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 Anti-Cancer Agents & Biologic Therapy
Colon Cancer
Rectal Cancer
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.