649 - Use of cetuximab (CTX) in 1st-line therapy of metastatic colorectal cancer (mCRC): patient characteristics, safety and effectiveness in the EREBUS c...

Date 28 September 2012
Event ESMO Congress 2012
Session Publication Only
Topics Anticancer agents
Colon and Rectal Cancer
Therapy
Biological Therapy
Presenter Denis Smith
Authors D. Smith1, M. Rouyer2, E. Mitry3, E. Francois4, A. Monnereau5, A. Sa-Cunha6, J. Jove2, P. Noize2, N. Moore2, A. Fourrier-Réglat2
  • 1Oncologie Digestive, Hôpital Saint André, Bordeaux/FR
  • 2Pharmacology Department, University Hospital, 33075 - BORDEAUX/FR
  • 3Oncologie Médicale, Institut Curie, Paris/FR
  • 4Medical Oncology, Antoine Lacassagne Cancer Institute, Nice/FR
  • 5Statistic Department, institut Bergonié, 33000 - bordeaux/FR
  • 6Digestive Surgery, Haut Lévêque Hospital, Pessac/FR

Abstract

Background

CTX has demonstrated improved survival outcomes in mCRC but information in real-life is sparse.

Methods

EREBUS is a French multicentre cohort with 92 centres. Patients initiating CTX 1st-line therapy for unresectable mCRC in 2009 and 2010 were identified from dispensation registries and followed 12 months. Presented here is preliminary data for those included in 2009.

Results

A total of 205 patients were included, all had wild-type (wt) KRAS gene. Median age: 64 yrs, 67.3% male, 65.8% ECOG = 0-1, 61% cardiovascular history, 78.5% colon primary site, 55.6% primary tumor resection, 73.7% synchronous metastasis, single metastatic site: 52.7% (39% exclusively liver). A multidisciplinary team considered 1st-line as palliative for 61.5% of pts, and 37.1% as potentially resectable. CTX was combined with oxaliplatin-based regimens: 37.6%, irinotecan-based regimens: 55.6%, and other regimens: 6.8%. For those receiving CTX + oxaliplatin (n = 77): median duration of CTX use was 3.6 months and 63.6% were treated every 2 weeks. For those receiving CTX + irinotecan (n = 114): it was 4.7 months and 81.6% treated every 2 weeks. Response rate (CR + PR) according to physician evaluation was 48.6% for CTX + oxaliplatin and 46.8% for CTX + irinotecan. 1-yr OS was 59.9% (95%CI 47.6-70.2) and median PFS was 8.6 months (6.3-10.5) for CTX + oxaliplatin. 1-yr OS was 69.1% (59.6-76.7) and median PFS was 9.3 months (7.4-10.5) for CTX + irinotecan. Incidence of any grade 3/4 event was 58% for CTX + oxaliplatin and 57% for CTX + irinotecan: neutropenia (18.2% and 19.3%, respectively), skin reaction (11.7% and 14%), asthenia (11.7% and 14.9%), hypokalaemia (13% and 4.4%), diarrhoea (6.5% and 10.5%) and infusion-related reactions (1.3% and 0.9%). Surgical evaluation was performed in 27.8%: 31.2% CTX + oxaliplatin and 24.6% CTX + irinotecan.

Conclusions

In France, CTX was frequently combined with irinotecan-based regimens in 1st-line wt KRAS mCRC. These results indicate a high proportion of exclusive liver metastases, and a high proportion of patients undergoing surgery. Effectiveness and safety profile of CTX in real-life were in line with pivotal trials.

Disclosure

All authors have declared no conflicts of interest.