563P - Skin rash and outcome in colorectal cancer (CRC) patients treated with anti-EGFR monoclonal antibodies

Date 01 October 2012
Event ESMO Congress 2012
Session Poster presentation III
Topics Complications of Treatment
Colon Cancer
Rectal Cancer
Presenter Fausto Petrelli
Authors F. Petrelli1, K.F. Borgonovo2, M. Cabiddu3, M. Ghilardi4, M. Cremonesi3, F. Maspero3, S. Barni5
  • 1Uo Oncologia, Azienda Ospedaliera Treviglio-Caravaggio, IT-24047 - Treviglio/IT
  • 2Oncologia Medica E Chemioterapia, A.O. Treviglio-Caravaggio, 24047 - Treviglio/IT
  • 3Medical Oncology Division, Azienda Ospedaliera Treviglio-Caravaggio, 24047 - Treviglio/IT
  • 4Medical Oncology Division, A.O. Trevilgio-Caravaggio, 24047 - Treviglio/IT
  • 5Azienda Ospedaliera Treviglio-Caravaggio, 24047 - Treviglio/IT



The most common toxicity associated with anti-EGFR monoclonal antibodies (MoAbs) is an acneiform rash, that occurs in nearly all patients. One of the more interesting and useful clinical observations regarding EGFR-targeted therapy has been the association of clinical benefit with development of skin rash. We have performed a systematic review and a pooled analysis of the predictive value of skin rash for patients with advanced CRC treated with cetuximab (C) and panitumumab (P) in prospective clinical trials or in retrospective case series.

Materials and methods

We searched PubMed and ASCO Meetings for publications reporting the correlation of skin rash with survival and/or response rate. The lower limit date for the search was February 11,2012 with no upper limit. The primary outcome was overall survival as a function of severity of cutaneous toxicity in patients treated with C or P (OS). Secondary endpoints were the predictive role of skin rash for progression free survival/time to progression and response rate (ORR).


Fourteen publications (for a total of 3,833 patients) were included in this meta-analysis. All included studies enrolled patients with advanced disease. For the primary endpoint (OS) 11 trials had available data; the occurrence of skin rash was significantly associated with reduced risk of death in patients treated with C or P (HR 0.51, P < 0.00001). For the association of risk of progression with skin rash (data available from 5 trials) the HR was significant too (HR 0.58, P < 0.00001). According to response rate analysis (15 trials available) skin rash was a significant predictor of activity with a RR of 2.23 (P < 0.00001) for patients with toxicity compared to patients with no or low-grade toxicity. ORR was 35% compared with 13% for high-grade compared to low-grade skin toxicity arms. The results appear similar for C and P trials for all the endpoints.


Skin rash represents an early predictive biomarker of response, however the prognostic value of this event is presently unknown.


All authors have declared no conflicts of interest.