P-0248 - Cetuximab with irinotecan or oxaliplatin for 1st-line metastatic colorectal cancer: updated data of effectiveness in the EREBUS cohort compared to p...

Date 28 June 2014
Event World GI 2014
Session Poster Session
Topics Anti-Cancer Agents & Biologic Therapy
Colon Cancer
Rectal Cancer
Presenter Denis Smith
Citation Annals of Oncology (2014) 25 (suppl_2): ii14-ii104. 10.1093/annonc/mdu165
Authors E. Mitry1, A. Monnereau2, A. Sa-cunha3, E. Bignon4, A. Balestra4, J. Jové4, N. Moore5, F. Annie4
  • 1Institut Curie - Hôpital R Huguenin, St Cloud/FR
  • 2Institut Bergonié, Bordeaux/FR
  • 3Hopital Paul Brousse, Villejuif/FR
  • 4Université de Bordeaux, Bordeaux/FR
  • 5Université de Bodeaux, Bordeaux/FR

Abstract

Introduction

Cetuximab has demonstrated improved survival outcomes in metastatic colorectal cancer (mCRC) but few studies have been conducted to describe cetuximab use in a real-life setting.

Methods

EREBUS, a French multicentre (n = 65 centres) cohort, included patients with unresectable mCRC and wild-type KRAS initiating CTX as 1st-line therapy between 2009 and 2010. Patients were followed up for 2 years and vital status was also collected at 3 years. Overall survival and progression-free survival were analyzed using the Kaplan-Meier method. Effectiveness from EREBUS was compared to efficacy and safety reported in the OPUS and CRYSTAL trials based on summary statistics.

Results

Among the 389 included patients, 218 received cetuximab with irinotecan-based chemotherapy (CTX + IRINOTECAN), and these were compared to the 316 patients similarly treated in the CRYSTAL trial (EREBUS vs. CRYSTAL): median age 64 vs. 61 years; male 68.8% vs. 62.0%, ECOG ≥ 2 16.5% vs. 4.1%, liver only metastases 34.9% vs. 21.5%. Median overall survival [95%CI] was 23.5 months [19.7-28.8] for CTX + IRINOTECAN in EREBUS and 23.5 months [21.2-26.3] in CRYSTAL. Median progression-free survival [95% CI] was 9.4 months [8.6-9.9] for CTX + IRINOTECAN in EREBUS vs. 9.9 months [9.0-11.3] in CRYSTAL. Best overall response rates [95%CI] were respectively 52.6% [45.9-59.2] and 57.3% [51.6-62.8]. Grade 3-4 adverse events were reported for 50% of the patients receiving CTX + IRINOTECAN in EREBUS vs. 81.1% in CRYSTAL. For the 147 patients treated by cetuximab with oxaliplatin-based chemotherapy (CTX + OXALIPLATIN) compared to the 82 patients similarly treated in the OPUS trial (EREBUS vs. OPUS): median age 63 vs. 62 years; male 65.3% vs. 51%, ECOG ≥ 2 18.4% vs. 7%, liver only metastases 40.8% vs. 30%. Median overall survival [95% CI] was 23.0 months [18.0-28.4] for CTX + OXALIPLATIN in EREBUS and 22.8 months [19.3-25.9] for OPUS. Median progression-free survival [95% CI] was 9.2 months [7.4-10.4] for CTX + OXALIPLATIN in EREBUS vs. 8.3 months [7.2-12.0] in OPUS. Best overall response rates [95% CI] were respectively 56.6% [48.6-64.7] and 57% [46–68]. Two-thirds of CTX + OXALIPLATIN in EREBUS (65.3%) had grade 3-4 adverse events reported vs. 82% in OPUS.

Conclusion

Despite differences in patient characteristics, in particular ECOG performance status, effectiveness of cetuximab in 1st-line mCRC clinical practice was close to efficacy reported in pivotal trials. The lower frequency of adverse events could be due to under-notification in real-life. Interpretation of these results should consider that this is a historical comparison of trial results only.