in m and f were compared by Fisher's exact test; survival outcomes by log-rank test. Subgroup analyses were performed according to age (


Higher rates of all grade nausea (61.8 vs 53.7%, p 


In this trial, women demonstrated significantly greater rates of various hematological and non-hematological AEs, especially under treatment with FOLFIRI. Thus, AEs need to be reported according to gender in future clinical trials. Further data investigating the relationship between gender and CT efficacy and toxicity is required.

Clinical trial identification

Legal entity responsible for the study





D. Cunningham: Amgen, AstraZeneca, Bayer, Celgene, Medimmune, Merck Serono, Merrimack, Sanofi: Research funding to my institution. All other authors have declared no conflicts of interest.